FDA Proposal Toughens Membership Requirements on Advisory Panels

New limit on financial ties would reduce potential conflict of interest, agency says

By Steven Reinberg
HealthDay Reporter

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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.

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In addition, anyone with a conflicting financial interest of less than $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"The draft guidance establishes more stringent standards for deciding who can participate in an advisory committee meeting and who should be excluded due to a conflict of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."

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