By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Anand Shah, M.D.

,
Deputy Commissioner for Medical and Scientific Affairs

Over the past year, we’ve seen first-hand the devastation and turmoil wreaked by
the COVID-19 pandemic; the unparalleled economic and personal tragedies inflicted
on families and communities across the nation. We’ve also had the opportunity to be
part of the extraordinary governmental response to this unparalleled public health
emergency.

Working closely with other government agencies, industry, the health care
community, researchers, and others, the U.S. Food and Drug Administration has
helped foster the knowledge and understanding of the SARS-CoV-2 virus necessary to
bring it and the disease it causes under control.
photo of Stephen M. Hahn, M.D.
Stephen M. Hahn, M.D.

We are extremely proud of the role the FDA has played on many different fronts in
this effort. That work has included expediting access to COVID-19 medical
countermeasures for the detection, protection against, and treatment of COVID-19,
supporting the stability and quality of medical product and food supply chains, and
ensuring that the agency’s decisions are guided firmly by science using an open and
transparent process to ensure continued public confidence.

To build on these efforts, in April 2020, we began the FDA COVID-19 Pandemic
Recovery and Preparedness Plan (PREPP) initiative, with a formal launch in August
2020. The goal was to strengthen our on-going COVID-19 response and resiliency for
future emergencies. To this end, we engaged an external third party for an
independent and objective review of the agency’s response, to assess actions, and
identify forward-looking opportunities for the agency’s consideration.

The external third party prepared an objective summary report of the PREPP
initiative. In furtherance of our commitment to openness and transparency, we are
pleased to make the report available here: FDA COVID-19 Pandemic Recovery and
Preparedness Plan (PREPP) Initiative: Summary report.

The report reflects highlights of the agency’s response, accomplishments and

activities and describes a broad set of potential prospective actions that the
agency could consider going forward. To be clear, the report’s recommendations are
not a “to do” list for the FDA and are deliberative, not binding and not
exhaustive. The agency will need to carefully consider the relevance and
implementation feasibility associated with the ideas as it decides the appropriate
courses of action in the continually evolving COVID-19 response and recovery.
Enhancing Regulatory Agility

From the beginning, we have worked to become more nimble in our regulatory
response, streamlining processes to make it easier for developers and scientists to
send inquiries and requests, and moving as quickly as possible to support medical
developments while ensuring scientific rigor. At the same time, we’ve responded
with appropriate flexibility when necessary and possible to adapt our processes and
regulatory tools.
photo of Anand Shah, M.D.
Anand Shah, M.D.

Since the start of the pandemic, we have published and revised more than 65
industry guidance documents related to COVID-19 to provide recommendations on
matters ranging from clinical trial conduct to emergency use authorizations (EUA)
for vaccines to prevent COVID-19. We’ve reviewed over 2,300 EUA requests and issued
over 600 EUAs for medical countermeasures, including therapeutics, vaccines, tests,
personal protective equipment, ventilators and other devices to address patients’
needs in preventing, diagnosing and treating COVID-19. We have reviewed and
conducted inspectional activities in relation to nearly 400 COVID-19 therapeutic
candidates and numerous COVID-19 vaccine Investigational New Drug applications.
Additionally, we’ve issued more than 150 warning letters to companies to enforce
the safety and quality of COVID-19-related products and identified over 1,240
fraudulent and unproven medical products related to COVID-19.

Moreover, even as we have been focused on the demanding and life-saving response to
COVID-19 and dealt with the enormous additional burdens in terms of work hours that
this has meant for our staff, it’s important to remember that the FDA has continued
to meet the agency’s vital non-COVID-related public health responsibilities.
Building on Our Strength to Respond to Public Health Emergencies

As an agency whose mission embraces using the most rigorous science and best
available data to protect and promote the health and safety of the American public,
the FDA’s role and responsibilities are only magnified during public health crises
such as this one.

Our expertise, combined with the tools and resources we have at our disposal, make
us uniquely equipped to respond to public health emergencies. At the FDA, we’ve
used this experience to develop and hone a number of effective strategies in the
course of our responses to previous public health crises, including the Ebola
Virus, outbreaks from foodborne illnesses, and dangerously tainted medical
products.

Today, we continue to develop and strengthen our ability to respond. One of the
hallmarks of being prepared is the continuous evaluation and application of lessons
learned from experience. Our response to the COVID-19 pandemic has been no
different.
Promise and Possibilities

It’s important to keep in mind that our response to COVID-19 is constantly evolving
given the dynamics of the public health emergency. Our workforce remains deeply
engaged in leading pandemic response actions, which continue to rapidly evolve.
Consequently, the FDA is regularly reviewing its actions and developing and
considering alternative approaches to achieve the best possible public health goals
under our current authorities. In doing so, the agency will evaluate the ideas in
the PREPP initiative report, along with other inputs and considerations, to
continue to adapt its approach to the COVID-19 response and to build future
resilience.

The FDA is at its core, a science-based, learning organization. What that means is
that the agency makes decisions based on the application of rigorous science and
that it continues to learn from those decisions and the actions it takes to
implement them by regularly reevaluating, revising and strengthening what we do to
help ensure the health and safety of American patients and consumers. We are
confident that the FDA will continue along this path, continually growing and
learning, on behalf of its mission to protect and promote the health and safety of
the American public.