Transmitted: January 21, 2022
To: Food and Drug Administration, Department of Health and Human Services, National Institutes of Health
Full Requests:
RE: FOIA Request for Records Regarding Former FDA Employees Drs. Marion Gruber and Philip Krause, as well as Government Authorization of COVID-19 Boosters
SUMMARY
Empower Oversight filed Freedom of Information Act (“FOIA”) requests with three government agencies seeking information on former Food and Drug Administration (FDA) employees, Dr. Marion Gruber, the director of the FDA’s vaccines office, and her deputy, Dr. Philip Krause, who reportedly left the agency over concerns about White House interference in the FDA’s normal process for authorizing COVID-19 booster shots. In addition to the FDA, Empower Oversight is seeking internal documents from the Department of Health and Human Services (HHS) and theNational Institutes of Health (NIH) about the controversy.
Several media outlets reported last August that both officials were leaving the agency over concerns about the White House involvement in the FDA’s review process. President Biden had pledged to “follow the science” on vaccines, but according to Business Insider, the two FDA officials wanted to leave because the White House planned to roll out COVID-19 boosters before the agency was ready to authorize them. After the two left the agency, they published a viewpoint in The Lancet in September that argued, “Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.” The viewpoint was signed by over a dozen other experts, including members of the World Health Organization.
In the months after their article in The Lancet, Dr. Anthony Fauci declared his disagreement with the two former FDA officials. It was later revealed in Roll Call that Dr. Peter Marks, the FDA’s top vaccine regulator, sided with the White House, and not his fellow FDA colleagues. STAT News later reported that the FDA approved vaccine boosters without consulting its independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, or VRBPAC. The outlet also reported that Dr. Rochelle Walensky of the CDC “sidestepped CDC’s independent vaccine experts, the Advisory Committee on Immunization Practices, or ACIP — an unusual move that is already drawing criticism.”
Empower Oversight is filing these FOIA requests so that the public can better understand why Drs. Gruber and Krause left the FDA by examining the internal communications of the three agencies about the controversy.
Currently, Empower Oversight is suing NIH for failure to comply with separate FOIA requests seeking documents regarding deletion of genetic data related to COVID-19. The deadline for NIH to file a reply to Empower Oversight’s complaint is February 7, 2022.
As part of its COVID-19 origins project, Empower Oversight also recently wrote to the Attorney General of Missouri to provide information about evidence available in the United States that could be relevant to that state’s lawsuit against the People’s Republic of China, the Chinese Communist Party, and others.
If you have first-hand information you’d like to disclose to assist Empower Oversight with these inquiries, please contact us confidentially here.