Jessica Karins and Maaisha Osman, Inside Health Policy News, April 17, 2025
FDA will not allow experts who are employed by regulated industry to serve on advisory committees, the agency said in an announcement Thursday (April 17), but though the statement was framed as a change in policy, one expert said it was similar to FDA’s existing policy and so vague as to be “an announcement of nothing.” Another researcher, however, said the move come signal an attempt to add voices to advisory committees who are less qualified but ideologically aligned with the Trump administration.
In its Thursday statement, FDA said it was announcing “a policy directive that limits individuals employed at companies regulated by the U.S. Food and Drug Administration, such as pharmaceutical companies, from serving as official members on FDA advisory committees, where statutorily allowed.” The statement also said FDA will “prioritize and elevate the role of patients and caregivers, strengthening the voices of their communities.”
“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,” FDA Commissioner Marty Makary wrote. “In fact, the FDA has a history of being influenced unduly by corporate interests.”
The announcement said employees of regulated industry can still serve on advisory committees when required by statute, and that “exceptions can be made in rare circumstances (i.e., when the scientific expertise in an area is only available from an employee of an FDA-regulated company) provided that the official strictly complies with the applicable ethics requirements.”
To Diana Zuckerman, president of the National Center for Health Research — an organization that has been critical of FDA advisory committees–the new policy sounded much like the existing policy.
Zuckerman said she’d like to see less industry influence on advisory committees. “It would be great if this is a new day, but it’s just not clear,” she said.
FDA advisory panel members are typically not employees of regulated companies, with the exception of industry representatives, who do not vote. Most expert members are physicians and academics, and most panels include at least one patient, consumer or caregiver representative; these members typically do not vote.
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Zuckerman said the impact of the policy will depend on multiple factors not made clear in the announcement, including whether FDA will also exclude from committees experts who have non-employment relationships with regulated companies. Those relationships, such as past consulting work, research funding or payments for licensed inventions, have been frequently criticized by Kennedy in the past.
At press time, HHS had not responded to Inside Health Policy’s questions on whether these relationships will be included.
Zuckerman also said the allowance for employees of regulated companies to serve on an advisory committee if deemed necessary makes the implications of the announcement more unclear.
Additionally, Zuckerman said, the announcement doesn’t mention other conflicts of interest FDA traditionally hasn’t recognized — such as cases in which a physician has prescribed a product in the past for which safety is now being reevaluated and is worried about being sued, or a physician whose livelihood depends in part on a medical product being examined, such as a plastic surgeon who frequently provides breast implants.
Patients can also have conflicts of interest, Zuckerman said, and the patients FDA typically hears from — whether as patient representatives, consumer representatives or speakers during public comment periods — tend not to be those who have been harmed by medical products.
Michael Abrams, a senior researcher at Public Citizen Health Research Group, said the shift from FDA is opaque but potentially dangerous.
“I think it may be a veiled pretext for RFK Jr. to dissolve existing advisory committees, regardless of membership conflicts, and replace them with individuals who are less scientifically accomplished and adept, but who share the new HHS Secretary’s . . . world view,” he told IHP.
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Abrams also pointed to the practical implications of dismantling or overhauling the current committee system, especially amid recent FDA staffing and budget cuts.
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— Jessica Karins (jkarins@iwpnews.com),