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FDA commissioner quits unexpectedly after rocky 2-month tenure

WASHINGTON—Embattled Food and Drug Administration Commissioner Lester M. Crawford resigned unexpectedly Friday, just two months after he survived a tough Senate confirmation.

President Bush appointed Dr. Andrew von Eschenbach, director of the National Cancer Institute, to be acting commissioner.

Crawford, 67, leaves an agency whose credibility and morale have been shaken by recent controversies, including the failure to act promptly on concerns about unsafe medications and repeated delays in making an emergency contraceptive available without a prescription.

Both issues made Crawford a lightning rod for criticism from lawmakers, drug safety advocates and women's rights activists during his tenure as interim, then permanent, FDA chief. Yet his abrupt resignation surprised many in and outside the agency.

In a brief farewell message to his staff, Crawford thanked Bush, Health and Human Services Secretary Michael Leavitt and "the extraordinary people of FDA for the honor of having served with them. ... After three and a half years as deputy commissioner, acting commissioner and finally as commissioner, it is time ... to step aside."

A veterinarian by training, Crawford served two stints as acting FDA commissioner and as deputy commissioner from 2002 to 2004. The former chair of the physiology and pharmacology department at the University of Georgia, he also served as administrator of the Food Safety and Inspection Service at the U.S. Department of Agriculture from 1987 to 1991.

In his farewell message, Crawford cited several career achievements, including the FDA's Drug Safety Program. Ironically, it was the agency's performance on drug safety that caused many in Congress to question his leadership.

The FDA has faced criticism in recent years for waiting nearly a year to require stronger warning labels for antidepressants after studies linked the drugs to suicidal tendencies in some children. The agency also was criticized for spending more than a year negotiating warning-label revisions with Merck & Co., the maker of Vioxx, after the drug was linked to heart problems and strokes. Merck voluntarily pulled Vioxx from pharmacy shelves late last year.

Sen. Charles Grassley, R-Iowa, the chairman of the Senate Finance Committee and a fierce FDA critic, said the agency had grown too close to the drug industry during Crawford's tenure.

"In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information," Grassley said Friday. "... Now is the time to reform the FDA's culture and reassert that the agency's top priority is what's good for John Q. Public."

Crawford's confirmation was complicated by the FDA's inaction on the emergency contraceptive, Plan B. Two FDA advisory panels voted overwhelmingly to approve the sale of the so-called "morning after pill" without a prescription in December 2003, finding that the drug was safe and effective. But strong opposition by religious and conservative groups and the Bush administration has delayed final agency action on the measure for nearly two years.

The FDA was first expected to decide the matter in February 2004 but requested more time to study adolescent use of the drug.

When the FDA missed another deadline to decide in January 2005, Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., blocked a vote on then-acting FDA Commissioner Crawford's bid to become the agency's permanent chief. The senators dropped their opposition only after the Bush administration promised action on the measure by Sept. 1. Crawford was subsequently confirmed as FDA commissioner in July.

But in a highly unusual move Aug. 26, Crawford deferred action on Plan B yet again, saying the drug was safe for women 17 and older but that issues surrounding its potential sale to younger teens remain unresolved. Dr. Susan F. Wood, the FDA's director of women's health, resigned in protest, and Murray and Clinton were outraged.

In a prepared statement, Murray hailed Crawford's resignation Friday and called on Bush to nominate a replacement who will "show his commitment to putting science ahead of politics."

Said Murray: "Dr. Crawford's ability to lead a strong and independent FDA was in question from the start. Unfortunately, during his tenure, the FDA's reputation as the gold standard in public health has been tarnished."


(c) 2005, Knight Ridder/Tribune Information Services.

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