FDA regulatory decisions being investigated by McMorris Rodgers, E&C Committee members

U.S. Rep. Cathy McMorris Rodgers (R-WA), chair of the U.S. House Energy and Commerce (E&C) Committee, is leading an investigation into how the U.S. Food and Drug Administration (FDA) handles internal scientific disagreements related to regulatory decisions. 

“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,” wrote Rep. McMorris Rodgers and two of the committee’s Republican members in a Jan. 3 letter sent to FDA Commissioner Robert Califf.

Rep. McMorris Rodgers and her colleagues cited an August 2021 incident in which the FDA said that two top vaccine regulators were leaving the agency, reportedly because 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, according to their letter. 

“Neither [regulator] 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,” they wrote. “It is unknown whether the FDA dispute resolution process was used, and if not, why not.”

Given the renewed interest in updated scientific integrity policy, they wrote that the E&C 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.

They requested that Califf provide written responses to several requests by Jan. 24, including copies of the administrative files related to all internal scientific disagreements at the FDA since Jan. 1, 2018, documenting whether and/or how the resolution was reached and the basis, and all documents related to the scientific disagreement within the FDA over coronavirus booster vaccination during summer 2021, among others.

Rep. McMorris Rodgers and the members also wrote that they will pursue compulsory measures if the FDA fails to respond by their deadline.