FDA Announces New Policy on Advisory Committee Members

FDA Commissioner Martin A. Makary, MD, has announced a policy directive that will limit employees of companies regulated by FDA, such as pharmaceutical companies, from serving as official members of FDA advisory committees (1). In a press release on April 17, 2025, the agency said the change was made in an attempt to boost public trust in FDA decisions, and to improve the operations of the committees.

“While [FDA] should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent,” Makary said in the release (1). “Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans. In fact, [FDA] has a history of being influenced unduly by corporate interests.”

As Makary mentioned, the new policy will not preclude any employees of FDA-regulated companies from attending, or presenting their views, at committee meetings—or even continuing to be selected to serve as representative members when required by statute (1).

Seeing as FDA uses its advisory committees to obtain independent advice and recommendations from experts in areas such as scientific, technical, and other policy decisions, exceptions will be made to the new policy in cases where an individual’s scientific expertise is of unique use to an FDA committee. However, Makary said, such exceptions will be rare, and are contingent on the employee strictly complying with applicable ethics requirements (1).

“Public trust in the healthcare-industrial complex is at an all-time low,” Makary said. “We need to restore impeccable integrity to the process and avoid potential conflicts of interest.”

Previously, on April 10, FDA announced it intended to phase out animal testing in the development of monoclonal antibody therapies and other drugs, in favor of “human-relevant” methods the agency said are more effective, including the integration of artificial intelligence-based computational models in some cases (2).

These announcements quickly follow Makary’s swearing in as FDA commissioner on April 1, after a bipartisan vote in the United States Senate (3). The confirmation came among changing tides at the agency, just one day after the resignation of Peter Marks, who had previously been director of FDA’s Center for Biologics Evaluation and Research (CBER) (4). Patrizia Cavazzoni, the previous director of FDA’s Center for Drug Evaluation and Research (CDER), retired in January 2025, at the same time that prior FDA Commissioner Robert Califf was also stepping down (3,5).

References

1. FDA. FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees. Press Release. April 17, 2025.
2. FDA. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. Press Release. April 10, 2025.
3. FDA. Martin A. Makary, MD, MPH, Sworn in as FDA Commissioner. Press Release. April 1, 2025.
4. Marks, P. Letter to Sara Brenner, MD, MPH Acting Commissioner of Food and Drugs US Food and Drug Administration. March 28, 2025. Posted by The New York Times.
5. CDER Trade Press. CDER Director Patrizia Cavazzoni to Retire from FDA. Email Correspondence. Jan. 10, 2025.