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FDA Proposes New, Tougher Procedures for Membership on Advisory Committees

Armen Hareyan's picture

The U.S. Food and Drug Administration (FDA) announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation. FDA is accepting public comments on the proposal for the next 60 days.

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"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 Randall Lutter, Ph.D., 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 "Today's draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process."

FDA currently screens all prospective advisory committee participants before each meeting to determine whether the potential for a financial conflict of interest exists. Under law, FDA may grant a waiver when certain criteria are met, such as when the need for an individual's expertise outweighs the potential for a conflict of interest.

The draft guidance document would replace guidance issued in 2000 on FDA Waiver Criteria. The 2000 guidance attempted to address the complex set of variables that can be applied in reaching a decision about an individual advisory committee participant. However, because of its complexity, FDA officials found it difficult to achieve consistent results that the public could readily understand.