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He says agency is swayed by politics

By Diedtra Henderson, Globe Staff | November 16, 2006

WASHINGTON -- Senator Edward M. Kennedy today will criticize the Food and Drug Administration during a Senate hearing for allowing "prevailing political winds" to trump science.

The Senate Committee on Health, Education, Labor, and Pensions session will give Democrats their first post election opportunity to say how they will strengthen the FDA when they become the majority party in Congress.

Some in Congress say the agency is more concerned with pleasing drug manufacturers than in ensuring patient safety.

"Science has, too often, had to take a back seat at the very agency which should be setting the standard for objectivity and integrity," Kennedy, a Democrat of Massachusetts and incoming committee chairman, said.

"There is also growing evidence that the dedicated professionals at the FDA have been pressured to trim their scientific views to the prevailing political winds. These are symptoms of a serious illness, and we should act without delay to provide the cure," the senator added.

The hearing, "Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation," is aimed to push ahead FDA reform legislation introduced by Kennedy and outgoing committee chairman Michael B. Enzi , a Wyoming Republican.

Kennedy plans to hold a series of FDA oversight hearings in early 2007 .

A Democratic majority means the committee "can enforce real oversight and discussions about how to get FDA back on track," said Senator Barbara A. Mikulski , Democrat of Maryland .

Today's hearing is scheduled to begin with testimony from the Institute of Medicine of the National Academies , independent science-based health advisers that said the FDA falls short on its drug safety mission due to chronic under funding, revolving door leadership, and a dysfunctional culture that ignores advice from staffers about drug safety. The i nstitute's blueprint for FDA reform is partly mirrored in the Kennedy-Enzi bill. The legislation would give the FDA the authority to update drug labels to indicate new risks and to require safety studies after drugs are on the market.

FDA advocates are counting on witnesses to reinforce the message that the agency needs more congressional funding to supplement the millions of dollars in user fees it now receives from industry.