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FDA Toughens Advisory Committee Guidelines

March 22, 2007

• FDA Toughens Advisory Committee Guidelines • Ex-FDA Chief Pleads Guilty to Conflict Of Interest Charges • FDA Promises More Transparency In Advisory Process • Study Finds Conflicts of Interest at FDA • Health Advocates Urge Reform of FDA Advisory Committees • Former Prozac Users Slam FDA • FDA Panel Members Indebted to Drug Companies

After mounting complaints that its advisory committees were dominated by members with drug industry ties, the Food and Drug Administration has tightened it rules on just who will be allowed to offer advice.

Under its draft guidance, advisors who receive money from a drug or device maker would not be allowed to vote on issues involving that company. At the same time, those who receive more than $50,000 from a company or competitor whose product is being considered would be barred from serving on committees.

The move is likely to be viewed as a retreat from FDA's previous position, defended as recently as last July. The agency 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"Today's draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process."

FDA said it 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.

Under the proposed new guidelines, 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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