FDA’s new expert panels raise concerns over transparency, bias, and legal process.
In recent months, the FDA has held several expert panel discussions on topics such as hormone therapy, SSRIs in pregnancy, talc in consumer products, and infant formula. These meetings are being led by Commissioner Marty Makary and Deputy Commissioner Sara Brenner. While presented as scientific roundtables, they’ve attracted criticism from longtime FDA watchers and legal experts who argue the gatherings skirt the rules that typically guide agency decision-making. Several of the concerns revolve around how these panels are formed and who gets invited. Critics say the experts selected don’t go through the normal review process, and meetings have been announced on very short notice. In some cases, audience space has been limited to people with prior connections to panelists. Those in attendance described the gatherings as lopsided and lacking the range of opinions expected at official FDA advisory meetings.
One such event on menopause treatments drew attention for having speakers who would not qualify for the agency’s standard advisory roles. The panel was described as more of a performance than a balanced discussion. Multiple people have said that the selection process appears informal and heavily influenced by top agency leadership. That alone raises red flags, especially when there is no record of public input or transparent vetting.
Under current law, advisory committee meetings must be announced at least 15 days ahead of time, with published materials and open time for public comment. None of these requirements have applied to the recent expert panels. The FDA says these are simply roundtable discussions meant to bring in fresh thinking, but many observers see them as a way to bypass normal checks.
A former FDA director who oversaw cosmetic safety said she had never seen anything quite like these events during her tenure. She pointed out that one speaker on the talc panel had previously served as a paid witness in legal cases on the topic, a detail not disclosed during the meeting. Typically, such conflicts would be flagged well in advance, allowing the public to weigh in. Instead, disclosures were only briefly flashed on screens and not included in the official livestream.
Some panelists, according to in-person observers, went further by mentioning that a change in FDA labeling could bring more business to their practices, something not noted in their official bios or conflict statements. Others said that the entire setup gave the impression that panelists were chosen because they agreed with agency leadership, not because they brought new or contested ideas to the table.
While the FDA says the events are livestreamed and well attended, others argue that this doesn’t replace proper public notice or the opportunity to participate. At one such meeting, people were already on-site for an earlier FDA hearing in a larger room but were not told about the panel happening right after. Those who did attend were mostly supporters or patients of the panelists.
Legal experts say these panels seem to fall into a regulatory grey area. They’re not technically advisory committees, so the usual rules don’t apply. But they’re also being used in ways that could influence future agency policy. That blurs the line between informal discussion and official guidance, creating confusion around how these events fit into the FDA’s structure.
In one case, a new FDA appointee had participated in panels just weeks after publishing a single paper on the topic, in a fringe journal with ties to COVID-19 skeptics. For some, this raised questions about qualifications and whether certain figures are being elevated more for their views than their scientific track record.
What these developments mean for the FDA’s credibility remains to be seen. Critics argue that by using panels to promote pre-set messages, the agency may be weakening its own standing as a neutral, science-based body. Without more clarity, concerns over fairness and ethics will likely grow.
Sources:
FDA ‘Expert Panels’ Raise Concerns of Evading Regulations, Ethics
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