Ensuring An Effective Public Health Emergency Medical Countermeasures Enterprise (2021)

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Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise
Ensuring an
Effective Public Health
Emergency Medical
Countermeasures
Enterprise
Committee on Reviewing the Public Health Emergency

Medical Countermeasures Enterprise
Board on Health Sciences Policy
Health and Medicine Division
A Consensus Study Report of
Copyright National Academy of Sciences. All rights reserved.

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Ensuring an effective public health emergency medical countermeasures enterprise.
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COMMITTEE ON REVIEWING THE PUBLIC HEALTH

EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE1
GIGI GRONVALL (Co-Chair), Senior Scholar, Johns Hopkins Center

for Health Security, Associate Professor in the Department of
Environmental Health and Engineering, Johns Hopkins Bloomberg
School of Public Health
ALAN I. LESHNER (Co-Chair), Chief Executive Officer Emeritus,
American Association for the Advancement of Science
JEFFREY BAKER, Senior Fellow, National Institute for Innovation in
Manufacturing Biopharmaceuticals; retired from appointment as
Deputy Director, Office of Biotechnology Products, U.S. Food and
Drug Administration
BRENDAN CARR, Endowed Chair, Mount Sinai Professor in Emergency
Medicine, Icahn School of Medicine at Mount Sinai and the Mount
Sinai Health System
BARUCH FISCHHOFF, Howard Heinz University Professor, Department
of Engineering and Public Policy, Institute for Politics and Strategy,
Carnegie Mellon University
JAMES G. HODGE, JR., Peter Kiewit Foundation Professor of Law,
Sandra Day O’Connor College of Law; Director of the Center for
Public Health Law and Policy, Arizona State University
ANJALI JOSHI, Former Vice President of Product Management, Google
KENT E. KESTER, Former Vice President and Head, Translational
Science and Biomarkers, Sanofi Pasteur
MONIQUE K. MANSOURA, Executive Director, Global Health Security
and Biotechnology, The MITRE Corporation
TIA POWELL, Dr. Shoshanah Trachtenberg Frackman Chair in
Biomedical Ethics, Albert Einstein College of Medicine, Montefiore
Health System
ROBIN ROBINSON, Chief Scientific Officer, RenovaCare
LAUREN SAUER, Associate Professor, University of Nebraska Medical
Center
JULIE SWANN, Department Head and A. Doug Allison Distinguished
Professor, Edward P. Fitts Department of Industrial and Systems
Engineering, North Carolina State University; Affiliate/Adjunct,
Biomedical Engineering, North Carolina State University and
University of North Carolina at Chapel Hill
W. CRAIG VANDERWAGEN, Partner, East West Protection, LLC
PATRICIA J. ZETTLER, Associate Professor, Moritz College of Law,
The Ohio State University
1 See Appendix C, Disclosure of Unavoidable Conflicts of Interest.

Study Staff
LISA BROWN, Study Director
EMMA FINE, Associate Program Officer
MATTHEW MASIELLO, Associate Program Officer
SHALINI SINGARAVELU, Associate Program Officer
MARGARET McCARTHY, Research Associate
MELVIN JOPPY, Senior Program Assistant
ANDREW M. POPE, Senior Director, Board on Health Sciences Policy
Consultants
REBECCA FREED, Senior Legal Researcher, Center for Public Health
Law and Policy, Arizona State University
JENNIFER PIATT, Research Scholar, Center for Public Health Law and
Policy, Arizona State University
Science Writer
AMANDA ARNOLD, Arizona State University
vi

Reviewers
This Consensus Study Report was reviewed in draft form by individuals

chosen for their diverse perspectives and technical expertise. The purpose
of this independent review is to provide candid and critical comments that
will assist the National Academies of Sciences, Engineering, and Medicine
in making each published report as sound as possible and to ensure that
it meets the institutional standards for quality, objectivity, evidence, and
responsiveness to the study charge. The review comments and draft manu-
script remain confidential to protect the integrity of the deliberative process.
We thank the following individuals for their review of this report:
PHYLLIS ARTHUR, Biotechnology Innovation Organization

LUCIANA BORIO, Council on Foreign Relations
GREG BUREL, Hamilton Grace LLC
MARIANNE GAUSCHE-HILL, Los Angeles County EMS Agency
PINAR KESKINOCAK, Georgia Institute of Technology
NICOLE LURIE, Coalition for Epidemic Preparedness Innovations
JEWEL MULLEN, The University of Texas at Austin
TARA O’TOOLE, In-Q-Tel
GERALD PARKER, Texas A&M University Health Science Center
SARAH PARKER, Virginia Tech Carilion School of Medicine
GOVIND PERSAD, Sturm College of Law
STEPHEN C. REDD, Centers for Disease Control and Prevention
MATTHEW WYNIA, University of Colorado
vii

viii REVIEWERS
Although the reviewers listed above provided many constructive com-

ments and suggestions, they were not asked to endorse the conclusions or
recommendations of this report nor did they see the final draft before its
release. The review of this report was overseen by BRUCE N. CALONGE,
The Colorado Trust, and LEWIS R. GOLDFRANK, New York University.
They were responsible for making certain that an independent examina-
tion of this report was carried out in accordance with the standards of
the N
ational Academies and that all review comments were carefully con
sidered. Responsibility for the final content rests entirely with the authoring
committee and the National Academies.

Preface
The U.S. experience during the COVID-19 pandemic, particularly

early on, has emphasized the imperative for an effective, well-coordinated
national emergency medical countermeasures (MCMs) preparedness and
response system. Many government agencies and nongovernmental stake-
holders and partners are by necessity involved in responding to public
health emergencies (PHEs), and their work must be well organized and
well equipped. This point has been made, as when considering U.S. perfor-
mance during emergencies, such as the SARS or H1N1 epidemics. It was
reiterated in the recent White House pandemic plan, American Pandemic
Preparedness: Transforming Our Capabilities, calling for a mission control
to handle PHEs.
The Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE) was formalized by Congress to serve this function, to ensure
that the responders to a PHE have the MCM products, facilities, supply
chains, and workforce that comprise the capabilities and capacities needed
to save lives. However, agreement is widespread that PHEMCE has fallen
short of its mandate over the years, and a series of reports have offered
recommendations to make it more responsive to its mission. Moreover, in
response to COVID-19, the overall U.S. MCM preparedness and response
system has evolved substantially and largely independently of PHEMCE, as
seen in Operation Warp Speed. This report was commissioned by the Health
and Human Services Office of the Assistant Secretary for Preparedness and
Response to consider ways, in light of the national COVID-19 experience,
to re-envision PHEMCE into the efficient and effective coordinating body it
was intended to be to serve the nation in times of crisis.
ix

x PREFACE
This committee was convened by the National Academies of Sciences,

Engineering, and Medicine to conceptualize this re-envisioned PHEMCE.
Toward that end, the committee offers here a series of recommendations
that we believe will set PHEMCE back on its intended course. Not all of
our recommendations are novel; unfortunately, several were noted in earlier
analyses but not addressed. They should be. Central to this re-envisioning
of PHEMCE is the need to make clear the mission, authority, and responsi-
bilities of the coordinating bodies responsible for PHEMCE’s decisions and
directives. PHEMCE and its representative members must also be empow-
ered to carry out their mission without overly long delays for approvals and
implementation. PHEMCE members should be held accountable for their
performance according to meaningful metrics, and its activities should be as
transparent as possible, to build public confidence that conflicts of interest
are avoided and its mission is appropriately addressed. It is essential that
PHEMCE is seen as a true partner to the various stakeholders and imple-
menting organizations central to its mission.
We are deeply grateful to our colleagues on this committee who have
worked so hard and diligently under a very short time line. We are particu-
larly grateful to the superb staff of the National Academies who worked
on this project. Their great commitment and skills have been essential to
the work of the committee and its product.
Gigi Gronvall, Co-Chair

Alan I. Leshner, Co-Chair
Committee on Reviewing the Public Health
Emergency Medical Countermeasures Enterprise

Contents
ACRONYMS AND ABBREVIATIONS xv
SUMMARY 1
1 INTRODUCTION 15
Rationale and Study Charge, 16
Looking Back to Look Forward: Historical Perspectives
of PHEMCE, 16
About This Report, 24
Concluding Remarks, 26
References, 26
2 DELIVERING ON PHEMCE’S MISSION 29

PHEMCE’s Mission and Scope, 30
Guiding Principles for PHEMCE, 30
Recommendations, 38
References, 39
3 ENSURING THAT PHEMCE DECISIONS AND

RECOMMENDATIONS ARE DEFENSIBLE 41
Sound Business Practices, 41
Priority Setting, 44
Evaluation and Accountability, 46
Data Systems and Technology, 47
xi

xii CONTENTS
Recommendations, 48
References, 49
4 ENGAGING NONFEDERAL AND PRIVATE-SECTOR

PARTNERS AND STAKEHOLDERS IN PHEMCE’S MISSION 51
Incorporating Nonfederal and Private-Sector Partners and
Stakeholders into PHEMCE Decision Making, 52
Partnership Levers, 58
Public Health Supply Chains and Stockpiling Considerations, 59
Global Considerations and Synergies, 62
Recommendations, 63
References, 64
5 LEGAL AND POLICY CONSIDERATIONS UNDERLYING

PHEMCE OPERATIONS AND IMPLEMENTATION 67
Brief Overview of the Federal Emergency Legal Landscape, 68
PHEMCE Regulatory Options, 72
Addressing and Solving Emergency Legal Issues in Real Time, 78
Recommendation, 82
References, 82
APPENDIXES
A STUDY METHODS 89
B COMMITTEE AND STAFF BIOSKETCHES 103
C DISCLOSURE OF UNAVOIDABLE CONFLICTS OF
INTEREST 119

Boxes and Figures
BOXES
S-1 Summary of Recommendations, 14
1-1 Statement of Task, 17
3-1 PHEMCE Prioritization Framework, 45
FIGURES
1-1 PHEMCE operating structure, 20
1-2 PHEMCE stakeholder engagement structure, 21
1-3 PHEMCE requirements setting process, 22
4-1 Supply chain actor and potential partnership levers, 58
xiii


Acronyms and Abbreviations
ACIP CDC Advisory Committee on Immunization Practices

ASPR Assistant Secretary for Preparedness and Response
BARDA Biomedical Advanced Research and Development Authority

BLA biologics license application
CAG Countermeasures Acceleration Group

CBRN chemical, biological, radiological and nuclear
CDC Centers for Disease Control and Prevention
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare & Medicaid Services
COI conflict of interest
COVID-19 coronavirus disease 2019
CSC crisis standards of care
DARPA Defense Advanced Research Projects Agency

DHS U.S. Department of Homeland Security
DoD U.S. Department of Defense
DPA Defense Production Act
EEC Enterprise Executive Committee

ESC Enterprise Senior Council
EUA Emergency Use Authorization
FDA U.S. Food and Drug Administration
xv

xvi ACRONYMS AND ABBREVIATIONS
FDCA Federal Food, Drug, and Cosmetic Act

FEMA Federal Emergency Management Agency
GAO U.S. Government Accountability Office
HHS U.S. Department of Health and Human Services

HSPD Homeland Security Presidential Directive
IOM Institute of Medicine

IPT Integrated Program Team
IRB institutional review board
KPI key performance indicator
LDT laboratory-developed test
MCM medical countermeasure
NBSB National Biodefense Science Board

NDA new drug application
NEA National Emergencies Act
NIAID National Institute of Allergy and Infectious Diseases
NIH National Institutes of Health
NIOSH National Institute for Occupational Safety and Health
NVAC National Vaccine Advisory Committee
OCR HHS Office for Civil Rights

OHRP HHS Office for Human Research Protections
OMB Office of Management and Budget
OWS Operation Warp Speed
PAHPA Pandemic and All-Hazards Preparedness Act

PAHPRA Pandemic and All-Hazards Preparedness Reauthorization
Act
PHE public health emergency
PHEMCE Public Health Emergency Medical Countermeasures
Enterprise
PHSA Public Health Service Act
PPE personal protective equipment
PREP Act Public Readiness and Emergency Preparedness Act
QMS Quality Management System

ACRONYMS AND ABBREVIATIONS xvii
R&D research and development
SIP Strategy and Implementation Plan

SNS U.S. Strategic National Stockpile
USDA U.S. Department of Agriculture
VA U.S. Department of Veterans Affairs
WHO World Health Organization

WMD weapon of mass destruction
WMD MCM Weapon of Mass Destruction Medical Countermeasures


Summary1
The U.S. medical countermeasures (MCMs)2 enterprise is inter

connected, complex, and dynamic. It includes public and private entities
that (1) develop and manufacture new and existing MCMs; (2) ensure
procurement, storage, and distribution of MCMs; and (3) administer,
monitor, and evaluate MCMs. The interagency group the Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE) is the n ation’s
sole coordinating body, based in the U.S. Department of Health and Human
Services (HHS) with interagency participation and responsible for ensur-
ing end-to-end MCM preparedness and response. PHEMCE’s authorities
limit its membership to federal entities. However, it must also collaborate
closely with nonfederal and private-sector partners and stakeholders, as
they are the ultimate implementers of PHEMCE’s mission and develop,
manufacture, distribute, and administer the MCMs over which PHEMCE
has r esponsibility. These engagements must support the entire life cycle of
MCM preparedness and response, where appropriate, including threat iden-
tification, development, manufacturing, deployment, distribution, admin-
istration, and evaluation. An effective national MCM enterprise requires
a mechanism to coordinate and integrate the activities and expertise of
1 This Summary does not include references. Citations for the discussion presented in the
Summary appear in the subsequent report chapters.

2 MCMs are “biologics, drugs, or devices that can be used to diagnose, prevent, protect
from, or treat conditions associated with chemical, biological, radiological, or nuclear (CBRN)
threats, or emerging infectious diseases and, MCMs may be used in the event of a potential
public health emergency stemming from a terrorist attack with a biological, chemical, or
radiological/nuclear material, or a naturally occurring emerging disease” (FDA, n.d.).

2 ENSURING AN EFFECTIVE PHEMCE
the diverse landscape of federal agencies involved in these activities, and

PHEMCE has the legislative mandate to serve that role.
Recognizing the important role of PHEMCE in coordinating the federal
MCM preparedness and response activities, HHS’s Office of the Assistant
Secretary for Preparedness and Response (ASPR) charged the National
Academies of Sciences, Engineering, and Medicine with convening an
ad hoc committee to evaluate PHEMCE’s policy and practices and make
recommendations for a re-envisioned PHEMCE. The committee heard from
knowledgeable experts reflecting a range of disciplines and experiences,
including developers, producers, funders, responders, and federal, state, and
local officials (see Appendix A). The committee also examined government
documents, including some first made public for this review.
Four priority areas of improvement emerged from committee delibera-
tions: (1) articulating PHEMCE’s mission and role and explicating the prin-
ciples guiding its operating principles and processes; (2) revising PHEMCE
operations and processes; (3) collaborating more effectively with external
public and private partners needed for the entire life cycle of MCMs,
from research through use; and (4) navigating legal and policy issues. This
report proposes recommendations for these four domains, re-envisioning
PHEMCE to service its mandate to protect the nation in public health
emergencies (PHEs).
HISTORICAL PERSPECTIVES ON PHEMCE:

LOOKING BACK TO LOOK FORWARD
The 2019 42 U.S. Code 300hh-10a charges PHEMCE with advancing
national preparedness for natural, accidental, and intentional threats by co-
ordinating research, advanced research, development, procurement, stock-
piling, deployment, distribution, and utilization with respect to MCMs
within HHS and in cooperation with partners in other federal agencies.
That mission has evolved in practice over the past two decades, from its
initial focus of advising on MCMs for weapons of mass destruction, to an
end-to-end MCM interagency body tasked with protecting the nation from
all chemical, radiological, biological and nuclear (CBRN) threats and pan-
demics and emerging infectious diseases. PHEMCE has developed processes
and procedures to help improve the coordination process, and it is now a
congressionally authorized coordination body.
Chapter 1 provides a brief history on PHEMCE’s evolution through
four distinct eras:
• Foundational Structures and Policy (2001–2008), a focus on WMD

MCMs;

SUMMARY 3
• Restructuring PHEMCE following the 2009 H1N1 experience

(2009–2016), a redesign to a capabilities-based approach, with
expanded authorities to deliver end-to-end MCM preparedness for
unknown, novel or re-emerging, and natural or intentional threats;
• The second restructuring (2017–2019) streamlined decision m
aking,
enhanced national security by classifying its deliberations, and
narrowed its scope; and
• COVID-19 and Operation Warp Speed (2020 and beyond), an
additional interagency coordinating group launched to identify
MCMs explicitly for COVID-19.
DELIVERING ON PHEMCE’S MISSION
Guiding Principles
These changes have left PHEMCE’s role in MCM preparedness and
response unclear. Presentations to the committee expressed substantial
confusion regarding its mission, scope, and responsibilities. The commit-
tee observed that the lack of clarity in PHEMCE’s authority would hinder
its ability to carry out its mandate and work with its federal and external
partners and the stakeholders depending on its success. If PHEMCE is to
play the important roles it is intended for, it will need clear exposition of
its of mission, scope, and responsibilities and an explicit affirmation to its
mission, especially by both federal authorities and stakeholders that have
may have undermined its function and authority in recent years. Chapter 2
proposes guiding principles for redesigning PHEMCE’s system. The com-
mittee advocates four sets of principles to guide PHEMCE decisions and
policies:
• Ethics
o Trust building: creating strong relations among PHEMCE
member agencies and partners by linking plans to outcomes,
promoting innovation, and respecting diverging opinions;
o Fairness: ensuring that PHEMCE planning and response opera
tions promote health equity and do not exacerbate existing
health inequities related to race, ethnicity, income, gender, loca-
tion, abilities, and age;
o Transparency: making PHEMCE processes accessible, com-
municating with partners and stakeholders, and creating ap-
propriate records, with explicit procedures for making and
documenting exceptions for national security or intellectual
property;

o
Accountability: making PHEMCE mission-driven to solve
problems innovatively and in collaboration with partners; per-
forming regular and unbiased after-action reviews, incorporat-
ing lessons learned and improving quality of processes and
outcomes; committing to processes that promote long-term
public well-being, evidence-based and collaborative decisions,
and protecting it from undue political or commercial influence;
and
o
Stewardship: demonstrating responsible management of re-
sources, especially under conditions of scarcity of resources.
• Operations
o Effectiveness
— Evidence-based decisions: employing sound decision-making
processes, based on the best evidence, while acknowledging
uncertainty; and
— Impact: delivering on all strategic objectives consistent with
PHEMCE’s mission, from development through u sage by
affected populations;
o Efficiency: carefully stewarding the resources for protecting
public health;
o Value: pursuing desired public health outcomes cost-effectively;
o Adaptability: responding agilely to new opportunities and
threats, based on long-term investments in capabilities;
o A systems approach: coordinating activities across the life cycle
of each MCM and across the portfolio, from development
to delivery, including research, facilities, supply chains, and
workforce;
o Collaboration: creating effective mechanisms for coordination
across federal agencies, private companies, and state or local
entities; and
o Metrics-driven: assessing performance with measures that
allow external evaluation and internal learning.
• Strategic objectives
o Aligning with PHEMCE’s mission, describing how the right
products, but also people and services, will be delivered to the
right population, at the right time; and
o Articulating in the annual Strategy and Implementation Plan,
as mandated by section 2811(d) of the Public Health Service
Act (PHSA) and amended by section 102 of the Pandemic and
All-Hazards Preparedness Reauthorization Act.

SUMMARY 5
• Budget
o Aligning across PHEMCE member agencies and the MCM
life cycle through a multiyear budget plan, as mandated by
section 2811(b)(7) of the PHSA, necessary to advance MCM
preparedness.
RECOMMENDATION 1. REAFFIRM THE PHEMCE MANDATE.

The Secretary of the U.S. Department of Health and Human Services
and, in turn, the Assistant Secretary for Preparedness and R
esponse
should recognize the critical functions of PHEMCE and reaffirm
PHEMCE’s mandate as the nation’s major coordinating body for all
aspects of U.S. medical countermeasures preparedness and response
programs, as directed by 42 U.S. Code 300hh-10A.
The administration and congressional leadership must provide PHEMCE

with the resources and authorities, both budgetary and h
uman, necessary
to achieve that mission.
RECOMMENDATION 2. ADOPT A SYSTEMS APPROACH.

PHEMCE should conduct its business under the framework of clear
ethical, operational, strategic, and budget goals.
RECOMMENDATION 3. ENSURE THAT PHEMCE STRATEGIES

REFLECT THE PERSPECTIVES OF, AND PROVIDE ACTIONABLE
GUIDANCE TO, ITS PARTNERS AND STAKEHOLDERS.
PHEMCE should ensure that the perspectives of its partners and stake-
holders are incorporated into the PHEMCE Strategy and Implementa-
tion Plan and multiyear budget.
These documents should clearly specify roles, actionable objectives,

accountability, measurable benchmarks, timelines, and budget require-
ments to enable nonfederal and private-sector PHEMCE partners to
make informed, responsible decisions for planning and engagement.
PHEMCE members and representatives should be of sufficient gov-
ernment rank to enable efficient recommendation development and
implementation.
ENSURING DEFENSIBLE PHEMCE RECOMMENDATIONS
Sound Business Practices in a Changing Environment

PHEMCE must develop and sustain the mutually supporting formal
and informal processes required for effective business practices. Formal pro-

cedures provide stability and accountability; informal processes and inter-

personal networks facilitate collaboration. The committee recognizes the
challenges that PHEMCE faces in establishing formal and informal processes
required for a predictable enterprise, including the need to do the following:
• Coordinate the work of multiple organizations.

• Accommodate personnel changes associated with political events or
public health emergencies, including hiring subject-matter experts
for any and all aspects of emergency operations.
• Shift priorities in response to emerging threats.
• Balance competing interests, including political, efficiency, and
effectiveness concerns and the considerations of stakeholders.
Stabilizing an enterprise faced with these challenges will require defin-

ing PHEMCE priorities through a transparent process that avoids conflicts
of interest (COIs) and then implementing those priorities with a robust
quality management system, enhancing coordination, resource allocation,
monitoring, and accountability across the enterprise with metrics-driven
evaluations. Chapter 3 recommends a strategic approach and implementa-
tion methods.
Priority Setting, Threat Assessments, and Needs Assessments

PHEMCE priority setting must consider the probabilities and poten-
tial impact of threats and the expected return on MCM investments (in
research, development, manufacturing, training, inventory, etc.). It is built
around threats to national security identified by the U.S. Department of
Homeland Security. In the past, PHEMCE has used a Preparedness Assess-
ment Framework and probabilistic risk analysis for risk factors that can be
quantified. PHEMCE may also look to procedures recently recommended
by the National Academies’ Committee on Equitable Allocation of Vaccine
for the Novel Coronavirus to set priorities, including
• Adopting widely acceptable ethical principles to maximize benefits,

mitigate health inequities, and promote fairness, transparency, and
evidence-based actions;
• Translating those factors into transparent operational metrics;
• Setting priorities in terms of those metrics;
• Using readily available data to estimate those metrics and monitor
progress;
• Conducting sensitivity analyses to create contingency plans; and
• Establishing two-way dialogue with stakeholders to communicate
and address concerns related to the priorities.

SUMMARY 7
Priorities should be informed by assessments of threats, operational ca-

pacities, and MCM multifunctionality, considering moderating criteria such
as population vulnerabilities, life cycle costs, and time needed to meet the
stated goals/objectives and see return on investments. Clear definitions of
priorities would be critical to focus on PHEMCE’s needs and give partners
greater confidence in engaging with clarity of timeline and expected invest-
ment. This, in turn, would provide a stronger environment for strengthen-
ing the industrial base.
Evaluation and Accountability

Regular monitoring and evaluation is essential for measuring
PHEMCE’s performance and ensuring continuous improvement. Evalua-
tion could be conducted through periodic performance assessments with
a metrics-driven approach. Performance may be assessed through audits,
exercises, and after-action reviews. Simulation and tabletop exercises pro-
vide opportunities to stress test organizational relationships across MCM
pathways. Whenever possible, simulations should involve realist emergency
and low-probability scenarios with the organizations and individuals who
will need to implement MCMs.
Metrics-driven evaluation requires establishing key performance indi
cators (KPIs) that are meaningful and representative of various outputs
throughout the MCM life cycle. A robust data system is required to collect
and analyze KPIs along with other indicators needed by the quality manage-
ment system, with the flexibility to adapt to changing MCM preparedness
or response requirements, while also continuously collecting and analyz-
ing other types of data that are important for preparedness planning and
response activities.
RECOMMENDATION 4. USE MEASURABLE OUTCOME METRICS.

PHEMCE processes should be metrics-driven with meaningful and
measurable outcomes that align at interagency and individual agency
levels and performance. PHEMCE should agree upon and articulate
metrics in the PHEMCE Strategy and Implementation Plan and assess
its progress toward strategic goals, outcomes, and processes across
component agencies.
As a regular part of quality assessment, PHEMCE should perform

rigorous and regular testing and evaluations of its preparedness and
response capabilities and capacities to security threats encompassed in
its mission. PHEMCE should consider working with an objective third
party for these evaluations, to further strengthen their objectivity and
value.

RECOMMENDATION 5. ESTABLISH AN INTEGRATED AND

ACCESSIBLE MCM DATA SYSTEM.
PHEMCE should establish an integrated and accessible data system to
support monitoring, evaluation, and quality management of end-to-end
medical countermeasure activities.
The data infrastructure must facilitate identifying vulnerabilities and

solutions for the entire MCM research, development, and deployment
life cycle. That system must be reliable and available to nonfederal and
private-sector partners and stakeholders, serviceable, interoperable,
and scalable while maintaining appropriate levels of security.
EXTERNAL PARTNERS AND THE PUBLIC

HEALTH SUPPLY CHAIN SYSTEM
PHEMCE must sustain a high-performing, collaborative network
involving nonfederal and private-sector partners and stakeholders. Main-
taining such a responsive, multisectoral enterprise requires transparent,
two-way communication within these partners; internal processes that
facilitate sustainable collaborations, including cross-sectoral learning and
collaboration; and end-to-end engagement through the public health supply
chain system. Chapter 4 addresses these issues.
Incorporating Nonfederal and Private-Sector

Partners and Stakeholders into PHEMCE Decision Making
PHEMCE must make decisions by incorporating the perspectives of
diverse nonfederal and private-sector partners, stakeholders, and experts
across the life cycles of MCM and PHEs. To avoid fragmentation that
undermines the mission, PHEMCE needs an advisory committee with an
encompassing view of its challenges, activities, and performance, for both
existing and potential threats and options. PHEMCE leadership may con-
sider, for example, a body similar to the Centers for Disease Control
and Prevention’s Advisory Committee on Immunization Practices or the
National Vaccine Advisory Committee (NVAC) for relevant experiences.
Both bodies include scientific leaders and liaison partner and stakeholder
organizations. Additional examples establish the precedent of an advisory
committee. One is the Federal Emergency Management Agency’s National
Advisory Committee, which focuses on decisions in the emergency pre-
paredness and response space, similar to PHEMCE.

SUMMARY 9
RECOMMENDATION 6. ESTABLISH AN ADVISORY C OMMITTEE

OF NONFEDERAL AND PRIVATE-SECTOR PARTNERS AND
STAKEHOLDERS.
PHEMCE should develop and maintain an advisory committee of rep-
resentative medical countermeasure partners and stakeholders to both
garner their expertise and ensure transparency in PHEMCE activities.
• The advisory committee’s input should be sought and considered

seriously in all major decisions and actions by PHEMCE regarding
the development and delivery of MCMs.
• The advisory committee should balance external partners and threat
portfolios to ensure the right combination of threat-specific exper-
tise and other relevant expertise on critical issues like supply chain
and stockpiling.
• The advisory committee should help aid PHEMCE in its communi-
cation with nonfederal partners, stakeholders, and the public. The
meetings should be conducted with appropriate transparency, con-
sidering both public discussions and assurances of confidentiality
among members, in order to accomplish the intent of this objective.
Transparency, Two-Way Communication, and Clarifying Expectations

with Nonfederal and Private-Sector Partners, Stakeholders, and the Public
As the nation’s MCM coordinating body, PHEMCE must be a reliable
partner in MCM priority setting, development, and distribution. To this end,
PHEMCE must establish and maintain two-way communication across the
enterprise, creating shared expectations and keeping the p arties apprised
of potential changes. PHEMCE must be transparent and trustworthy in
fulfilling its obligations to its partners, stakeholders, and the p ublic. Early,
accurate, evidence-based communication fosters trust, preempts misinforma-
tion, and ensures appropriate expectations with the public, partners, and
stakeholders. The advisory committee will have the overarching perspective
needed to allow PHEMCE to speak with a clear voice even during disagree-
ments and uncertainties.
PHEMCE must sustain two-way communication to clarify roles and
expectations with nonfederal and private-sector partners and stakeholders.
Clear, coordinated roles and authorities, with mutually accepted perfor-
mance measures, are the foundation for effective collaboration. They may
be formalized through contracting, advance commitments, pricing agree-
ments, and incentives, designed for routine and crisis operations. Partner-
ships should be stress tested periodically through simulation exercises.

RECOMMENDATION 7. IMPLEMENT TRANSPARENT COM-

MUNICATION STRATEGIES.
PHEMCE should establish mechanisms for transparent communica-
tions across the government and with nonfederal and private-sector
partners and stakeholders and the public.
Functions and responsibilities of these mechanisms would include:
• Coordinating internal and external communications within

PHEMCE and between PHEMCE and nonfederal and private-
sector partners and stakeholders and the public to ensure trusted
two-way communication channels with all partners and the provi-
sion of dependable, actionable information.
• Balancing the tension between transparency and national security
or proprietary concerns.
• Involving the public to assist in driving messages that resonate
with various communities; political messaging should be discour-
aged. These communications need to be culturally and linguistically
appropriate, as well as tailored to the literacy and understanding of
multiple population groups.
• Providing advance information of MCM priorities for public and
private sectors, as well as the public itself, prior to and during public
health emergencies.
RECOMMENDATION 8. ESTABLISH CLEAR AUTHORITIES,

ROLES, AND RESPONSIBILITIES FOR EXTERNAL PARTNERSHIPS.
PHEMCE should develop, document, and clearly define authority,
roles, and responsibilities among federal and nonfederal and private-
sector partners and stakeholders, whose perspectives on the status and
role of partnerships are vital to the medical countermeasure mission.
PHEMCE should regularly assess the perspectives of federal and non-

federal and private-sector partners and stakeholders on the state of the
partnerships vital to the MCM mission.
Public Health Supply Chains and Stockpiling Considerations

PHEMCE plays a critical governance, leadership, and coordination
role in ensuring that the U.S. Strategic National Stockpile (SNS) meets the
nation’s preparedness and response needs. Per the National Strategy for
a Resilient Public Health Supply Chain, a re-envisioned PHEMCE must
create appropriate incentives and commitments for private-sector engage-
ment if it is to help promote a resilient and adaptable public health sup-

SUMMARY 11
ply chain with strong business practices and effective coordination. These
relationships should be designed to reveal vulnerabilities to the industrial
base needed to scale MCM provisions in response to public health crises;
the approaches and relationships may also build on best practices from
emergency management.
Faithful completion of the mandated SNS Annual Review and the
associated findings are necessary as a signal to PHEMCE and its member
agencies of potential gaps in MCM preparedness and ways to improve
stockpiling decisions for future emergencies. As noted in the 2021 U.S.
Government Accountability Office (GAO) report, that annual SNS re-
view has not been conducted since 2016, creating a major vulnerability in
our nation’s ability to respond to the COVID-19 pandemic. It is urgently
necessary to understand and address SNS failures through a root-cause
assessment (e.g., including a lack of mandated annual review, investments
without PHEMCE partner input or full transparency, and insufficient fund-
ing), understanding that this is just one of many after-action reports reports
to be done regarding the COVID-19 response.
RECOMMENDATION 9. CONDUCT A ROOT-CAUSE ASSESS-

MENT OF COVID-19 U.S. STRATEGIC NATIONAL STOCKPILE
(SNS)-SPECIFIC LESSONS LEARNED.
PHEMCE should commission an independent, evidence-based, root-
cause assessment of lessons learned from COVID-19 and other past
public health emergencies specific to the SNS.
This should include assessing the intended purpose and value of the SNS
annual reviews and whether they drove findings and recommendations
that were tied to meaningful outcome measures, budget justifications,
and accountability across PHEMCE. Any SNS expansion should be
reviewed and validated through PHEMCE. This assessment should
be conducted in the context of the end-to-end mission elements and the
life cycle management of the SNS assets and explicitly coupled with a
prospective risk assessment.
Global Considerations and Synergies

MCM preparedness and response is inherently international in nature
and structure, involving a global network of resources, manufacturing, and
distribution, therefore making it imperative that PHEMCE be engaged at
the international level. U.S. efforts to improve MCM development and
delivery must consider opportunities for global coordination, leveraging
relationships with international governmental, nonprofit, and industry
organizations that are recognized leaders in MCM preparedness. The global

impact of COVID-19 presents opportunities for lessons learned, challenges,

opportunities, and barriers to be evaluated.
RECOMMENDATION 10. WORK SYNERGISTICALLY WITH

RELEVANT GLOBAL ORGANIZATIONS.
PHEMCE should work synergistically with global and other national-
level organizations with relevant missions and goals to benefit from their
experiences and leverage global expertise and resources as appropriate.
LEGAL AND POLICY ISSUES
Overview of the Federal Emergency Legal Landscape

PHEMCE is bound and empowered by federal and other laws and poli-
cies. Some of these laws are routine, standing provisions. Others respond to
crises, enacted through presidential national security powers (e.g., executive
orders, federal emergency declarations) or state-based emergency declara-
tions. Federal law may override state law, as demonstrated for the C
OVID-19
pandemic in Public Readiness and Emergency Preparedness (PREP) Act
declarations addressing local actions prohibiting MCM administration.
PHEMCE Regulatory Options

MCM development, authorization, procurement, and distribution ex-
ist within a complex regulatory landscape. The committee recognizes the
regulatory challenges underlying several PHEMCE core functions:
MCM research support and procurement: PHEMCE makes recom-

•
mendations to ASPR on MCM research and procurement, while
agency partners, such as the National Institutes of Health, the U.S.
Food and Drug Administration (FDA), and the Biomedical Ad-
vanced Research and Development Authority, support biomedical
research, regulatory science, and procurement of end products.
Thus, PHEMCE must be aware of issues related to and, to the
extent of its power, ensure research support; fair, documented,
and efficient procurement processes; and adequate supply, while
minimizing COIs and providing appropriate incentives to industry
partners.
MCM research regulation and FDA marketing authorization path-
•
ways: MCM development requires establishing and monitoring
compliance with safety and effectiveness standards. During emer-
gencies, legal flexibility and regulatory tools exist, and have been
used, to accelerate research, evidence review, and authorization

SUMMARY 13
processes while still helping to ensure sufficient information about

safety and effectiveness.
Legal concerns facing nongovernmental partners in MCM manufac-
•
turing and distribution: Nongovernmental partners face additional
legal challenges related to MCM manufacturing and distribution,
including concerns related to balancing the need to protect pro-
prietary information against the need to collaborate on difficult
scientific questions and ensuring adequate protections for intel-
lectual property. Although HHS and PHEMCE partner agencies
have some tools and programs intended to help, nongovernmen-
tal partners nevertheless may remain reticent about entering the
MCM market if they do not perceive these programs as adequately
addressing their concerns, particularly in light of high-profile bank-
ruptcies in the space.
Addressing and Solving Emergency Legal Issues in Real Time

The legal and regulatory landscape underpinning PHEMCE has been
evolving in response to PHEs such as COVID-19, which have presented
novel legal questions and actual and perceived regulatory barriers. Substan-
tial legal and policy changes have come about as a result, and additional
legal adjustments in emergency preparedness and response are highly pre-
dictable. In response, PHEMCE agencies must triage legal principles and
options to reduce uncertainty, mitigate barriers, and generate solutions to
actual or perceived barriers. Regulatory readiness helps ensure awareness
of legal flexibilities in PHEs among PHEMCE agencies.
RECOMMENDATION 11. IDENTIFY, ASSESS, AND RESOLVE THE

LEGAL BARRIERS THAT MAY IMPEDE PHEMCE O BJECTIVES.
ASPR and the U.S. Department of Health and Human Services’ O ffice
of the General Counsel in consultation with outside legal experts
should regularly identify, assess, and resolve the perceived or actual
legal b
arriers that may continue to impede PHEMCE objectives.
This assessment should also occur outside crises and should include the
foundational regulatory framework underlying PHEMCE operations
and its mission as well as real-time needs and capabilities required to
support its emergency implementation. Flexibility and transparency
should be cultivated to foster open dialogue, communication, and
sharing creative options within the legal and regulatory framework
supporting PHEMCE, particularly, but not exclusively, in declared
emergencies when real-time decisions and solutions may be compro-
mised absent advanced review and consideration.

CONCLUDING REMARKS
The COVID-19 pandemic has created an urgent need to re-envision
PHEMCE, so that it can protect public health in the current emergency
and those to come. PHEMCE plays a critical coordinating role in all-of-
government MCM preparedness and response. The recommendations set
forth in this report provide the high-level strategic guidance that ASPR,
and all federal partners, need to ensure that PHEMCE fulfills its mission.
BOX S-1
Summary of Recommendations
The following points collectively summarize the necessary actions recom-

mended by the committee that are needed to implement a re-envisioned PHEMCE:
1. Affirm the PHEMCE mandate, as codified in 42 U.S. Code 300hh-10A, to

fulfill the mission as the major U.S. coordinating body for all aspects of
MCM preparedness and response.
2. Conduct business guided by principles in ethics, operations, strategy, and
budget.
3. Incorporate the perspectives of nonfederal and private-sector partners
and stakeholders in the PHEMCE Strategy and Implementation Plan and
multiyear budget with clearly specified roles, objectives, accountability,
benchmarks, timelines, and budget requirements.
4. Establish metrics-driven processes, with meaningful and measurable out-
comes aligned at inter- and intra-agency levels, and perform rigorous
after-action reviews of preparedness and response activities, evaluated
by an objective third-party observer.
5. Establish an integrated and accessible data system to support monitoring,
evaluation, and quality management of end-to-end MCM activities.
6. Develop and maintain an advisory committee of representative MCM
partners and stakeholders to both benefit from their expertise and ensure
transparency in the diverse aspects of PHEMCE activities.
7. Establish a mechanism for transparent communications both across the gov-
ernment and with nonfederal and private-sector partners and stakeholders.
8. Develop, document, and clearly define authorities, roles, and responsibili-
ties among ASPR, PHEMCE, and nonfederal and private-sector partners
and stakeholders.
9. Commission an independent root-cause assessment of lessons learned
from COVID-19 and other public health emergencies specific to the U.S.
Strategic National Stockpile.
10. Work synergistically with global organizations with relevant missions and
goals to benefit from their experiences and leverage each other’s expertise
and resources as appropriate.
11. Identify, assess, and resolve the perceived or actual legal barriers that may
impede PHEMCE objectives.

Introduction
Over the past 18 months, federal, state, and local governments; private
developers, manufacturers, and distributors; and responders in both the
public and private health care sectors together with multisector essential
workers forged new pathways of coordination under fire while mounting a
nationwide pandemic response to COVID-19. Even with these heroic per-
sonnel and coordinated organizational efforts, the pandemic revealed signifi-
cant gaps in our national public health emergency (PHE) p reparedness—lack
of overall coordination and willingness to leverage all resources hindered
efforts. The devastating effects on population health, the economy, and, by
extension, national security, create compelling motivations to re-examine the
nation’s approach to future PHE preparedness and response.
Effective national PHE preparedness and response requires the capabil-
ity to produce, procure, and use medical countermeasures (MCMs)1 and,
given the inevitable complexity, a highly effective coordinating mechanism
among the core federal agencies and an array of nonfederal partners. The
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)
was created to meet that coordination need and protect the nation from
health security threats with a focus on MCM.
Over its nearly two-decade history, PHEMCE has changed substan-
tially, in both structure and function. COVID-19 experiences suggest the
1 MCMs are “biologics, drugs, or devices that can be used to diagnose, prevent, protect
from, or treat conditions associated with chemical, biological, radiological, or nuclear (CBRN)
threats, or emerging infectious diseases and, MCMs may be used in the event of a potential
public health emergency stemming from a terrorist attack with a biological, chemical, or
radiological/nuclear material, or a naturally occurring emerging disease” (FDA, n.d.).
15

time is right to revisit its structure, operating principles, and practices and
assess how PHEMCE is serving the mission to prepare the nation. This
report was commissioned to provide guidance about that re-envisioning.
RATIONALE AND STUDY CHARGE

In light of the catastrophic experience of the COVID-19 pandemic, the
committee looks to a future in which PHEMCE is a critical coordination
node for all-of-government MCM preparedness and response infrastructure
in a malicious or natural PHE. The purpose of this report is to help ensure
that the United States has an effective and efficient coordinating mechanism
to anticipate health security threats and, to the extent possible, be prepared
to limit their impact with the appropriate MCMs.
In recognition of the important role of PHEMCE in coordinating the
federal MCM preparedness and response and the platform for action that
historical PHEMCE activities provided for the COVID-19 MCM response,
the U.S. Department of Health and Human Services’ (HHS’s) Office of the
Assistant Secretary for Preparedness and Response (ASPR) charged this

ad hoc committee of the National Academies of Sciences, Engineering, and
Medicine (the National Academies) with conducting a study to evaluate exist-
ing policy and practices of PHEMCE in order to enhance its ability to deliver
on its critical mission (see Box 1-1). As requested, this report provides high-
level strategic guidance to the ASPR on PHEMCE programs and activities.
The committee comprised 15 members with academic backgrounds
and professional expertise in fields including medical and PHE prepared-
ness and response; MCM research and development (R&D); chemical,
biological, radiological and nuclear (CBRN) threats; biosecurity and bio-
defense; legal and regulatory issues; supply chains; and decision science and
organizational management. Appendix B provides the biographies of the
committee members.
LOOKING BACK TO LOOK FORWARD:

HISTORICAL PERSPECTIVES OF PHEMCE
PHEMCE’s functions are fully summarized in 42 U.S. Code 300hh-10a.
Its responsibilities include making recommendations to the HHS secre-
tary regarding advanced research, development, procurement, stockpiling,
deployment, distribution, and use of MCM; identifying national health
security needs, including gaps in public health preparedness and response
related to MCMs and challenges to addressing such needs; and assist-
ing the secretary in developing strategies related to logistics, deployment,
distribution, dispensing, and use of MCMs that may be applicable to the
activities of the U.S. Strategic National Stockpile (SNS).

INTRODUCTION 17
BOX 1-1
Statement of Task
An ad hoc committee of the National Academies of Sciences, Engineering,

and Medicine will conduct a study to evaluate existing Public Health Emergency
Medical Countermeasure Enterprise’s (PHEMCE’s) policy and practices and make
recommendations for a re-envisioned PHEMCE, particularly after COVID-19. This
review will provide high-level strategic guidance to the Assistant Secretary for Pre-
paredness and Response on emerging issues, research, and activities relevant to
the PHEMCE programs, goal, and activities.
The committee shall
• Review the effectiveness of existing PHEMCE activities and areas for im-
provement by assessing available charters, memorandums of understand-
ing, process documents, and public documents (e.g., PHEMCE Strategy
and Implementation Plan) and engaging with PHEMCE personnel in a
series of interviews to garner understanding of historical practices.
• Provide recommendations on business practices to best incorporate indus-
trial base, supply chain, and stockpiling strategies toward medical counter-
measure preparedness.
• Provide recommendations on business practices to ensure defensible
recommendations, conduct enterprise-wide review of programs and priori-
ties and harmonization across agencies.
• Provide recommendations on the integration of partners in PHEMCE deci-
sion making and activity execution.
A report with the committee’s findings and recommendations will be developed.
PHEMCE is administratively managed by the PHEMCE Branch within

ASPR. The PHEMCE Branch is located within the Division of Require-
ments, within the Office of Strategy, Policy, Planning, and Requirements,
which is led by a deputy assistant secretary. According to the current
ASPR, the goal of this structure is to ensure that PHEMCE meetings are
held regularly, statutory mandates are met, and ASPR deliverables, such
as the PHEMCE Strategy and Implementation Plan (SIP) and SNS Annual
Review, are completed. The PHEMCE Branch is deliberately managed
outside of ASPR program authorities to ensure a separation of policy and
program determinations and reduce potential inappropriate influence by
program staff on policy decisions. PHEMCE was managed by the Divi-
sion of Requirements from its inception in 2005–2006 until 2017, when
it was reassigned to the Biomedical Advanced Research and Develop-
ment A uthority (BARDA) and the ASPR Immediate Office. In 2020, the
PHEMCE Branch was reestablished within the Division of Requirements

to ensure that an organizational unit was dedicated to implementing its

statutory requirements.
PHEMCE as it exists today developed over time. Four eras of change
that shaped PHEMCE are reviewed in the next section. The first era (2001–
2008) is represented in early foundations, before it was named and detailed
in legislation. The second era (2009–2016) was shaped by a restructuring
following the experience of H1N1. The third era follows the restructuring
in 2017. The fourth era outlines the role of PHEMCE both during and
moving forward from the COVID-19 pandemic. This report is intended to
help refine the role and functioning of PHEMCE going forward.
Foundational Structures and Policy (2001–2008)

Prior to the formal establishment of PHEMCE, the first era in this over-
view, the government entity tasked with providing advice for planning, co-
ordination, and acquisition of MCM was the interagency Weapons of Mass
Destruction Medical Countermeasures (WMD MCM) Subcommittee. The
WMD MCM was convened by the White House in response to the terror
attacks of September 11, 2001. A subcommittee of the Office of Science and
Technology Policy’s National Science and Technology Council, it was led
by HHS, in consultation with senior leadership from the U.S. Department
of Homeland Security (DHS) and the U.S. Department of Defense (DoD).
WMD MCM focused on questions of which MCMs should be prioritized
in response to the threats related to WMD, submitting its recommendations
through the Office of Management and Budget (OMB). Once approved by
OMB, HHS would then manage the MCM procurement process by issuing
Requests for Proposals (Russell, 2007).
The Project BioShield Act in 2004 connected threat assessment, led by
DHS, with acquisitions, led by HHS. It established a 10-year, $5.6 billion
reserve fund for government purchase of MCMs.2
2 From a 2005 congressional committee hearing, “To date, the Secretary of DHS has issued
material threat determinations for four agents: anthrax, smallpox, botulinum antitoxin and
radiological/nuclear devices. In addition, threat and risk assessments are currently under way
and will be completed this year for plague, tularemia, radiological devices, and chemical
nerve agents; and a threat assessment for viral hemorrhagic fevers will be issued next month
in August. Once a material threat determination has been issued, HHS assesses the potential
public health consequences of the identified agent, determines the needs for countermeasures,
evaluates the availability of current countermeasures and the possibility of development of
new countermeasures. They are assisted by the interagency Weapons of Mass Destruction
Countermeasures Subcommittee. Any recommendations issued for the acquisition of a specific
countermeasure are evaluated through the interagency process that forms the basis of U.S.
government requirements. After approval of these requirements by the Office of Management
and Budget, HHS issues a request for proposals and implements and manages the subsequent
acquisition process through the delivery of countermeasures through the strategic national
stockpile. Throughout this process DHS works very closely with HHS. HHS subject-matter

INTRODUCTION 19
The 2006 Pandemic and All-Hazards Preparedness Act (PAHPA) estab-

lished the ASPR in HHS and provided authority for HHS to create BARDA
and an early version of the SNS (Biocom, n.d.). The 2007 Homeland
Security Presidential Directive/HSPD-18 further specified the PAHPA goals,
including an integrated approach to what the administration referred to as
“WMD medical countermeasure development” and seamless integration of
public and private partners throughout the product development life cycle
(Bush, 2007).
Restructuring PHEMCE Following the

2009 H1N1 Experience (2009–2016)
The second era was structured by the 2009 H1N1 experience, which
prompted re-envisioning the MCM enterprise. This effort, driven by the pres-
ident himself, was completed in 2010 (ASPR, 2010a). A capabilities approach
governed the new PHEMCE design, stating the vision of a “nimble, flexible
capability to produce MCMs rapidly in the face of any attack or threat,
known or unknown, including a novel, previously unrecognized n aturally
occurring emerging infection disease” (ASPR, 2010a, p. 6). The mission
included threats beyond WMD, with a focus on infectious disease. Specific
goals in the 2010 report included supporting partnerships, removing con-
straints, modernizing regulatory oversight, and encouraging transformative
technologies (ASPR, 2010b). As a result, PHEMCE operated according to
the structures briefly described next and depicted in Figure 1-1 (ASPR, 2015).
As shown in Figure 1-1, the Enterprise Senior Council (ESC), an in-
teragency group of top agency leaders, such as the ASPR, the Centers for
Disease Control and Prevention (CDC) director, and the U.S. Food and
Drug Administration (FDA) commissioner, provided coordinated, strategic
direction and policy oversight for HHS’s “end-to-end” MCM preparedness
activities. The Enterprise Executive Committee (EEC) reported to the ESC,
providing operational-level decision making and coordination for all com-
ponents of PHEMCE. Components reporting to the EEC included topic-
specific Integrated Program Teams (IPTs) and the Flu Risk Management
Meeting; Project Coordination Teams focused on acquisition and estab-
lished as needed by the BARDA director; the Emerging Infection Diseases
Working Group; the Public Readiness and Emergency Preparedness (PREP)
Act Working Group, which was established by the ESC in 2012; and the
experts participate in threat assessments and risk assessments. HHS, DHS, and Department of
Defense co-chair the WMD Medical Countermeasures Subcommittee; and HHS keeps DHS
informed about the subsequent acquisition processes. These interactions occur at multiple
levels, from formal interagency committees through bilateral management interactions to
informal but important contact and collaborations amongst the working scientists” (U.S.
Congress, 2005).

FIGURE 1-1 PHEMCE operating structure.

SOURCE: ASPR, 2017.
Requirements Working Group that addressed a core mission component of

PHEMCE that is outlined in the next sections.
Stakeholder Engagement Structure

Figure 1-2 is a graphical representation of PHEMCE stakeholder
engagement structure from this era, depicting mission components in
yellow, federal agencies in blue (within HHS) and green (outside of HHS),
and nonfederal stakeholders in green.
The eight mission components were (1) requirements setting, led by
ASPR in consultation with DHS, described in more detail later; (2) early
stage research, led by the National Institutes of Health (NIH) in con-
sultation with DoD and the U.S. Department of Agriculture (USDA);
(3) advanced development/manufacturing, led by ASPR/BARDA in con-
sultation with DoD and USDA; (4) regulatory science management, led by
FDA; (5) procurement/inventory/management/stockpiling, led by CDC for
procuring and maintaining commercially available MCM for the SNS and
BARDA for procuring certain MCM using the Special Reserve Fund, while
DoD and the U.S. Department of Veterans Affairs (VA) support planning
or executing stockpiling; (6) response planning, policy, guidance, and com-
munication, led by CDC and ASPR in consultation with DoD, DHS, and
the VA; (7) deployment/distribution/dispensing/administration, led by CDC

INTRODUCTION 21
FIGURE 1-2 PHEMCE stakeholder engagement structure.

SOURCE: Korch, 2016.
and ASPR in consultation with the VA; and (8) monitoring/evaluation/

assessment, led by CDC and FDA (ASPR, 2007, 2008, 2011).
The specific engagement paths for nonfederal agencies are not specified
in Figure 1-2, but the external stakeholders identified as PHEMCE partners
include industry, academia, professional societies, state, local, tribal, and
territorial entities, and the American public.

Requirements Setting: One Example of a Critical Mission Component in

Greater Depth
The requirements setting process was a major focus of PHEMCE’s
work during this era and emerged multiple times in the committee’s discus-
sions. Based on a DHS intelligence assessments, PHEMCE IPTs tabulated
the need-based quantities of MCMs, identified solutions if that quantity
was likely to be unavailable, and identified the acquisitions target based on
available funds (ASPR, 2012, 2015). BARDA and partners, including CDC,
used the results to prioritize HHS funding to deploy acquisition plans for
the MCM. Figure 1-3 outlines this process (Korch, 2016). The SNS Review
is a major part; it is the mechanism by which PHEMCE recommends a
portfolio of holdings for the SNS, identifying threats and estimating the
costs of meeting them. The review, like the PHEMCE SIP, is mandated by
the 2013 Pandemic and All-Hazards Preparedness Reauthorization Act
(PAHPRA) (ASPR, 2014).
The Second Restructuring of PHEMCE (2017–2019)

The third era is defined by another restructuring of PHEMCE, initiated
in 2017 (ASPR, 2020). According to then-current documents, these changes
PHEMCE Requirements Process
FIGURE 1-3 PHEMCE requirements setting process.

SOURCE: Korch, 2016.

INTRODUCTION 23
were undertaken based on goals such as expediting decision-making pro-

cesses through a top-down approach and narrowing the scope of PHEMCE
to MCM development and procurement.15 However, during this period,
the required SNS annual reviews for 2017, 2018, and 2019 were not con-
ducted, and the statutorily mandated SIP was not published after December
2017 (GAO, 2021a). Thus, the role of PHEMCE in federal preparedness
and response MCM activities during this era is not clear.
• According to the ASPR Strategic Plan for 2020–2023, two aims

drove the 2019 restructuring: (1) streamline the deliberative process
to enhance speed and more robustly engage all relevant agencies,
including DoD and (2) better protect national security–sensitive
and proprietary information in PHEMCE deliberations (ASPR,
2020). Ten strategies were proposed, ranging from new efforts to
“solicit priorities from nonfederal stakeholders regarding activities
and priorities of the PHEMCE” and “develop improved business
models for MCM development and acquisition to address the
strategic risks posed by supply chain disruptions” (ASPR, 2020).
The ASPR Strategic Plan for 2020–2023 also determined that all
PHEMCE meetings “involving discussion of aggregated informa-
tion that may present security risks would be held in secret or at a
higher classified level” (ASPR, 2020).
COVID-19 and Operation Warp Speed (2020 and Beyond)

In the fourth era, beginning May 2020, the White House launched a
new interagency coordinating body jointly led by HHS and DoD called
Operation Warp Speed (OWS). The goal was to develop therapeutics and
vaccines for COVID-19, with a specific target of 300 million doses of a safe
and effective vaccine available by January 2021. A GAO report on OWS
describes the strategies adopted by OWS leadership in partnership with
vaccine companies as accelerating development and mitigating financial
risk to producers (GAO, 2021b). During meetings with the committee,
government leaders involved in OWS did not refer to PHEMCE. As the
committee understands it, OWS became the de facto all-of-government
MCM preparedness and response effort for COVID-19. The COVID-19
pandemic required unprecedented, urgent action; surge in federal con-
tracting; and operational leadership with the authority to make urgent
decisions. Over the years, PHEMCE developed valuable and deliberative
processes, but COVID-19 demanded urgent and new capacity leadership
paradigms, provided by OWS without involving the PHEMCE mechanism.
The committee also heard testimony and commentary indicating OWS was
built on two decades of PHEMCE activities and used its personnel, staff,

and many of its leaders. At the time of this writing, OWS is transitioning
to a program known as the Countermeasures Acceleration Group (CAG).
Integrating and/or coordinating CAG and PHEMCE will be key. These two
entities must be complementary and neither competing nor redundant. An
important question is whether ad hoc bodies, such as OWS/CAG, should
be encouraged as separate entities or a plan to expand PHEMCE during
emergencies would be more appropriate.
ABOUT THIS REPORT
Study Approach and Scope

This report offers a new vision for how PHEMCE can optimize the
development and use of MCMs for future PHEs, serving as the consistent,
resilient, and steadfast coordinating entity for MCMs that is critical to
effective PHE preparedness and response. The following principles guided
the committee’s deliberations and resulting recommendations.
• Meeting the Mandate. PHEMCE is the only coordinating body

tasked with all-of-government MCM preparedness and response.
It must be empowered with clear and powerful leadership. The
metrics for meeting the mandate are to reduce mortality, morbidity,
inequities, and costs in PHEs.
• Transparency. PHEMCE must make clear decisions that it can
defend in compelling recommendations, conveyed to the White
House through ASPR and HHS. The metrics for transparency are
clear, ethical business practices, reinforcing its public legitimacy.
• Adaptability. PHEMCE must evolve as threats, vulnerabilities, and
MCM options change. The metrics for adaptability are continu-
ous two-way communication with all PHEMCE partners and with
experts in threats, vulnerabilities, and response options.
The committee reviewed an array of earlier reports on PHEMCE and

heard testimony from many individuals with varying experiences with
the government’s efforts to organize and coordinate MCM preparedness
and response. The committee’s analysis of this input clearly indicates a
significant lack of clarity about PHEMCE’s mission, role, and authorities
because, in practice, they have shifted substantially with circumstances such
as PHEs and budgets and political leadership. It could be assumed from the
establishing legislation (42 U.S. Code 300hh-10A) that PHEMCE’s mandate
is to serve as the major coordinating body for all aspects of U.S. MCM
preparedness and response. However, little evidence indicates that it has

INTRODUCTION 25
functioned in this way for the last several years or more, in part because
the relevant federal landscape has evolved substantially. Other entities, such
as OWS, have at least partly supplanted PHEMCE’s coordinating function.
This report aims to be forward looking and presents a high-level blueprint
of how a group with the roles and responsibilities articulated in 42 U.S.
Code 300hh-10A should function.
Report Audiences and Uses

This report is intended for the immediate use, by request, of ASPR
and federal PHEMCE partners engaged in strengthening PHEMCE. The
committee hopes that the report will find audiences among all PHEMCE
stakeholders: the White House; congressional members; federal partners;
state, tribal, local, and territorial governments; private-sector developers,
manufacturers, and distributors; public health; and health care. The com-
mittee sees these partnerships as an enterprise working together to ensure
MCM preparedness and response.
Organization of the Report

This first chapter reviewed PHEMCE’s intended role, finding that it is
not currently fulfilling its mission, despite dedicated efforts by many partici-
pants. The next four chapters offer recommendations for addressing issues
identified in different sectors, drawing on scientific research, members’
experience, and interactions with PHEMCE partners and participants. The
committee believes that their adoption will strengthen PHEMCE’s ability
to meet its mission and protect America from PHEs. Chapter 2 recom-
mends general principles across four areas (ethics, operations, strategy, and
budget) to guide PHEMCE decisions and policies. Chapter 3 recommends
ways to enhance PHEMCE operations to produce defensible decisions and
recommendations. Chapter 4 recommends ways to enhance communica-
tions and transparency needed to achieve public trust, emphasizing formal
and informal collaboration with nongovernment partners and stakeholders.
Chapter 5 recommends ways to work within and revise the legal framework
for PHEMCE, drawing lessons from COVID-19.
The ongoing COVID-19 pandemic creates an urgent need to reinvent
PHEMCE, in ways that will position it for future challenges. It echoes
and elaborates on themes found in the concurrently (and independently)
developed White House American Pandemic Preparedness: Transforming
Our Capabilities. That White House plan strengthens the committee’s belief
that an effective, consistent, and reliable lead coordinating body is critical
to develop, produce, and deliver MCM and related support (e.g., supplies,

staffing) for PHEs. PHEMCE was designed to fill that role. The following
chapters review steps to adapt PHEMCE functions to do so and better
protect the nation.
CONCLUDING REMARKS
The stakes could not be higher. The risks from emerging infectious
diseases pose a growing threat to population health. Intentional acts of
bioterrorism remain. The White House American Pandemic Preparedness:
Transforming Our Capabilities highlights the need for a federal, central
“mission control” operation to lead PHE preparedness and response.
PHEMCE was designed to serve and support that role. This report recom-
mends ways for it to do so. The cost of improving the nation’s ability to
respond to PHEs in the twenty-first century will be substantial, in both
material resources and changes to current systems and practices. However,
the cost of not making needed changes is incalculable, in terms of lives lost
or irrevocably altered and economies and communities ravaged by the loss
of jobs, homes, and educational opportunity.
REFERENCES
ASPR (Office of the Assistant Secretary for Preparedness and Response). 2007 [unpublished].
MOU among ASPR and OS (HHS) and CDC and FDA and NIH. Materials shared by
ASPR and accessible by request in the committee’s public access file.
ASPR. 2008 [unpublished]. MOU among ASPR, OS (HHS), CDC, FDA, and NIH. Materials
shared by ASPR and accessible by request in the committee’s public access file.
ASPR. 2010a. The Public Health Emergency Medical Countermeasures Enterprise
review: Transforming the enterprise to meet long-range national needs. https://www.
medicalcountermeasures.gov/media/1138/mcmreviewfinalcover-508.pdf (accessed Decem
ber 16, 2021).
ASPR. 2010b. 2010 PHEMCE review. https://www.phe.gov/Preparedness/mcm/phemce/Pages/
review-2010.aspx (accessed September 1, 2021).
ASPR. 2011 [unpublished]. MOU among HHS and DoD and DHS and VA and USDA.
Materials shared by ASPR and accessible by request in the committee’s public access file.
ASPR. 2012 [unpublished]. Integrated program teams (IPTS) charter. Materials shared by
ASPR. 2014. About the Division of Medical Countermeasures strategy and requirements.
https://www.phe.gov/about/OPP/mcsr/Pages/about.aspx (accessed September 1, 2021).
ASPR. 2015 [unpublished]. Integrated program teams (IPTS) charter. Materials shared by
ASPR. 2017. PHEMCE governance. https://www.phe.gov/Preparedness/mcm/phemce/Pages/
governance.aspx (accessed September 1, 2021).
ASPR. 2020. Strategic plan for 2020–2023. https://www.phe.gov/about/aspr/Documents/2020-
ASPR-Strategic-Plan-508.pdf (accessed September 1, 2021).
Biocom. n.d. Pandemic and All-Hazards Preparedness Act. https://www.biocom.org/wp-content/
uploads/2019/03/PAHPAOne-PagerFINAL.pdf (accessed September 21, 2021).
Bush, G. W. 2007. Homeland Security Presidential Directive/HSPD-18. https://irp.fas.org/
offdocs/nspd/hspd-18.html (accessed September 1, 2021).

INTRODUCTION 27
FDA (U.S. Food and Drug Administration). n.d. What are medical countermeasures? https://
www.fda.gov/emergency-preparedness-and-response/about-mcmi/what-are-medical-
countermeasures (accessed September 16, 2021).
GAO (U.S. Government Accountability Office). 2021a. Continued attention needed to enhance
federal preparedness, response, service delivery, and program integrity. https://www.gao.
gov/assets/gao-21-551.pdf (accessed September 1, 2021).
GAO. 2021b. Operation Warp Speed: Accelerated COVID-19 vaccine development status and
efforts to address manufacturing challenges. https://www.gao.gov/assets/gao-21-319.pdf
(accessed September 1, 2021).
Korch, G. W. 2016. Product life cycle management and the PHEMCE. https://int.nyt.com/
data/documenttools/korch-presentation-mta/a30b4451c27577ba/full.pdf (accessed Sep-
tember 1, 2021).
Russell, P. K. 2007. Project Bioshield: What it is, why it is needed, and its accomplishments
so far. Clinical Infectious Diseases 45(Suppl 1):S68–S72.
U.S. Congress, Committee on Homeland Security House of Representatives, Subcommittee
on Emergency Preparedness, Science, and Technology. 2005. Project Bioshield: Linking
bioterrorism threats and countermeasure procurement to enhance terrorism pre-
paredness. https://www.govinfo.gov/content/pkg/CHRG-109hhrg27217/html/CHRG-
109hhrg27217.htm (accessed December 16, 2021).


Delivering on PHEMCE’s Mission
Presentations to the committee revealed a lack of clarity regarding Public

Health Emergency Medical Countermeasures Enterprise’s (PHEMCE’s)
mission, scope, and responsibilities. One knowledgeable speaker described
PHEMCE as a “policy shop,” a second as advisory in nature, and a
third as overseeing the development and stockpiling of medical counter
measures (MCMs) (Mair, 2021). Speakers also displayed confusion about
relationships among the Assistant Secretary for Preparedness and Response
(ASPR), the Biomedical Advanced Research and Development Authority
(BARDA), the U.S. Strategic National Stockpile (SNS), and PHEMCE.
Although all presenters agreed that PHEMCE’s roles included coor-
dinating the development, production, and availability of MCMs, they
defined the MCMs within PHEMCE’s purview differently. For example,
some individuals considered only therapeutics, such as medicines and vac-
cines, while others added personal protective equipment (PPE) consistent
with the definition of MCMs in federal law.1,2 Some presenters defined
MCMs as just the products, while still others included information shar-
ing and distribution to the level of medical providers. Some speakers also
interpreted PHEMCE as primarily engaged in supplying the MCMs needed
to counter bioterrorism, while others noted the broader mandate, supported
by PHEMCE’s statutorily directed functions and the Pandemic and All-
1 (2015). 42 U.S. Code § 300hh-10a—Public Health Emergency Medical Countermeasures
Enterprise.
2 (2017). 42 U.S. Code § 247d-6b—Strategic National Stockpile and Security Countermeasure
Procurements.
29

Hazards Preparedness Act (PAHPA), which also covers emerging infectious

diseases and pandemic threats beyond influenza (e.g., COVID-19).
The recent White House report American Pandemic Preparedness:
Transforming Our Capabilities calls for strong MCM program manage-
ment, setting as a goal that the lead agency “manage this crucial national
endeavor with the seriousness of purpose, commitment, and accountability
of an Apollo Program” (White House, 2021). PHEMCE, as originally
conceptualized, could do so. However, for PHEMCE to fulfill this role, a
unified view of the underlying principles that define PHEMCE’s mission,
role, scope, and responsibilities will be required.
PHEMCE’S MISSION AND SCOPE

PHEMCE was established in 42 U.S. Code 300hh-10a as an advi-
sory body with the mission “to advance national preparedness for
natural, accidental, and intentional threats by coordinating medical
countermeasure-related efforts within HHS [U.S. Department of Health
and Human Services] and in cooperation with PHEMCE interagency part-
ners” (HHS, 2015).4 Past MCM-related efforts have traditionally focused
on developing and procuring products. Experiences from the C OVID-19
pandemic and past influenza pandemics have highlighted the importance
of the entire mission of PHEMCE and the need to leverage protections
under the Public Health Readiness and Emergency Preparedness (PREP)
Act to make MCMs accessible to the public. PREP Act declarations sup-
port PHEMCE interagency activities to develop and administer MCMs,
including through ensuring the availability of associated ancillary supplies
(e.g., needles, ventilators), personnel (e.g., medical providers, pharmacists,
MCM manufacturing personnel), and infrastructure. The committee found
this mission statement encoded in the 42 U.S. Code to be appropriate.
PHEMCE should continue to engage with internal and external stake
holders to ensure that the overall mission is clear, activities are conducted
by relevant federal agencies and other partners as necessary, and funding
gaps to achieve the mission are clear to decision makers.
GUIDING PRINCIPLES FOR PHEMCE

Presentations to the committee and a recent GAO report highlighted
concerns raised by interagency partners regarding the 2018–2020 restruc-
turing of PHEMCE that resulted in a lack of clarification on how decisions
are made, challenges in collaborating effectively, and issues with transpar-
ency (GAO, 2021). These findings point to the need for a re-envisioned
PHEMCE to guide decision making and operations with a set of principles
in order to deliver on the mission. Previous frameworks to allocate scarce

DELIVERING ON PHEMCE’S MISSION 31
MCMs, including the COVID-19 vaccine, provide a basis to consider

foundational principles that must be adopted to maximize benefits to the
public and mitigate health burdens of the most vulnerable (NASEM, 2020).
Based on past PHEMCE reports, public discussions, committee members’
experiences, and good government and business practices, the committee
recommends four sets of principles that should guide PHEMCE decisions
and policies: (1) ethics, (2) operations, (3) strategy, and (4) budget.
Ethics
Guidance documents related to PHEs and response often prominently
discuss ethics. Many factors support this practice, but perhaps the most
important is that allocating crucial and scarce resources falls to govern-
ment and institutions; when the population perceives that allocation to be
flawed, it may erode trust, which can increase the difficulty of successfully
responding to the public’s needs. Thoughtful planning for an entity such
as PHEMCE, whose tasks prominently feature emergency preparedness
and response, will incorporate ethical principles (IOM, 2012; NASEM,
2020).
Different guidance documents related to PHEs offer various selec-
tions of ethics principles. Maximizing benefits to the public while alleviat-
ing adverse health impacts are core ethical principles that must guide all
PHEMCE activities, as highlighted in past Strategy and Implementation
Plans (SIPs) (HHS, 2012, 2014). Beyond this basic public health function,
several substantive principles, which state values and goals, and procedural
principles, which tell us how to accomplish those goals, are specifically
relevant. The principles of trust, fairness, transparency, accountability, and
stewardship discussed here address e ssential ethical principles that should
be upheld by any government entity. Presentations made to the committee
and lessons learned from COVID-19 underscored the need for PHEMCE
activities to adhere to this set of principles during times of preparedness,
PHEs, and periods of transformation.
Trust
Maintaining trust in and across PHEMCE is fundamental to deliver-
ing on its mission of securing and delivering MCMs, working as a reliable
partner for internal and external entities. PHEMCE cannot fulfill its mission
unless it demonstrates it is worthy of trust and is a trusted partner. The
below mentioned principles of fairness, transparency, and accountability
also support trust, by demonstrating that PHEMCE’s goals and processes
have a solid ethical foundation. Demonstrating its adherence to these opera
tional principles will also cultivate trust with members and external part-

ners. Trust must be addressed in terms of both the public and federal and
nonfederal partners and stakeholders:
• Public trust is critical to effectively implement PHEMCE policies

and deliver on its mandate (Martin et al., 2020). Without that,
acceptance, and recognition of the importance of MCM, adoption
efforts can be severely hampered. Establishing or building on exist-
ing trusted, two-way communication channels (see Chapter 4) can
preempt misinformation and build trust in PHEMCE’s work.
• Among federal and nonfederal partners and stakeholders, trust
in and across PHEMCE can be cultivated by demonstrating it
is a reliable business partner in producing outcomes, promoting
innovation, and adapting to change. Incorporating partners and
stakeholders in the PHEMCE decision-making process is one way
to build trust in MCM preparedness and response activities led by
PHEMCE interagency members (see Chapter 4). Improved two-
way communication and greater transparency, discussed below,
also foster trust in and across PHEMCE.
Fairness
The central ethics principle for a public entity charged with protecting
public health is fairness. Fairness here can be defined as both the outcome
of mitigating injustice and inequities and creating procedures likely to
promote just outcomes. Fair policies should promote health equity across
populations, with consideration to race, ethnicity, income, gender, location,
abilities, and age. These actions must treat both individuals and organiza-
tions fairly to ensure equitable health care delivery, access to public health
services, and distribution of resources. Fairness does not require that all
people are treated equally, but differences in treatment or access to re-
sources must support important and clearly stated values, including equity.
For instance, older adults have had a particularly high risk of serious illness
with COVID-19, so they received early access during the initial vaccine
roll-out. First-come, first-served approaches to delivering scarce resources
in PHEs are often criticized because they unfairly disadvantage those with
challenges in mobility and transportation (NASEM, 2020).
Processes that enhance fairness include proactively engaging with
stakeholders who have been underrepresented in policy formation and
implementation, including underresourced health providers, public health
providers, and community organizations. Fair policies must attend to the
disparate needs of different and vulnerable populations, including pregnant
people, older people, and children. Engaging with historically underserved
populations, with a focus on building community resilience in public health

preparedness and response, is one way to make sure that PHEMCE prac-
tices do not contribute to health inequities (Plough et al., 2013; Powell et
al., 2020; Wells et al., 2013).
Experiences from the early days of COVID-19 provide an example of
how a lack of fairness in MCM delivery can lead to health inequity. For in-
stance, the dearth of PPE in the SNS forced health facilities to seek additional
PPE on the international market, which had a critically different impact on
different populations. Medical institutions with substantial budgets were
able to outbid health facilities with limited resources. Nonprofit, indepen-
dent nursing homes serving urban populations with high rates of poverty
especially encountered great difficulty in obtaining adequate PPE for staff
and patients, many of whom were minorities. This contributed to the high
numbers of fatalities among both residents and workers at nursing homes in
the earliest phase of the pandemic (McGarry et al., 2020; Seelye et al., 2020).
Transparency
Transparency applies to PHEMCE’s practices in a number of key
omains, including documentation, effective communication among agency
d
and commercial partners, and security concerns. PHEMCE must commit
to legally required recordkeeping for how key decisions are made and by
whom. Meeting minutes should be maintained with regular report submis-
sions to Congress, which has long been required but was not observed in
recent years (GAO, 2021). A Quality Management System (QMS), as dis-
cussed in Chapter 3, can provide the structure needed to support documen-
tation practices. Formally, required documentation must be supplemented
by the formal and informal communications needed to make PHEMCE a
trusted partner for its many stakeholders. Without that trust and predict-
ability, it cannot fulfill its mission.
Concerns may arise about sharing information that is proprietary or
has national security sensitivity. Transparency must be weighed against the
ethical and operational costs of restricting access to information. To meet
its transparency obligations, PHEMCE should have a formal procedure for
justifying any such restrictions, and those decisions should be documented
for independent review. Greater transparency can also be achieved via an
advisory committee with the ability to provide oversight and review of
PHEMCE actions (see Chapter 4).
Accountability
Accountability requires that decisions are evidence based, the rationale
is clear, and PHEMCE has coordinated input from federal agencies and
other partners to reach collaborative decisions. PHEMCE’s actions should

also demonstrate commitment to long-term, public well-being and remain

independent of undue political influence (Fernandez Lynch et al., 2021).
Accountability is enhanced by formal processes and regular reassessment,
such as through metrics-based evaluations or unbiased after-action reviews
of emergency responses, to learn how to improve practices (see Chapter 3).
One option would be to have such evaluations conducted by a knowl-
edgeable third party, such as GAO. To ensure that decisions are based on
available evidence, PHEMCE will need senior government officials (cabinet
members, presidential appointees) who demand objective action, supported
by independent experts who can review its work.
As a steward of public funds, PHEMCE must demonstrate respon-
sible management of resources, especially in the scarcity and time pressure
that characterize PHEs. A commitment to stewardship must be reflected
in PHEMCE processes and by ensuring MCMs maximize benefit to the
public. PHEMCE’s role in MCM preparedness and response requires an
enterprise that manages resources efficiently in day-to-day work, with-
out compromising on quality. This enables PHEMCE member agencies
to respond rapidly to meet emergent needs during a PHE. Stewardship
also requires that the costs (e.g., money, time, manpower, socioeconomic
disruption) associated with making MCMs available are balanced against
improved public health protection, and MCM utility in a multitude of
public health emergency contexts (Lurie, 2021).
Operations
Additional operational principles are crucial for PHEMCE’s successful
function: effectiveness, adaptability, systems approach, collaboration, and
metrics-driven were mentioned frequently in presentations to the committee
as areas where PHEMCE could be improved.
Effectiveness
For PHEMCE to be effective, MCM will need to be successful from
conception through production, storage, delivery, and actual use. Effective-
ness requires that evidence-based decisions lead to desired impacts:
• Evidence-based decisions—PHEMCE products and operations

require a sound decision-making process informed by the best-
available evidence. PHEMCE must also have access to relevant
expertise to guide decision making for MCM planning and imple-
mentation. In rapidly evolving PHEs, evidence is often sparse, hard
to obtain, or disputed; PHEMCE will need to leverage judgment
from trusted experts.

• Impact—PHEMCE must demonstrate impact, for partners and the

public, by ensuring that MCM with demonstrated efficacy reach
affected populations in a timely manner to mitigate potential harm.
This impact includes successfully managing the entire MCM life
cycle, from conception through development, production, storage,
distribution, and use. To protect elements of public health identi-
fied by its mandate, PHEMCE must ensure effective MCMs are
available or rapidly obtainable to respond to a range of PHEs, with
inventories monitored to allow stakeholder planning.
Adaptability
PHEMCE’s role in preparing for and responding to PHEs requires that
it is able to respond nimbly to unexpected and evolving situations (HHS,
2017). PHEMCE must address both new opportunities and threats and
ensure the long-term project investment needed to see progress (Altevogt,
2021). Specific processes, including for obtaining authorization, funding,
reprogramming funds, contracting, and development, must explicitly allow
for supporting both preparedness and acute emergency response phases.
Mechanisms for risk sharing between PHEMCE member agencies and
partners is also essential to support adaptability while maintaining trust in
the enterprise (see Chapter 4).
Systems Approach
Investment in the MCM system, in addition to the products, is needed to
deliver on PHEMCE’s mission (Hatchett, 2021). Taking a systems approach
requires considering the life cycle of each MCM asset across the portfolio,
including facilities, supply chains, quality management, and workforce, from
development to delivery stages, and results in prioritizing across scenarios.
A systems approach also requires appropriate engagement and com-
munication with the public throughout the MCM life cycle. For this to be
successful, PHEMCE member agencies must make efforts to understand
and prioritize end-user needs across the system—which is critical to equity.
Delivering on the historical end-to-end mission will require member agen-
cies to sustain meaningful engagement with and sufficient resourcing of
actors across the system, in addition to end users at state and local levels
(Lamprecht, 2021).
Collaboration
PHEMCE requires formal authority to convene public- and private-
sector actors, allocate budgets, and coordinate joint decision making among

its partners.3 PHEMCE structure and processes should facilitate collabora-

tion and trust at interagency, interagency, and individual staff levels with
the ability to adapt quickly per the needs of activities. PHEMCE’s role also
requires meaningful relationships and coordinating mechanisms able to
provide both continuity and rapid response adaptation with federal agen-
cies, private companies, and state or local entities (see Chapter 4).
Metrics-Driven
It is essential to measure in order to constantly improve PHEMCE’s
capability to prepare and respond. Metrics are necessary to facilitate q
uality
improvement by benchmarking within and across organizations, moni-
tor progress toward goals, enhance performance (see Chapter 3), ensure
accountability, meet end-user needs, and track impact (Swann, 2021).

Robust metrics are required for each of PHEMCE’s functions.
Strategy
Under the requirements of section 2811(d) of the Public Health Ser-
vice Act (PHSA) and amended by section 102 of the PAHPRA, ASPR must
“develop and submit to the appropriate committees of Congress a coordi-
nated strategy and accompanying implementation plan for medical counter
measures to address chemical, biological, radiological, and nuclear threats”
(HHS, 2017) in consultation with the directors of PHEMCE member agen-
cies annually. However, the SIP was last published in December 2017 (GAO,
2021). As recommended in the National Strategy for a Resilient Public Health
Supply Chain, reporting annually will help ensure that Congress remains
informed about the most current state of MCM preparedness (HHS, 2021).
PHEMCE’s strategy should have short-, mid-, and long-term goals that
are developed and shared with nonfederal and private-sector partners and
stakeholders. PHEMCE’s strategy must include objectives consistent with
its mission, directed by status, which describe how it will deliver the right
products, at the right time, and to the right population, such as the following:
• Identifying, aligning, and communicating the operational role of

each member and enterprise partner in executing PHEMCE process
and outcome.
• Establishing and monitoring annual product development goals
with member-specific responsibilities in the process and progress
measured with functional metrics.
3 (2015). 42 U.S. Code § 300hh-10a—Public Health Emergency Medical Countermeasures
Enterprise.

• Monitoring the industrial base for vulnerabilities in MCM produc-

tion and distribution and, when identified, acting to mitigate them.
• Establishing a transparent system for MCM distribution and
administration.
• Establishing an accountable lead from a PHEMCE member agency
to provide a smooth transition of leadership between emergency
phases.
Budget
Under section 2811(b)(7) of the PHSA, ASPR is required to submit a
coordinated 5-year budget plan for PHEMCE, with annual reviews and
updates (HHS, 2019). The multiyear budget plan requirement can be b etter
leveraged by adopting a life cycle management approach and aligning
budget planning across all PHEMCE member agencies. In consideration
of budget requirements, PHEMCE must consider all members’ budgetary
resources. While many MCM development efforts are vital to long-term
capabilities, these efforts ultimately become useless when there is no long-
term budget planned to continue the purchase of the developed MCMs. The
disparity between investment in initial development particularly through
BARDA and the ability for the SNS to continue long-term investment with-
out more resources is untenable.
A life cycle management approach to MCM, with detailed budget plans
covering all stages —from requirements setting to distribution—will help to
ensure that funds are sufficient for various stages of development. More ac-
curate funding allocation can be achieved through a probabilistic approach
based on anticipated project success. Furthermore, joint, complementary
budget submissions, with harmonized agency schedules and functions
across all PHEMCE agencies, would clarify true costs of MCM activities
throughout the life cycle to avoid a product in development encountering a
budget gap (Korch, 2021; Swann, 2021). Translating the true costs of end-
to-end product development through the SNS Annual Review is essential to
support a robust annual budget recommendation to the HHS secretary in
order to fully meet preparedness and response goals. As the costs of both
development and procurement are also subject to market forces, negotia-
tions, etc., PHEMCE needs strong authority to negotiate on pricing.
The National Strategy for a Resilient Public Health Supply Chain rec-
ommends supplementing these reporting requirements with annual budget
analysis “to advance MCM preparedness in a fiscally responsible m anner,
industrial base expansion, commercial supply chain and inventory solu-
tions, and the SNS” (HHS, 2021). These reforms’ success depends on
member agencies’ authority to implement the budget and congressional
willingness to approve budget requests.

CONCLUDING REMARKS
The definition of PHEMCE’s mission, scope, and responsibilities has
evolved with the nature of public health needs over the past two decades.
The committee recognizes that opinions differ about PHEMCE’s appropri-
ate role, past performance, and current activities. Given the varied public
health threats facing the nation, and the reality that the different federal
agencies will continue to work on aspects of MCM preparedness and
response, a coordinating body is and will always be needed. PHEMCE is
that body, and its scope, authorities, and responsibilities should reflect its
original mandate as the nation’s primary coordinating body for MCMs.
Guiding principles in ethics, operations, strategy, and budget are neces-
sary to provide a foundation to evaluate or redesign PHEMCE operations
to meet its specific key goals. These principles present a road map for those
functions that permit PHEMCE to fulfill its core mission.
RECOMMENDATIONS
RECOMMENDATION 1. REAFFIRM THE PHEMCE MANDATE.
The Secretary of the U.S. Department of Health and Human Services
and, in turn, the Assistant Secretary for Preparedness and R
esponse
should recognize the critical functions of PHEMCE and reaffirm
PHEMCE’s mandate as the nation’s major coordinating body for all
aspects of U.S. medical countermeasures preparedness and response
programs, as directed by 42 U.S. Code 300hh-10A.
The administration and congressional leadership must provide

PHEMCE with the resources and authorities, both budgetary and
human, necessary to achieve that mission.
RECOMMENDATION 2. ADOPT A SYSTEMS APPROACH.

PHEMCE should conduct its business under the framework of clear
ethical, operational, strategic, and budget goals.
RECOMMENDATION 3. ENSURE THAT PHEMCE STRATEGIES

REFLECT THE PERSPECTIVES OF, AND PROVIDE ACTIONABLE
GUIDANCE TO, ITS PARTNERS AND STAKEHOLDERS.
PHEMCE should ensure that the perspectives of its partners and stake-
holders are incorporated into the PHEMCE Strategy and Implementa-
tion Plan and multiyear budget.
These documents should clearly specify roles, actionable objectives,

accountability, measurable benchmarks, timelines, and budget require-
ments to enable nonfederal and private-sector PHEMCE partners to

make informed, responsible decisions for planning and engagement.

PHEMCE members and representatives should be of sufficient gov-
ernment rank to enable efficient recommendation development and
implementation.
REFERENCES
Altevogt, B. M. 2021. Strengthening PHEMCE through stakeholder engagement and sustain-
able investment. Paper read at PHEMCE: Public Session, Meeting 3.
Fernandez Lynch, H., S. Joffe, and M. S. McCoy. 2021. The limits of acceptable political
influence over the FDA. Nature Medicine 27(2):188–190.
GAO (U.S. Government Accountability Office). 2021. Continued attention needed to enhance
gov/products/gao-21-551 (accessed December 16, 2021).
Hatchett, R. 2021. Committee on Reviewing the Public Health Emergency Medical Counter
measure Enterprise (PHEMCE). Paper read at Committee Meeting 2. Open Session
Speaker Guide. Discussion with PHEMCE Personnel.
HHS (U.S. Department of Health and Human Services). 2012. 2012 Public Health Emergency
Medical Countermeasures Enterprise (PHEMCE) SIP. Washington, DC: HHS.
HHS. 2014. 2014 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)
SIP. Washington, DC: HHS.
HHS. 2015. PHEMCE mission components. https://www.phe.gov/Preparedness/mcm/phemce/
Pages/mission.aspx (accessed October 15, 2021).
HHS. 2017. 2017–2018 Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE) SIP. Washington, DC: HHS.
HHS. 2019. PHEMCE multiyear budget FY 2018–2022. Washington, DC: HHS.
HHS. 2021. National strategy for a resilient public health supply chain. Washington, DC:
HHS.
IOM (Institute of Medicine). 2012. Crisis standards of care: A systems framework for cata-
strophic disaster response: Volume 1: Introduction and CSC framework. Washington,
DC: The National Academies Press.
Korch, G. 2021. Committee on Reviewing the Public Health Emergency Medical Counter
Speaker Guide. Discussion of PHEMCE Management and Operations.
Lamprecht, L. 2021. Committee on Reviewing the Public Health Emergency Medical Counter
Speaker Guide. Sponsor Briefing: Discussion of the Committee’s Charge.
Lurie, N. 2021. Committee on Reviewing the Public Health Emergency Medical Counter
Speaker Guide. What Is the Value of PHEMCE.
Mair, M. 2021. Committee on Reviewing the Public Health Emergency Medical Counter
Speaker Guide. Discussion with PHEMCE Personnel.
Martin, A., R. Orr, K. Peyton, and N. Faulkner. 2020. Political probity increases trust in gov-
ernment: Evidence from randomized survey experiments. PLOS ONE 15(2):e0225818.
McGarry, B. E., D. C. Grabowski, and M. L. Barnett. 2020. Severe staffing and personal
protective equipment shortages faced by nursing homes during the COVID-19 pandemic:
Study examines staffing and personal protective equipment shortages faced by nursing
homes during the COVID-19 pandemic. Health Affairs 39(10):1812–1821.

NASEM (National Academies of Sciences, Engineering, and Medicine). 2020. Framework for
equitable allocation of COVID-19 vaccine. Washington, DC: The National Academies
Press.
Plough, A., J. E. Fielding, A. Chandra, M. Williams, D. Eisenman, K. B. Wells, G. Y. Law, S.
Fogleman, and A. Magaña. 2013. Building community disaster resilience: Perspectives
from a large urban county department of public health. American Journal of Public
Health 103(7):1190–1197.
Powell, T., E. Bellin, and A. R. Ehrlich. 2020. Older adults and COVID-19: The most vulner-
able, the hardest hit. The Hastings Center Report 50(3):61–63.
Seelye, K. Q., A. Jacobs, J. Becker, and T. Arango. 2020. Doctors and governors vie for masks
in cloak-and-dagger deals. The New York Times. https://www.nytimes.com/2020/04/20/
us/coronavirus-states-masks.html (accessed December 16, 2021).
Swann, J. 2021. Performance measures in health and humanitarian supply chains. Paper read
at Committee Meeting 3. Open Session Speaker Guide. What Is the Value of PHEMCE.
Wells, K. B., J. Tang, E. Lizaola, F. Jones, A. Brown, A. Stayton, M. Williams, A. Chandra,
D. Eisenman, S. Fogleman, and A. Plough. 2013. Applying community engagement to
disaster planning: Developing the vision and design for the Los Angeles County Commu-
nity Disaster Resilience Initiative. American Journal of Public Health 103(7):1172–1180.
White House. 2021. American pandemic preparedness: Transforming our capabilities. https://
www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-
Transforming-Our-Capabilities-Final-For-Web.pdf (accessed October 15, 2021).

Ensuring That PHEMCE Decisions and

Recommendations Are Defensible
During the course of its work, the committee heard numerous com-
ments about problems with operations in the Public Health Emergency
Medical Countermeasures Enterprise (PHEMCE). For example, PHEMCE
processes for reviewing, assessing, and procuring medical countermeasures
(MCMs) for the U.S. Strategic National Stockpile (SNS) were described
as not fully scientific, justifiable, transparent, adaptive, or accountable.
Political transitions were described as limiting PHEMCE’s effectiveness,
with changes in the presidency leading to inappropriate neglect of estab-
lished practices and mandates, often without repercussions.1
SOUND BUSINESS PRACTICES
Formal and Informal Processes

Organizations depend on both formal and informal management pro-
cesses for their success. The former provide predictability and account-
ability; the latter provide the detailed local knowledge and personal ties
needed for collaborative efforts, especially for organizations that are tested
in emergencies. The formal processes must be clearly specified and sup-
ported by policies for recruiting, rewarding, and retaining personnel—they
provide predictability and operationalize the principle of accountability
(see Chapter 2). The informal processes must be flexible enough to adapt
1 This section draws on remarks presented during the committee’s third open-session meet-
ing (see Appendix A).
41

to unexpected conditions and have that knowledge incorporated in formal

processes (NRC, 2011a,b).
As not all knowledge is codified in formal procedures, organizations
depend on people who know “how to get things done” and “who knows
what.” Effective organizations support those vital individuals. Ineffective
organizations push them out of the way, losing their institutional knowl-
edge (Hansen, 1999; Kaufman, 1960). The combination of stable formal
procedures and informal interpersonal networks is especially important
when leadership or conditions change (Argote et al., 2018; Fuchs, 2010;
Ren and Argote, 2011).
PHEMCE faces distinct challenges in creating the mutually supportive
formal and informal processes needed for effective, predictable business
practices:
• Coordinate the work of multiple organizations.

• Accommodate personnel changes associated with political events or
public health emergencies (PHEs), including hiring subject-matter
experts for any and all aspects of emergency operations.
• Shift priorities in response to emerging threats.
• Balance competing interests, including political, efficiency, and effec-
tiveness concerns and the considerations of PHEMCE stakeholders.
Quality Management Systems (QMSs) are a recognized way to create

and sustain such organizations.
Quality Management Systems

The U.S. Government Accountability Office (GAO) recommended that the
Assistant Secretary for Preparedness and Response (ASPR) implement records
management practices within PHEMCE after identifying discrepancies in
PHEMCE’s document management practices (GAO, 2021)—a recommenda-
tion that could be readily operationalized within a mission-appropriate QMS.
A QMS creates stable and predictable business practices, structures change
control and documentation practices, and supports a culture of continuous
learning. Widely used and globally accepted QMS frameworks include the
international standards for QMSs and development of Q uality Culture articu-
lated in ISO 90012 and ISO 10018.3 The U.S. Food and Drug Administration
(FDA) has already adopted ISO 9001 in its 2020 Staff M anual Guide, as has
the Pharmaceutical Inspection Cooperation Scheme, a cooperative arrange-
ment of 54 regulatory bodies aligning global pharmaceutical inspection prac-
2 See https://www.iso.org/iso-9001-quality-management.html (accessed September 17, 2021).

3 See https://www.iso.org/standard/69979.html (accessed September 17, 2021).

PHEMCE DECISIONS AND RECOMMENDATIONS 43
tices. The International Council for Harmonization of Technical Requirements

for Pharmaceuticals for Human Use (ICH) published the Q10 Pharmaceutical
Quality System,4 which is considered guidance in the United States but a rule
elsewhere. The International Society for Pharmaceutical Engineering published
its Baseline Guide 55 on Commissioning and Qualification of pharmaceutical
manufacturing facilities and Good Automation Manufacturing Practices6 for
ensuring quality management in manufacturing facilities. These systems have
been used by global concerns that routinely face demanding timelines and
high failure costs. In addition to renewing systemic oversight of PHEMCE
procedures, adopting a QMS using one of them would stabilize operations via
terms and practices compatible with its national and international partners,
increasing trust and efficiency in interactions with them.
Addressing Conflicts of Interest

Similar to government agencies, PHEMCE must avoid conflicts of inter-
est (COIs) to the extent possible. These may arise when setting priorities
and fulfilling them. PHEMCE’s complex partner networks (e.g., developers,
manufacturers, consultants), spread across agencies with different disclo-
sure requirements, can make it difficult to observe conflicts and violations.
The pressures of PHEs can hamper normal vetting procedures. QMS can
reduce these risks, by anticipating and addressing potential problems, while
increasing transparency.
The committee suggests that PHEMCE and ASPR consider two specific
options:
• A firewall between PHEMCE and the Biomedical Advanced

Research and Development Authority (BARDA), so that PHEMCE
decisions on developing MCMs are independent of BARDA’s execu
tion of those decisions.
• A COI policy that is as robust as the COI policies of PHEMCE
partner agencies, such as FDA’s prohibited financial interests
guidance7 and the Defense Advanced Research Projects Agency’s
(DARPA’s) contract management procedures.8
4 See https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-
harmonisation-technical-requirements-registration-pharmaceuticals-human_en.pdf (accessed
September 17, 2021).
5 See https://ispe.org/publications/guidance-documents/baseline-guide-vol-5-commissioning-
qualification-2nd-edition (accessed September 17, 2021).

6 See https://ispe.org/product-types/gamp-good-practice-guides (accessed September 17, 2021).
7 See https://www.fda.gov/about-fda/ethics/fact-sheet-prohibited-financial-interests-fda-
employees (accessed September 3, 2021).

8 See https://www.darpa.mil/work-with-us/contract-management (accessed September 3,
2021).

PRIORITY SETTING
While a current description of the PHEMCE priority-setting process
was not provided to the committee, it is known that PHEMCE’s prior-
ity setting is built around threats to national security identified by DHS.
PHEMCE needs a transparent, publicly acceptable process for defining its
priorities, recognizing these as ethical decisions, based on scientific evi-
dence, not technical, bureaucratic ones. Clear definitions of priorities would
be critical to focus on the enterprise’s needs and give partners greater con-
fidence in engaging with clarity of timeline and expected investment. This
would provide a stronger environment for strengthening the industrial base.
Faced with a related priority-setting dilemma, the National Academies
Committee on Equitable Allocation of Vaccine for the Novel Coronavirus
adopted a process that might guide PHEMCE priority setting (NASEM,
2020):
• adopting widely acceptable ethical principles (maximize benefits,

equal regard, mitigate health inequities, fairness, evidence based,
transparent);
• translating those principles into easily understood quantitative
measures (probability of getting the disease, probability of severe
consequences, probability of transmitting to others, impact on
others if unavailable);
• using readily available (or produced) data to estimate those four
measures for various population groups (e.g., first responders,
K–12 teachers and staff and child care workers, children);
• setting priorities using those estimates;
• conducting sensitivity analyses to identify priorities that would
change with changes in the estimates or external circumstances;
and
• establishing two-way communications with stakeholders to under-
stand their concerns, ensure their understanding, and increase the
legitimacy of its priorities.
Since the committee’s review was limited to the scarce vaccine supply,
PHEMCE would have to consider how it can embrace such an approach
within the constraints of its own scope (e.g., a broad range of MCM
addressing a large threat space, often with sparse data).
Box 3-1 shows the criteria used in the 2014 PHEMCE SIP (ASPR,
2015), which can inform the work of a revitalized PHEMCE and its
broad mission space while also adopting a principled approach akin to
the Framework for Equitable Allocation of COVID-19 Vaccine. Details
on the committee’s analytical and consultation process can be found in
its report (NASEM, 2020), which draws on the extensive research litera-

BOX 3-1
PHEMCE Prioritization Framework
Two Core Principles

• Limit adverse health impacts
• Be prudent with resources—fiscal responsibility
Primary Criteria
• Threat: Address high-priority threats that pose greatest threat to national
health security for which sufficient MCM capabilities do not exist
• Multifunctionality: Prioritize investments that address multiple threats, have
routine public health uses, and/or leverage commercial markets
• Operational Capacity: Determine the degree to which a product is opera-
tionally and logistically practical and acceptable to its end users
Moderating Criteria
• At-Risk Population Needs: Address the needs of all segments of the U.S.
civilian population, including at-risk populations
• Time: Achieve a balance between rapid returns on investment and signifi-
cant gains in capabilities possible through longer sustained efforts
• Cost: Consider life cycle costs (development, acquisition, and sustainment)
SOURCE: Adapted from ASPR presentation Introduction to the PHEMCE (ASPR,

2015).
tures regarding consultative processes, risk communication, and priority

setting (e.g., Fischhoff, 2013; NASEM 2017a,b; NRC, 2008; Pidgeon et
al., 2014).
Threat and Needs Assessment

Risk reflects both the probability of threats and their impact on valued
outcomes (e.g., morbidity, mortality, equity, social, economic, national
morale). The value of an MCM depends on risks with and without that
countermeasure. Establishing the priority for MCM investments requires
estimating those risks and this requires a threat and needs assessment.
For existing MCMs, PHEMCE has used a Preparedness Assessment
Framework to identify gaps and options for closing them (ASPR, n.d.).
When applied comprehensively, it considers the entire MCM life cycle,
including threats to supply chains, storage and maintenance, deployment,
and usability, given recipients’ training, legal constraints, and competing
duties. Such an analytical framework is a natural component of a QMS. By
identifying vulnerabilities, these analyses of threats and needs identify ways

to ensure the usability of existing MCMs, while accepting the priorities that
guided the investment in them.
To identify future MCM needs, the analytical approach must suit the
problem. Probabilistic risk analysis is appropriate for problems where risk
factors can be quantified, by reliable observation, modeling, or expert judg-
ment (Fischhoff, 2015; Morgan, 2017). Two National Academies work-
shops on gain-of-function research aired many concerns about extending
such a nalyses beyond PHEMCE’s domain (NASEM, 2016; NRC and IOM,
2015). Simulation and tabletop exercises can stress test a supply chain for
robustness and resilience (Gao et al., 2019) while building informal organi-
zational ties. Additionally, machine learning and artificial intelligence may
provide unique insights, when training sets are available to calibrate the
quality of predictions, though such tools would require enhanced transpar-
ency to maintain their credibility.
Creating a shared understanding of such potentially complex, uncer-
tain, and changing analyses will require a concerted effort. Without it,
effective collaboration and trust may be impossible. In its threats and needs
assessments, PHEMCE leadership may wish to consider the Benefit-Risk
Framework adopted by FDA’s Center for Drug Evaluation and Research
and Center for Biologics Evaluation and Research (FDA, 2018). Designed to
navigate uncertain and sparse data, the framework creates a shared top-level
summary table, pooling estimates and interpretations from diverse experts.
FDA uses it to both coordinate the analytical process and communicate with
internal and external stakeholders. Although it may have certain limitations
(NASEM, 2017c), the standard format reflects FDA’s priorities, along with
the supporting evidence, with links to additional documentation.
EVALUATION AND ACCOUNTABILITY
Performance Metrics and Quality Assurance

Measurement drives continuous quality improvement. The ultimate
measure of PHEMCE’s effectiveness is whether it delivers needed MCM at
the right time in the right place to the right people. PHEMCE’s leadership
needs to know not only how well the system is performing overall but also
where it can, and must, be improved (Frazelle, 2002).
PHEMCE needs KPIs that assess its efficiency, effectiveness, and equity
for each major threat type. KPIs should provide the information needed by
external stakeholders (e.g., companies stockpiling product, entities admin-
istering it); address the whole of PHEMCE and the life cycle of its MCM,
reflect its overall goals, and inform its budgetary process; and be as stable as
possible, to allow comparisons across time, while being flexible enough to re-
flect changes in PHEMCE and the world, and both backward looking (asking

how the system has performed, and why) and forward looking (asking how
possible actions will affect future performance). As with threat assessments,
these measures should use the best-available methods (e.g., artificial intel-
ligence, decision analytics) while also recognizing their potential limitations.
Evaluation
As part of PHEMCE’s QMS, these summary measures should be com-
plemented by after-action reports, providing narrative root-cause analyses
of PHEMCE successes and failures, and plans to address the failures and
build on the successes. PHEMCE and its nonfederal and private-sector
partners and stakeholders should meet periodically to review its processes
and preparedness. One approach that PHEMCE leadership may consider
is a joint evaluation that it designs and conducts, in collaboration with
independent parties, knowledgeable about PHEMCE but not directly in-
volved in its current operations. These reports could be timed to inform
periodic revisions of its SIP. Another useful evaluation would be a series of
PHEMCE portfolio reviews.
Another form of joint evaluations that could address PHEMCE opera-
tional assumptions is preparedness “sprints”9: rapid simulation exercises,
involving the people and organizations that will use MCM systems, in re-
alistic scenarios, at appropriate scales. They are designed to test processes
and systems for specific scenarios, to reveal gaps and challenges, and should
simulate both likely and emerging threat scenarios, which range in size but
should also dovetail with real-life need and deliver a public good, including
progress toward an MCM for public health.
PHEMCE should make these evaluations as widely available as possi-
ble, resorting to classification or For Official Use Only, only when essential.
DATA SYSTEMS AND TECHNOLOGY

To fulfill its mission, PHEMCE needs reliable, redundant data infra
structure and supporting quality management of MCM life cycles. PHEMCE
must know, and be able to share, the status of its operations in real time.
That infrastructure should have the properties of robust data systems
(Rudolph, 1989). The committee understands that the current system lacks
these properties, in part due to the lack of a robust digital infrastructure
throughout the federal government limiting PHEMCE’s ability to protect
the American people, but believes that aspirational goals for updating the
data infrastructure are key to a re-envisioned PHEMCE.
9 This section draws on remarks presented to the committee by Matthew Hepburn during
the public workshop of the committee’s third meeting (see Appendix A).

• Reliability and Availability. The data infrastructure and the mea-

sures it provides must allow real-time analyses meeting PHEMCE’s
needs. The system must be resilient to natural disasters and cyber-
security threats.
• Serviceability. The data infrastructure must require little mainte-
nance that interrupts its service and be usable by operators.
• Interoperability. The data system must support pooling data from
multiple sources, so that it is interoperable with federal agencies
and relevant external entities.
• Scalability. The data system must be adaptable to preparedness
and response activities of the different types and scales, within
PHEMCE’s responsibility.
A cross-HHS data system that provides information from raw materials

to “last-mile” capability is ideal. Its utility is first and foremost to identify
areas of vulnerability that need to be addressed nimbly and strategically.
It should also be useful for regulators and response and logistics planning.
While classification concerns pose challenges for cross-agency data systems,
too much classification limits sharing of and access to information that
encourages innovation and participation.
CONCLUDING REMARKS
The committee heard many reports of failures in PHEMCE’s opera-
tions. While it could not investigate these, it could observe that PHEMCE
needs strengthening in several areas essential to its mission, including sound
business practices, support for priority setting, and tools for evaluation and
accountability.
RECOMMENDATIONS
RECOMMENDATION 4. USE MEASURABLE OUTCOME METRICS.
PHEMCE processes should be metrics-driven with meaningful and
measurable outcomes that align at interagency and individual agency
levels and performance. PHEMCE should agree upon and articulate
metrics in the PHEMCE Strategy and Implementation Plan and assess
its progress toward strategic goals, outcomes, and processes across
component agencies.
As a regular part of quality assessment, PHEMCE should perform

rigorous and regular testing and evaluations of its preparedness and
response capabilities and capacities to security threats encompassed in
its mission. PHEMCE should consider working with an objective third

party for these evaluations, to further strengthen their objectivity and

value.
RECOMMENDATION 5. ESTABLISH AN INTEGRATED AND

ACCESSIBLE MCM DATA SYSTEM.
PHEMCE should establish an integrated and accessible data system to
support monitoring, evaluation, and quality management of end-to-end
medical countermeasure activities.
The data infrastructure must facilitate identifying vulnerabilities and

solutions for the entire MCM research, development, and deployment
life cycle. That system must be reliable and available to nonfederal and
private-sector partners and stakeholders, serviceable, interoperable,
and scalable while maintaining appropriate levels of security.
REFERENCES
ASPR (Office of the Assistant Secretary for Preparedness and Response). 2015. Introduction to
the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). Material
shared by ASPR and accessible by request in the committee’s public access file.
ASPR. n.d. [unpublished]. Preparedness assessment framework. Material shared by ASPR and
accessible by request in the committee’s public access file.
Argote, L., B. L. Aven, and J. Kush. 2018. The effects of communication networks and turnover
on transactive memory and group performance. Organization Science 29(2):191–206.
FDA (U.S. Food and Drug Administration). 2018. Benefit-risk assessment in drug regulatory
decision-making. https://www.fda.gov/media/112570/download (accessed October 15,
2021).
Fischhoff, B. 2013. The sciences of science communication. Proceedings of the National
Academy of Sciences of the United States of America 110(Suppl 3):14033–14039.
Fischhoff, B. 2015. The realities of risk-cost-benefit analysis. Science 350(6260):aaa6516.
Frazelle, E. 2002. Supply chain strategy: The logistics of supply chain management. New
York: McGraw-Hill.
Fuchs, E. R. H. 2010. Rethinking the role of the state in technology development: DARPA and
the case for embedded network guidance. Research Policy 39:1133–1147.
Gao, S. Y., D. Simchi-Levi, C.-P. Teo, and Z. Yan. 2019. Disruption risk mitigation in supply
chains: The risk exposure index revisited. Operations Research 67(3):831–852.
Hansen, M. T. 1999. The search-transfer problem: The role of weak ties in sharing knowledge
across organization subunits. Administrative Science Quarterly 44(1):82–111.
Kaufman, H. 1960. The forest ranger: A study in administrative behavior. Washington, DC:
Resources for the Future.
Morgan, M. G. 2017. Theory and practice in policy analysis. Cambridge, UK: Cambridge
University Press.
NASEM (National Academies of Sciences, Engineering, and Medicine). 2016. Gain-of-function
research: Summary of the second symposium, March 10–11, 2016. Washington, DC: The
National Academies Press.

NASEM. 2017a. Building communication capacity to counter infectious disease threats: Pro-
ceedings of a workshop. Washington, DC: The National Academies Press.
NASEM. 2017b. Communicating science effectively: A research agenda. Washington, DC: The
NASEM. 2017c. Pain management and the opioid epidemic: Balancing societal and individual
benefits and risks of prescription opioid use. Washington, DC: The National Academies
Press.
NASEM. 2020. Framework for equitable allocation of COVID-19 vaccine. Washington, DC:
The National Academies Press.
NRC (National Research Council). 2008. Public participation in environmental assessment
and decision making. Washington, DC: The National Academies Press.
NRC. 2011a. Intelligence analysis for tomorrow: Advances from the behavioral and social
sciences. Washington, DC: The National Academies Press.
NRC. 2011b. Intelligence analysis: Behavioral and social scientific foundations. Washington,
NRC and IOM (National Research Council and Institute of Medicine). 2015. Potential risks
and benefits of gain-of-function research: Summary of a workshop. Washington, DC:
Pidgeon, N., C. Demski, C. Butler, K. Parkhill, and A. Spence. 2014. Creating a national
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Berlin/Heidelberg: Springer. Pp. 132–143.

Engaging Nonfederal and

Private-Sector Partners and
Stakeholders in PHEMCE’s Mission
The U.S. medical countermeasure (MCM) enterprise is interconnected,

complex, and dynamic. It includes public and private entities that (1) develop
and manufacture new and existing MCMs; (2) ensure procurement, stor-
age, and distribution of MCMs; and (3) administer, monitor, and evaluate
MCMs. The Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE) has authority to convene federal entities. However, it must also
collaborate closely with nonfederal and private-sector partners and stake-
holders, as they are the ultimate implementers of PHEMCE’s mission and
develop, manufacture, distribute, and administer the MCMs over which
PHEMCE has responsibility. These engagements must support the entire
life cycle of MCM preparedness and response, where appropriate, including
threat identification, development, manufacturing, deployment, distribution,
administration, and evaluation. PHEMCE should provide opportunities for
iterative feedback before, during, and after each of stage (Fuchs, 2021).
This report is not the first to call for these important efforts. After
the 2009 H1N1 pandemic, the President’s Council of Advisors on Science
and Technology called for “a new way of doing business” and stated that
“[w]hatever the details of this new management structure, it is essen-
tial that any planning activities for this reengineering take place with the
full cooperation and participation of the private sector” (PCAST, 2010,
p. 57). The 2021 government report National Strategy for a Resilient Public
Health Supply Chain similarly directed PHEMCE to “coordinate with rel-
evant stakeholder groups to build and strengthen communication, identify
and close gaps, and build collaborative solutions that more efficiently lever-
age government resources and stabilize private-sector investment” (HHS,
51

2021a, p. 40). It can overcome the complex series of challenges of its

critical mission by strengthening these relationships across the enterprise
and specifically between federal partners and nonfederal and private-sector
partners and stakeholders.
This chapter describes challenges to creating and sustaining these vital
partnerships with nonfederal and private-sector partners and stakeholders,
along with potential solutions involving transparent two-way communica-
tions that engage them in PHEMCE decision making; taking advantage of
partnership levers that will enhance PHEMCE’s capacity to meets its mission;
and collaborating with global governmental and nongovernmental entities
to enhance effectiveness. These analyses and recommendations reflect docu-
ments and testimony presented to the committee, its m embers’ experience,
and scientific research on individual and organizational d ecision-making
processes.
INCORPORATING NONFEDERAL AND

PRIVATE-SECTOR PARTNERS AND STAKEHOLDERS
INTO PHEMCE DECISION MAKING
While the federal PHEMCE partners set policy, secure resources,
rchestrate the component functions, and manage programs, this commit-
o
tee recognizes the near complete dependence on nonfederal and private-
sector partners and stakeholders. PHEMCE cannot achieve its mission
objectives without the successful performance, expertise, knowledge, expe-
rience, engagement, and support of these partners and stakeholders, who
also have a responsibility to actively understand PHEMCE’s mission and
communicate their needs and preferences.
These partners and stakeholders include, but are not limited to, state
and local governments, private developers, manufacturers, distributors,
public health, community-based organizations, and public and private
health care organizations that deliver services in PHEs. The committee
recommends that PHEMCE leadership create a standing advisory com-
mittee incorporating representatives of these partners and stakeholders,
experts with the technical knowledge that its mission demands (e.g., differ-
ent stakeholders and business leaders with various expertise could weigh in
on marketing, MCM research and development, production, distribution,
etc.), and ex officio members.
Other advisory committees currently play vital roles on issues within
PHEMCE’s remit. For example, the Advisory Committee on Immunization
Practices (ACIP), which advises the Centers for Disease Control and Preven-
tion (CDC), and the National Vaccine Advisory Committee (NVAC), which
advises the U.S. Food and Drug Administration (FDA), provide a reli-
able, enduring conduit for two-way communication to ensure coordination

ENGAGING NONFEDERAL AND PRIVATE-SECTOR PARTNERS AND STAKEHOLDERS 53
among the parties. Both are primarily composed of scientific leaders, with
a liaison committee with representatives of partner and stakeholder orga-
nizations (CDC, 2021; HHS, 2021b). These committees hold public meet-
ings and also serve to broadly communicate their entity’s roles, decisions,
and priorities, which also demonstrates the value of the federal mission to
important potential champions, such as the public and policy makers (e.g.,
members of Congress). ACIP and NVAC are effective because they have a
clear scope of responsibility and engage in specific, focused tasks and mis-
sions (approval and recommendations for vaccines) with those recommen-
dations directed to FDA and CDC. PHEMCE has a broader membership
and much broader scope of practice, and PHEMCE decisions are by their
nature typically inherently governmental or highly complex. Some decisions
must be considered and made in highly classified environments, and it will
be helpful to define what exactly such a committee would be able to provide
input on for decision making without disclosure issues. Therefore, to be
successful, this advisory committee will require appropriate resources, in-
cluding staffing and leadership, and a clearly defined scope of responsibility.
Additional examples, both domestic and international, establish the
relevant precedent. One is the Federal Emergency Management Agency
(FEMA) National Advisory Committee, which focuses on decisions in the
emergency preparedness and response space, similar to PHEMCE, and
also can convene related subcommittees and include ex officio members
(FEMA, 2021). The National Biodefense Science Board (NBSB) provides
expert advice to the U.S. Department of Health and Human Services (HHS)
secretary and the Assistant Secretary for Preparedness and Response (ASPR)
on public health emergency (PHE) issues. The proposed advisory committee
would differ from NBSB in that it would serve PHEMCE, a coordinating
body, and advise the numerous PHEMCE member agencies (ASPR, 2020a).
Additional precedent also exists in the World Health Organization (WHO)
International Health Regulations Emergency Committee, which advises the
director-general on when to declare PHEs of international concern (WHO,
2021a). More broadly, WHO uses the Independent Oversight and Advisory
Committee for its Health Emergencies Program, which also serves to guide
and advise the director-general regarding more broad health issues (WHO,
2021b). The advisory committee should consider short-, mid-, and long-
term issues on strategic and operational topics, including managing part-
nerships for private-sector MCM development, balancing MCM portfolio
management, and leveraging existing and new technologies. In addition to
regular review of core topics, the advisory committee would address emerg-
ing ones, both of its own choosing and raised by PHEMCE leadership. It
would pay particular attention to historically problematic topics, such as
pivoting to new technologies, ensuring last-mile MCM distribution and
allocation realities, incorporating end-user concerns in product develop-

ment and testing, and creating realistic expectations regarding timelines and
supplies. The committee must also be flexible enough to convene ad hoc
meetings and subcommittees to expand the scope of intellectual capabil-
ity and the reach of PHEMCE when necessary, as exhibited by the WHO
International Health Regulations advisory committee. While an advisory
committee cannot make decisions, a mechanism should be put in place to
ensure consideration and, where possible, to encourage that PHEMCE’s
federal agency members act on recommended decisions.
One major benefit of a properly constituted (diverse, inclusive, and rep-
resentative) partner and stakeholder advisory committee is improved ability
to address health equity issues, a primary PHEMCE goal (see Chapter 2).
Two-way communication with state, local, and community partners, who
can apprise PHEMCE of the issues, aid it in creating responsive solutions,
and help with their execution. Partners and stakeholders in direct contact
with vulnerable populations are in the best position to serve these repre-
sentative roles.
The technical experts on the advisory committee should be scientists
and engineers who are broadly informed about cutting-edge research that
is either ready for application or could be with suitable investments. They
should have expertise across the MCM life cycle, including innovation, test-
ing, manufacturing, distribution, usage, finance, and regulation.
The advisory committee should be engaged in designing, observing, and
reviewing the evaluations essential to PHEMCE’s transparency, accountabil-
ity, performance, and continuous learning. That includes metrics, exercises,
audits, annual reviews, and after-action analyses. As discussed in Chapter 3,
these evaluations provide triangulating perspective on problematic issues
such as appropriate turnover of products in the SNS and the readiness of
partners and stakeholders who will play roles in PHEs.
Enhancing Two-Way Communication and Transparency with

Nonfederal and Private-Sector Partners, Stakeholders, and the Public
An effective advisory committee affords two-way communication with
those represented on it. PHEMCE also needs effective two-way communica-
tion with the diverse individuals, organizations, and communities whose trust
is essential to its mission. An important issue that needs to be a ddressed is
how to make sure the public will be willing to use MCM as recommended.
PHEMCE could do a “perfect” job preparing, responding, and delivering
MCM, but that does not mean that the public will comply. Such communi-
cation provides the accountability and transparency needed for PHEMCE
to understand public needs and develop products that people will use (e.g.,
without the pushback seen with the COVID-19 vaccines). As discussed in
Chapter 2, transparency is an ethical obligation and essential to effectiveness.

PHEMCE can reduce needless conflict by creating a shared understand-

ing with effective, evidence-based communication that is both culturally
and linguistically appropriate and tailored to the literacy and understanding
of varied population groups. That demonstrates that PHEMCE hears, re-
spects, and understands the concerns, needs, and challenges of its partners,
stakeholders, and the public well enough to address its information needs
regarding PHEs and plans for meeting them. PHEMCE should be a trusted
source of information. PHEMCE must hear their concerns and address their
needs, for both information and communication that reflects that strategies
and plans have taken inequities into consideration. Engagement with the
public needs to respect their right to know and be heard. Effective two-way
communication is essential to PHEMCE’s mission but also to overall PHE
response.
Two-Way Communication
PHEMCE’s communications require a strategic approach. It must en-
gage groups that vary in their knowledge, experiences, needs, and resources
and their trust in PHEMCE and its partners. It must manage media environ-
ments rife with misinformation and where complex interactions between
where science and politics mix in complex ways. It must convey such chal-
lenging content as the following:
• Technical information (e.g., about diseases, weapons of mass

destruction [WMDs], and countermeasures);
• Uncertain information that may change with evolving science and
circumstance;
• Policies that must balance costs and benefits to different groups;
• Proper interpretations of unintuitive lay observations (e.g., random
“clusters” of apparent side effects, exponential processes that grow
unexpectedly fast);
• Priorities influenced by classified information that cannot be shared
without compromising the public’s security;
• Priorities influenced by proprietary information that must be made
transparent without compromising intellectual property; and
• Willful dissemination of misinformation, which valid information
must preempt.
To these ends, PHEMCE must create trusted two-way communica-

tion channels allowing it listen and speak to these diverse groups. It needs
trusted partners who know these groups’ needs and concerns and can tailor
trusted messages explaining its responses to them (IOM, 1999; NASEM,
2020; NRC, 2008). Communication content and process must complement

one another, with timely, relevant, comprehensible messages demonstrating

that PHEMCE recognizes these diverse groups’ needs (NRC, 1989). Sound
communications preempt misinformation, whose effects can be hard to undo
(Lewandowsky, 2021; NASEM, 2021a,b; Rathje et al., 2021). Trust must be
established prior to a PHE, if the parties are to work collaboratively.
Various models (in person and not) exist for two-way communication
in the federal government. For example, FDA created a Voice of the Patient
Initiative to understand the realities facing its stakeholders. It included
regional meetings on sensitive subjects (e.g., chronic fatigue syndrome,
sickle cell disease) designed to hear from people whose voices are normally
missing (e.g., patients, providers, caregivers, advocates). These listening ses-
sions provided opportunities to hear life experiences, ask questions about
unmet needs, and demonstrate good faith. PHEMCE leadership might
consider similar consultations to reduce the risk and appearance of losing
touch with the diverse external stakeholders depending on its success. The
proposed advisory committee should include such processes. Without them,
PHEMCE cannot ensure equity and fairness in its operations.
Transparency as an Obligation
PHEMCE has an obligation to be fair, transparent, and accountable
to the public it serves, demonstrating that it treats nonfederal and private-
sector partners and stakeholders equitably and has done everything possible
to support them during PHEs (see Chapter 2). Without transparency, others
may lose trust in PHEMCE’s products, directives, and communications.
Without accountability, PHEMCE cannot expect nonfederal partners and
stakeholders to work with it. Thus, the federal agency members that com-
prise PHEMCE must honor promises and contracts, subject to independent
evaluations (see Chapter 3).
The committee heard descriptions of major procurement decisions that
appeared to violate good business practices, including major investments re-
directed or terminated without adequate communication or justification and
decisions made outside established channels. Such practices undermine the
quality of PHEMCE’s work by preventing critical review of products, ven-
dors, and user readiness. They also undermine the legitimacy of PHEMCE’s
work by suggesting COI. All of PHEMCE’s federal agency members’ busi-
ness agreements should be transparent, providing vendors with clear, explicit
and stable agreements as required by ethical business practices.
Limits to Transparency
The committee heard evidence suggesting both inappropriate sharing
and inappropriate secrecy of sensitive information. The committee under-

stands there can be tension between the demands of transparency and the
need to protect information that may compromise national biosecurity or
intellectual property. Sharing classified information can aid adversaries.
Sharing proprietary information can limit private partners’ willingness and
ability to participate. Conversely, failing to share security-related informa-
tion can deny partners and stakeholders knowledge that is essential to their
duties and impair preparations, responses, and coordination.
PHEMCE must develop policies that balance legitimate needs for
secrecy with the demands for communication and transparency, in con-
sultation with its partners and stakeholders and informed by practices in
other domains (NASEM, 2017). When PHEMCE decisions must rely on
restricted data, it should use clear protocols for making and documenting
those decisions. Its partners and stakeholders must be made aware of what
information has been withheld.
Clarifying Roles and Expectations with Nonfederal

and Private-Sector Partners and Stakeholders
A lack of clarity and consistency in priorities and goals can lead
to fragile partnerships. PHEMCE must establish clear, consistent roles
and expectations in dealings with all nonfederal and private-sector part-
ners and stakeholders engaged with a threat or product. It must clarify how
risks are shared, how success is measured, where accountability (and for
what) resides, and how the system is sustained. PHEMCE must be a reliable
partner, and its business practices must be flexible and adequately prepared
to give related industries a chance to pivot their business priorities as needs
can quickly shift. It must have orderly processes for revisiting these roles as
conditions change, as when manufacturing is relocated, transport systems
are disrupted, staff are unavailable, or PHEs are imminent. Given its overall
perspective and responsibility, and the diverse perspectives of its members,
the advisory committee should be actively involved in developing these
processes, specifying performance metrics (see Chapter 2), and evaluating
their success (see Chapter 3).
It is critical to engage these entities meaningfully and substantively,
particularly during preparedness as opposed to only in PHEs. By building
up preparedness capabilities, PHEMCE can, and must, have a much more
accountable system for developing and acquiring products amenable to effec-
tive use by nonfederal and private-sector partners and stakeholders for PHEs.
As the nation’s MCM coordinating body, it is essential for PHEMCE
to ensure sufficient engagement and partnering with these nonfederal and
private-sector partners and stakeholders is occurring, with appropriate
metrics and evaluation in place to ensure that such partnerships are capable
of the agile, adaptable response that is needed in a PHE.

Workforce Alignment and Recruitment

PHEMCE needs a strong industrial base with a trained workforce
for producing and distributing MCM, before and during PHEs. All of the
federal agencies involved need better ways and means to recruit, train,
and retain technical talent. PHEMCE leadership, in consultation with its
advisory committee, can ensure the long-term commitment, inside and
outside government, to create these capabilities. The National Strategy for
a Resilient Public Health Supply Chain directs PHEMCE to “coordinate a
comprehensive public health supply chain talent and capability study to
identify U.S. Government gaps in skilled labor” (HHS, 2021a, p. 54).
PARTNERSHIP LEVERS
PHEMCE has numerous levers and incentives to create a shared, in-
tegrated approach toward the common goal of national preparedness and
response, including establishing business practices that attract and sustain
high-performing private-sector partners. A second lever is adopting a life
cycle approach for strategic and budgetary planning and management (see
Chapter 2), ensuring the existence and coordination of all needed elements
in MCM readiness. Figure 4-1 depicts such an integrated process. The
advisory committee should provide valuable overview and oversight.
The advisory committee that has been recommended is an important
start toward understanding the needs, concerns, wishes, and other perspec-
tives from nonfederal and private-sector partners and stakeholders. That
understanding can be used to design and choose the right levers to achieve
particular actions in partnerships or collaborations.
FIGURE 4-1 Supply chain actor and potential partnership levers.

NOTE: This figure illustrates examples of supply chain actors and partnership
levers that can sustain partnerships to develop, produce, procure, transport, and/
or administer MCMs.

Contracting
PHEMCE contracting should suit the situation, considering factors
such as whether the MCM is new or existing, other markets exist, and the
product supply chain is vulnerable to disruptions. PHEMCE has a range
of such contract options, and Operation Warp Speed (OWS) demonstrated
that contracting can move at/near the speed of science. Here, too, the
advisory committee can inform policy and practice about how PHEMCE
can establish a world-class acquisition capability commensurate with the
demands of the mission.
The committee heard concerns about the need for contracts that would
hold through the entire development process for drugs, diagnostics, and
devices—contingent on suitable performance. Without such guarantees,
potential partners are unlikely to invest their talent and resources. Those
guarantees may include advance purchase commitments, sharing risks be-
tween the federal government and its external partners, and minimum
commitment contracts to bring products to the scale needed for broader
market adoptions.
PHEMCE has a history of partnering with federal and private enti-
ties for distributing and warehousing products during emergencies. Those
arrange ments would benefit from transparent, predetermined contract
mechanisms enhancing the robustness of these critical supply chain com-
ponents during PHEs (see Chapter 5).
Risk Sharing
Informed by its advisory committee, PHEMCE should create policies
that balance risks wisely among its partners and stakeholders. Private-
sector partners should bear some risks while being protected from undue
ones. Health systems should be encouraged to take the financial risks of
creating MCM surge capacity for PHEs, with the assurance of appropriate
reimbursement practices. PHEMCE should engage the Centers for Medicare
& Medicaid Services in creating these policies and encourage educational
institutions, accrediting bodies, state education agencies, workforce invest-
ment boards, and professional societies to invest in programs for expected
workforce needs, by projecting the demand for their graduates.
PUBLIC HEALTH SUPPLY CHAINS AND

STOCKPILING CONSIDERATIONS
Public health supply chains, including the U.S. Strategic National
Stockpile (SNS), are critical to our nation’s preparedness and response.
Responsibility for different parts of this—beyond the SNS—but interacting
with PHEMCE will need to be determined (e.g., it could fall to PHEMCE to

establish a robust industrial base, a resilient public health supply chain, or

a process for updating foundational platform technologies). The National
Strategy for a Resilient Public Health Supply Chain directs PHEMCE to
establish “transformative” business practices to secure the supply chains
needed for MCM preparedness (HHS, 2021a). To that end, PHEMCE must
specify requirements for the security, staffing, and management of public
health supply chains, partnering with the private sector and guided by its
advisory committee. PHEMCE leadership should consider lessons learned
by large organizations (e.g., Walmart, Amazon, World Food Programme),
while recognizing its unique needs (e.g., accepting that some products will
never be used). For some products, the described business partnerships
will not work, such as MCMs that do not have regular demand or the regu-
lar demand is not sufficient to cover the needs of a stockpile. In the former,
it may be necessary to continue stocking some products or consider paying
for capacity that can be rapidly scaled up within manufacturers or research
centers. The National Strategy for a Resilient Public Health Supply Chain
directs PHEMCE to
develop a transformative overarching business framework and strategy,

with a focus on building long-term, end-to-end capabilities that ensure
future readiness of the nation’s public health supply chain while priori-
tizing diverse manufacturing and logistics strategies. This work includes
advising on building public health readiness; enhancing engagement with
pharmaceutical and biotechnology industries to develop and ensure emer-
gency access to novel MCMs; developing requirements and acquisition
processes that ensure new MCMs will meet the needs of the American
public (especially those on the front lines in public health and the medical
community); and prioritizing a comprehensive approach that maximizes
fiscal responsibility through cost-effective strategies by implementing a
“planning, programming, budget, evaluation” life cycle framework that
harmonizes PHEMCE partner missions focused on MCM preparedness.
(HHS, 2021a, p. 38)
U.S. Strategic National Stockpile

The SNS is a critical resource that PHEMCE coordinates (within HHS
and in cooperation with other federal partners), including activities such
as deployment, distribution, dispensing, and administration. Innovations
in how the SNS1 is maintained are a major lever of PHEMCE, and positive
1 The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Multi-Year
Budget notes, “The primary challenge faced by PHEMCE is the sustainability of the MCM
response capabilities and capacities of the SNS built through Project BioShield (PBS). Success-
ful procurement of an MCM obligates SNS to expend additional funding for sustainment.
First, SNS faces replenishment requirements upon expiration for products added to the SNS

changes in partnership with nonfederal and private-sector organizations

could yield cascading benefits for national preparedness and response. Key
stockpiling decisions include what, how much, where, and how to stock;
how to allocate limited resources; and how to resupply. The appropriate-
ness and size of a stockpile may also depend on the type of threat (e.g.,
chemical or radiological threat versus infectious threat with global scale).
One possible strategy is having the federal government maintain physical
stockpiles while relying on private-sector expertise to manage inventory,
especially for products with a short shelf life. Other options include con-
signed inventory, virtual inventory, and reserved capacity (Coleman et al.,
2012). If the business strategy has been tried, root-cause analysis should
be performed and/or external experts consulted to identify if it can be used
more effectively, to promote the availability of critical resources at times
of need. As stated in other documents, the strategies need to be combined
with additional resources for the SNS, both financial and human capital
(Finkenstadt et al., 2020; Gerstein, 2020).
Whatever approach is used, SNS decisions must be defensible, trans-
parent, and fair (see Chapter 2). The SNS must allow for responsiveness to
anticipated threats, sensitivity to relative risks, and equitability, consider-
ing key measures, such as mortality, morbidity, equity, and other societal
costs. Managers of the SNS should use appropriate methods in projecting
demands and supply. The efficient and equitable distribution of scarce
resources during the chaos of a PHE will always be challenging. New
research from various scholars and groups may illuminate improved ways
of enhancing fairness and efficiency of stockpiling and deployment (DeJong
et al., 2020; Emanuel et al., 2020; Minnesota Department of Health, 2021).
PHEMCE must improve the SNS, whose limits hampered early re-
sponse to the COVID-19 pandemic. As noted in Chapter 1, the mandated
SNS annual reviews were not submitted after 2016. Months into the pan-
demic, shortages of PPE, intensive care unit (ICU) medications, ventilators,
and test-kit supplies persisted. Other problems related to the SNS have
been identified, including stockpiles items without fully considering distri-
bution in the last mile, chronic underfunding, expansion of scope over the
years to possibly unrealistic expectations, changes to SNS mission in April
2020, and insufficient planning exercises to uncover potential gaps. Prob-
lems have also been documented in investments, as described elsewhere.
by BARDA through PBS contracts. PBS funding used for initial MCM procurement rarely
supports ongoing maintenance and replacement of the products after it is approved by FDA.
In the past, the PHEMCE SNS Annual Review recommended tradeoffs when available SNS
funds were insufficient to both maintain current capabilities and absorb additional products.
These tradeoffs translated to increasing levels of risk across the threat portfolios potentially
jeopardizing the nation’s ability to realize the full benefits of prior research and development
investments” (emphasis added) (ASPR, 2020b).

A root-cause assessment of SNS failures and limitations should be a high

priority, if PHEMCE is to avoid repeating history. The National Strategy
for a R esilient Public Health Supply Chain recommended that any SNS
expansion be reviewed and validated through PHEMCE (HHS, 2021a).
GLOBAL CONSIDERATIONS AND SYNERGIES

While PHEMCE has long strived to engage international partners,
particularly through the Global Health Security Initiative following the
2015–2016 Ebola outbreaks in West Africa (ASPR, 2017), new entities
were catalyzed and others expanded their efforts. MCM preparedness is
a global effort with partners that include the European Union and non-
governmental organizations (NGOs), such as the Coalition for Epidemic
Preparedness Innovations, Gavi, UNICEF, and the American Red Cross.
PHEMCE should do the following:
• formalize and expand coordination with these global entities;

• look for lessons in the practices and experiences of bodies with
different goals, capabilities, and national and organizational cul-
tures; different countries perceive threats differently, calling for
improved surveillance, information sharing, and development of
new tools, including point-of-care diagnostics and policies regard-
ing emergency deployment of assets related to personnel and stock-
pile sharing;
• use the situational awareness from the collaboration to inform its
understanding of the vulnerability and resilience of public health
supply chains, as seen throughout the COVID-19 pandemic;
• seek and share best practices; and
• create the personal and organizational ties and trust needed in
PHEs; its perspective and experience should also be included for
international negotiations of critical trade deals, treaties, etc., as
many of these are key to resilient supply chains for critical MCM.
CONCLUDING REMARKS
PHEMCE needs a comprehensive approach to integrating nonfederal
and private-sector partners, stakeholders, and communities across its ac-
tivities. That approach should include a strong overarching advisory com-
mittee, respectful two-way communications, clearly delineated roles, and
collaboration with global entities with similar missions.

RECOMMENDATIONS
RECOMMENDATION 6. ESTABLISH AN ADVISORY C OMMITTEE
OF NONFEDERAL AND PRIVATE-SECTOR PARTNERS AND
STAKEHOLDERS.
PHEMCE should develop and maintain an advisory committee of rep-
resentative medical countermeasure partners and stakeholders to both
garner their expertise and ensure transparency in PHEMCE activities.
• The advisory committee’s input should be sought and considered

seriously in all major decisions and actions by PHEMCE regarding
the development and delivery of MCMs.
• The advisory committee should balance external partners and threat
portfolios to ensure the right combination of threat-specific exper-
tise and other relevant expertise on critical issues like supply chain
and stockpiling.
• The advisory committee should help aid PHEMCE in its commu-
nication with nonfederal partners, stakeholders, and the public.
The meetings should be conducted with appropriate transparency,
considering both public discussions and assurances of confiden-
tiality among members, in order to accomplish the intent of this
objective.
RECOMMENDATION 7. IMPLEMENT TRANSPARENT COMMU

NICATION STRATEGIES.
PHEMCE should establish mechanisms for transparent communica-
tions across the government and with nonfederal and private-sector
partners and stakeholders and the public.
Functions and responsibilities of these mechanisms would include the

following:
• Coordinating internal and external communications within PHEMCE

and between PHEMCE and nonfederal and private-sector partners
and stakeholders and the public to ensure trusted two-way commu-
nication channels with all partners and the provision of dependable,
actionable information.
• Balancing the tension between transparency and national security
or proprietary concerns.
• Involving the public to assist in driving messages that resonate
with various communities; political messaging should be discour-
aged. These communications need to be culturally and linguistically
appropriate and tailored to the literacy and understanding of mul-
tiple population groups.

• Providing advance information of MCM priorities for public and

private sectors, as well as the public itself, prior to and during public
health emergencies.
RECOMMENDATION 8. ESTABLISH CLEAR AUTHORITIES,

ROLES, AND RESPONSIBILITIES FOR EXTERNAL PARTNERSHIPS.
PHEMCE should develop, document, and clearly define authority,
roles, and responsibilities among federal and nonfederal and private-
sector partners and stakeholders, whose perspectives on the status and
role of partnerships are vital to the medical countermeasure mission.
PHEMCE should regularly assess the perspectives of federal and non-

federal and private-sector partners and stakeholders on the state of the
partnerships vital to the MCM mission.
RECOMMENDATION 9. CONDUCT A ROOT-CAUSE ASSESSMENT

OF COVID-19 U.S. STRATEGIC NATIONAL STOCKPILE (SNS)-
SPECIFIC LESSONS LEARNED.
PHEMCE should commission an independent, evidence-based root-
cause assessment of lessons learned from COVID-19 and other past
public health emergencies specific to the SNS.
This should include assessing the intended purpose and value of the SNS
annual reviews and whether they drove findings and recommendations
that were tied to meaningful outcome measures, budget justifications,
and accountability across PHEMCE. Any SNS expansion should be
reviewed and validated through PHEMCE. This assessment should
be conducted in the context of the end-to-end mission elements and the
life cycle management of the SNS assets and explicitly coupled with a
prospective risk assessment.
RECOMMENDATION 10. WORK SYNERGISTICALLY WITH

RELEVANT GLOBAL ORGANIZATIONS.
PHEMCE should work synergistically with global and other national-
level organizations with relevant missions and goals to benefit from their
experiences and leverage global expertise and resources as appropriate.
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CTA530-1.pdf (accessed October 11, 2021).
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resilient public health supply chain. https://www.phe.gov/Preparedness/legal/Documents/
National-Strategy-for-Resilient-Public-Health-Supply-Chain.pdf (accessed September 3,
2021)
HHS. 2021b. NVAC members. https://www.hhs.gov/vaccines/nvac/members/index.html (ac-
cessed September 15, 2021).
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Minnesota Department of Health. 2021. Ethical framework for allocation of monoclonal
antibodies during the COVID-19 pandemic. https://www.health.state.mn.us/diseases/
coronavirus/hcp/mabethical.pdf (accessed October 14, 2021).
NASEM (National Academies of Sciences, Engineering, and Medicine). 2017. Dual use r esearch
of concern in the life sciences: Current issues and controversies. Washington, DC: The
NASEM. 2020. Framework for equitable allocation of COVID-19 vaccine. Washington, DC:
NASEM. 2021a. Strategies for building confidence in the COVID-19 vaccines. Washington,
NASEM. 2021b. Understanding and communicating about COVID-19 vaccine efficacy,
effectiveness, and equity. Washington, DC: The National Academies Press.
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National Academy Press.
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PCAST (President’s Council of Advisors on Science and Technology). 2010. Report to the pres-
ident on reengineering the influenza vaccine production enterprise to meet the challenges
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advisory-committee (accessed October 6, 2021).

Legal and Policy Considerations

Underlying PHEMCE Operations
and Implementation
Just as identifying, assessing, and resolving scientific and operational

issues associated with medical countermeasures (MCMs) are critical to
the success of a re-envisioned Public Health Emergency Medical Counter-
measures Enterprise (PHEMCE), effectively assessing, implementing, and
solving legal and policy issues is crucial, particularly because PHEMCE
relies on active and integrated contributions from multiple federal agencies,
state and local governments, and industry partners. PHEMCE’s collective
goal of generating MCMs essential to national security and preparedness
depends on numerous laws that govern their development, production,
assessment, and approval. Distributing and using these MCMs in real-time
public health emergencies (PHEs) pose additional legal and policy chal-
lenges because emergency declarations can shift legal norms and tempo-
rarily change powers at all levels of government (as documented later). A
critical performance objective underlying PHEMCE initiatives is the ability
of public and private sectors to conceptualize, create, and distribute MCMs
using emergency authorities, as seen during the COVID-19 pandemic and
prior PHEs. Meeting this objective is challenging. Actual or perceived
legal and regulatory barriers during declared emergencies can obstruct or
derail laudable program goals. Appropriately implementing and enforcing
existing legal authorities, leveraging untested legal preparedness strategies,
and developing new policies to address emerging issues related to MCM
production and distribution can be precarious. Yet, as described in later
examples, substantial opportunities also arise in declared national emergen-
cies when an array of invoked powers at the federal and state/territorial
levels enables new or flexible approaches. When used effectively and within
67

constitutional boundaries, these powers provide options to ensure timely

execution and implementation of PHEMCE initiatives. Substantial regula-
tory issues related to operationalizing PHEMCE include MCM product
development and approval and concerns among nongovernmental partners
(e.g., manufacturers, distributors). Assessing and solving law and policy
questions in real time through flexible regulatory standards, emergency
waivers, liability protections, and other options are vital to execution and
accountability.
BRIEF OVERVIEW OF THE

FEDERAL EMERGENCY LEGAL LANDSCAPE
Since its inception in 2006 (HHS, 2015), PHEMCE has integrated
multiple federal, state, and nongovernmental agencies and partners charged
with developing, producing, and distributing timely MCMs in response to
extensive public health threats (e.g., emerging infectious diseases, nuclear
exposures, natural disasters). Each threat implicates varying federal laws
and policies. PHEMCE’s efforts to determine appropriate leadership, roles,
and responsibilities among extensive partners will be subject to ongoing
shifts in the federal emergency legal landscape shaped by legislative, execu-
tive, and judicial responses to the COVID-19 pandemic.
The Trump and Biden administrations have responded to the pandemic
through an unprecedented series of emergency declarations, executive or-
ders, and extensions of national security interests altering the scope and
balance of federal and state PHE powers. Extensive federal emergency
authorities are reflected in expansive federal acts enacted by Congress
during the pandemic, including the (1) Families First Coronavirus Re-
sponse Act1 (March 18, 2020); (2) Coronavirus Aid, Relief, and Economic
Security Act2 (March 27, 2020); (3) Paycheck Protection Program and
Healthcare Enhancement Act3(April 24, 2020); (4) Consolidated Appro-
priations Act4 (December 27, 2020); and (5) American Rescue Plan Act
(March 11, 2021).5 Collectively, these laws authorized new federal public
health interventions and provided massive economic relief to individuals
and businesses.
1 Families First Coronavirus Response Act, Pub. L. No. 116-127, 134 Stat. 178 (2020).
2 CARES Act, Pub. L. No. 116-136, 134 Stat. 281 (2020).
3 Paycheck Protection Program and Healthcare Enhancement Act, Pub. L. No. 116-139,
134 Stat. 620 (2020).

4 Consolidated Appropriations Act, Pub. L. No. 116-260 (2020).
5 American Rescue Plan Act, Pub. L. No. 117-2, 135 Stat. 2 (2021).

LEGAL AND POLICY CONSIDERATIONS 69
Extent and Scope of Presidential National Security Powers

Substantial congressional enactments during the COVID-19 pandemic
are coupled with a strengthening reliance on national security designa-
tions and powers uniquely and constitutionally vested in the federal gov-
ernment.6 Presidents Trump7 and Biden characterized the pandemic as a
national security threat (akin to prior classifications for other emerging
infectious diseases) (Fidler, 2003; White House, 2021b). These classifica-
tions help mobilize federal responses internationally8 and authorize greater
control over domestic responses impacting the nation’s health. In concert
with express federal powers authorized by national emergency declarations
(noted later), the president can (1) coordinate effective plans and responses
on issues implicating national security and (2) allocate materials, services,
and facilities to promote national defense and control market forces in
crises.9 The Project BioShield Act in 2004,10 for example, authorized the
DHS secretary to issue material threat determinations for chemical, biologi-
cal, radiological and nuclear (CBRN) threats and fund essential develop-
ment of MCM11 (including Operation Warp Speed [OWS]) (Scott, 2020).
National and State Emergency Declarations

National security powers are augmented through federal emergency
declarations issued during the COVID-19 pandemic. Congress has vested
considerable emergency powers and corollary funding in the president and
other federal agencies via various laws, including the (1) Robert T. S tafford
Disaster Relief and Emergency Assistance Act (Stafford Act),12 (2) National
Emergencies Act (NEA),13 (3) Public Health Service Act (PHSA),14
(4) Pandemic and All-Hazards Preparedness Act (PAHPA)15 (renewed in
2013 and 2019), (5) Public Readiness and Emergency Preparedness (PREP)
Act,16 and (6) Defense Production Act (DPA)17 (discussed below).
6 U.S. CONST., art. 1 § 8, art. 2 § 2, art. 4 § 4.

7 Executive Order 13944, Combating Public Health Emergencies and Strengthening National
Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are
Made in the United States, 85 Fed. Reg. 49929 (Aug. 6, 2020).
8 Foreign Assistance Act, 22 U.S.C.A. § 2151 (1974); Exec. Order No. 13155, 65 Fed. Reg.
30521 (May 12, 2000).

9 Defense Production Act of 1950, 50 U.S.C. §§ 4501–4568 (2015).
10 Project BioShield Act of 2004, 42 U.S.C. § 247d-6b (2004).
11 42 U.S.C. § 247d-6b(c)(2) (2012).
12 42 U.S.C.A. § 5121 et seq. (West 2020).
13 50 U.S.C.A. §§ 1601, 1621, 1622, 1631, 1641, 1651 (West 2020).
14 42 U.S.C.A. § 201 et seq. (2020).
15 Pub. L. No. 109-417, 120 Stat. 2831 (2006).
16 42 U.S.C. § 247d-6d (2012).
17 50 U.S.C. § 4501 et seq.

These laws authorize the federal government to declare states of

“emergency,”18 “disaster,”19 or “PHE”20 to invoke extensive federal powers
related to emerging infectious diseases and other substantial threats. PHSA
specifically authorizes federal declarations of PHE in response to “significant
outbreaks of infectious diseases or bioterrorist attacks.”21 On January 31,
2020, U.S. Department of Health and Human Services (HHS) Secretary Alex
Azar declared a PHE in response to COVID-19 (HHS, 2020a); with this
90-day declaration (renewed several times), HHS rapidly executed specific
grants and contracts, conducted and supported disease investigation and
response efforts (ASPR, 2019), and waived specific health laws inhibiting
emergency response efforts (after national emergency declarations).22 Co-
extensive with his PHE declaration, Secretary Azar also issued an emergency
declaration via the PREP Act.23 Through providing substantial liability
protections and extensive preemption of conflicting state-based laws, it can
help facilitate real-time development and manufacturing of qualified MCM
through public–private partnerships.
On March 13, 2020, President Trump issued concurrent national emer-
gency and disaster declarations under the Stafford Act and NEA (FEMA,
2020). These declarations, carried over by the Biden administration, enable
substantial federal response powers and options through the U.S. Depart-
ment of Homeland Security (DHS), HHS, the U.S. Department of Defense
(DoD), and other agencies (CRS, 2020c). The Stafford Act declaration, for
example, directed FEMA to coordinate state disaster-relief administration
and allocate public assistance grants to state, territorial, tribal, and local
governments to aid in response and recovery (FEMA, 2019, 2021). Grant
recipients are held to specific federal procurement requirements that pre-
empt conflicting state or local rules for contracting. Federal PHE powers
were accompanied by state-based emergency declarations. Between Febru-
ary 29 and March 15, 2020, every state and major territory declared varied
states of emergency, disaster, or PHE—a first in U.S. history (Hodge et al.,
2021). Consistent invocations of state-level emergency declarations did not,
however, result in uniformity of public health responses. Differentiation in
legal approaches among state and local governments has led to repeated
calls for greater federal direction and authorities, especially through the
Biden administration.
1842 U.S.C.A. §§ 5170, 5122(1) (West 2020).

1942 U.S.C.A. § 401 (West 2020).
20 42 U.S.C.A. § 247d(a) (West 2020).
21 42 U.S.C.A. § 247d(a) (West 2020).
22 42 U.S.C. § 1320b-5 (West, 2020).
23 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020).

Defense Production Act

DPA24 authorizes the president to direct private-sector entities to pri-
oritize federal contracts25 and allocate materials, services, and facilities if
“necessary or appropriate to promote the national defense” (Siripurapu,
2021). Crafted by Congress to address wartime economic mobilization
and control efforts, DPA has been used extensively to support PHE efforts
during the COVID-19 pandemic. In March 2020, President Trump ordered
private companies to produce ventilators and PPE for federal disbursement
to hospitals (White House, 2020). Substantial products were manufactured
and allocated due to this executive order both initially and during the Biden
administration. President Trump also invoked DPA to prevent hoarding and
increase production of essential health supplies. With presidential approval,
HHS leveraged DPA to expedite production and shipment of COVID-19
tests to nursing homes (HHS, 2020c). In January 2021, President Biden
invoked the act via executive order directing federal agencies to address
vaccination supply shortages and accelerate vaccine manufacturing and
delivery (White House, 2021a). Though purposeful, invocations of DPA can
impact other market forces, leading to disruptions of critical supply chains
of components needed for medical or other products.
Federal Conditional Spending Powers

In addition to its substantial PHE powers vested through Congress,
the federal government can also dictate or shape subnational emergency
responses through the “power of the purse.” Congress may lawfully im-
pose myriad conditions on the disbursement of federal funds to which
public- and private-sector recipients generally must adhere to gain or keep
access, subject to some constitutional limits.26 Conditions on federal funds
must (1) serve some general purpose, (2) clearly lay out choices and condi-
tions, (3) be related to some national project or program, (4) avoid induc-
ing recipients to engage in unconstitutional acts (e.g., First Amendment
violations),27 and (5) not entail compulsion or mandates to accept the
funds. Coercive tactics employed under this last factor are rare. However, in
a 2012 case reviewing the Patient Protection and Affordable Care Act, the
U.S. Supreme Court clarified that an “all or nothing” approach to encour-
age state Medicaid expansion constituted compulsion.28 Using conditional
spending powers via PHEMCE offers extensive possibilities, particularly
24 50 U.S.C. § 4501 et seq.
25 50 U.S.C. § 4511.
26 South Dakota v. Dole, 483 U.S. 203 (1987).
27 Agency for International Development v. Alliance for Open Society International, 570
U.S. 205 (2013).

28 NFIB v. Sebelius, 567 U.S. 519 (2012).

when federally produced MCM (e.g., COVID-19 PPE and vaccines) may
be distributed to state, tribal, or local governments (Robbins et al., 2020).
Preemption
Under principles of federalism and supremacy (Hodge, 2021),29 federal
law may expressly or impliedly preempt (or override) state law (Hodge
et al., 2017). The scope of federal preemption was illustrated during the
COVID-19 pandemic via PREP Act declarations, which supplant state or
local actions contravening federal directives related to MCM (Office of the
Secretary, 2021). In October 2020, for example, Nevada health authorities
attempted to restrict use of a federally authorized COVID-19 test deemed
inaccurate in nursing facilities (Wu, 2020). ASPR responded that the PREP
Act declaration overrode Nevada’s objections (Evans and Clayton, 2020b).
“Under federal law,” clarified a senior ASPR official, “PREP Act cover-
age preempts any state or local provision of law or legal requirement that
prohibits or effectively prohibits … licensed [HCWs] from administer-
ing or prescribing FDA [U.S. Food and Drug Administration]-authorized
COVID-19 tests” (Office of the Secretary, 2020a). The PREP Act decla-
ration was amended to preempt contrary state laws related to medical
licensure and personnel needed to distribute and administer vaccinations
(Office of the Secretary, 2020b), despite traditional reservations of licensure
to state-based professional regulatory boards (CDC, 2021).
PHEMCE REGULATORY OPTIONS

MCMs, such as vaccines, antiviral drugs, diagnostics, and PPE (FDA,
n.d.-b), are core to PHEMCE’s functions (CRS, 2020a).30 MCMs are
developed, authorized, procured, and distributed within a complex regu-
latory landscape involving many agency partners. This section considers
(1) spending on MCM research and procurement, (2) the regulation of
MCM research and FDA marketing authorization pathways, and (3) certain
legal concerns facing nongovernmental partners in MCM manufacturing
and distribution.
MCM Research Support and Procurement

Effective government research support and procurement can help ensure
MCM development, particularly when private manufacturers lack sufficient
profit incentives to enter the market (CRS, 2020a). PHEMCE makes recom-
29 U.S. Const. art. IX.

30 42 U.S.C. § 300bb-10a(c).

mendations to ASPR on MCM research and procurement, while its agency

partners play key roles in supporting MCM research and regulatory science
and procuring the end products.31 For example, the National Institutes
of Health (NIH) funds a wide range of basic biomedical research and as-
sists with responses to new infectious diseases through the National Insti-
tute of Allergy and Infectious Diseases (NIAID). The Biomedical Advanced
Research and Development Authority (BARDA) supports advanced research
and development of MCM manufacturing capabilities and procures FDA-
authorized MCMs under its Project BioShield authorities (HHS, 2017). FDA
financially supports MCM regulatory science research and provides input
and guidance on MCM development before authorization. FDA’s statutory
authorities also provide postmarket incentives for products, such as market
exclusivity periods awarded for new MCMs.
Multiple challenges include (1) providing sufficient research sup-
port; (2) procuring products in fair, well-documented, and efficient ways;
(3) makingsure supplies are available for the SNS; (4) minimizing COI
(noted earlier); and (5) providing adequate incentives and certainty to
industry (GAO, 2021). During the pandemic, PHEMCE agency partners
sought to streamline research and provide regulatory certainty to indus-
try partners—such as through NIH’s Accelerating COVID-19 Therapeutic
Interventions and Vaccines public–private partnership and FDA’s Corona-
virus Treatment Acceleration Program for clinical trials (FDA, 2021a; NIH,
2020). Not every research program will yield a safe and effective MCM,
and significant questions remain regarding the commercial viability of
MCM development, even with government support. In 2019, for example,
the antibiotic company Achaogen declared bankruptcy despite receiving
tens of millions of dollars from BARDA to support drug development
(and FDA approval for the drug in 2018) (Alder and Lee, 2019; Årdal et
al., 2020). As another example, beginning in 2015 and with support from
BARDA, companies began developing vaccine candidates for Zika, but that
work ultimately stalled shortly thereafter when the epidemic waned; no
vaccine is approved as of 2021.
MCM Development and Authorization

FDA authorization is generally required before “drugs,” “biological
products,” or “device” MCMs may be distributed.32,33 In implementing its
authorization processes during PHEs, FDA is faced with the difficult task
of balancing the urgent need for timely access to MCMs with the need for
rigorous evidence about safety and effectiveness. Producing sufficient data
31 42 U.S.C. § 300hh-10a.
32 21 U.S.C. § 321(g), (h).
33 42 U.S.C. § 262(i).

for FDA authorization can be difficult or time-consuming, and the regula-

tory landscape is complex. But FDA can use legal flexibility and regulatory
tools to clarify and accelerate the processes. Moreover, requiring rigorous
evidence of safety and effectiveness is critical to protect people from unsafe
or ineffective MCMs and ensure generating necessary information about
MCMs’ effects (Eisenberg, 2006). This, in turn, encourages developing
effective products (and discourages the clinical use of ineffective ones)
(Gottlieb, 2021; London and Kimmelman, 2020).
Research Regulation
MCM studies are typically subject to federal requirements for human
subjects research (HSR) under the Common Rule—implemented by the HHS
Office for Human Research Protections (OHRP)—and FDA regulations.34
The Common Rule applies to HSR funded by Common Rule agencies
(and research conducted at institutions that have agreed to conduct all of
their research in compliance with the Common Rule). FDA regulations apply
to studies of drug, biological product, and device safety and effectiveness.35
Both sets of regulations include similar requirements for informed consent
and institutional review board (IRB) oversight.36,37,38 MCM r esearch is over-
seen by local IRBs responsible for reviewing HSR protocols and determining
if they adhere to federal, state, and local regulations. Each IRB develops its
own procedures supporting this process (Ford et al., 2021).
FDA and OHRP recognize the need for enhanced regulatory flexibility
in emergencies (HHS, 2020b). They possess legal tools to help streamline
research and IRB review in emergencies while maintaining research integ-
rity and protecting human welfare. Existing authorities allow agencies to
waive regulatory requirements, exercise discretion not to enforce certain
requirements, or clarify legal interpretations (Fernandez Lynch et al., 2020).
During COVID-19, for example, FDA issued initial guidance (subsequently
revised) to help sponsors and researchers conduct clinical trials amid pos-
sible disruptions caused by the pandemic and related public health measures
(FDA, 2020a).
Regulatory pathways can also be expedited during PHEs through pre-
developed protocols, prepositioned through a central or single IRB across
large research networks or a national emergency trials network (Gottlieb,
2021). This may include platform protocols where investigational thera-
peutics or devices can be dropped in and swapped out as needed. Other
34 45 CRF 46.
35 21 CFR part 312; 21 CFR part 812.
36 21 CFR 50.
37 21 CFR 56.
38 45 CFR part 46.

strategies, such as patient registries and adaptive trials, can also be useful.
Nevertheless, concerns remain about a lack of national coordination in
research efforts (Gottlieb, 2021). Ensuring sufficient evidence generation
about MCM and participants’ safety is paramount to PHEMCE’s ongoing
ability to be operational and effectively responsive in an emergency.
Rapid reviews of HSR that ensure systematic underlying procedures for
evidence collection and subject protection are critical to initiating research
during PHEs. However, the approach and procedure must be cultivated
in advance to ensure that PHEMCE is as effective as possible. Existing
emergency clinical research networks could develop template nondisclosure
agreements, material transfer agreements, and reliance agreements to opera-
tionalize pre-placed protocols efficiently and effectively (Kraft et al., 2019).
FDA Authorization Pathways

Although certain products needed during PHEs may not require FDA
authorization, such as blood (FDA, 2018a,b), authorization is legally re-
quired for most MCMs covered by PHEMCE’s work. The regulatory routes
for FDA authorization of MCMs include (1) routine paths available in non-
emergency periods, such as drug, biological product, or device approval
and nontrial preapproval access, and (2) Emergency Use Authorization
(EUA) paths available only when the HHS secretary formally declares that
“circumstances exist justifying the authorization” based on a declared PHE,
domestic emergency, military emergency, or material threat.39
Such authorizations are needed even if a MCM is already approved for
a use different than the emergency issue for which it would be distributed
from the SNS. For example, early in the COVID-19 pandemic, FDA issued
an EUA for hydroxychloroquine and chloroquine—drugs already approved
for other uses, such as malaria—to “allow [the] products donated to the
SNS to be distributed and used” for COVID-19 patients. But FDA also
may, in some circumstances, choose to exercise its discretion not to enforce
authorization requirements, as the agency did for certain COVID-19 tests.
Drug and Biological Product Approval

For new drugs, therapeutic biological products, and vaccines, the typi-
cal route to market is FDA approval of a new drug application (NDA) or
a biologics license application (BLA) based on evidence that the product
is safe and effective for its intended use and on assurances of its quality.40
To make the necessary showing of safety, effectiveness, and quality, manu-
39 21 U.S.C. § 360bbb-3(b).
40 21 U.S.C. § 355(d); 42 U.S.C. § 262.

facturers typically generate significant information about their products

through preclinical testing and clinical trials in humans and provide detailed
chemistry, manufacturing, and control data.41 Some exceptions and means
for speeding the process do exist. For example, FDA regulations permit
MCM approval based solely on animal studies when human effectiveness
studies would be unethical, and FDA guidance encourages certain uses of
vaccine platforms to expedite product development (CBER, 2020).42 FDA
can also complete its review of NDAs or BLAs on rapid timelines during
PHEs, as it did when approving the Pfizer/BioNTech COVID-19 vaccine
(FDA, 2021c, n.d.-a).
Device Approval and Clearance

The statutory pathways to FDA authorization for devices (e.g., ventila-
tors, personal protective equipment [PPE], diagnostics) are more varied than
for drugs and biological products. The Federal Food, Drug, and Cosmetic
Act (FDCA) requires FDA to organize all devices into one of three categories,
based on risk level and the regulatory controls necessary to mitigate risk.
The riskiest “class III” devices typically go through a premarket a pproval
process like that for drugs and biological products described earlier. The
lowest-risk “class I” devices generally do not require premarket authori
zation.43 Most devices, however, are “class II,” moderate-risk devices, which
can include surgical gowns, ventilators, and masks (CRS, 2020b). Class II
devices typically do not require premarket approval. Instead, they generally
undergo less-burdensome premarket clearance processes, such as FDA clear-
ance of a “510(k)” submission demonstrating that the device is “substan-
tially equivalent” to a legally marketed predicate device.44
Specific device categories are subject to additional regulatory regimes.
For example, the National Institute for Occupational Safety and Health
(NIOSH) and FDA have overlapping jurisdiction over disposable respi-
ratory protective devices. NIOSH-approved N95 masks do not require
a 510(k) clearance (FDA, 2017). Diagnostic tests are another example.
In addition to FDA oversight, clinical laboratories performing diagnostic
testing are regulated by the Centers for Medicare & Medicaid Services
(CMS) under the Clinical Laboratory Improvement Amendments (CLIA).
These labs must obtain a CLIA certification from CMS. Moreover, FDA’s
jurisdiction over laboratory-developed tests (LDTs) (in vitro diagnostic tests
designed, manufactured, and used within a single laboratory) has long been
41 21 CFR § 314.50; 21 CFR § 601.2.

42 21 U.S.C. § 360bbb-4(d); 21 CFR part 314 subpart I; 21 CFR part 601 subpart H.
43 CFR Title 21.
44 21 U.S.C. § 360(k); 21 U.S.C. § 360c(f)(1).

controversial, and FDA has historically declined enforcements for them

(CRS, 2019; Evans and Clayton, 2020a).
Nontrial Preapproval Access

The FDCA and FDA regulations also provide pathways for seriously
and terminally ill patients to access unapproved products for treatment use
outside clinical trials even in non-emergencies, including the “expanded
access” pathway (FDA, 2021b). Under this pathway, a sponsor may request
FDA authorization to provide an investigational drug, biological product, or
device outside clinical trials in certain circumstances.45 During the Ebola out-
break in 2014–2015, Zmapp was provided to patients through an e xpanded
access program (Kraft et al., 2019). Although FDA authorization is required,
FDA grants the overwhelming majority of requests, usually within days or
sometimes even hours (Jarow et al., 2017a,b). In 2018, the federal Right
to Try Act created an additional pathway for nontrial preapproval access
for drugs (but not devices) that does not require FDA authorization.46 The
“right to try” pathway, however, has rarely been used and does not appear
to have been used for MCMs. Additionally, both pathways pose a risk of
thwarting enrollment in necessary trials, as happened with the expanded
access program through which COVID-19 patients accessed convalescent
plasma (Sachs, 2020), and restrict what sponsors may charge for MCMs.47
Emergency Use Authorizations

In emergencies, FDA may issue EUAs permitting the distribution of un-
approved drugs, biological products, or devices, or allowing unauthorized
uses of already authorized products (Zettler et al., 2021). Various criteria
must be met for FDA to issue an EUA, including that “it is reasonable to
believe” that “the product may be effective” for the relevant condition—a
lower standard than legally required for FDA approval (FDA, 2020c).48
This lower bar creates the regulatory flexibility necessary to allow quick
distribution of promising products in emergencies. At the same time, federal
law permits FDA to set a higher evidentiary bar for EUAs, as it seemingly
did for COVID-19 vaccines (CBER, 2020).
FDA also has broad power over products under EUAs.49 For instance,
FDA may require that information about a product’s safety and effective-
45 21 U.S.C. § 360bbb-0a; 21 CFR part 312 subpart I; 21 CFR § 812.36.

46 S.204—Emergency Relief for Federal Workers Act of 2019.
47 21 U.S.C. § 360bbb-0a(b); 21 CFR §§ 312.8, 312.305(a)(3).
48 21 U.S.C. § 360bbb-3.
49 21 U.S.C. § 360bbb-3; https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3808328

ness be collected and analyzed, determine which health care professionals

may administer a product, and restrict the patient populations that may
receive a product. While EUAs are only effective for the duration of the
secretary’s declaration, FDA has wide discretion to revoke or revise EUAs
based on emerging scientific and public health information as seen repeat-
edly during the COVID-19 pandemic.
Legal Challenges Facing Nongovernmental Partners

Nongovernmental partners, including industry, health care p
rofessionals
and entities, and the public, face numerous legal challenges and concerns
underlying PHEMCE’s mission (noted elsewhere in this chapter). Some
concerns relate directly to MCM development and authorization. For ex-
ample, MCM manufacturers may need to protect proprietary information
to preserve future market share and profits, while scientific understanding
would be advanced by sharing and fostering collaboration among multiple
manufacturers and regulators. PHEMCE partner agencies have implemented
programs to help balance these competing needs, such as the Critical Path
Institution public–private partnership. PAHPA permits HHS, in certain
circumstances, to engage in collaborative activities with multiple MCM
manufacturers that may otherwise violate antitrust laws (Zettler et al.,
2021). Nevertheless, challenges remain, such as with sharing manufactur-
ing knowledge for COVID-19 vaccines. Intellectual property rights provide
another example of critical legal concerns (BIO, 2021; Branswell, 2018). In
May 2021, the Office of the U.S. Trade Representative announced support
for a proposed World Trade Organization waiver of COVID-19 vaccine
intellectual property protections (USTR, 2021). Although some experts have
argued that the proposal would have little effect on manufacturers’ profits,
industry partners may be reticent about entering the MCM market under
such broad waivers (McMurray-Heath, 2021).
ADDRESSING AND SOLVING

EMERGENCY LEGAL ISSUES IN REAL-TIME
Much of the legal landscape, authority, and flexibility underlying
PHEMCE’s work are a result of statutory and regulatory changes in the af-
termath of PHEs. Following the September 11, 2001, attack and subsequent
anthrax letters, for example, Congress passed the Project BioShield Act of
2004, which created a special fund for HHS to procure MCMs and amended
the FDCA to create the EUA pathway for MCMs (ASPR, 2010). Ongoing
reforms to emergency laws and policies based on prior experiences, how-
ever, do not alone ensure a well-functioning, or adequate, legal response to
emergencies. Real-time facts during the COVID-19 pandemic, for example,

present novel legal and regulatory questions about the scope, extent, and
interrelationship of federal and state powers in a federalist system of gov-
ernment. The legal environment itself changes with emergency declarations
or new statutory authorities. Flexibility and extensive discretion provided
to government actors during declared emergencies enable nimble, timely
responses but can also lead to confusion (Hodge and Anderson, 2008).
Various legal and regulatory tools available to PHEMCE agencies
can help identify and mitigate actual or perceived regulatory barriers to
MCM development, authorization, procurement, and distribution. For ex-
ample, to clarify agency positions and reduce uncertainty, agencies can
issue guidance or seek public input through public meetings/workshops.
Early in the pandemic, FDA and OHRP issued guidance—albeit perhaps
insufficiently—to explain the agencies’ interpretations of regulatory re-
quirements for C OVID-19 research, such as describing how to conduct the
informed consent process with infectious COVID-19 patients (Fernandez
Lynch et al., 2020). Similarly, before COVID-19 vaccine EUAs were issued,
FDA issued guidance on its expectations for the kinds of evidence needed to
support such EUAs and held public advisory committee meetings.
Using legal tools quickly, effectively, and appropriately in emergencies
is essential to PHEMCE’s work. Through “legal triage,” multiple actors
must assess and “prioritize legal issues and solutions in real time that facili-
tate legitimate public health responses.” Identifying legal issues and crafting
meaningful solutions are critical components of public health legal prepared-
ness and response (Hodge, 2006, p. 631). “Regulatory readiness”—or the
awareness and use of significant flexibilities among PHEMCE a gencies pur-
suant to their statutory authorities in emergencies—helps ensure improved
preparedness and response, as seen throughout the COVID-19 pandemic. For
example, regulatory readiness would include b eing well positioned to quickly
identify areas of legal flexibility for research regulation and implement poli-
cies that would enable innovative research approaches, such as registries to
capture real-world evidence or coordinated trials. These legal skills do not
arise via happenstance. Cultivating a culture and organizational structure
through which agency and industry attorneys align with other PHEMCE
personnel to generate legally supportable paths to accomplish PHEMCE’s
mission is key to its successful implementation (Wion, n.d.).
Federal Waiver or Suspension of Conflicting Legal Requirements

A premier example of legal triage, including regulatory readiness, re-
lates to the power of the federal (and state) governments to temporarily
waive or suspend existing legal requirements to promote efficient and effec-
tive interventions. Waiver of federal laws can simultaneously operate to sus-
pend conflicting state laws through concepts of supremacy and preemption

(as discussed above). The Social Security Act (SSA) § 1135 is illustrative. It
vests the HHS secretary with broad waiver authority when two distinct fed-
eral emergency declarations are in effect: (1) a declaration of emergency by
the secretary via the PHSA and (2) either a Stafford Act or NEA declaration
by the president (SSA, n.d.).50 On March 13, 2020, after PHSA, Stafford
Act, and NEA emergencies were declared, HHS Secretary Azar invoked
SSA § 1135 to waive certain federal requirements applicable to Medicare,
Medicaid, the Children’s Health Insurance Program, the Health Insurance
Portability and Accountability Act Privacy Rule, and the Emergency Medi-
cal Treatment and Active Labor Act (ASPR, 2020).
Liability Risks and Protections

One of the most contentious issues related to emergency response
e fforts involves personal and entity liability. Governments and other quasi
governmental entities may largely be immune from claims grounded in
failures to act to prevent the spread of infectious diseases or other conse-
quences of PHEs under principles of sovereign immunity or federal or state
torts claims acts. Private health care employees, emergency responders, or
other workers or volunteers and entities involved in effectuating PHEMCE
objectives, however, are understandably concerned about potential liability
for actions, or failures to act, leading to injuries or deaths during emer-
gencies (IOM, 2012). Pervasive concerns over such liability can diminish
participation in response efforts or lead to detrimental, defensive practices
(Carrier et al., 2013). No single, national standard protects workers, vol-
unteers, and entities from all potential liability in emergency responses.
Rather, a patchwork of federal, state, and local laws provides protections
for acts of ordinary negligence in various circumstances. After a PREP Act
declaration, for example, immunity from liability is extended to covered
persons and entities involved in the domestic development, distribution,
and administration of MCMs51 (with unclear protections for federally
supported vaccines or other MCMs exported internationally and certain
off-label uses of approved MCMs). Virtually no political or legal support
exists for protections to immunize or indemnify practitioners or entities for
gross negligence, willful or wanton misconduct, criminal behaviors, or, for
governmental actors, unconstitutional interventions.
Patients or others seeking recourse for injuries during emergencies may
rely on victim compensation funds. The Countermeasures Injury Com-
pensation Program, authorized via the PREP Act (HHS, 2021), provides
limited benefits to individuals claiming specific injuries related to MCMs
50 42 U.S.C. § 1320b-5(g)(1).
51 42 U.S.C.A. §§ 319F-3(a)(1), § 247d-6d(a)(1).

recommended by HHS during a declared emergency (ASTHO, 2021). As

with PREP Act protections, some areas of coverage are uncertain, such
as off-label uses of approved COVID-19 vaccines (deSante-Bertkau et al.,
2021). The National Vaccine Injury Compensation Program pays eligible
individuals for injuries connected to specifically listed vaccines authorized
by Congress (subject to change) (HRSA, n.d.).
Measures Regulating Allocations and Distributions

One of the core objectives of PHEMCE is to help ensure that alloca-
tions and distributions of MCMs are fair and equitable. Meeting this objec-
tive presents challenging legal and ethical issues (see Chapter 2). Real-time
efforts to expeditiously distribute these resources to persons in need can
exacerbate health disparities among specific racial, ethnic, disabled, or older
populations. Preventing such outcomes is key. The National Academies
produced guidance on the ethical distribution of COVID-19 vaccines prior
to their introduction in the U.S. market (NASEM, 2020), which informed
the ethical principles for allocation adopted by CDC’s ACIP (McClung
et al., 2020), which ACIP later endorsed. However, when vaccines were
distributed to states, allocations to their populations only partly adhered
to national guidance. Some state approaches diverged directly from ex-
plicit CDC directions. Antidiscrimination measures impacted allocations of
MCMs and health services in other contexts as well. Almost from the begin-
ning, disability- and other rights-based groups opposed vaccine allocation
plans and crisis standards of care (CSC) implementation on legal grounds.
On March 28, 2020, HHS’s Office for Civil Rights (OCR) issued guidance
on the application of civil rights laws during the COVID-19 emergency.52
It later launched multiple investigations of state-based CSC plans alleging
violations of federal antidiscrimination laws (including the Americans with
Disabilities Act [Fink, 2020],53 Rehabilitation Act,54 and Civil Rights Act of
1964).55 Additional concerns regarding discrimination based on age, race,
color, national origin, limited English proficiency, religion, and sex also
arose, leading to additional OCR guidance and substantial policy modifica-
tions by states, localities, and hospitals (Piatt and Hodge, 2021). Navigating
these and other rights-based requirements to specific distribution and allo-
cation efforts through PHEMCE is essential to (1) ensure equity of benefits
across at-risk populations (consistent with constitutional principles of equal
52 Bulletin: Civil Rights, HIPAA & the Coronavirus Disease 2019, HHS OCR (Mar. 28,
2020).
53 42 U.S.C. §§ 12101–12213 (2012).
54 29 U.S.C. § 701 et seq.
55 Pub. L. 88-352, 78 Stat. 241.

protection) and (2) justify specific allocations or governmental policies

(consistent with procedural or substantive due process).
RECOMMENDATION
RECOMMENDATION 11. IDENTIFY, ASSESS, AND RESOLVE THE
LEGAL BARRIERS THAT MAY IMPEDE PHEMCE O BJECTIVES.
The Assistant Secretary for Preparedness and Response and the U.S.
Depart ment of Health and Human Services’ Office of the General
Counsel in consultation with outside legal experts should regularly iden-
tify, assess, and resolve the perceived or actual legal barriers that may
continue to impede PHEMCE objectives.
This assessment should also occur outside crises and should include the
foundational regulatory framework underlying PHEMCE operations
and its mission as well as real-time needs and capabilities required to
support its emergency implementation. Flexibility and transparency
should be cultivated to foster open dialogue, communication, and
sharing creative options within the legal and regulatory framework
supporting PHEMCE, particularly, but not exclusively, in declared
emergencies when real-time decisions and solutions may be compro-
mised absent advanced review and consideration.
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COVID-19 policy playbook: Legal recommendations for a safer, more equitable future.
Boston, MA: Public Health Law Watch.


Appendix A
Study Methods
At the request of the Office of the Assistant Secretary for Prepared-

ness and Response (ASPR), the National Academies of Sciences, Engineer-
ing, and Medicine (the National Academies) convened the Committee on
Reviewing the Public Health Emergency Medical Countermeasures Enter-
prise (PHEMCE). In addressing its charge and preparing its final report, the
committee pursued several avenues for information collection and analysis.
The committee held five virtual meetings, three of which included open pub-
lic sessions that incorporated remarks from and discussion between invited
stakeholders and experts. This appendix describes the committee’s study
process in detail, including a summary of the written public comments
received by the committee and copies of the three open-session agendas.
MEETINGS AND INFORMATION-GATHERING ACTIVITIES

The committee held five virtual meetings from August 2021 through
September 2021. The first, second, and third meetings included portions
open to the public. The agendas for these sessions are included at the end of
this appendix. The remaining meetings were held entirely in closed session.
To inform its deliberations, the committee gathered information
through a variety of mechanisms: (1) reviews of PHEMCE charter and
process documents and materials shared by ASPR and (2) the first, second,
and third committee meetings, which included sessions open to the public.
All written information provided by external sources is available by request
through the National Academies’ Public Access Records Office.
89

PHEMCE Charter and Process Materials

ASPR provided public documents that describe PHEMCE and some
activities from approximately 2006 to 2015. Sharing these materials with
the committee allowed deeper insight into PHEMCE during that time.
Charter documents primarily described the mission and organizational
structure of PHEMCE, while process documents showcased activities such
as requirements setting, development of Strategy and Implementation
Plans (SIPs), and threat and preparedness assessments. ASPR also shared
materials describing PHEMCE’s responsibilities with the U.S. Strategic
National Stockpile (SNS), including the congressionally mandated annual
reviews of the SNS. Lastly, ASPR provided a description of the current
PHEMCE organizational structure.
Open Sessions
The first meeting’s open session provided an opportunity for the com-
mittee to hear the sponsors’ perspectives on the charge and scope of the
study. This session afforded the members the chance to discuss anticipated
challenges and points of clarification and define the project’s boundaries.
The second meeting’s open session allowed the committee to hear from
former and current PHEMCE personnel on key issues related to the com-
mittee’s scope. The committee also had an opportunity to reengage with the
sponsor to discuss PHEMCE materials shared by ASPR.
The third meeting’s open session heard perspectives on issues related
to PHEMCE mission, ensuring defensible PHEMCE recommendations and
enterprise-wide reviews, integrating external partners and stakeholders into
PHEMCE decision making and activity execution, and best business practices
of the industrial base, supply chain, and stockpiling/inventory management
for medical countermeasures preparedness. Relevant stakeholders from fed-
eral, state, and local government; the industrial base; and the medical sector
were able to share their perspectives on PHEMCE and what the committee
should consider in its review.

APPENDIX A 91
PUBLIC AGENDAS
First Committee Meeting Public Agenda
Friday, August 6, 2021
3:00–5:00 p.m. ET
Meeting Objective
• Hold an open session to hear from the sponsor of the study regard-
ing their perspectives on the charge to the committee and to hear
from former PHEMCE personnel.
OPEN SESSION
SESSION Sponsor Briefing: Discussion of the Committee’s Charge

Objectives: 1) To hear from the sponsor of the study regarding their
perspectives on the charge to the committee.
2) To introduce the committee to PHEMCE materials shared
by ASPR, including available charters, memorandums
of understanding, process documents, and other related
documents to inform the committee’s understanding of
past decision making, business practices, and other policy
approaches.
3:00 p.m. Welcome and Introductions
Gigi Gronvall, Committee Co-Chair

Senior Scholar
Johns Hopkins Center for Health Security
Alan Leshner, Committee Co-Chair

Chief Executive Officer Emeritus

3:05 p.m. Sponsor Perspective on Charge to the Committee
David (Chris) Hassell, Study Sponsor

Deputy Assistant Secretary
Senior Science Advisor
Office of the Assistant Secretary for Preparedness and
Response
U.S. Department of Health and Human Services
Lara Lamprecht, Study Sponsor

Branch Chief, PHEMCE
Division of Requirements
Office of Strategy, Policy, Planning, and Requirements
Response
Chad Hrdina, Study Sponsor

Director, Division of Requirements
Response
3:35 p.m. Discussion with Committee
4:00 p.m. Preview of Shared PHEMCE Materials

Response

Response

APPENDIX A 93
SESSION Discussion of PHEMCE Management and Operations

Objective: 1) To gather information from former PHEMCE personnel
on the management and operations of PHEMCE,
including any challenges, major accomplishments, and
recommendations for the future.
4:30 p.m. Discussion of PHEMCE Management and Operations
George Korch
Director, National Biodefense Analysis and Countermeasures
Center
Former Senior Science Advisor to the ASPR
Former Chair, Enterprise Executive Committee (2009–2017)
Joanna Prasher
Senior Advisor, Centers for Disease Control and Prevention
Center for Preparedness and Response
Founder and Former Chief, PHEMCE Branch
5:00 p.m. ADJOURN OPEN SESSION
Second Committee Meeting Public Agenda

2:00–4:30 p.m. ET
Meeting Objectives
• Gather information from former and current PHEMCE personnel
on key issues
• Continue discussion with ASPR on shared PHEMCE materials

OPEN SESSION
2:00 p.m. Welcome and Introductions

Senior Scholar
Alan Leshner, Committee Co-Chair

Chief Executive Officer Emeritus
SESSION Discussions with PHEMCE Personnel

Objective: 1) To gather information from former and current PHEMCE
personnel on the following issues:
• What should PHEMCE be required to do?
• What is the value that PHEMCE can and should provide?
• How can PHEMCE be organized to provide that value
and ensure improved transparency and communication
and consistent decision making?
• What criteria should PHEMCE use when selecting areas
of focus?
2:15 p.m. Views of Former and Current PHEMCE Personnel (7–10

minutes)
Robert Kadlec
Former U.S. Department of Health and Human Services
Assistant Secretary for Preparedness and Response
Stephen Redd
Former Director of the Office of Public Health Preparedness
and Response
Centers for Disease Control and Prevention
Michael Mair
Acting Assistant Commissioner for Counterterrorism
Policy
Acting Director of the Office of Counterterrorism and
Emerging Threats
U.S. Food and Drug Administration

APPENDIX A 95
Michael Kurilla
Director, Division of Clinical Innovation
National Center for Advancing Translational Sciences
Former Director, Office of Biodefense Research Affairs
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Richard Hatchett
CEO
Coalition for Epidemic Preparedness Innovations
Former Acting Director of the Biomedical Advanced
Research and Development Authority
SESSION Discussion of Shared PHEMCE Materials

Objective: 1) To review, engage, and understand more in depth the
materials (such as available charters, MOUs, process
documents, and other related documents) provided by ASPR.
4:00 p.m. Q&A with ASPR on Shared PHEMCE Materials
David (Chris) Hassell, Study Sponsor

Deputy Assistant Secretary
Senior Science Advisor
Response

Response

Response

4:30 p.m. ADJOURN OPEN SESSION
Third Committee Meeting Public Agenda

Thursday, August 19, 2021
1:30–6:00 p.m. ET
Meeting Objective
• To hear perspectives on issues related to PHEMCE mission, ensur-
ing defensible PHEMCE recommendations and enterprise-wide
reviews, the integration of external partners and stakeholders into
PHEMCE decision making and activity execution, and best busi-
ness practices of the industrial base, supply chain, and stockpiling/
inventory management for medical countermeasures preparedness.
Day 1: Thursday, August 19, 2021
OPEN SESSION
1:30 p.m. Welcoming Remarks

Senior Scholar
SESSION I What Is the Value of PHEMCE?

Objective: 1) To hear perspectives on the following issues related to the
PHEMCE mission:
• What should PHEMCE be required to do? What is the
strategic and policy direction of PHEMCE?
• What should be the scope of PHEMCE’s mission?
• How can health equity principles be incorporated into
the PHEMCE mission?
• What is the value that PHEMCE can and should provide?
• Who should be the primary recipient of PHEMCE’s
analysis and advice?
• How should PHEMCE be organized to meet its mission
and have the authority to act?
• How can programs and budgets be aligned and
coordinated to support PHEMCE’s mission?

APPENDIX A 97
• How can PHEMCE be organized to ensure improved

transparency and communication and consistent decision
making?
• How can PHEMCE be organized to ensure efficient and
effective business operations?
• What are lessons learned from the ongoing COVID-19
pandemic?
1:35 p.m. Re-envisioned PHEMCE Mission, Operating Structure, and

Authorities
Nicole Lurie
U.S. Director
Coalition for Epidemic Preparedness Innovations
Former Assistant Secretary for Preparedness and
Response
Prabhavathi Fernandes
Chairperson
National Biodefense Science Board
SESSION II Business Practices for Defensible PHEMCE Recommendations

Objective: 1) To hear perspectives on the following issues related to
the ensuring defensible PHEMCE recommendations and
enterprise-wide reviews:
• How do/should threat assessments and national security
considerations factor into PHEMCE decision making?
• What best practices/lessons learned from Operation Warp
Speed are important to incorporate in a re-envisioned
PHEMCE?
• What best practices related to decision making/
investments, quality systems/standards, work flows,
processes, and technology are important to incorporate
in a re-envisioned PHEMCE?
• What evidence-based organizational models and
processes would better support both long-term policy
planning and urgent policy decision needs?
pandemic?

2:30 p.m. Threat Assessments, National Security Considerations, and

Operation Warp Speed
Daniel Gerstein
Senior Policy Researcher
RAND Corporation
Andrew Kilianski
Senior Director for Emerging Infectious Diseases
IAVI
Tara O’Toole
Senior Fellow and Executive Vice President
In-Q-Tel
Matthew Hepburn (joining at 3 p.m.)

Director, COVID Vaccine Development
U.S. Department of Health and Human Services-U.S.
Department of Defense Countermeasures Acceleration
Group (formerly Operation Warp Speed)
2:40 p.m. Decision Making, Workflows, Technology, and Processes
Valerie Karplus
Associate Professor, Engineering and Public Policy
Carnegie Mellon University
3:15 p.m. 30-Minute Break
SESSION III Integration of Partners into PHEMCE

Objective: 1) To hear perspectives on the following issues related to
the integration of external partners and stakeholders into
PHEMCE decision making and activity execution:
• How can PHEMCE be organized to allow greater
engagement of external partners and stakeholders and to
recognize the spectrum of external performers?
• How can PHEMCE be organized to ensure improved
transparency and communication with partners and
stakeholders?
• How can PHEMCE better understand its partner
relationships?

APPENDIX A 99
• How can health equity principles be incorporated into

each step of the medical countermeasures process?
• From the state and local perspectives, how can PHEMCE
incorporate last-mile issues into upstream decision
making?
• From the industry perspective, what are best practices
related to contracting?
• From the industry perspective, how does one mitigate
risk assumption and its impact on willingness to
participate and performance?
• How PHEMCE might better influence/impact/understand
the industry economy to support government medical
countermeasures preparedness mission?
pandemic?
3:45 p.m. State and Local Perspectives
Karen Smith
Former State Public Health Officer and Director
California Department of Public Health
David Gruber
Associate Commissioner for Regional and Local Health
Operations
Texas Department of State Health Services
John Hick
Deputy Chief Medical Director
Hennepin EMS
Medical Director for Emergency Preparedness
Hennepin Healthcare
Mary Grealy
President
Healthcare Leadership Council
James Lawler
Associate Professor, Department of Internal Medicine
Director, International Programs and Innovation,
Global Center for Health Security
Director, Clinical and Biodefense Research
University of Nebraska Medical Center

4:00 p.m. Business Partners and Industry
Phyllis Arthur
Vice President, Infectious Diseases and Diagnostics Policy
Biotechnology Innovation Organization
Mary Kosinski
Chief of Staff and Deputy Vice President for Science and
Regulatory Advocacy
PhRMA
Bruce Altevogt
Vice President and Head External Medical Engagement
Pfizer
Edward Cox
Vice President Regulatory Affairs
Regeneron
Patrick Lucy
President and CEO
Lykan Bioscience
SESSION IV Industrial Base, Supply Chain, and Stockpiling

Objective: 1) To hear perspectives on the following issues related
to best business practices of the industrial base, supply
chain, and stockpiling/inventory management for medical
countermeasures preparedness:
• What best business practices related to the industrial
base, supply chain, and inventory management are
important to incorporate in a re-envisioned PHEMCE?
• How does PHEMCE ensure thorough end-to-end medical
countermeasures life cycle consideration?
• How PHEMCE might better influence/impact/understand
the industry economy to support government medical
countermeasures preparedness mission?
pandemic?

APPENDIX A 101
5:00 p.m. Industrial Base, Supply Chain, and Stockpiling
Robert Handfield
Bank of America University Distinguished Professor of
Supply Chain Management
Executive Director, Supply Chain Resource Cooperative
North Carolina State University
Nicolette Louissaint
Executive Director
Healthcare Ready
Jon Mogford
Chief Operating Officer and Senior Vice President
Texas A&M Health
5:45 p.m. Summary of Public Workshop Presentations

Senior Scholar
6:00 p.m. ADJOURN PUBLIC WORKSHOP


Appendix B
Committee and Staff Biosketches
COMMITTEE MEMBERS
Gigi Gronvall, Ph.D. (Co-Chair), is a Senior Scholar at the Johns Hopkins
Center for Health Security and an Associate Professor in the Depart
ment of Environmental Health and Engineering at the Johns H opkins
Bloomberg School of Public Health. She is an immunologist by train-
ing. During the COVID-19 pandemic, she has led the Center’s ongoing
efforts to track the development and marketing of molecular and anti-
gen tests and serology tests and the development of national strategies
for COVID-19 serology (antibody) tests and SARS-CoV-2 serosurveys
in the United States. She has also written about the scientific response
to the COVID-19 pandemic and implications for national and interna-
tional security. Dr. Gronvall is the author of Synthetic Biology: Safety,
Security, and Promise. In the book, she describes what can be done to
minimize technical and social risks and maximize the benefits of syn-
thetic b
iology, focusing on biosecurity, biosafety, ethics, and U.S. national
competitiveness—important sectors of national security. Dr. Gronvall is
also the author of Preparing for Bioterrorism: The Alfred P. Sloan Founda-
tion’s Leadership in Biosecurity. Through her description of major grants
that represented the foundation’s investments in civilian preparedness,
public health law, law enforcement, air filtering in buildings, influenza pre-
paredness, and business preparedness, she constructed, for a nontechnical
audience, a chronicle of early gains in U.S. efforts to confront the threat of
bioterrorism. Dr. Gronvall is a member of the Threat Reduction Advisory
Committee, which provides the Secretary of Defense with independent
advice and recommendations on reducing the risk to the United States,
103

its military forces, and its allies and partners posed by nuclear, biological,
chemical, and conventional threats. In 2014–2015, she led a preparatory
group that examined the U.S. government response to the Ebola outbreak
in West Africa as a case study for the U.S. Department of Defense’s (DoD’s)
strategic role in health security and made recommendations for future
DoD actions in response to disease outbreaks. She is also a member of the
Novel and Exceptional Technology and Research Advisory Committee,
which provides recommendations to the Director of the National Institutes
of Health and is a public forum for the discussion of the scientific, safety,
and ethical issues associated with emerging biotechnologies. She served as
the Science Advisor for the Commission on the Prevention of Weapons of
Mass Destruction Proliferation and Terrorism from April 2009 until the
Commission ended in February 2010. She has testified before Congress
about the safety and security of high-containment biological laboratories
in the United States and served on several task forces related to laboratory
and pathogen security. Dr. Gronvall has investigated and presented policy
recommendations on the governance of science to the Biological Weapons
Convention in Geneva, Switzerland. In addition to b eing a life member of
the Council on Foreign Relations, Dr. Gronvall is an Associate Editor
of the journal Health Security (formerly Biosecurity and Bioterrorism).
She is a founding member of the Center. Prior to joining the faculty, she
worked at the Johns Hopkins University Center for Civilian Biodefense
Strategies. She was a National Research Council Postdoctoral Associate
at the U.S. Army Medical Research Institute of Infectious Diseases in Fort
Detrick, Maryland. Dr. Gronvall received a Ph.D. from Johns H opkins
University for work on T-cell receptor/MHC I interactions and worked
as a protein chemist at the Memorial Sloan K ettering Cancer C enter. She
received a B.S. in biology from Indiana University, Bloomington.
Alan I. Leshner, Ph.D. (Co-Chair), is the Chief Executive Officer, Emeritus,

of the American Association for the Advancement of Science (AAAS) and
the former Executive Publisher of the journal Science and the Science f amily
of journals. Before joining AAAS, Dr. Leshner was the Director of the
National Institute on Drug Abuse at the National Institutes of Health. He
also served as the Deputy Director and the Acting Director of the National
Institute of Mental Health, and in several roles at the National Science
Foundation. Before joining the government, Dr. Leshner was a Profes-
sor of psychology at Bucknell University, where he taught and conducted
research on the relationship between hormones and behavior. Dr. Leshner
is an elected fellow of AAAS, the American Academy of Arts & Sciences,
the National Academy of Public Administration, and many others. He is
a member and served as the Vice Chair of the governing Council of the
National Academy of Medicine (NAM) (formerly the Institute of Medicine)

APPENDIX B 105
of the National Academies of Sciences, Engineering, and Medicine. He

served two terms on the National Science Board, appointed first by Presi-
dent Bush and then reappointed by President Obama. Dr. Leshner received
a Ph.D. and an M.S. in physiological psychology from Rutgers University
and an A.B. in psychology from Franklin and Marshall College. Dr. Leshner
has received many honors and awards, including the Walsh McDermott
Medal from the NAM and seven honorary Doctor of Science degrees.
Jeffrey Baker, Ph.D., holds a bachelor’s degree in biochemistry and m

olecular
biology from Northwestern University, a doctorate in biochemistry from
the University of North Texas, and pursued postdoctoral studies at the
University of California, Berkeley. He joined Eli Lilly and Company in 1988
and led the development and launch of several first-in-class biologics and
supported post-launch manufacturing process development activities. Dr.
Baker received the Lilly President’s Award twice, once for work associated
with the development and launch of Humalog, the first insulin analog, and
once for work associated with the development and launch of drotrecogin
alfa, the first recombinant protein therapeutic manufactured from human
cells. Dr. Baker left Lilly to be the Senior Director of Manufacturing Sci-
ence and Technology at MedImmune, a subsidiary of AstraZeneca and, in
2011, was appointed the Deputy Director of the Office of Biotechnology
Products in the Center for Drug Evaluation and Research (CDER) at the
U.S. Food and Drug Administration (FDA). Dr. Baker has received six
CDER awards or citations for leadership and program development and in
2018 received an FDA Honors Award for contributions to “modernizing
the U.S. regulatory system for biotechnology products through sustained
creative leadership and collaboration.” In 2019, Dr. Baker was detailed
to the Advanced Manufacturing National Program Office at the National
Institute of Standards and Technology, where he worked with private and
interagency biopharmaceutical manufacturing stakeholders to advance bio-
pharma elements of the National Strategic Plan for Manufacturing in the
United States. He was recalled to FDA in 2020, where he participated in
responses to the global pandemic and Advanced Manufacturing programs
in the Office of the Commissioner. He retired from FDA in April 2021. He
remains active in the biotech community as a Senior Fellow in the National
Institute for Innovation in Manufacturing Biopharmaceuticals, participat-
ing in conferences, and working with several universities as a both a lecturer
and an advisor on program development.
Brendan Carr, M.D., M.S., is a Professor and the System Chair of Emer-
gency Medicine at the Icahn School of Medicine at Mount Sinai and the
Mount Sinai Health System. Dr. Carr, who also has a secondary appoint-
ment in the Department of Population Health Science and Policy, is a

renowned emergency physician and health policy researcher whose work

has focused on building regional systems of care for emergency care and
developing innovative delivery system solutions to create a more distributed
and accessible acute care delivery system. Dr. Carr joined Mount Sinai
from the Sidney Kimmel Medical College at Thomas Jefferson University in
Philadelphia in February 2020, 1 month before the first case of COVID-19
in New York City was diagnosed in the Mount Sinai Hospital Emergency
Department. He had a central role in coordinating the Health System’s
response to the epidemic, efforts that were recently recognized by Crain’s
Healthcare. Dr. Carr earned his M.D. from the Temple University School of
Medicine, completed his residency in emergency medicine at the University
of Pennsylvania, then fellowships in trauma and surgical critical care as
well as the Robert Wood Johnson Foundation Clinical Scholar’s Program,
also at the University of Pennsylvania. He previously served on the faculty
in emergency medicine, surgery, and epidemiology at Penn as well as the
Thomas Jefferson University Health System, where he was a Professor and
an Associate Dean for Healthcare Delivery Innovation. He holds master’s
degrees in clinical psychology and health policy research and has received
research funding from the National Institutes of Health, the Agency for
Healthcare Research and Quality, the Centers for Disease Control and Pre-
vention, and multiple foundations. His research focuses on systems of care
for trauma, stroke, cardiac arrest, and sepsis. He has authored more than
150 peer-reviewed publications, received awards both for teaching and for
research, and has advised and supported global not-for-profit foundations,
the World Health Organization, and the National Academy of Medicine
(NAM). In addition to his academic portfolio, Dr. Carr served as the Direc-
tor of the Emergency Care Coordination Center and as the Senior Advisor
within the U.S. Department of Health and Human Services from 2012 to
2020. His federal portfolio focused on improving trauma and emergency
care services at the national level, and included working with the U.S.
Department of Veterans Affairs and the U.S. Department of Defense to
integrate military and civilian health care response during disasters and
public health emergencies. In fall 2020, Dr. Carr was elected to the NAM,
which is considered one of the highest honors in health and medicine,
recognizing individuals who have demonstrated outstanding professional
achievement and commitment to service.
Baruch Fischhoff, Ph.D., is the Howard Heinz University Professor in the

Department of Engineering and Public Policy and the Institute for Politics
and Strategy at Carnegie Mellon University, where he has been since 1987.
He has a B.S. (mathematics, psychology) from Wayne State University and
an M.A. and a Ph.D. (psychology) from the Hebrew University of Jerusalem.
He has served on the U.S. Environmental Protection Agency Scientific Ad-

APPENDIX B 107
visory Board and the Homeland Security Advisory Committee (Chair), the
U.S. Department of Homeland Security Science and Technology Advisory
Committee, and the U.S. Food and Drug Administration Risk Communica-
tion Advisory Committee (Chair). He is an elected member of the National
Academy of Sciences and the National Academy of Medicine. He has served
on roughly three dozen committees of the National Academies of Sciences,
Engineering, and Medicine, including current membership on the Stand-
ing Committee on Emerging Infectious Diseases and 21st Century Health
Threats and recent membership on the Committee on Equitable Alloca-
tion of Vaccine for the Novel Coronavirus. He chaired the Committee on
Behavioral and Social Science Research to Improve Intelligence Analysis for
National Security and co-chaired the Committee on Future Research Goals
and Directions for Foundational Science in Cybersecurity, and the colloquia
The Science of Science Communication (I, II, III).
James G. Hodge, Jr., J.D., LL.M., is the Peter Kiewit Foundation Profes-
sor of Law at the Sandra Day O’Connor College of Law and the Director
of the Center for Public Health Law and Policy at Arizona State Univer-
sity. Through scholarship, teaching, and applied projects, Professor Hodge
delves into multiple areas of health law, public health law, global health
law, ethics, and human rights. Since 2010, he has served as the Direc-
tor of the Western Region Office of the Network for Public Health Law,
one of five centers nationally funded by the Robert Wood Johnson Foun-
dation. Since its inception, the office has assisted public health lawyers,
officials, p
ractitioners, students, and others across 11 states and nationally
on more than 4,300 claims. Professor Hodge is a prolific scholar, having
published more than 275 articles in journals of law, medicine, public health,
and bioethics; 2 books in public health law; 25 book chapters; and guest
edited four symposium issues in the Journal of Law, Medicine, and Ethics,
Jurimetrics, and the Annals of Health Law. He is regularly ranked among
the top 1.5 percent of cited authors in the Social Science Research Network.
With others, he has drafted several model public health laws, including the
Model State Public Health Information Privacy Act, the Model State Emer-
gency Health Powers Act, the Turning Point Model State Public Health Act,
and the Uniform Emergency Volunteer Health Practitioners Act. Professor
Hodge is a national expert on emergency legal preparedness, obesity laws
and policies, vaccination laws, and public health information privacy. His
work on these and other topics has been cited in The New York Times, The
Wall Street Journal, The Washington Post, USA Today, U.S. News & World
Report, Time, Newsweek, The Atlantic, National Law Journal, NBC News,
Baltimore Sun, Dallas Morning News, and additional regional newspapers,
social media cites, and journals, including Science, JAMA, New England
Journal of Medicine, American Journal of Public Health, and Public Health

Reports. Professor Hodge regularly publishes a column on public health

law for the Journal of Law, Medicine, and Ethics. He advises numerous
federal, state, and local governments on public health law and policy issues
and has lectured extensively on diverse topics in international locations,
including Sydney, Toronto, Barcelona, Geneva, and Dublin. B efore join-
ing the College of Law in 2009, he was a Professor at the Johns Hopkins
Bloomberg School of Public Health, an Adjunct Professor of law at the
Georgetown University Law Center, and core faculty at the Johns Hopkins
Berman Institute of Bioethics.
Anjali Joshi, M.S., currently serves as a board member of Lattice Semi

conductor, a provider of low-power FPGA products; Iteris, a provider
of smart mobility infrastructure and services; and Alteryx, a provider of
automated analytics solutions. She was on the board of The McClatchy
Company, a newspaper publisher, and MobileIron, a security applications
provider until they were acquired in 2020. Until March 2019, Ms. Joshi
was the Vice President of Product Management at Google, where most
recently she worked on products focused on emerging markets. Earlier she
led the product teams for search products, Maps, Translate, News, Finance,
and Global Infrastructure. She also led early efforts for Cloud services and
Fiber networks. Prior to Google, from 1998 to 2004, Ms. Joshi was the
Executive Vice President of Engineering for Covad Communications, Inc.,
a company providing voice and data communications products and services
to consumers and businesses. Before that, she held positions at AT&T Bell
Labs, working in the areas of voice and high-speed data from 1989 to 1998.
She received a master’s degree in management science and engineering from
Stanford University, a master’s degree in computer engineering from the
State University of New York, and a bachelor’s degree in electrical engineer-
ing from IIT, Kanpur. In 2017, she was awarded the Distinguished Alumni
Award from IIT, Kanpur. She has served in advisory roles to many start-ups
and on the board of TIE, Silicon Valley.
Kent E. Kester, M.D., was most recently the Vice President and the Head of
Translational Science and Biomarkers at Sanofi Pasteur. During a 24-year
career in the U.S. Army, he worked extensively in clinical vaccine develop-
ment and led multiple research platforms at the Walter Reed Army Institute
of Research, the U.S. Department of Defense’s largest and most diverse bio-
medical research laboratory—an institution he later led as its C
ommander/
Director. His final military assignment was as the Associate Dean for Clini-
cal Research in the School of Medicine at the Uniformed Services Univer-
sity of the Health Sciences (USUHS). Dr. Kester holds an undergraduate
degree from Bucknell University and an M.D. from Jefferson Medical
College. He completed his internship and residency in internal medicine at

APPENDIX B 109
the University of Maryland and a fellowship in infectious diseases at the

Walter Reed Army Medical Center. A malaria vaccine researcher with more
than 70 scientific manuscripts and book chapters, Dr. Kester has played a
major role in the development of the malaria vaccine candidate known as
RTS,S. C urrently a member of the U.S. Government Presidential Advisory
Council on Combating Antibiotic-Resistant Bacteria, he previously chaired
the Steering Committee of the National Institute of Allergy and Infectious
Diseases (NIAID)–USUHS Infectious Disease Clinical Research Program,
and has served as a member of the U.S. Food and Drug Administration’s
Vaccines and Related Biologics Products Advisory Committee, the NIAID
Advisory Council, and the Centers for Disease Control and Prevention’s
Office of Infectious Diseases Board of Scientific Counselors. Board certified
in both internal medicine and infectious diseases, he holds faculty appoint-
ments at USUHS and the University of Maryland and is a Fellow of the
American College of Physicians, the Infectious Diseases Society of America,
the Royal College of Physicians of Edinburgh, and the American Society of
Tropical Medicine and Hygiene.
Monique K. Mansoura, Ph.D., M.B.A., joined The MITRE Corporation, a

not-for-profit organization working in the public interest, as the Executive
Director for Global Health Security and Biotechnology in September 2017.
She brings technical, policy, and business expertise from both the public and
private sectors and a systems approach to the complexities of the Global
Health Security mission. Her current efforts include particular focus on the
sustainability of the biopreparedness industrial base and the public–private
partnerships that are vital to national and global health security as well
as the bioeconomy. She brings more than two decades of proven success
designing and driving missions of international importance through inno-
vative public–private partnerships, particularly in market-challenged envi-
ronments and an array of skills and perspectives given extensive training
and expertise in business, science, and policy. She has been deeply engaged
on two of the most vital issues of our times: the Human Genome Project
(1996–2001) and Global Health Security (2002–present) for threats, in-
cluding chemical, biological, radiological and nuclear (CBRN) agents and
pandemic/epidemic threats, such as influenza and COVID-19. Her pivotal
career transition was driven by a call to service following September 11 and
the 2001 anthrax attacks. From January 2002 to 2011, she led strategic
policy, programming, and budgeting for a pioneering multibillion-dollar
medical countermeasure (MCM) development and acquisition program
in the United States that still stands as a model for the world under the
authorities of the Project BioShield Act of 2004 and the Pandemic and All-
Hazards Preparedness Act of 2006. She was a leader in the design and
performance of the Public Health Emergency Medical Countermeasures

Enterprise (PHEMCE) from its inception through 2011 and drove initial
accomplishments, including the development of the inaugural U.S. Depart-
ment of Health and Human Services’ PHEMCE Strategy and Implemen-
tation Plan for CBRN Threats that established a framework for priority
setting and established a precedent-setting roadmap for a $5.6 billion civil-
ian MCM program. Following government service, she led an MCM busi-
ness unit at Novartis Vaccines. She has been a successful executive leader
in government, industry, and nonprofit sectors by building effective teams
across diverse organizations and functions, developing talent, leveraging
multi-stakeholder networks through effective engagement with partners in
biotechnology and multinational companies, academia, professional and
patient advocacy organizations, and international governments.
Tia Powell, M.D., is the Director of the Montefiore Einstein C enter for
Bioethics and of the Einstein Cardozo Master of Science in Bioethics pro-
gram. She holds the Trachtenberg Chair in Bioethics and is a Professor of
epidemiology in the Division of Bioethics and Psychiatry. She focuses on
bioethics issues related to public policy, dementia, consultation, end-of-
life care, LGBT people, and public health disasters. She participated as a
member or a leader of numerous national expert groups who developed
guidance related to public health disasters, social determinants of health,
and community engagement, including the Centers for Disease Control
and Prevention, the Society of Critical Care Medicine, and the National
Academy of Medicine (NAM). Dr. Powell completed chairing a committee
for the National Academies of Sciences, Engineering, and Medicine, the
Decadal Survey of Behavioral and Social Science Research on Alzheimer’s
Disease and Alzheimer’s Disease-Related Dementias, which will recommend
a roadmap for the next 10 years of funded research in this domain. She has
worked on multiple prior National Academies committees, including the
following related to crisis response during public health disasters: National
Workshops on Disaster Management, 2008; Personal Protective Equip-
ment for Health Care Professionals, 2009; Crisis Standards of Care, 2010,
and Revised, 2012; and Pre-Positioning Countermeasures Against Anthrax
Attack (Co-Chair), 2011. During the current pandemic, she has actively
engaged in scholarship and policy development, both at her institution and
more broadly to help form an ethically sound response. She served 4 years
as the Executive Director of the New York State Task Force on Life and
the Law, which functions as New York State’s bioethics commission. Dr.
Powell graduated magna cum laude from Harvard-Radcliffe College. At
Yale Medical School, she earned the Parker Prize, Yale’s highest award for
a graduating medical student. She completed her internship, psychiatric
residency, and consultation-liaison fellowship at Columbia. She is a board-
certified psychiatrist and a Fellow of The New York Academy of Medi-

APPENDIX B 111
cine, the American Psychiatric Association, and The Hastings Center. Dr.
Powell’s book, Reimagining Dementia, was published in 2019 and featured
on numerous media outlets, including Fresh Air with Terry Gross.
Robin Robinson, Ph.D., currently serves as the Chief Scientific Officer

for RenovaCare, Inc., directing research and development (R&D) of
cellular therapies for wound healing and as an independent consultant
to the pharmaceutical and financial sectors in the areas of vaccine, bio
preparedness, and infectious diseases. He reentered the biopharmaceutical
business sector after retiring in 2016 from federal public service at the U.S.
Department of Health and Human Services (HHS), where he served from
2008 to 2016 as the first Director of the Biomedical Advanced Research
and Development Authority (BARDA), the Deputy Assistant Secretary
for Preparedness and Response, and as BARDA’s Influenza and Emerging
Disease Program Director (2004–2008). Dr. Robinson brought BARDA
into prominence as one of the top 10 fully integrated R&D organizations
worldwide supporting advanced development and acquisition of drugs, vac-
cines, diagnostics, and medical devices to address the deleterious outcomes
of weapons of mass destruction (i.e., smallpox, anthrax, botulism, chemical
agents, and radiological threats), pandemic influenza, and emerging infec-
tious diseases, including Ebola and Zika viruses. Thirty-eight of its more
than 250 medical countermeasure products that BARDA supported since
2008 were fully approved and licensed by the U.S. Food and Drug Admin-
istration (FDA) during his tenure; today that total is 60. In 2013–2015,
Dr. Robinson was recognized as one of the top 50 most influential persons
worldwide in vaccines by Vaccine Nation. In 2018, Dr. Robinson was rec-
ognized by Medicine Maker as one of the top 100 innovators in medicine.
Dr. Robinson established a pandemic influenza program beginning in 2004
with scientific and technical experts to implement the national and global
strategic plans and policies for the development of new influenza anti
viral drugs, vaccines, and diagnostics outlined in the National Strategy for
Pandemic Influenza. For his leadership in this role, Dr. Robinson was the
recipient of the U.S. Department of Defense’s Clay Dalrymple Award in
2008, the HHS Distinguished Service Award three times, and a finalist for
the Service to America Medal in 2009. Prior to federal public service, Dr.
Robinson served as the Director of Vaccines at Novavax, Inc. (Rockville,
Maryland) from 1995 to 2004, where he led the development of more than
20 vaccines to hepatitis B and E, influenza, HIV, noroviruses, and human
papillomaviruses from early development, clinical trials, manufacturing
scale-up, and commercialization through FDA licensure. While at Novavax,
he developed patented platform vaccine technologies, including virus-like
particles and subunit protein vaccines for human pathogens, including
malaria, h uman papillomavirus, hepatitis, and influenza and for prostate,

melanoma, and cervical cancers. Dr. Robinson pursued his own research in
academic medicine as a faculty member in the Department of M icrobiology
and Immunology at the University of Texas Southwestern Medical School
from 1983 to 1992 on the molecular pathogenesis of herpesviruses and HIV.
Dr. Robinson received a B.S. in biology from Millsaps College in 1976, an
M.D. in 1981 from the University of Mississippi Medical School in medical
microbiology under Dr. Dennis O’Callaghan on herpesvirus oncogenesis,
and completed in 1983 a National Institutes of Health postdoctoral fellow-
ship at the State University of New York at Stony Brook under Dr. Arnold
Levine on molecular mechanisms in oncology. Dr. Robinson also served on
the Senior Advisory Group for the World Health Organization on emerging
infectious diseases and pandemic influenza (2006–2017). Additionally, he
continues to serve as an editorial board member and reviewer for several
professional scientific and technical journals on virology, vaccines, public
health, and biotechnology. Concurrently, he is a Fellow for Regenerative
Medicine and Biomedical Research at the Thought Leadership and Innova-
tion Foundation on regenerative medicines and a member of multiple of
Scientific Advisory Boards for biopharmaceutical products.
Lauren Sauer, M.Sc., is an Associate Professor in the College of Public

Health in the Department of Environmental, Agricultural, and Occupa-
tional Health at the University of Nebraska Medical Center (UNMC) and
Core Faculty of the UNMC Global Center for Health Security. She is an
Adjunct Associate Professor of emergency medicine in the Johns Hopkins
University (JHU) School of Medicine, with a joint appointment in the
Johns Hopkins Bloomberg School of Public Health. She has been working
in the field of disaster and public health emergency research and education
for almost two decades. In addition to her work at JHU, Ms. Sauer has
advised national governments, research and response networks, and non-
profit organizations. She is the Director of the Special Pathogens Research
Network, the research arm of the National Ebola Training and Education
Center, and is an alumni of the Emerging Leaders in Biosecurity program
at the Johns Hopkins Center for Health Security, where she is a contribut-
ing scholar. She also serves on the American Red Cross Scientific Advisory
Committee, where she sits on the Disaster Preparedness Subcommittee,
supporting the Red Cross’s operations with a scientifically sound evidence
base. She previously served as the Director of Operations for the Johns
Hopkins Office of Critical Event Preparedness and Response and the Direc-
tor of Research for the Johns Hopkins Biocontainment Unit, where she ran
the inpatient C OVID-19 biobank and served on the COVID-19 research
steering committee for JHU. She also previously served as the JHU focal
point for its partnership with the World Health Organization Global Out-
break and Alert Response Network. Ms. Sauer’s research focuses mainly

APPENDIX B 113
on human subjects research in bio-emergencies and acute disasters and

immediate post-disaster and post-outbreak infrastructure, including the
impact of disasters and outbreaks on health care systems, resource avail-
ability and access, and the impact of policy on preparedness and response
capabilities. Much of her work is focused on the ethical implementation
of human subjects research and navigating the regulatory environment and
the way policy, guidance, and new science impact disaster and outbreak-
affected populations. Her research has focused on providing health care
systems tools that facilitate the implementation of policy requirements
and clinical trials in emergencies. Planning tools for hospital bed capacity,
patient management, and other disaster- and outbreak-related needs allow
hospitals and health care systems to break down complex, potentially un-
familiar concepts into manageable pieces. Additionally, she has focused on
the appropriateness of disaster response and aid for affected populations to
observe positive and negative effects of the distribution of aid, implementa-
tion of response strategies such as novel therapeutics, and other resources,
and affected population outcomes.
Julie Swann, Ph.D., is the department Head and the A. Doug Allison Distin-
guished Professor of the Edward P. Fitts Department of Industrial and Sys-
tems Engineering at North Carolina (NC) State University. She is an affiliate
faculty in the Joint Department of Biomedical Engineering at NC State and
the University of North Carolina at Chapel Hill. Dr. Swann is a Fellow of
IISE and a member of INFORMS. Throughout her career, Dr. Swann has
conducted research, outreach, and education to improve how health and
humanitarian systems operate worldwide. Her work with analytics relates
to public health, public policy, epidemiology, infectious disease, supply
chain management, and disaster response. This work allowed her to serve
as a science advisor for the H1N1 pandemic response at the Centers for
Disease Control and Prevention. Recently she co-organized the Interna-
tional Workshop on COVID-19 Lessons to Inform Pandemic Influenza
Response for the National Academy of Medicine and she previously spoke
at a National Academies of Sciences, Engineering, and Medicine workshop
on medical product shortages titled COVID-19 Lessons to Inform Pandemic
Influenza Response. Worldwide, she has contributed to the education of
thousands of practitioners in health and humanitarian systems through the
co-creation and teaching in a professional certificate program at Georgia
Tech, teaching in the MASHLM program in Lugano, Switzerland, and co-
chairing the annual Health and Humanitarian Logistics Conference. She
has consulted with several organizations such as the Bank of Montreal,
SCRedesign, Third Bridge, Zoetis, and the Task Force for Global Health.
She has collaborated with organizations such as the American Red Cross,
The Carter Center, CARE USA, Children’s Healthcare of Atlanta, Emory

University Hospital, State Departments of Public Health, and many other

companies.
W. Craig Vanderwagen, M.D., RADM, is a retired family physician who

spent 29 years as a Commissioned Officer in the U.S. Public Health Service.
Raised in the Zuni Pueblo, he spent the majority of his career in Indian
Health Service, serving in a variety of local, regional, and national roles in
the agency. During that period, he also was deployed for a wide variety of
disaster and humanitarian responses, including care for Balkan (Kosovar)
refugees, the World Trade Center after September 11, Afghanistan and Iraq
(both helping to strengthen civilian health systems), the Indonesian t sunami,
and he led health response/recovery efforts after Hurricane K atrina for
3 months. His final assignment in uniform was as the Assistant Secretary for
Preparedness and Response at the U.S. Department of Health and H uman
Services from 2006 to 2009 where he participated in the original stand-
up of the Public Health Emergency Medical Countermeasures Enterprise.
Since retirement from active duty, Dr. Vanderwagen has provided consulting
services to hospitals and state health department on disaster preparedness
and response through a company that he co-founded with Fuad El Hibri.
He also has equity in a company that builds specialized vehicles (e.g.,
mobile high containment labs) and a company that builds long-endurance
drones for commercial and other uses. He has also served on and chaired
boards for two entities in Canada (a nongovernmental organization and a
university-based translational organization in vaccine development).
Patricia J. Zettler, J.D., is an Associate Professor at The Ohio State Univer-

sity Moritz College of Law and a member of Ohio State’s Drug Enforcement
and Policy Center and its Comprehensive Cancer Center. She writes and
teaches about U.S. Food and Drug Administration (FDA) law and p olicy,
torts, and legislation and regulation. Her scholarship has appeared in lead-
ing legal and health sciences journals such as the Indiana Law J ournal, the
Boston College Law Review, JAMA, JAMA Oncology, and Science, and
has covered various topics including the regulation of COVID-19 counter-
measures. She currently serves on the Presidential Task Force on the Use
of Unproven and/or Unethical Cell & Gene Therapies for the International
Society of Cell & Gene Therapy and the Black Lives Matter Advisory Com-
mittee for the Food and Drug Law Institute. In past years, she has served
as a member of the editorial advisory board for the Food and Drug Law
Journal (2015–2020), a member of the Task Force to Revise Guidelines
for the International Society for Stem Cell Research (2019–2021), and a
Consultant to the National Academies of Sciences, Engineering, and Medi-
cine’s Committee on Pain Management and Regulatory Strategies to Ad-
dress Prescription Opioid Abuse (2016–2017). Before entering a cademics,

APPENDIX B 115
Ms. Zettler served as an Associate Chief Counsel in the Office of the Chief
Counsel at FDA. She received her undergraduate and law degrees from
Stanford University, both with distinction. She is currently retained as an
expert witness by certain plaintiffs in In re Suboxone Antitrust Litigation
and In re Opana Antitrust Litigation.
STAFF
Lisa Brown, M.P.H. (Study Director), is a Senior Program Officer on the
Board on Health Sciences Policy at the National Academies and develops
and manages projects at the National Academies related to solving the
nation’s most pressing health security issues. She currently serves as a
Director for the Standing Committee on Emerging Infectious Diseases and
21st Century Health Threats and the Security of America’s Medical Prod-
uct Supply Chain. Previously, she directed several projects, including the
Committee on Equitable Allocation of Vaccine for the Novel Coronavirus,
the Committee on Data Needs to Monitor Evolution of SARS-CoV-2, the
Committee on Evidence-Based Practices for Public Health Emergency Pre-
paredness and Response, and the Committee on Strengthening the D isaster
Resilience of Academic Research Communities. Prior to the National
Academies, Ms. Brown served as a Senior Program Analyst for Public
Health Preparedness and Environment Health at the National Association
of County and City Health Officials (NACCHO). In this capacity, Ms.
Brown served as the project lead for medical countermeasures and the U.S.
Strategic National Stockpile, researched radiation preparedness issues, and
was involved in high-level Centers for Disease Control and Prevention ini-
tiatives for the development of clinical guidance for anthrax and botulism
countermeasures in a mass casualty event. In 2015, Ms. Brown was selected
as a Fellow in the Emerging Leaders in Biosecurity Initiative at the Center
for Health Security, a highly competitive program to prepare the next gen-
eration of leaders in the field of biosecurity. Prior to her work at NACCHO,
Ms. Brown worked as an Environmental Public Health Scientist at Public
Health England (PHE) in London, England. While at PHE, she focused on
climate change, the recovery process following disasters, and the impact
of droughts and floods on emerging infectious diseases. She received her
M.P.H. from King’s College London in 2012 and her B.S. in biology from
The University of Findlay in 2010.
Emma Fine is an Associate Program Officer primarily working on the Board

on Health Sciences Policy and has worked at the National A cademies for
5 years. Within Board, she previously supported research on the COVID-19
pandemic, including work on Rapid Expert Consultations that directly
informed the White House Office of Science and Technology Policy. Ms.

Fine also works with the National Academies’ Division on Behavioral

and Social Sciences and Education’s Board on Behavioral, Cognitive, and
Sensory Sciences on a project that is designing a tool for intelligence ana-
lysts to better understand social polling, attitude measurement, and group
behavior in non-Western countries, sponsored by the Office of the Director
of N
ational Intelligence (ODNI). Previously, she staffed a project on the
Board on Global Health assessing morbidity and mortality from HIV/AIDS
in Rwanda. Ms. Fine began her career at the National Academies as an SPA
in the National Academy of Medicine’s Leadership Consortium. Prior to
joining the National Academies, Ms. Fine interned for the U.S. Department
of Health and Human Services in the Office of the Assistant Secretary for
Preparedness and Response, where she contributed research to the National
Health Security Strategy Implementation Plan and the intersection between
terrorism and public health preparedness. In 2016, Ms. Fine graduated
from the University of California, Berkeley, where she earned her B.A. in
public health and public policy. She is particularly interested in the nexus
among public health, intelligence, and national security and she plans to
pursue a degree in national security and enter the field of intelligence.
Matthew Masiello, M.P.H., is an Associate Program Officer on the Board

on Health Sciences Policy, and has supported the Committee on Reviewing
the Public Health Emergency Medical Countermeasure Enterprise. He com-
pleted his M.P.H. in May 2021 at Emory University, where he focused on
disaster epidemiology and COVID-19 vaccine uptake. His thesis measured
COVID-19 vaccine intent among the Emory student body and captured
predictors for vaccine uptake and hesitancy. While completing his M.P.H.,
Mr. Masiello interned at the Council for State and Territorial Epidemiolo-
gists, where he supported the Tribal Epidemiology Subcommittee and the
Epidemiological Capacity Assessment. Prior to his M.P.H. program, Mr.
Masiello spent 3 years at the National Academies supporting four consen-
sus studies across the Health and Medicine Division. He earned his B.A. at
American University in May 2016.
Shalini Singaravelu, M.Sc., is an Associate Program Officer on the Board on

Health Sciences Policy. Her primary interests are in health security, particu-
larly socio-behavioral approaches to pandemic and epidemic preparedness
and response. Prior to joining the National Academies, Ms. Singaravelu
managed a portfolio of digital health tools as a Program Manager at IBM.
From 2015 to 2019, she was a consultant for the World Health Organiza-
tion Health Emergencies Programme in Geneva, Switzerland. In this role,
she supported preparedness and response to emerging infectious disease
epidemics with a focus on operational data systems, risk communication,
and community engagement. Before this, she worked on psychosocial sup-

APPENDIX B 117
port programming for HIV-affected orphans and vulnerable children in

South Africa. Ms. Singaravelu is currently a part-time Dr.P.H. student
in health security at the Johns Hopkins Bloomberg School of Public Health.
She received her M.Sc. in global mental health from the London School of
Hygiene & Tropical Medicine (2014) and her B.A. in anthropology from
Union College (2012).
Margaret (Maggie) McCarthy, M.Sc., is a Research Associate with the

Board on Health Sciences Policy. She is currently working with the Com-
mittee on the Security of America’s Medical Product Supply Chain and
the Standing Committee on Emerging Infectious Diseases and 21st Cen-
tury Health Threats. In 2018, Ms. McCarthy interned with the National
Academies’ Committee on Human Rights and the Office of News and
Public Information, where she collaborated with fellow colleagues to orga-
nize the Second International Summit on Human Genome Editing. Before
rejoining the National Academies as a Research Associate, she previously
worked at Brigham and Women’s Hospital in Boston, Massachusetts, as an
Infectious Diseases Research Assistant. Currently, she is working part-time
with Public Health England on a systematic review involving migrant health
and health care utilization across England. Her interests include migration,
biosecurity, and European politics. She received her B.A. in international
studies from American University and her M.Sc. in global health and
development from University College London.
Melvin Joppy is a Senior Program Assistant on the Board on Health Sci-

ences Policy with the Forum on Drug Discovery, Development, and Trans-
lation. He was recently a Program Assistant at the U.S. Department of
Energy (DOE) working in the Office of Basic Energy Sciences. Prior to
DOE, Mr. Joppy served as the Committee Manager for the Presidential
Advisory C ouncil on HIV/AIDS within the U.S. Department of Health and
Human Services. He received his B.S. in communications from Bowie State
University.
Andrew M. Pope, Ph.D., is the senior director of the Board on Health

Sciences Policy of the National Academies of Sciences, Engineering, and
Medicine. He has a Ph.D. in physiology and biochemistry from the Univer-
sity of Maryland and has been a member of the National Academies staff
since 1982 and the Health and Medicine Division staff since 1989. His
primary interests are science policy, biomedical ethics, and environmental
and occupational influences on human health. During his tenure at the
National Academies, Dr. Pope has directed numerous studies on topics that
range from injury control, disability prevention, and biologic markers to
the protection of human subjects of research, National Institutes of Health

priority-setting processes, organ procurement and transplantation policy,

and the role of science and technology in countering terrorism. Since 1998,
Dr. Pope has served as the director of the Board on Health Sciences Policy,
which oversees and guides a program of activities that is intended to en-
courage and sustain the continuous vigor of the basic biomedical and clin-
ical research enterprises needed to ensure and improve the health and
resilience of the public. Ongoing activities include forums on neuroscience,
genomics, drug discovery and development, and medical and public health
preparedness for disasters and emergencies. Dr. Pope is the recipient of the
Health and Medicine Division’s Cecil Award and the National Academy of
Sciences President’s Special Achievement Award.

Appendix C
Disclosure of
Unavoidable Conflicts of Interest
The conflict of interest policy of the National Academies of Sci-

ences, Engineering, and Medicine (http://www.nationalacademies.org/coi)
prohibits the appointment of an individual to a committee authoring a
Consensus Study Report if the individual has a conflict of interest that is
relevant to the task to be performed. An exception to this prohibition is per-
mitted if the National Academies determines that the conflict is unavoidable
and the conflict is publicly disclosed. A determination of a conflict of inter-
est for an individual is not an assessment of that individual’s actual behav-
ior or character or ability to act objectively despite the conflicting interest.
Kent Kester has a conflict of interest in relation to his service on the
Committee on Reviewing the Public Health Emergency Medical Counter-
measures Enterprise (PHEMCE) because he is employed by Sanofi Pasteur.
The National Academies has concluded that for this committee to accom-
plish the tasks for which it was established, its membership must include at
least one person who has relevant and recent industry experience in medical
countermeasures (MCMs) research and development (R&D) and medi-
cal supply chains. Dr. Kester has current experience in MCM R&D as the
Vice President and the Head of Translational Sciences and Biomarkers at
Sanofi Pasteur. Dr. Kester’s industry experience is combined with his exten-
sive experience in the organizational and operational aspects of PHEMCE
in the interagency environment at the U.S. Department of D efense, in-
cluding developing policies relating to clinical and research aspects of
infectious diseases and clinical vaccine development at the Walter Reed
Army Institute of Research. The National Academies has determined that
the experience and expertise of Dr. Kester is needed for the committee
119

to accomplish the tasks for which it has been established. The National
Academies could not find another available individual with the equivalent
experience and expertise who does not have a conflict of interest. Therefore,
the National Academies has concluded that the conflict is unavoidable.
The National Academies believes that Dr. Kester can serve effectively as
a member of the committee, and the committee can produce an objective
report, taking into account the composition of the committee, the work to
be performed, and the procedures to be followed in completing the study.
Robin Robinson has a conflict of interest in relation to his service
on the Committee on Reviewing the Public Health Emergency Medi-
cal Countermeasures Enterprise (PHEMCE) because he is employed by
RenovaCare, Inc. The National Academies has concluded that for this com-
mittee to accomplish the tasks for which it was established, its membership
must include at least one person who has substantial relevant experience
in the operational aspects of PHEMCE from the standpoint of the Bio
medical Advanced Research and Development Authority (BARDA), as
well as relevant expertise and recent experience in MCM R&D and chemi-
cal, b iological, radiological and nuclear (CBRN) defense. Dr. R obinson
served as the D irector of BARDA (2008–2016), leading the agency in the
development and acquisition of MCMs, and as BARDA’s Influenza and
Emerging Disease Program Director (2004–2008), where he gained valu-
able expertise and perspective on the development of vaccines, therapeutics,
diagnostics, and medical d evices to address CBRN threats. While serving as
the Director of BARDA, Dr. Robinson was also the Deputy Assistant Sec-
retary, Office of the Assistant Secretary for Preparedness and Response. Dr.
Robinson has extensive current experience in R&D as the Chief Scientific
Officer for RenovaCare, Inc. In addition, from 1995–2004, Dr. R obinson
served as the Director of Vaccines at Novavax, Inc., leading vaccine devel-
opment, clinical trials, manufacturing, and licensing. The National Acad-
emies has determined that the experience and expertise of Dr. Robinson
is needed for the committee to accomplish the tasks for which it has been
established. The National Academies could not find another available indi
vidual with the equivalent experience and expertise who does not have
a conflict of interest. Therefore, the National Academies has concluded
that the conflict is unavoidable. The National Academies believes that Dr.
Robinson can serve effectively as a member of the committee, and the com-
mittee can produce an objective report, taking into account the composition
of the committee, the work to be performed, and the procedures to be fol-
lowed in completing the study.

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Consensus Study Reports published by the National Academies of Sciences,

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COMMITTEE ON REVIEWING THE PUBLIC HEALTH

GIGI GRONVALL (Co-Chair), Senior Scholar, Johns Hopkins Center

1 See Appendix C, Disclosure of Unavoidable Conflicts of Interest.

Copyright National Academy of Sciences. All rights reserved.

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This Consensus Study Report was reviewed in draft form by individuals

PHYLLIS ARTHUR, Biotechnology Innovation Organization

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Although the reviewers listed above provided many constructive com-

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The U.S. experience during the COVID-19 pandemic, particularly

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This committee was convened by the National Academies of Sciences,

Gigi Gronvall, Co-Chair

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ACRONYMS AND ABBREVIATIONS xv

2 DELIVERING ON PHEMCE’S MISSION 29

3 ENSURING THAT PHEMCE DECISIONS AND

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4 ENGAGING NONFEDERAL AND PRIVATE-SECTOR

5 LEGAL AND POLICY CONSIDERATIONS UNDERLYING

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Boxes and Figures

1-1 Statement of Task, 17

3-1 PHEMCE Prioritization Framework, 45

4-1 Supply chain actor and potential partnership levers, 58

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Acronyms and Abbreviations

ACIP CDC Advisory Committee on Immunization Practices

BARDA Biomedical Advanced Research and Development Authority

CAG Countermeasures Acceleration Group

DARPA Defense Advanced Research Projects Agency

EEC Enterprise Executive Committee

FDA U.S. Food and Drug Administration

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xvi ACRONYMS AND ABBREVIATIONS

3 ENSURING THAT PHEMCE DECISIONS AND

4 ENGAGING NONFEDERAL AND PRIVATE-SECTOR

5 LEGAL AND POLICY CONSIDERATIONS UNDERLYING

The U.S. medical countermeasures (MCMs)2 enterprise is inter

RECOMMENDATION 6. ESTABLISH AN ADVISORY C OMMITTEE

• The advisory committee’s input should be sought and considered

• Coordinating internal and external communications within