'It's high time we had this debate and this vote. Without a Senate-confirmed leader we can't expect the FDA to be as effective as it needs to be.'

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 on Crawford's 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 agency, which many claim has drifted without the guidance of a congressionally approved commissioner.

Questionable Financial Bonuses

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

The position has been vacant for two-thirds of Bush's 4 1/2-year tenure in office. Crawford's predecessor, Mark McClellan, who stepped down in 2004, was the president's fourth choice in a first-term confirmation fight that dragged on for almost two years. After McClellan departed, Crawford was the agency's acting director, but many lawmakers believed his interim status weakened his influence.

As health care costs continue upward, 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 process from broader, more contentious regulatory issues.

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, an emergency overnight contraceptive.

Coburn wants 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 met.

Public Relations Crisis

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, Merck Inc.'s blockbuster 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.

'Instinct To Be Too Careful'

John Calfee, a resident scholar at the American Enterprise Institute, a conservative think tank here, said the agency lacked the leadership and discipline to defend its procedures in the wake of the flare-up over Vioxx. 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 came off the shelves, the FDA recommended that drug giant Pfizer pull Bextra, an arthritic pain reliever similar to Vioxx, from the market. On the same day, it stamped its most serious warning on the label of Celebrex, 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 chaired 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."