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 redone guidelines to mitigate give the communal more information on the experts the agency places on its all-important hortatory committees, which help approve drugs and devices. The FDA has in the past been criticized for allowing individuals with battle of interests to serve on these panels.

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

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

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