The Food and Drug Management (FDA) is facing scrutiny over its increasing reliance on informal “expert panels” for critical decisions, prompting worries about transparency and potential conflicts of interest.These panels,unlike established advisory committees,ofen operate without public notice,formal transcripts,or standard conflict of interest reviews,according to experts.

Critics argue that this shift away from traditional advisory committees undermines the agency’s commitment to open and rigorous scientific evaluation. The panels have been used to shape policy on critically important issues such as talc safety, infant formula, hormone replacement therapy, and antidepressant use during pregnancy.

According to physician-scientist and drug safety expert,”This shift from advisory committees to ‘expert’ panels isn’t bureaucratic streamlining – it’s a retreat from transparency,scientific rigor,and public accountability.”

The Drawbacks of Informal Expert Panels

Traditional FDA advisory committees are governed by the 1972 Federal Advisory Committee Act (FACA), which mandates transparency and balanced depiction. these committees include diverse members such as clinicians,statisticians,and patient advocates,who openly debate data and record formal votes. This process provides the public with a clear understanding of the scientific basis for the FDA’s decisions.

In contrast, the new expert panels often lack these safeguards. Meetings may occur with little advance notice, and comprehensive briefing materials or recorded votes may not be available. This makes it arduous for outside scientists and the public to scrutinize the evidence or understand points of disagreement.

“Expert panels give FDA leadership the veneer of consultation without the constraints of genuine peer review.”

Furthermore, because these panels are assembled ad hoc, the selection of members and the agenda can be influenced by the conveners, potentially leading to biased outcomes. This raises concerns that the panels may not provide the balanced, scientifically focused deliberation that has long made advisory committees so valuable.

Specific Instances of Concern

Several recent instances have raised concerns about the use of expert panels. in may,regulators convened a panel on talc safety with only days’ notice on the FDA website. In June,an infant-formula nutrition roundtable was held,and in July,the agency livestreamed a panel on antidepressant use during pregnancy.

critics point out that one panelist had been a paid expert witness in ongoing litigation, a financial conflict that was never disclosed. The antidepressant-in-pregnancy panel disproportionately elevated skeptics of SSRIs, potentially downplaying the risks of untreated perinatal depression and anxiety.

The need for Transparency and accountability

Experts are calling for greater transparency and accountability in the FDA’s use of expert panels. They argue that Congress should amend FACA to clarify that any FDA meeting convened to offer regulatory advice must comply with FACA’s transparency and balance requirements.

Additionally, they recommend restoring funding for the agency staff that support advisory committees and requiring the FDA to explain publicly why a committee isn’t convened when statutes or guidance suggest one is warranted.

Without these safeguards, the FDA risks undermining public trust and compromising the integrity of its regulatory decisions.