By Jessica Karins and Maaisha Osman, April 17, 2025 | From: InsideHealthPolicy

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.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC), for example, has been subject to speculation that HHS Secretary Robert F. Kennedy Jr. could make changes to the panel because of his views on vaccination. VRBPAC includes a non-voting industry representative and alternative representative, who are non-voting, as well as a voting patient representative. The remaining members are academics.

VRBPAC’s charter says the committee “may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative.”

That implies the industry representative is not mandatory and FDA could opt not to include one -- but the Thursday announcement doesn’t say whether it will.

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.

Abrams emphasized that FDA has long maintained policies requiring disclosure of financial conflicts and the issuance of formal waivers before individuals with potential conflicts can participate in advisory panel deliberations.

“At least -- and I believe this is current policy -- potential conflicts must be disclosed and made public, and proper waivers issued before participation in FDA advisory committee meetings,” he said. “Again, I believe this is standard for FDA advisory committees--though notably (the Department of Government Efficiency) is certainly not following such transparency rules.”

Abrams also pointed to the practical implications of dismantling or overhauling the current committee system, especially amid recent FDA staffing and budget cuts. “Given all the cuts at the FDA, one should be concerned that the agency may not have the personnel to muster and manage--let alone wholly reconstitute and utilize--the efforts of the many external advisory committees it relies upon,” he said.