FDA TO RELEASE RULES ON ADVISERS WITH INDUSTRY TIES

Outside experts who advise the government on drugs and other regulated products often have financial ties to industry, creating the potential for conflicts of interest.

Bar these scientists from review panels, say some members of Congress and critics of the FDA. Not possible, the agency says, because so many scientists whose expertise the government relies on have ties to industries under FDA regulation.

But the agency is trying to bring its decisionmaking more into the open, by spelling out how and why it grants waivers for outside experts that allow them to serve as FDA advisers.

The agency plans to release new guidelines to clarify its actions when an expert might have a conflict of interest, said Scott Gottlieb, the FDA's deputy commissioner for Medical and Scientific Affairs. The FDA says that simply eliminating all outside reviewers with potential conflicts would deny the FDA access to advisers with the expertise and experience it seeks.