CDER Director George Tidmarsh said on two separate events last week that he thought advisory committee meetings for specific drug applications were redundant, but then denied having said the agency would abandon them.
George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research, has walked back a previous statement suggesting that the agency could do away with advisory committee reviews for drug applications.
Speaking to Endpoints News on Friday, Tidmarsh insisted he “never said” that the FDA would abandon independent panel meetings, though he also did not clarify his views regarding the necessity of these external reviews.
A spokesperson for the Department of Health and Human Services told Endpoints that advisory committees “will continue to be a critical tool that FDA uses to obtain external expertise when needed. The decision to convene an advisory committee, including whether to convene a committee to discuss a particular application, is made on a case-by-case basis.”
Tidmarsh’s pushback is in response to a piece from KFF Health News, also published on Friday, which stated that the director is considering a move to “abandon” the use of advisory committee meetings. KFF referenced Tidmarsh’s statements at a meeting of health care product developers last Tuesday and to an advocacy group last Wednesday, in which he said that the FDA “would like to get away” from these external expert panels.
“I don’t think they’re needed,” Tidmarsh said, referring to meetings addressing specific drugs. He added that the reviews are redundant and required “a tremendous amount of work for the company and for the FDA.” Instead of investing resources into these panels, Tidmarsh said that the agency would rather “use that work and our time to focus on the big questions,” without elaborating on what these questions are.
Tidmarsh’s statements do not constitute official agency policy, but a division director at the HHS told Endpoints that despite the lack of formal announcements, the agency hasn’t been convening advisory panels.
Tidmarsh is hardly the first high-ranking FDA official to push back against the committee meetings. In early 2024, President Joe Biden’s FDA Commissioner Robert Califf said that the agency was eyeing “systemic” changes to the advisory committee system, though he did not specify what areas of the process he was looking to amend.
“This is complicated because of conflict of interest and . . . getting the right people who actually know the field and can help the FDA with good advice,” he said at the time, while insisting that the regulator would remain “very dependent on external input” for its reviews.
