Senate Confirms Crawford as FDA Chief

WASHINGTON – After waiting in limbo for months, Lester Crawford (search), President Bush's choice to be commissioner of the Food and Drug Administration, was confirmed easily by the Senate on Monday.

Three senators — Hillary Rodham Clinton, D-N.Y., Tom Coburn, R-Okla., and Patty Murray, D-Wash. — had placed holds on Crawford's nomination, each for reasons unrelated to his qualifications. But last week they lifted their objections to a vote after winning assurances from the Department of Health and Human Services, which oversees the FDA, that their concerns would be addressed.

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

But Crawford still faces scrutiny over financial bonuses some FDA employees received while he was acting director during the last year. Further, the agency has been criticized for its approval of some drugs that manufacturers had to pull from the market.

The position has been vacant for two-thirds of Bush's tenure. Crawford's predecessor, Mark McClellan (search), stepped down last year.

After McClellan departed, Crawford was the agency's acting director, but many lawmakers believed his interim status weakened his influence.

As health-care costs climb, drug regulation has moved toward the forefront of congressional debate. That upped the ante in the battle over the vacancy.

For their part, Clinton and Murray objected to a vote on Crawford until the FDA made a definitive ruling on the over-the-counter sale of Plan B, a morning-after contraceptive pill. Coburn wanted the FDA to push manufacturers to change the wording on condom labels to reflect what he believes 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 addressed.

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 have 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 public relations crisis for the agency after he accused senior officials of suppressing his safety concerns over Vioxx, Merck & Co. Inc.'s arthritis painkiller, which was later pulled off the market.

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

John Calfee, a resident scholar at the American Enterprise Institute, a conservative think tank, said the agency lacked the leadership and discipline to defend its procedures in the aftermath of the Vioxx case. Instead, Calfee said, the FDA responded with a series of unneeded regulations.

A lack of direction from above "makes it easier for the staff to overreact to criticism, and it makes it easy for the staff to pursue their own agenda," Calfee said. "The FDA's biggest problem has always been its instinct to be too careful."

Months after Vioxx (search) came off the shelves, the FDA recommended that drug giant Pfizer Inc. pull Bextra (search), an arthritis painkiller similar to Vioxx, from the market. On the same day, it stamped its most serious warning on the label of Pfizer's Celebrex (search), another top-selling painkiller.

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

"It's high time we had this debate and this vote," said Sen. Michael Enzi, R-Wyo., who led the committee responsible for initially reviewing Crawford. "Without a Senate-confirmed leader we can't expect the FDA to be as effective as it needs to be."