Experts argue recent FDA expert panels may violate FACA requirements

The US Food and Drug Administration’s (FDA) increasing reliance on holding expert panels, rather than advisory committees, for external expert advice may violate the Federal Advisory Committee Act (FACA), a pair of experts argued in a recent JAMA Health Forum Viewpoint article.

While expert panels resemble advisory committees, they “differ in critical ways,” C. Joseph Ross Daval, JD; and Aaron S. Kesselheim, MD, JD, MPH, of the Program On Regulation, Therapeutics, And Law (PORTAL) group at Brigham and Women’s Hospital and Harvard Medical School, wrote in their paper.

Advisory committee memberships are ongoing, the members vote and discuss regulatory questions posed by the agency, conflicts of interest are screened before the meeting, and the length of the meeting can range from 5 hours to 18 hours over multiple days, Daval and Kesselheim explained. In contrast, expert panels convened so far have included members that appear at a single panel, make short individual presentations, do not discuss questions presented by FDA, and do not have conflicts of interest screened ahead of time, they noted.

“Since the 1960s, the FDA has relied frequently on advisory committees comprised of physicians, public health experts, and epidemiologists,” the authors wrote. “Advisory committees have at times proven to be a source of controversy, but also have been an essential way for FDA to obtain reliable, actionable advice and to demonstrate to the public that it is making its decisions in a scientifically rigorous way.”

Daval and Kesselheim said many speakers selected to present at expert panels are “seemingly handpicked to share views that are known in advance to align with the positions of advocates of the Make America Healthy Again movement on these topics.”

“The result is that the FDA is soliciting advice after it has decided what to do, rather than deciding what to do after hearing and appropriately considering independent experts’ advice,” they added.

For instance, when FDA convened its first expert panel in July 2025 to reconsider boxed warnings on hormone therapy products, “panelists sequentially presented their own evidence, analysis, and opinion, and were not asked to deliberate collectively or provide a recommendation on any particular question,” Daval and Kesselheim said. (RELATED: Panel urges FDA to remove boxed warning on women’s hormone therapy, Regulatory Focus 17 July 2025)

When FDA announced its request for manufacturers to remove boxed warnings for hormone replacement therapy products, the authors noted FDA Commissioner Marty Makary said the change was “based on” the expert panel, but not in response to any questions posed by the agency (RELATED: FDA to remove boxed warnings from hormone therapies for menopause, Regulatory Focus 10 November 2025; RELATED: FDA approves labeling changes for six menopausal hormone therapy products, Regulatory Focus 12 February 2026).

Daval and Kesselheim said FDA’s apparent switch to using expert panels over advisory committees “raises questions about their lawfulness” due to FACA’s requirement that when the agency uses an external group to solicit advice or recommendations, it must make the meeting public, publish relevant documents, and post an announcement ahead of the meeting.

While it would appear that expert panels fit this description, Daval and Kesselheim argued they do not meet FACA’s requirements, citing a US Court of Appeals case from 1993 that states an advisory committee meets FACA requirements “when it is asked to render advice or recommendations, as a group, and not as a collection of individuals.” The decision also stated a FACA advisory committee “must be greater than the sum of the parts.”

Daval and Kesselheim said FDA is “exploiting this loophole in requirements of FACA” by noting on the website for these expert panels that individuals on a panel “may offer their recommendations for regulatory action—language that may have been drafted with the aim of putting the panels outside of the reach of FACA.”

The authors appeared unconvinced that these changes would hold up to scrutiny. “The panels seem engineered to give the appearance of a true advisory committee, with the legitimacy that such a committee can lend to the decision-making process, without requiring the FDA to actually have to face an independent advisory committee making clear recommendations it cannot predict,” they said. “It seems plausible that if a federal court asked to review the lawfulness of these panels under FACA, it could see it this way too.”

By law, the agency is required to hold advisory committees for new drug approvals “regularly and at appropriate intervals, implying that the FDA cannot simply stop convening them altogether, as it appears to be doing now,” Daval and Kesselheim wrote. This potentially opens the agency up to litigation and for FDA to be compelled to hold the minimum number of independent advisory committees allowable by law for new drug applications, they noted.

‘These panels are likely unlawful’

Genevieve P. Kanter, PhD, senior scholar at the University of Southern California (USC) Schaeffer Institute, who was not involved with the paper, told Focus in an interview that there is “a general consensus among FDA-watchers that these panels are likely unlawful.”

“These panels certainly do not meet the criteria for advisory committees and do not conform to any other known permissible mode of interaction between agencies and external experts advising agencies,” she said.

FDA’s expert panels do not issue recommendations as a group, and it raises an “interesting issue of whether there is an important substantive difference between advice given to federal agencies when there are individual experts giving the advice versus as part of a group,” she said.

“There may be greater legal vulnerability if the group is asked to deliberate as a group because the agency could be sued for not complying with the requirements of the Federal Advisory Committee Act,” Kanter noted.

With that said, it is also unlikely that a group will emerge with enough to gain to file a lawsuit against the agency for this issue, said Kanter, who is also associate professor of public policy at the USC Sol Price School of Public Policy.

“Litigants may have slightly more success by forcing expert panels to comply with the federal advisory committee law in terms of transparency, conflict of interest screening, and so on, but those are small procedural victories, and won’t stop the agency’s use of these expert panels as justification for their pre-decided policy positions,” Kanter explained.

JAMA Health Forum Daval et al.

Experts argue recent FDA expert panels may violate FACA requirements

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