FDA Proposal Toughens Membership Requirements on Advisory Panels

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Advisory committees are designed to provide FDA with independent advice by outside experts on issues related to human and veterinary drugs, biological products, medical devices and food.

These committees usually include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be consulted as needed. The committees provide FDA officials with advice, but their recommendations are not binding. However, the FDA, which makes all final decisions on drug approvals and other matters, usually follows the committees' advice.

Lutter said he believed that the $50,000 limit strikes a balance among the needs of the agency for scientific input, the transparency of the process, and public confidence.

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"The limit would cover financial interests over the proceeding 12 months and cover, for example, stock and consulting fees," he said.

According to Lutter, these new procedures will affect a significant number of people already serving on advisory committees. "It may cause some people to be disqualified," Lutter said. "At the same time, we are expanding our efforts to get people to serve on committees."

This new policy will simplify the process of selecting committee members, Jill Hartzler Warner, the agency's senior policy advisor and counselor in the Office of Policy and Planning, said during the teleconference. "This will increase the transparency, clarity and consistency of the advisory committee process, and enhance public trust," she added.

Currently, the FDA screens all prospective advisory committee members 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, Hartzler Warner noted.

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