FDA to Strengthen Impartiality of Advisory Committees

Facing widespread criticism over potential conflicts of interest, the U.S. Food and Drug Administration (FDA) announced plans today to add stricter guidelines to its process of choosing advisory committee members.

“FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Dr. Randall Lutter, the FDA’s acting deputy commissioner for policy. “Today’s draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process.”

The agency currently screens all potential committee members for financial conflicts of interest, but often waives that requirement when they believe that the individual’s “expertise outweighs the potential for a conflict of interest.” The new guidelines would “tighten its policy for considering eligibility for participation,” they note.

According to the new rules, individuals with combined financial interests exceeding $50,000 would no longer be eligible for a spot on the committee. In addition, individuals with any financial ties whatsoever would only be eligible to participate as non-voting members. According to the FDA, “Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members.”

“As part of FDA’s recent internal assessment of its advisory committee process,” the new document states, “the agency has targeted its assessment of potential conflicts of interest and granting of waivers as an area that needs improvement.”

The new guidelines revolve around a step-by-step algorithm that clearly (by FDA standards anyway) “sets out the questions and considerations” involved in determining eligibility for advisory committee participation. Of course, the FDA also notes that the recommendations and votes of these committees are still non-binding.

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