FDA Commissioner Steps Down After Rocky Two-Month Tenure

By Marc Kaufman
Washington Post Staff Writer
Saturday, September 24, 2005

Food and Drug Administration Commissioner Lester M. Crawford announced his resignation yesterday, just two months after he was confirmed for the job. His e-mail notice to the FDA staff gave no reason for his surprise decision to step down.

Sources familiar with his departure said Crawford was asked to resign, though it was unclear why. Crawford has had a stormy tenure at the agency, which has been beset by criticism from both the left and the right over its actions regarding drug safety and emergency contraception.

He was also accused before his confirmation of having an improper relationship with a female colleague -- a charge that independent investigators said both parties denied. The final report did note, however, significant discrepancies between Crawford's testimony and that of others in the commissioner's office.

Within an hour of the resignation, the White House announced that President Bush had asked National Cancer Institute Director Andrew von Eschenbach to serve as acting agency commissioner, and said he would take over the agency immediately.

Crawford, an affable Georgian who has worked at the agency on four occasions over 30 years, explained his departure yesterday by saying: "After three and a half years as Deputy Commissioner, Acting Commissioner and, finally, as Commissioner, it is time at the age of 67, to step aside."

A spokeswoman for Health and Human Services Secretary Mike Leavitt, who helped guide Crawford through his nomination, said Leavitt accepted the resignation "with sadness." Asked why Crawford had resigned, HHS spokeswoman Christina Pearson said she could not discuss a "personnel matter."

Crawford is the second high-ranking administration official to resign in the past two weeks. Michael D. Brown resigned as director of the Federal Emergency Management Agency under pressure because of the agency's performance during and after Hurricane Katrina.

Under Crawford's leadership, the agency has been accused of being lax in its safety requirements after the discovery a year ago that the popular arthritis painkiller Vioxx increased the risk of heart attacks and strokes. The agency has also been buffeted by abortion politics over a proposal to make emergency contraception more easily available.

Crawford announced last month that the agency had delayed, once again, its decision on whether the "morning-after pill," Plan B, would be available without a prescription. An agency expert advisory panel overwhelmingly recommended in 2003 that the application be approved, but the agency on three occasions said the proposal was either unacceptable or incomplete.

Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) complained that Crawford's latest Plan B decision broke a promise made to them that the issue would be resolved by Sept. 1. On the basis of that promise, the two lifted holds they had placed on Crawford's Senate confirmation vote.

Clinton and Murray yesterday welcomed Crawford's departure.

"With the resignation of Dr. Crawford, the FDA has a real opportunity to restore its battered reputation and nominate a leader with vision and drive to ensure that the FDA upholds its gold standard of drug regulation," Clinton said in a statement.

After reading a scathing statement about the FDA and Crawford's leadership on the Senate floor last week, Murray succeeded in persuading colleagues to include language in the agency's final appropriations bill expressing congressional concern over the direction of the FDA and a call for an expedited decision on Plan B.

Sen. Charles E. Grassley (R-Iowa), a vocal critic of FDA policies and Crawford, welcomed yesterday's departure as well, and said he hopes the new commissioner will reform the agency and take it in a new and more consumer-oriented direction. "FDA scientists and employees are by and large hardworking and committed to fulfilling the agency's mission," he said. "They deserve a commissioner who will reinvigorate the agency."

Crawford, who trained in veterinary medicine and pharmacology, was generally popular with leaders of the pharmaceutical industry, as well as those involved with food safety. Yesterday, he presented his most important accomplishments as efforts to speed drug development, to introduce new drug safety measures, and to bring additional money to the agency through manufacturer-paid fees.

Crawford spoke Monday morning in Washington at a conference sponsored by the Consumer Federation of America, outlining the FDA's plans over the next few months for deciding whether cloned animals should be allowed into the food supply. He told jokes and fielded questions on several issues, offering no hint that his tenure would be over before the week was out.

Von Eschenbach, the new acting commissioner, is a surgeon and cancer survivor from Texas. Since coming to the National Cancer Institute from the University of Texas M.D. Anderson Cancer Center, he has won both friends and critics for his professed goal of making cancer a chronic disease that patients can live with, rather than a fatal disease, by 2015. Many oncologists have criticized von Eschenbach for promising more than the science will likely be able to deliver.

Staff writer Justin Gillis contributed to this report.

© 2005 The Washington Post Company