FDA Would Enhance Transparency And Disclosure Of Conflicts Of Interest Of Medical Advisers – Part 2 of 3
So “The primary goal of the advisory committee process is to bring high-quality input to FDA to brief 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 increase the information disclosed to the public whenever the FDA grants a conflict of interest waiver.
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 impart conflict of interest waivers before committee meetings, naming the company or institution and any financial interest advisers might have as well as the specific disagreement of interest.
So “In my view, it is clearly better for the agency in fulfilling its public health mission when advisers have no conflicts of interest,” FDA Commissioner Dr Margaret A Hamburg wrote in a correspondence to senior agency officials. “FDA staff should search far and wide for experts who have the requisite knowledge without conflicts of interest. At the same time, however, I recognize the fact that many of the top authorities in spelled out areas may have conflicts of interest”.