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Archive for Monday, July 24, 2006

Under pressure, FDA moves to ensure independence of advisers

July 24, 2006

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— 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 Food and Drug Administration.

Not possible, the agency says, because so many scientists whose expertise the government relies on have ties to industries under FDA regulation.

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

Eventually, new guidelines - plans for which are being announced today - should clarify its actions when an expert might have a conflict of interest, said Dr. Scott Gottlieb, the FDA's deputy commissioner for Medical and Scientific Affairs.

Few details were available about the proposed guidelines.

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.

"We probably couldn't recruit department chairmen. It would hinder us from recruiting all but junior faculty members," Gottlieb said.

Rep. Maurice Hinchey, D-N.Y., called that claim "absolutely untrue," adding that any action short of barring advisers with conflicts would be a "charade."

That blanket approach is too restrictive, while the FDA's is too permissive, said Dr. Peter Lurie, author of a recent study on the issue that appeared in The Journal of the American Medical Assn.

Outside advisers, while independent of the FDA, often have ties to the drug, vaccine, medical device and other industries regulated by the agency.

The FDA turns to its advisory committees for outside advice. The agency is not required to follow the recommendations of its outside advisers but usually does.

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