The head of the House Energy and Commerce Committee, Cathy McMorris Rodgers (R-Washington); Subcommittee on Health Chair Brett Guthrie (R-Kentucky); and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), are looking into the resignations of two reputable FDA scientists. The scientists resigned in 2021 after hasty approval of Covid vaccine boosters.
The retirements of Dr. Marion Gruber, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research (CBER), and Dr. Philip Krause, deputy director of the office, were announced in late summer of 2021 by the agency. No mention was made about why Gruber and Krause were leaving the agency.
However, multiple news reports circulated that doctors Gruber and Krause were frustrated with the Biden administration’s plans to move forward with recommending COVID-19 booster shots without the scientists’ prior approval. In other reports, sources told Politico that the two officials were at odds with the FDA’s top vaccine official, Peter Marks, and were discontented over the roles of the CDC and its Advisory Committee on Immunization Practices in decisions that they believed should be handled by the FDA.
On behalf of the Health and Oversight Subcommittee Republicans, the members of Congress sent a letter to FDA commissioner Robert Califf, addressing their concerns.
Key excerpts from the letter:
“[I]n August 2021, the FDA announced two top vaccine regulators were leaving the agency. One reason cited for the departures was that they were upset about the Biden administration’s announcement that adults should get a coronavirus booster vaccination eight months after they received their second shot. Neither reportedly believed there was enough data to justify offering booster shots yet, and both viewed the announcement by President Biden as pressure on the FDA to authorize the shots quickly.
It is unknown whether the FDA dispute resolution process was used, and if not, why not. We are concerned that the FDA may have retaliated against career FDA regulators who were viewed as insufficiently cooperative with the Biden administration’s agenda.”
“Given the renewed interest in updated scientific integrity policy, the Committee seeks information on the adequacy of the FDA’s existing policies for handling scientific disagreements, and whether FDA leadership has taken retaliatory actions against dissenting FDA officials.”
- A September 2023 Government Accountability Office (GAO) report highlighted the Department of Health and Human Services’ (HHS) interest in developing processes for differing scientific opinions.
- The GAO also noted that the FDA has existing dispute resolution policies and may continue to use them when the updated scientific integrity policy is finalized.
- In addition, the GAO has issued two other recent reports that are pertinent to the FDA’s handling of internal scientific disagreements.
- In June 2012, the HHS Office of Inspector General (OIG) issued a study, Scientific Disagreements Regarding Medical Device Regulatory Decisions.
- The OIG found that accountability for the completeness of administrative files related to scientific disagreements was unclear as
- Not all Center for Devices and Radiological Health (CDRH) managers and reviewers received training on the new procedures
- CDRH faced broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion
- Further, the OIG recommended that the FDA:
- (1) define more clearly its requirements for documenting and resolving scientific disagreements
- (2) train all reviewers and managers on the new policies and procedures for resolving scientific disagreements
- (3) more clearly assign accountability for the contents of the administrative files of all submissions
- The FDA concurred with all three recommendations.
The Chairs requested a response with the following information by January 17, 2024:
-Copies of the administrative files related to all internal scientific disagreements at the FDA since January 1, 2018, documenting whether and/or how the resolution was reached and the basis, including any joint memoranda.
-All documents since January 1, 2018, related to the Office of Chief Scientist handling of appeals of internal scientific disagreements at the FDA.
-All documents related to the scientific disagreement within the FDA over coronavirus booster vaccination during summer 2021.
-If the internal process was not used, please provide all documents related to any changes in decision-making authority on the coronavirus booster vaccination during summer 2021 (e.g., authority removed from the director and deputy director of the Center for Biologics Evaluation and Research (CBER) vaccines office and reassigned to the CBER director).
All documents since January 1, 2018, related to all instances where decision-making authority was removed from FDA officials involved in regulatory decisions.
CLICK HERE to read the full letter.