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Tuesday, July 19, 2005 - Page updated at 12:00 AM

Senate confirms new FDA chief

Chicago Tribune

WASHINGTON — After waiting in limbo for months, Lester Crawford was confirmed by the Senate yesterday as commissioner of the Food and Drug Administration.

Three senators — Patty Murray, D-Wash.; Hillary Rodham Clinton, D-N.Y.; and Tom Coburn, R-Okla. — had placed holds on Crawford's nomination, each for reasons unrelated to his qualifications. He has served as acting commissioner for the past year, and he previously served as deputy commissioner.

Last week the three senators lifted their objections to a vote on the nomination after winning assurances from the Department of Health and Human Services that their concerns would be addressed.

Supporters said they hope Crawford's confirmation, by a 78-16 vote, would bring stability to the FDA, which many say has drifted without the guidance of a permanent commissioner.

But Crawford still faces scrutiny over questionable financial bonuses that some FDA employees received under his watch as acting director. Further, the agency has been criticized for its approval of drugs that manufacturers later pulled from the market.

As health-care costs continue to rise, drug regulation has moved toward the forefront of congressional debate. That upped the ante in the battle over the vacancy and made it more difficult for the Senate to separate the confirmation from broader, more-contentious regulatory issues.

Murray and Clinton had objected to a vote on Crawford's nomination until the FDA made a definitive ruling on over-the-counter sales of Plan B, an emergency "morning-after" contraceptive. Coburn wanted the FDA to push manufacturers to change the wording on condom labels to reflect what he thinks is their ineffectiveness in preventing some types of sexually transmitted diseases.

The FDA promised a Plan B decision by Sept. 1, and Coburn was told his concerns would be met.

Robert Goldberg, director of the Manhattan Institute's Center for Medical Progress, said the lack of guidance at the top has left the FDA fragmented. Crawford hasn't been able to control "disparate elements like David Graham, who've been going around saying totally unscientific and unsupportable statements," Goldberg said.

Graham, an associate science director at the FDA's Office of Drug Safety, became a walking public-relations crisis for the agency after he accused senior officials of suppressing his safety concerns over Vioxx, the blockbuster arthritis painkiller that drug maker Merck later pulled off the market.

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Graham's complaints became fodder for critics of the agency's drug-approval process. Sen. Charles Grassley, R-Iowa, called for legislation to create an independent review board within the FDA with the power to pull pharmaceuticals from the market.

Senators emphasized the urgency and need for strong leadership at the FDA.

"Without a Senate-confirmed leader we can't expect the FDA to be as effective as it needs to be," said Sen. Michael Enzi, R-Wyo., who chaired the committee responsible for initially reviewing Crawford.

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