The U.S. Food and Drug Administration (FDA), under President Donald Trump, has sharply reduced its reliance on independent advisory committees for new drug evaluations. This shift has raised concerns among former officials, scholars, and public health advocates about transparency and accountability in the drug approval process.
FDA Advisory Committees: A 50-Year Tradition
Since 1972, FDA advisory committees—composed of independent experts—have played a key role in weighing the risks and benefits of new drugs. While their recommendations are not binding, they have historically influenced FDA decisions and provided one of the few opportunities for public input into drug approvals.
Notably, in 2021 the FDA approved Biogen’s Aduhelm, an Alzheimer’s drug, despite the advisory committee’s recommendation against approval—a decision that exposed tensions between scientific evidence, industry pressure, and public expectations.
Why the FDA Is Scaling Back Expert Meetings
George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research, argued that drug-specific advisory meetings are “unnecessary and unproductive” for the agency and pharmaceutical companies. Instead, he said, the FDA prefers to focus on broader regulatory issues and use complete response letters to explain why a drug application was rejected. According to Tidmarsh, these letters offer transparency comparable to public meetings.
Critics Warn of Reduced Transparency
Former FDA commissioner Robert Califf and bioethics expert Holly Fernandez Lynch strongly disagree. They argue that advisory committees bring forward diverse expert opinions and uncover concerns that may not emerge in closed discussions.
- Califf noted that advisory panels help FDA staff hear multiple perspectives before finalizing decisions.
- Lynch stressed that advisory meetings often raise critical questions that would otherwise be overlooked.
- Peter Lurie of the Center for Science in the Public Interest added that response letters cannot replace the interactive, deliberative nature of public advisory sessions.
Impact of Trump-Era FDA Policy
Since Trump returned to office, the FDA has significantly reduced advisory committee meetings and even canceled planned sessions, such as one on Capricor Therapeutics’ Duchenne muscular dystrophy drug. Current and former FDA staff warn that consolidating decision-making internally risks eroding public trust and regulatory accountability.
The Debate Over FDA Transparency and Drug Approvals
Supporters of reform agree that the advisory process could be modernized. However, critics stress that scaling back expert review panels undermines public oversight and confidence in FDA decisions. With fewer opportunities for open scientific debate, concerns are growing that the FDA is becoming less transparent in its approach to new drug approvals.
