FDA Chief Crawford Resigns 2 Months After Confirmation

Food and Drug Administration Commissioner Lester M. Crawford resigned Friday, a move that stunned agency staffers, lawmakers, industry and the medical community.

Two months after winning Senate confirmation to a post he had sought for much of his career, Crawford sent FDA employees an e-mail Friday afternoon saying, “It is time, at the age of 67, to step aside.”

The White House quickly announced that President Bush would nominate Texas cancer surgeon Andrew C. von Eschenbach, head of the National Cancer Institute, as acting FDA commissioner.

White House officials refused to comment on the reasons for Crawford’s departure, saying it was a “personnel matter.” Crawford hastily met with his senior staff to break the news but did not give any reason for his departure, an FDA official said.

Congressional aides and some outside observers said the resignation could be related to controversy over his Crawford’s announcement last month delaying a decision on whether to allow over-the-counter sales of Plan B, the “morning-after” contraceptive.

The indefinite delay of the politically charged decision -- Crawford’s first major action as permanent FDA chief -- prompted a storm of criticism in the scientific community. The head of the FDA’s office of women’s health resigned in protest.

Although some social conservatives were pleased, other prominent Republicans were dumbfounded because Crawford had promised the Senate a firm ruling as a condition of his confirmation.

Sen. Michael B. Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee, was among those who expected Crawford to issue a clear decision.

“Enzi in particular felt he had been burned by the administration on this,” said a Senate staffer who works on drug policy issues and who spoke on condition of anonymity. A spokesman for Enzi could not be reached.

Crawford’s mission as chief had been to help restore public confidence in the FDA. Last year’s recall of Vioxx, a painkiller, revealed flaws in the agency’s oversight of drug safety and prompted criticism that it had grown too cozy with the pharmaceutical industry.

The Plan B delay led prominent academics to openly question the agency’s scientific integrity. The FDA’s staff had concluded that the drug was safe. But Crawford had said the delay was needed to determine whether over-the-counter distribution could be restricted to those 17 years of age and older.

“You squander the public trust if you move away from a science-based decision-making process,” said Dr. Alastair J.J. Wood, Vanderbilt University medical school associate dean.

Wood, who has advised the FDA on drug safety, co-wrote an article highly critical of the agency’s handling of the Plan B decision in this week’s New England Journal of Medicine.

“The recent actions of the FDA leadership have made a mockery of the process of evaluating scientific evidence, disillusioned many of the participating scientists both inside and outside the agency, squandered the public trust, and tarnished the agency’s image,” it concluded.

On Capitol Hill, FDA critics said Crawford’s resignation offers the possibility of a fresh start for the agency.

“Dr. Crawford’s ability to lead a strong and independent FDA was in question from the start,” Sen. Patty Murray (D-Wash.) said. “During his tenure, the FDA’s reputation as the gold standard in public health has been tarnished.”

Sen. Charles E. Grassley (R-Iowa) said: “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.”

Prior to his confirmation, Crawford underwent a two-month investigation by the Health and Human Services inspector general into allegations that he had had an affair with a subordinate. The inquiry found no evidence to support the charges. Officials said Friday that his resignation did not appear to be related to the investigation.

Crawford had served as acting commissioner for more than two years before winning confirmation to head the agency. He was known as a low-key, affable boss. His background was unusual for an FDA commissioner; he is not a physician, but holds degrees in veterinary medicine and pharmacology.

Von Eschenbach, the proposed acting FDA chief, is a prostate cancer specialist who performed surgery at the University of Texas M.D. Anderson Cancer Center in Houston. As head of the National Cancer Institute, he has worked with the FDA to develop medical imaging techniques that can be used to deliver chemotherapy treatments more precisely.

He has also been a cancer patient, having been treated for melanoma and prostate cancer.

Academic experts said the FDA needs permanent leadership.

“Every day they go without permanent leadership, they lose some good professional people at the agency,” said Dr. Raymond Woosley, president of the C-Path Institute, an Arizona nonprofit organization that seeks to improve the process for developing drugs.

Dr. Brian L. Strom, chairman of the biostatistics and epidemiology department at the University of Pennsylvania School of Medicine, criticized the Bush administration for encroaching on the FDA’s independence.

“This should be one of the best jobs in American medicine, but at present, I’m afraid it’s become one of the most undesirable because of the perception that science is secondary” in agency decisions, Strom said.

Pharmaceutical Research and Manufacturers of America, which supported Crawford’s nomination to head the FDA, had no comment.

Several consumer groups critical of the agency said they were pleased.

“His time at the FDA has been a disaster for consumers,” said Peter Lurie of Public Citizen’s drug safety project. “The scientific climate has not been an open one.”

“A fresh start is desperately needed,” said Diana Zuckerman, president of the National Research Center for Women & Families. “The Plan B decision was a fiasco.”

But the Center for Science in the Public Interest, which focuses on food safety, said Crawford’s departure would leave a void.

“Despite various policy disagreements, we’ll miss Dr. Crawford for his openness, and because he’s really one of the only FDA commissioners who has had substantive experience with food safety,” said Michael F. Jacobson, executive director.