April 10, 2023

Dr. Marion Gruber

Vice President, Public Health & Regulatory Science
International AIDS Vaccine Initiative
125 Broad Street, 9th Floor
New York, NY 10004

Dear Dr. Gruber:

The Committee on the Judiciary is investigating allegations that the Biden Administration
interfered in the U.S. Food and Drug Administration’s (FDA) authorization and licensure of the
COVID-19 vaccines. According to reports, you resigned your position as a senior FDA vaccine
official in wake of President Biden’s premature and rushed announcement in August 2021
calling for adults to receive a COVID-19 booster shot, which put undue pressure on FDA health
officials to quickly authorize the vaccinations.1 Accordingly, we believe that you may possess
information relating to this matter, and we request your assistance with our inquiry.

At the beginning of his administration, President Biden pledged to “[l]isten to science”;

“[e]nsure public health decisions are informed by public health professionals”; and “[p]romote
trust, transparency, common purpose, and accountability in our government.”2 President Biden
broke his promise when it came to COVID-19 vaccines, most notably when it came to boosters,
urging boosters from the White House bully pulpit before the boosters received FDA
authorization. In an Oval Office meeting, President Biden stated: “We were going to start mid-
September, but we’re considering . . . that we should start earlier. The question raised is should it
be shorter than eight months? Should it be as little as five months? That’s being discussed.”3 At
the time of President Biden’s statements, however, the FDA was still reportedly “racing to
collect and analyze data” to assess the “safety and efficacy of booster shots.”4

During this relevant time period, and prior, you were the Director of the FDA’s Office of
Vaccines Research and Review, with responsibility for examining, authorizing, and approving

1
Noah Weiland and Sharon LaFraniere, Two Top F.D.A. Vaccine Regulators Are Set to Depart During a Crucial
Period, N.Y. TIMES (Aug. 31, 2021).
2
The White House, COVID-19, The Biden-Harris plan to beat COVID-19,
https://www.whitehouse.gov/priorities/covid-19/ (last visited Mar. 25, 2023).
3
Sharon LaFraniere, Biden floats faster access to booster shots amid spread of variant, N.Y. TIMES (Aug. 27, 2021).
4
Id.
Dr. Marion Gruber
April 10, 2023
Page 2

vaccines including booster shots.5 According to a subsequent report in the New York Times, you
believed that the existing data at the time of President Biden’s statement was inadequate to
justify authorizing booster shots at that time.6 A separate report from Axios noted that the
pressure caused by “the White House getting ahead of the FDA on booster shots” reportedly led
you to leave the FDA.7

In light of this information, and given your disagreement with the FDA’s decision to
move forward on authorizing these booster shots,8 we believe that you are uniquely situated to
provide information that will advance the Committee’s oversight and inform potential legislative
reforms. We therefore request that you produce the following materials in your personal
possession:

1. All records and communications referring or relating to your departure from the Food
and Drug Administration; and

2. All records and communications referring or relating to the Food and Drug
Administration’s consideration, authorization, and approval of COVID-19 vaccines.

Please provide this information as soon as possible but no later than 5:00 p.m. EST on
April 24, 2023. In addition, we ask that you appear for a transcribed interview about these
matters. Please contact Committee staff by April 24, 2023, to schedule your interview. If you are
represented by counsel, please ask your attorney to contact Committee staff on your behalf.

Pursuant to the Rules of the House of Representatives, the Committee on the Judiciary
has jurisdiction to conduct oversight of matters concerning “civil liberties” and “administrative
practice and procedures” to inform potential legislative reforms.9 In addition, H. Res. 12
authorized the Committee’s Select Subcommittee on the Weaponization of the Federal
Government to investigate “issues related to the violation of the civil liberties of citizens of the
United States.”10

Furthermore, this letter serves as a formal request to preserve all existing and future
records and materials in your possession relating to the topics addressed in this letter. You should
construe this preservation notice as an instruction to take all reasonable steps to prevent the
destruction or alteration, whether intentionally or negligently, of all records, communications,
and other information, including electronic information and metadata, that are or may be
responsive to this congressional inquiry. This instruction includes all electronic messages sent

5
Juliegrace Brufke, Two senior FDA officials resign over Biden administration booster shot plan, N.Y. POST (Sept.
1, 2021).
6
Noah Weiland and Sharon LaFraniere, Two Top F.D.A. Vaccine Regulators Are Set to Depart During a Crucial
Period, N.Y. TIMES (Aug. 31, 2021).
7
Caitlin Owens, The bureaucracy pushes back on Biden’s booster plan, AXIOS (Sept. 1, 2021).
8
Phillip R. Krause, et al., Consideration in boosting COVID-19 vaccine immune responses, LANCET (Sept. 13,
2021), https://www.thelancet.com/action/showPdf?pii=S0140-6736%2821%2902046-8.
9
Rules of the House of Representatives R. X (2023).
10
H. Res. 12 § 1(b)(1).
Dr. Marion Gruber
April 10, 2023
Page 3

using your official and personal accounts or devices, including records created using text
messages, phone-based message applications, or encryption software.

If you have any questions about this request, please contact Committee staff at (202) 225-
6906. Thank you for your attention to this important matter.

Sincerely,

Thomas Massie
Chairman
Subcommittee on the Administrative State,
Regulatory Reform, & Antitrust

cc: The Honorable David N. Cicilline, Ranking Member, Subcommittee on the

Administrative State, Regulatory Reform, & Antitrust