FDA Issues Revised Procedures For Panel Conflict Disclosures

Main Category: Litigation / Medical Malpractice
Article Date: 19 Nov 2007 - 7:00 PDT

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FDA on Thursday issued proposed guidelines to increase transparency regarding potential conflicts of interest of members on its advisory panels, Dow Jones reports. Advisory panels -- convened to offer recommendations to FDA on health policy issues, and new drugs and medical devices -- are made up of external academic, medical and federal experts (Corbett Dooren, Dow Jones, 11/15). Under the new proposed rules, experts on advisory panels would be required to disclose any financial ties to the industry being considered, and they also would be asked to detail the reasons that they still should be allowed to serve, AP/Long Island Newsday reports. If FDA issues a waiver, the disclosure form then would be posted on the agency's Web site about two weeks before the panel convenes for a meeting, AP/Newsday reports.

Under current procedures, FDA announces when waivers are granted but does not publicly post the disclosure forms. FDA Commissioner Andrew von Eschenbach said the objective is to have the process "conducted in an open, transparent way so people will have confidence and the appropriate trust" in the agency. The proposed rules will be open for 60 days of public comment, after which FDA will decide whether to adopt or revise them (Yen, AP/Long Island Newsday, 11/15).

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