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Lester Crawford's abrupt departure after just two months as Food and Drug Administration commissioner has left some stunned agency observers wondering who would want to replace him.
Crawford, widely criticized for the agency's handling of Vioxx and emergency contraception, among other drugs and devices, has not revealed his reason for resigning. In an e-mail to FDA staff members Friday, he wrote, "It is time, at the age of 67, to step aside."
Shortly after his announcement, the White House said it planned to name urologist Andrew von Eschenbach, National Cancer Institute director, acting FDA commissioner. Von Eschenbach said in an interview Sunday that he would continue to work full-time as NCI director as well as acting FDA commissioner, two positions he says complement each other.
"I'm going into it (FDA) with the clear understanding that I am going to continue my commitment to the National Cancer Institute," he said. He declined to say whether he is interested in holding the FDA job permanently.
Whoever assumes the post permanently will first have to be confirmed by the Senate. And that's a problem, says pharmacologist Raymond Woosley, who in 2001 withdrew from consideration for the position to accept the job of vice president for health sciences at the University of Arizona.
"It really should be taken out of the realm of politics," Woosley says. "It's a public health job. The head of the CDC (Centers for Disease Control and Prevention) isn't a political appointment, and it's in the same realm."
Woosley is now president of the Critical Path to Accelerate Therapies Institute, a non-profit organization created to help the FDA revamp the drug regulatory process.
"The good thing is (von Eschenbach) has really been a good partner with the FDA," Woosley says. "NCI and FDA have got some very exciting collaborative programs."
The NCI is the only institute at the National Institutes of Health whose director is a political appointee, albeit one who does not require Senate confirmation.
Von Eschenbach came to the cancer institute from the University of Texas M.D. Anderson Cancer Center, where he led prostate cancer research and was executive vice president. President Bush's parents have been fundraisers for M.D. Anderson, which last year named the Robin Bush Child and Adolescent Clinic for the daughter the Bushes lost to leukemia in 1953.
Bush took nearly two years to replace Jane Henney, who quit as FDA commissioner in January 2001. Her successor, Mark McClellan, was confirmed in November 2002 but left after 16 months to lead the Centers for Medicare & Medicaid Services.
"If they can find another Mark McClellan hiding under a rock somewhere, it would be a good outcome," Woosley says.
Vanderbilt University pharmacologist Alaistair Wood echoed Woosley's concerns about politicizing the FDA. "The issue is, once you've involved politics in the drug approval process, there's no way to put that genie back in the bottle."
As a member of the agency's Nonprescription Drugs Advisory Committee, Wood voted with the majority in December 2003 in favor of selling Plan B emergency contraception over-the-counter. In August, Crawford acknowledged that research shows women 17 and up can safely use Plan B without a doctor's advice. But he put off approving OTC sales because, he said, the FDA isn't sure if an age cutoff for an OTC drug is legal or enforceable.
Some women's groups and congressional Democrats accused the FDA of bowing to White House pressure. Conservative groups such as Concerned Women of America oppose making Plan B more widely available. Abortion opponents say it causes abortions by preventing fertilized eggs from implanting in the uterus.
Steven Burrill, CEO of Burrill and Co., an influential biotech investor in San Francisco, says he worries that Bush could take as long as 18 months to nominate a new FDA commissioner because he's busy with the Gulf Coast recovery, selecting a second Supreme Court nominee and fighting the Iraq war.
Contributing: Jim Hopkins
in San Francisco
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