GOP lawmakers prod FDA over internal scientific disputes resolution process

Congressional Republicans are seeking answers from the US Food and Drug Administration’s (FDA) about its internal scientific dispute resolution process. The investigation follows a recent Government Accountability Office (GAO) report that raised concerns about political interference during the COVID-19 pandemic.

In a letter to FDA Commissioner Robert Califf dated 3 January, House Energy and Commerce (E&C) Committee Chair Cathy McMorris Rodgers (R-WA), E&C Health Subcommittee Chair Brett Guthrie (R-KY) and Subcommittee on Oversight and Investigations Chair H. Morgan Griffith (R-VA) wrote that they are concerned about potential political pressure from the Biden Administration that may have compromised the agency’s ability to make independent decisions.

The lawmakers referenced the high-profile departure of two of the agency’s top vaccine regulators – Marion Gruber, director of the Office of Vaccines Research and Review (OVRR) within the Center for Biologics Evaluation and Research, and Philip Krause, deputy director of OVRR – in late 2021. The two cited disagreement with the Biden Administration’s recommendation that adults get a booster shot of the COVID-19 vaccine eight months after their primary series.

“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,” the lawmakers wrote. “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,” they added.

The lawmakers said they want information on whether FDA’s existing system to handle internal scientific disagreements is adequate and whether the agency took any retaliatory actions against dissenting officials.

The lawmakers also noted that GAO published a September report highlighting allegations of political interference during the pandemic, especially under the Trump administration, to influence decisions at the Department of Health and Human Services (HHS). They noted that in the report FDA acknowledged it has a scientific dispute resolution system that it plans to use until a new scientific integrity policy is finalized.

The GAO report made a number of recommendations that FDA agreed with, including more clearly defining how to document and resolve scientific disagreements, training staff on the process to resolve such disagreements and being clearer about who is responsible for the contents of the documents related to scientific disagreements.

As part of their investigation to understand potential political interference at the FDA, the lawmakers have asked the agency to provide copies of documents related to all internal scientific disagreements since January 2018 and how they were handled, as well as documents related to how FDA’s Office of Chief Scientist has handled appeals of such disagreements.

The lawmakers also requested documents regarding any internal scientific disagreements at FDA over the COVID-19 vaccine booster during the summer of 2021 and documentation regarding any instances where decision-making authority was removed from an FDA official with regulatory decision-making capacity.

“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),” said the lawmakers.

The lawmakers have asked Califf to respond to their request by 24 January.

GOP lawmakers prod FDA over internal scientific disputes resolution process

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