Saturday, September 24, 2005

FDA Commissioner Lester Crawford resigns


FDA Commissioner Lester Crawford resigns

By Lisa Richwine

WASHINGTON (Reuters) - U.S. Food and Drug Administration Commissioner Lester Crawford abruptly resigned on Friday after a bruising fight over whether the agency would approve over-the-counter sales of a morning-after pill and a string of drug-safety controversies.

Crawford's resignation takes effect immediately, health officials said. They offered no reason for his sudden departure less than three months after he was confirmed for the job.

President George W. Bush asked National Cancer Institute Director Andrew Von Eschenbach to serve as acting FDA commissioner, the White House said.

Crawford won a contentious confirmation battle in the Senate after Health and Human Services Secretary Mike Leavitt assured Senate Democrats the FDA would act on over-the-counter sales of the morning after pill Plan B by September 1.

But he came under fresh attack in late August when the FDA indefinitely postponed a ruling on whether Barr Pharmaceuticals Inc. could sell the Plan B contraceptive without a prescription. The agency's top women's health official resigned in protest.

The FDA also faced a string of drug safety controversies during Crawford's tenure. Some critics charged the agency with being too slow to react to signs of serious side effects from Merck & Co. Inc.'s recalled painkiller Vioxx and other medicines.

"In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information. The opportunity to name a new commissioner is a chance to take the agency in a necessary new direction," said Iowa Republican Sen. Charles Grassley, the Senate Finance Committee chairman.

Others said the agency was letting politics trump science in decisions about Plan B and other issues. Conservatives lobbied heavily to keep Plan B from being sold without a prescription.

Crawford's nomination had also been delayed for months by charges of an affair with a female subordinate. An investigation by the Department of Health and Human Services inspector general found no basis for the charges of an affair, which were sent anonymously to the Senate.


The FDA is a vast agency that regulates medicines, most foods, medical devices and many other consumer products.

Crawford is a food safety expert and a veterinarian with a doctorate in pharmacology. He served as FDA deputy commissioner and acting commissioner for more than three years before becoming permanent FDA chief.

Sen. Barbara Mikulski, a Maryland Democrat, said Crawford's resignation was "a move toward reforming FDA."

"Lester Crawford's leadership at FDA since 2002 has been both tepid and passive. There were so many problems under his watch," Mikulski said.

Viren Mehta, a drug industry analyst and principal of Mehta Partners, said he was concerned Crawford's resignation could slow down the speed of drug reviews, as has happened during leadership transitions at the agency in earlier years.

"Even though Crawford was in charge too briefly to establish a track record, his resignation is unfortunate because there could be a protracted debate on his permanent replacement," Mehta said.

Earlier this week, Crawford joked about his future during a speech to the Consumer Federation of America after promising new rules regarding cattle feed and mad-cow disease would be released soon.

"If it's not out very soon, they're going to have to have someone else giving these speeches in the next few months because I'm telling you, it's coming," he said.

(Additional reporting by Ransdell Pierson in New York)