FDA Proposal Toughens Membership Requirements on Advisory Panels

By Steven Reinberg
HealthDay Reporter
Wednesday, March 21, 2007; 12:00 AM

WEDNESDAY, March 21 (HealthDay News) -- U.S. health officials on Wednesday proposed setting stricter standards for membership on U.S. Food and Drug Administration advisory committees.

The biggest change bars anyone from serving on a committee who has a financial interest of $50,000 or more that could have an impact on the drug, device or other issue the committee is considering. Overriding this rule would require a special waiver. If such a waiver is granted, that person could attend meetings, consult and express his views, but could not vote.

In addition, anyone with a conflicting financial interest oflessthan $50,000 could sit on an advisory committee, but could not vote. There will be a 60-day comment period before the proposals take effect.

"Advisory committees have been subject to increased scrutiny," Randall Lutter, the FDA's acting deputy commissioner for policy, said during a teleconference. "There has been increased attention to advisory committee members' potential conflict of interest and how FDA reviews and allows waivers allowing participation in advisory committee meetings."

Lutter noted the changes were undertaken in response to last year's report by the Institute of Medicine, which found the FDA needed to make serious internal changes, including how advisory committee members were selected.

"The draft guidance establishes more stringent standards for deciding who can participate in an advisory committee meeting and who should be excluded due to a conflict of interest," Lutter said.

One expert called the FDA move a step in the right direction.

"This is a movement away from FDA's prior claim that you can't find sufficient expertise among people without conflict," said Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, a consumer advocacy organization based in Washington, D.C. "It is also a movement away from a growing trend in medicine, that you can manage conflict of interest."

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.

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

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