Do panels cherry-pick experts and evidence that align with FDA leadership’s views?
Bypassing its standard pathways for scientific discussions, FDA has recently held a slew of so-called “expert panels” that sidestep legal procedures and ethics guardrails, raising concern about cherry-picking of experts and evidence.
The panels appear to be a new feature of Trump administration officials, and have no parallel in agency programs from years past, sources said. They’re usually moderated by FDA Commissioner Marty Makary, MD, MPH, and FDA principal deputy commissioner Sara Brenner, MD, MPH.
There have been about four panels so far: one on selective serotonin reuptake inhibitors (SSRIs) and pregnancy; another on hormone therapyopens in a new tab or window for menopause; one on infant formula ; and another on talc in food, drugs, and cosmetics.
Adriane Fugh-Berman, MD, director of PharmedOut, a project at Georgetown University Medical Center in Washington, D.C., said she suspects these expert panels “may be a run around advisory committees,” which are usually vetted, occupationally diverse, academically credentialed researchers who address a particular question.
Fugh-Berman told MedPage Today that most of the panelists at the menopause meeting, which she attended as an audience member, would not have met the criteria to serve on an advisory committee.
“There was no process for selection; they seem all to have been chosen by Makary,” Fugh-Berman said. “It was a parody.”
Steven Grossman, JD, an FDA regulatory and policy consultant, also weighed in on the menopause expert panel on his FDA Matters blogopens in a new tab or window. He noted that the panel quickly elevated an important topic, although it completely veered from the advisory committee system, which while not perfect, “has served FDA very well for many years.”
However, convening the expert panel broke many norms, and “poor adherence to process renders any conclusion highly suspect,” he wrote.
Regulatory Grey Zone
The Federal Advisory Committee Act requires that advisory committee meetings be announced in the Federal Register 15 days in advance and that meeting materials must be made public. A period of open comment where anyone can speak is also necessitated under this law, explained Sarah Wicks, JD, MPH, an associate at Hyman, Phelps & McNamara.
She noted these panels “don’t seem to fit squarely within the scope of the law.” So far, they have been announced just days in advance, with panelists selected behind closed doors.
“That doesn’t necessarily mean it’s wrong, it’s just more a question of what the intent of these meetings are, and how the information gained from these meetings [is] going to be used,” she told MedPage Today.
An HHS spokesperson told MedPage Today that these expert panels “are roundtable discussions with diverse panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and individual experts may offer their recommendations for regulatory action.”
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Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, D.C., also attended the menopause expert panel, even though it was announced just days in advance.
“If people aren’t being given enough notice to attend, that’s a real problem,” she told MedPage Today.
The panel had a limited number of slots for in-person attendees, so many people who would have attended could not. Yet the room was full of supporters of the panelists, including some of their patients. Zuckerman suspected that some people were alerted to the meeting before others, though an FDA spokesperson did not answer MedPage Today’s question on whether that was the case.
Earlier in the day of the expert panel, Zuckerman was already at FDA in an advisory committee meeting hosted in a large room that ended before the expert panel, meaning there could have been space to host the menopause panel in a room with the capacity for anyone who wished to attend.
“It felt like they only wanted invited guests there in the same way that the panel was all invited to have a particular point of view,” Zuckerman said. “When you have a meeting where everybody’s selected to have a consistent point of view with each other and presumably with the commissioner, and nobody from the public is allowed to say a word, and most people from the public aren’t even allowed to be in the room, that’s … not the transparency that this FDA promised.”
The HHS spokesperson said the “fact that our rooms are filling up for the expert panels proves just how successful they are,” adding that the events are livestreamed for anyone to watch.
The spokesperson did not answer MedPage Today‘s specific questions about upcoming expert panels, if everyone is invited to attend the panel at the same time, or why the public is not permitted to speak.
Susan Mayne, PhD, a former director of the FDA’s Center for Food Safety and Applied Nutrition — who has served in three different administrations, including the first Trump term — and said she’s never seen FDA veer from established processes like this before.
For instance, Mayne, who regulated talc in cosmetics during her tenure at FDA, knew that one of the panelists at the talc meeting, Daniel William Cramer, MD, ScD, had been a paid expert witness in litigation against manufacturers who used talc in their products — a significant conflict of interest that wasn’t disclosed at the panel.
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Zuckerman, who was in the room, noted that several panelists mentioned other ways they would financially benefit from the boxed warning being removed from hormone therapy labels — like having more business at their practice — that weren’t included in their disclosures.
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By hosting these panels without following established FDA processes, Makary is acting “like a spokesperson rather than a commissioner,” Zuckerman said.