The Senate confirmed President Bush's pick to head the FDA Monday evening, ending a series of drawn-out controversies that had left the post vacant for nearly a year and a half.

Senators voted 78-16 to confirm Lester B. Crawford as the agency's next commissioner, elevating the veterinarian and experienced Washington bureaucrat from his post as acting director.

Crawford takes over the FDA at a time of close public scrutiny over how it handles approvals and safety monitoring for drugs and other medical products. The agency's safety approval protocols are under investigation in several quarters, including on Capitol Hill, where lawmakers are vowing to push legislation reforming how the agency operates.

Senate Majority Leader Bill Frist (R-Tenn.) called Crawford a "strong leader" but warned that he takes over FDA at a critical time.

"The FDA currently faces a number of challenges and responsibilities to ensure the safety of our nation's food and drug supplies, and Dr. Crawford's experience as acting commissioner will help make this a smooth transition for the agency," Frist said.

Crawford's bid reached the Senate floor just days after two Democrats, Sens. Patty Murray (Wash.) and Hillary Rodham Clinton (N.Y.), lifted a monthlong block on the nomination. The pair had accused the FDA of foot-dragging on a year-old application to allow the Plan B morning-after contraceptive pill to be sold without a prescription.

The hold was lifted after Health and Human Services Secretary Michael O. Leavitt sent a letter to senators late last week promising that the FDA would rule on allowing Plan B to be sold with a prescription by Sept. 1. Both Murray and Clinton voted to reject the nomination.

FDA Under the Microscope

Scrutiny of the FDA began in earnest last year when several agency scientists complained that their warnings about potentially unsafe drugs were ignored or quashed by higher-ups. The accusations came into sharp focus as the agency was forced to change policy on a host of popular drugs that had been on the U.S. market for years.

The FDA strengthened warnings on possible suicide risk associated with antidepressants. Safety officer Andrew Mosholder, MD, complained publicly at the time that he had long warned of the risk but had been prevented by his bosses from speaking publicly.

Later that year, another officer, David Graham, MD, accused the agency of ignoring data showing that Cox-2 drugs, including Vioxx and Celebrex, raised the risk of heart attacks. Information on the risks eventually led to the removal of Vioxx and Bextra from the market and spurred new health warnings for more than 20 other pain medications.

Crawford's nomination hit one final, though brief, snag Monday when freshman Sen. David Vitter (R-La.) threatened to block a vote in order to force action on a bill to allow the importation of prescription drugs. Vitter eventually dropped his threat, though it was unclear whether he had struck a deal on importation with Senate Leaders.

Despite wide support for Crawford, a pair of key lawmakers -- Sen. Charles E. Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.) -- voted against his nomination. Grassley and Baucus are the lead Republican and Democrat of the Finance Committee, which is investigating several aspects of how FDA reviews, approves, and monitors medical products.

Grassley said on the Senate floor before the vote that Crawford failed to address vital problems at the FDA during his tenure as acting director. He also vowed further investigations of how the agency performs.

"It is becoming more and more obvious to me that the FDA is plagued by structural, personnel, cultural, and scientific problems. Those problems should be equally obvious to Dr. Crawford. But under the leadership of Dr. Crawford, the FDA appears to be in a state of denial," Grassley said.

By Todd Zwillich, reviewed by Michael W. Smith, MD

SOURCES: Sen. Bill Frist (R-Tenn.). Sen. Charles E. Grassley (R-Iowa).