The FDA under President Trump is moving to abandon a decades-old practice of convening outside expert panels to review individual drug applications, marking a significant shift in how the agency evaluates new medications. George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research, announced that the agency "would like to get away" from assembling panels of experts to examine and vote on individual drugs because "I don't think they're needed."
Tidmarsh delivered this message at meetings with healthcare product makers and FDA advocacy groups, describing advisory meetings on specific drugs as "a tremendous amount of work for the company and for the FDA." He argued that the agency wants to "use that work and our time to focus on the big questions."
Historical Context and Current Practice
The FDA's advisory committees were established in their current form by a 1972 law aimed at expanding and regulating the government's use of experts in technical decisions. These panels are periodically summoned to review evidence and vote on whether the FDA should approve drugs, vaccines, and medical devices, particularly when officials face difficult decisions.
FDA actions have traditionally aligned with committee votes, with a 2023 study finding that the FDA agreed with 97% of "yes" votes and 67% of "no" votes. Departures from committee recommendations can provoke controversy, as demonstrated by the contentious 2021 decision to approve Biogen's Alzheimer's drug Aduhelm despite a "no" vote from the advisory committee.
Transparency Alternative
As part of this policy shift, the FDA began publishing "complete response letters" this month—documents sent to companies when their products are declined for approval. These letters, which previously required Freedom of Information Act requests to obtain, are intended to provide transparency similar to advisory meetings.
"Advisory committee meetings on individual drugs are redundant when you have the complete review letters," Tidmarsh told KFF Health News. The FDA published a batch of 89 such letters in September and will now release them as they are sent.
Expert Opposition
Former FDA officials and academics strongly disagree with this approach. Former FDA Commissioner Robert Califf called Tidmarsh's reasoning "hard to follow," emphasizing that "it's extremely useful for people inside FDA to find out what other experts think before they make their final decisions."
Holly Fernandez Lynch, an associate professor of bioethics and law at the University of Pennsylvania, noted that "experts might ask questions of the company or FDA that neither of them thought of on their own. The public has few other opportunities to comment about FDA decisions."
Peter Lurie, a former associate FDA commissioner who heads the Center for Science in the Public Interest, highlighted the fundamental difference between the two approaches: "A disclosed complete response letter tells the public that a company's application was rejected and why. An advisory committee meeting says to outside experts and the public, 'Here's what we're thinking of doing and we'd love your input before we decide.' Plainly, those are not equivalent."
Implementation Already Underway
The policy changes are already evident in practice. The FDA has held only seven advisory committee meetings since Trump reentered the White House, compared with 22 over the same time frame last year. This reduction has surprised experts who initially attributed meeting postponements to transition-related disruptions.
"Everyone thought it was temporary, with the transition and all the firings," said Genevieve Kanter, an associate professor of public policy at the University of Southern California. "Another theory is that this decision is strategic, in terms of consolidating power in the agencies so that you are no longer accountable to outside experts or the public."
Alternative Expert Panels
FDA Commissioner Marty Makary has to some extent replaced traditional advisory committees with panels of handpicked scientists who support his views on specific topics. Diana Zuckerman, who leads the National Center for Health Research, attended a July hormone replacement therapy panel where Makary wanted to remove black-box warnings. She described the event as hastily organized with no opportunity for public review or comment.
"All that was transparent was that they didn't want to hear from anyone who disagreed with them," Zuckerman said.
Industry and Academic Response
The Pharmaceutical Research and Manufacturers of America maintains that advisory committees are "an important resource" for the FDA and "can play an important part of the rigorous human drug review process we have in the U.S."
Reshma Ramachandran, a health services researcher and clinician at the Yale School of Medicine, noted that committees often help settle internal FDA disagreements about regulatory decisions. She pointed to the canceled July advisory committee meeting for a Duchenne muscular dystrophy drug from Capricor Therapeutics as an example where public deliberation could have provided a "calmer, public, less politicized atmosphere" for reviewing the drug's risks and benefits.
Tidmarsh indicated that committees would still be consulted on broader regulatory questions, such as how to evaluate entire classes of drugs or determine appropriate endpoints for specific conditions. However, the elimination of drug-specific advisory panels represents a fundamental shift in the FDA's approach to transparency and expert consultation in drug approval decisions.
