FDA Would Enhance Transparency And Disclosure Of Conflicts Of Interest Of Medical Advisers

FDA Would Enhance Transparency And Disclosure Of Conflicts Of Interest Of Medical Advisers.
The US Food and Drug Administration on Wednesday proposed changed guidelines to advise give the free more information on the experts the agency places on its all-important consultative committees, which help approve drugs and devices. The FDA has in the past been criticized for allowing individuals with war of interests to serve on these panels.

In some cases, prospective committee members with monetary or other ties to a product under discussion can still receive special conflict of interest waivers that sanction their participation on an advisory panel. But on Wednesday the agency proposed new guidelines that, in its words, would "expand transparency and visible disclosure" whenever one of these waivers are handed out.

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

So "The germinal goal of the advisory committee process is to bring high-quality input to FDA to notify our decision making," Jill Hartzler Warner, the FDA's acting associate commissioner for major medical programs, explained during a press conference Wednesday. The new guidelines would spread the information disclosed to the public whenever the FDA grants a conflict of interest waiver, Warner said.