Target of critics, FDA chief resigns

His leadership had been assailed

move is a surprise

September 24, 2005|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON — [WASHINGTON] -- Lester M. Crawford, the nation's top food and drug regulator, resigned suddenly yesterday after months of criticism about his leadership and the agency's ability to protect the public health.

Crawford, the commissioner of the Food and Drug Administration, told his staff in an e-mail message that "it is time, at the age of 67, to step aside."

He is departing, effective immediately, two months after he formally got the job, which he had held on an acting basis since last year. It was a surprise to members of Congress, industry officials and consumer advocates.

Crawford gave no indication this week that he was planning to leave. At a food conference, he cracked jokes while discussing the FDA's achievements and goals, and talked about working on the agency's 100th anniversary celebration next year.

"We're excited by this opportunity," he said, before talking about a public relations campaign the FDA is to begin soon.

The FDA ensures the safety of the country's food and drug supply, including guarding against bioterrorism.

President Bush quickly named an acting replacement, Andrew C. von Eschenbach, a Texan who heads the National Cancer Institute, a federal research agency.

"We wanted to move forward with an acting commissioner so the work does continue," said Erin Healy, a White House spokeswoman.

She declined to provide details about Crawford's resignation, saying it was a personnel matter. The FDA and the Health and Human Services Department did not release details, and Crawford was not available for comment.

The silence left Capitol Hill to speculate and Crawford's many critics to applaud his departure and call for a replacement who is a strong leader steeped in science.

Sen. Barbara A. Mikulski of Maryland joined several other Democrats who ignored the politesse that usually accompanying Washington departures. She assailed Crawford's leadership as "tepid and passive."

"Every day, I have grown more concerned about what's going on," she said in a statement expressing hope that his leaving will be a "move toward reforming FDA."

A veterinarian by training who has shuttled among academia, industry and government over his career, Crawford was not a popular choice.

While he was acting commissioner of the FDA, a position Bush appointed him to in March last year, the FDA failed to re-inspect a major supplier of flu vaccine after finding contamination problems. Last year, the British shut down the plant, and the United States suffered a shortage of the vaccine.

The 19th leader of the FDA, Crawford had the shortest tenure. He endured attacks concerning the safety of drugs and medical devices, and the possible influence of politics on the FDA's scientific mission.

The publicity surrounding two trials over deaths blamed on the painkiller Vioxx brought renewed attention to the FDA's handling of drug safety.

There were also disclosures about malfunctioning pacemakers and other heart devices.

"In his watch, some of the worst drug disasters in the last decade took place," said Peter Lurie of Public Citizen, a liberal watchdog group that has repeatedly assailed the agency's work.

The most withering criticism was aimed at Crawford last month, after he delayed a decision on approving sales of the "morning-after" pill without a prescription.

Senators assailed him for breaking a Bush administration promise to make a final judgment. Many doctors and scientists criticized the move as political. Agency staff members were said to be demoralized, and a senior official, the head of the women's health office, resigned.

"He was really under the gun," said Art Levin, who sits on a drug safety advisory panel at the FDA. "He was not a person who enjoyed controversy, and it may well be at 67, maybe fully vested, he said, `Who needs this?'"

Crawford's acting replacement, von Eschenbach, is one of the few political appointees at the National Institutes of Health. He joined three years ago, after serving as chief academic officer of the University of Texas.

Von Eschenbach is an expert on prostate cancer and is a cancer survivor. He has strived to step up research into cancer cures and treatment, and this year he set a goal of "eliminating suffering and death due to cancer" by 2015.

Whoever takes the helm of the FDA faces significant challenges, said William Vodra, the FDA's associate chief counsel for drugs from 1974 to 1979, who now represents drug and device companies.

Controversy and allegations of bias have sapped morale, Vodra said, and budget cuts have limited the agency's ability to oversee the safety of the country's food and drug supply.

"It's not different from FEMA," said Vodra, referring to the Federal Emergency Management Agency, which has been widely criticized for its reaction to Hurricane Katrina. "You can't cut the budget and politicize an agency and expect it to function the way it is supposed to function."

jonathan.rockoff@baltsun.com

Sun reporters Julie Hirschfeld Davis and Gwyneth Shaw contributed to this article.

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