FDA News

FDA Proposes New, Tougher Procedures for Membership on Advisory Committees

(March 21, 2007)--The FDA announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending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.

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 "Today's draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process."

The draft guidance document would replace guidance issued in 2000 on FDA Waiver Criteria.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.

This new guidance would reduce the likelihood that the process for recommending waivers would vary from meeting to meeting. In addition to a more streamlined approach for considering who may participate in meetings, FDA would tighten its policy for considering eligibility for participation. If an individual has disqualifying financial interests whose combined value exceeds $50,000, after applying certain exemptions, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. If the financial interests are $50,000 or less, after applying certain exemptions, the individual might be recommended to participate as a non-voting member. Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members.

Financial interest means the potential for gain or loss to a person (or their family and outside affiliations) as a result of the government's action on a particular topic. Financial interests screened include, but are not limited to, stock ownership, related research and consulting arrangements.

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