BMJ  2005;331:713 (1 October), doi:10.1136/bmj.331.7519.713

News

FDA chief resigns without warning

New York

After only two months as commissioner, but 30 years at the organisation, Lester Crawford, head of the Food and Drug Administration, abruptly resigned last Friday. He sent an email message to FDA staff members saying, "It is time, at the age of 67, to step aside."

President Bush immediately named Andrew von Eschenbach, director of the National Cancer Institute, as temporary commissioner. Dr von Eschenbach said he would continue to hold both jobs.

The New York Times this week reported an anonymous government official as claiming that Dr Crawford's resignation was related to the fact that he had not fully disclosed financial information during Senate hearings on his confirmation (Sep 24; Sect A: 1). Dr Crawford's wife, Catherine W Crawford, subsequently denied this on his behalf (New York Times, Sep 27; Sect A: 21).

Dr Crawford's resignation comes after a difficult year for the FDA, in which it has been criticised for refusing to allow availability over the counter of the emergency contraceptive Plan B ( BMJ 2005;331: 596[Free Full Text], 17 Sep) and for failing to act quickly enough on evidence indicating that the cyclo-oxygenase-2 inhibitor rofe-coxib (Vioxx) had serious side effects ( Lancet 2005;365: 449-51[Web of Science][Medline]). The drug was withdrawn by its manufacturer Merck last year ( BMJ 2004;329: 816[Free Full Text]).

The agency has also had to contend with criticism arising from malfunctions in implanted cardiac defibrillators, a shortfall in flu vaccine because of problems with a British supplier ( BMJ 2004;329: 876[Free Full Text]), and delay in warning about an increased risk of suicide in children and adolescents taking antidepressants ( BMJ 2004;329: 702[Free Full Text]).

Susan Wood, who resigned as assistant commissioner for women's health on 31 August because of Dr Crawford's decision to delay approval of over the counter availability of Plan B, said she was surprised by Dr Crawford's sudden decision. "I don't know why he left," she said. "It might have to do with issues around scientific decision making at the agency."

She said Dr Crawford's resignation would be unsettling for people at the agency. After she resigned the agency first named a male veterinarian to head the women's health office and later named Theresa Toigo, head of the FDA's Office of Special Health Issues, as temporary head of the women's office.

"The new acting commissioner has a very strong scientific background, so perhaps we can hope he will take another look at Plan B," Dr Wood added.

Dr Crawford, a veterinarian and expert in pharmacology and food safety, had finally been named commissioner in July, after two senators released a "hold" on his nomination when they were promised a decision on Plan B by 1 September. Instead Dr Crawford postponed the decision ( BMJ 2005;331: 472[Free Full Text]).

Senator Chuck Grassley of Iowa (Republican), chairman of the Senate committee which oversees the FDA, welcomed the change, saying, "In recent years the FDA has demonstrated a too cosy relationship with the pharmaceutical industry."

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Longer versions of these articles are on bmj.com

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