FDA Proposal Toughens Membership Requirements on Advisory Panels

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.

Controversy over FDA advisory board appointees has increased over the past few years, most notably over the approval and subsequent withdrawal of cox-2 inhibitor prescription painkillers.

According to a 2006 report in theNew York Times, 10 of the 32 FDA advisory committee members who voted at that time to allow the continued sale in the United States of the three painkillers -- Bextra, Celebrex and Vioxx -- had previously acted as consultants for the drugs' manufacturers. If these members had not voted, the recommendations would have been for Bextra to be withdrawn and Vioxx to not be returned to the market, theTimessaid.

As it was, panel advisors with company ties voted overwhelmingly for Bextra to stay on the market and for Vioxx to return to pharmacy shelves. Celebrex would not have been affected.

Both Bextra and Vioxx remain off U.S. drug store shelves, however. Vioxx was pulled in September 2004, after studies linked long-term use to cardiovascular trouble. Similar data prompted the withdrawal of Bextra from the market in April 2005. Celebrex remains available to consumers.

A study published last April in theJournal of the American Medical Associationadded more fuel to the debate. In that study, researchers examined agendas and transcripts from all FDA drug advisory committee meetings listed on the agency's Web site as taking place between Jan. 1, 2001, and Dec. 31, 2004.

A total of 221 meetings held by 16 advisory committees were included in the analysis. In almost three-quarters (73 percent) of the meetings, at least one committee member or voting consultant disclosed a conflict, yet only 1 percent of committee members disqualified themselves from participation, the study found.

Lurie said he is concerned that, even after Wednesday's announcement, nonvoting members will still have some impact on FDA panels. But he believes that their status as nonvoting members will also become a kind of stigma that the voting members will take into account, he said.

In addition, this change will make recruiting people without conflicts of interest more desirable, according to Lurie. "And that's as it should be," he said.

More information

For more information on FDA advisory committees, visit the U.S. Food and Drug Administration.

SOURCES: March 21, 2007, teleconference with Randall Lutter, Ph.D., acting deputy commissioner, policy, and Jill Hartzler Warner, J.D., senior policy advisor and counselor, Office of Policy and Planning, U.S. Food and Drug Administration; Peter Lurie, M.D., M.P.H., deputy director, Public Citizen's Health Research Group, Washington, D.C.;New York Times