Drugs

FDA Expert Panels Skirt Transparency Standards: Opinion

FDA’s recent use of ad hoc “expert panels” in place of traditional advisory committees risks undermining scientific rigor and public trust, according to an online opinion piece in STAT by Johns Hopkins Bloomberg School of Public Health’s drug safety expert G. Caleb Alexander.

In recent months, the agency has convened panels to discuss talc safety, infant formula, hormone replacement therapies, and antidepressant use during pregnancy. And unlike formal advisory committees, these gatherings have not followed Federal Advisory Committee Act (FACA) procedures such as convening without advanced Federal Register notice, formal transcripts, standard conflict of interest reviews, or recorded votes, Alexander said.

The FACA procedures “force the agency to disclose data, document dissent, and let clinicians, patients, and the public watch the sausage being made,” he wrote. “The FDA’s new expert panels offer the veneer of consultation but none of the safeguards. In streamlining the process, the agency is sacrificing its own credibility." The standards also ensure meeting materials, background memos, and transcripts are posted online, “allowing outside experts to test — not just trust — the FDA’s reasoning," he said. “Without these safeguards, it becomes harder for families and clinicians to understand how evidence maps to policy, especially on issues as consequential as treating pregnant patients’ depression.”

FDA officials have defended the practice as a way to foster “robust scientific discussions,” but without the safeguards of FACA, these panels may provide only the appearance of consultation, Alexander contended.

He said it is time for Congress to intervene, suggesting that FACA could be amended to cover any FDA body offering regulatory advice, restoring funding for advisory committee support staff, and requiring the agency to explain when a panel is used instead of a committee.

“Public health depends on trust that regulators apply consistent, transparent standards,” Alexander said. “If the FDA wants to keep that trust, it must turn the lights back on.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome