FDA Pushes Plan to Scale Back Advisory Committees
FDA under President Donald Trump is pushing forward with plans discussed during the Biden Administration under commissioner Robert Califf to scale back its long-standing practice of convening independent advisory committees to review new drug applications — a shift that critics warn could reduce transparency and weaken public trust in the agency’s decisions.
CDER director George Tidmarsh said this week the agency “would like to get away” from asking outside experts to weigh in on individual products, according to KFF Health News. Speaking at a health care industry meeting, Tidmarsh argued this use of advisory committees is redundant, burdensome for companies and staff, and less useful than broader discussions about how entire categories of drugs should be evaluated.
Tidmarsh’s concern echoed that of Biden’s commissioner, Robert Califf, who a year ago outlined areas he felt could be optimized to help improve the advice received from advisory committee meetings. Writing in the 9/2025 journal Nature, Califf and other top officials said at the time that they planned to refine the areas through future public engagements.
One of the top focus areas for optimizing advisory committees (ACs) is to “explore how to improve the utility of the advice the FDA receives from ACs, including by evaluating the composition of existing committees and considering how to best solicit useful feedback from committees,” according to the Califf article. He further said voting should not be a mandatory part of AC meetings, and is not beneficial at meetings discussing general issues, such as clinical trial designs or guidance documents. “At other AC meetings, members may cast formal votes on particular issues, such as whether benefits outweigh risks in a product submission," he wrote.
Tidmarsh noted the agency has begun publishing the “complete response letters” it sends to companies when it rejects applications (see story), a transparency measure that he said could substitute for advisory meetings. Holly Fernandez Lynch of the University of Pennsylvania added that ACs often raise critical questions neither regulators nor companies had considered.
Critics are also worried about a recent trend where Trump’s commissioner, Marty Makary, has replaced public advisory committees with handpicked panels that align with his policy views, including a July meeting on hormone replacement therapy that excluded dissenting voices. “All that was transparent was that they didn’t want to hear from anyone who disagreed,” said Diana Zuckerman of the National Center for Health Research.
KFF notes the shift is already taking effect. Since Trump’s return to office, FDA has convened only seven advisory committee meetings, compared with 22 during the same period last year. Some canceled meetings, such as one planned for a Duchenne muscular dystrophy drug, were instead followed by a complete response letter — without public deliberation.
Observers, KFF notes, warn the move away from open advisory sessions may consolidate decision-making inside the agency and reduce accountability. A 2023 study found the FDA sided with advisory committees in the vast majority of cases, agreeing with 97% of “yes” votes and two-thirds of “no” votes.