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 further guidelines to labourer give the admitted more information on the experts the agency places on its all-important admonitory committees, which help approve drugs and devices manual. 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 economic or other ties to a product under discussion can still receive special conflict of interest waivers that cede to their participation on an advisory panel additional info. But on Wednesday the agency proposed new guidelines that, in its words, would "expand transparency and known disclosure" whenever one of these waivers are handed out.

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

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