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FDA to Broaden Disclosure on Advisers' Conflicts of Interest
Date:4/21/2010

Agency has faced criticism in the past over the issue

WEDNESDAY, April 21 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday proposed new guidelines to help give the public more information on the experts the agency places on its all-important advisory committees, which help approve drugs and devices.

The FDA has in the past been criticized for allowing individuals with conflict of interests to serve on these panels. In some cases, prospective committee members with financial or other ties to a product under discussion can still receive special conflict-of-interest waivers that allow their participation on an advisory panel.

But on Wednesday the agency proposed new guidelines that, in its words, would "expand transparency and [public] disclosure" whenever one of these waivers are handed out.

FDA advisory committees provide the agency with advice on a wide range of topics, including drugs, medical devices and tobacco. They also provide key advice on regulatory decisions, such as product approvals and general policy matters. While the FDA is not bound to follow its committees' recommendations, it usually does.

"The primary goal of the advisory committee process is to bring high-quality input to FDA to inform our decision making," Jill Hartzler Warner, the FDA's acting associate commissioner for special medical programs, explained during a press conference Wednesday.

The new guidelines would expand the information disclosed to the public whenever the FDA grants a conflict-of-interest waiver, Warner said.

The FDA has 49 advisory committees with room for more than 600 members. Currently, there are over 200 vacancies on these committees, according to the agency.

Under the proposed guidelines, the FDA would disclose conflict-of-interest waivers before committee meetings, naming the company or institution and any financial interest advisers might have as well as t
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