FDA chief took over Plan B

In deposition, Crawford says he bypassed usual approval process

May 25, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- Circumventing normal practices, the nation's top drug regulator seized control of a request to sell the "morning-after" pill without a prescription and delayed the drug's approval, two senior Food and Drug Administration officials told lawyers suing the agency over the decision.

Lester M. Crawford, then acting commissioner of the FDA, intervened in early 2005 as the agency's staff was preparing to authorize over-the-counter sales to women 17 years and older, the two FDA officials said in sworn depositions last month.

The two officials, Dr. Janet B. Woodcock and Dr. Steven Galson, said Crawford effectively cut them out of a process they normally participate in and handled the matter by himself. The two were interviewed for a suit filed by the New York-based Center for Reproductive Rights.

Barbara van Gelder, Crawford's lawyer, said he confirmed yesterday in his deposition for the suit that Plan B "was his decision."

After being appointed permanent FDA commissioner, Crawford announced last August that the agency was indefinitely delaying approval to further study the effectiveness of allowing some women to buy the pill over the counter but not others.

Crawford said the pill could be sold safely to women over 17, but he needed to be sure younger girls would not be able to obtain it without a prescription. He has since left the agency.

Abortion foes praised the Plan B delay for protecting teenage girls from promiscuous behavior and sexually transmitted diseases, but abortion supporters said what should have been a decision based on medical science had been politicized.

A nonpartisan congressional investigation reported in November the "unusual" involvement of the commissioner's office, but the nature of his role in the decision was not clear until yesterday.

As part of the lawsuit, Woodcock, an FDA deputy commissioner, testified that she had asked Crawford why she wasn't involved in the Plan B approval process. "He said he was, you know, going to take this decision by himself," she said, according to the deposition.

Galson, who heads the FDA's drug evaluation division, said he "saw a clear path to approve" Plan B, but Crawford expressed concern and said "he was going to make the decision on what to do with the application."

Galson said he recommended approval, and there was no scientific basis for Crawford's decision. Galson told Woodcock that Crawford might have been acting under pressure from Congress, the Bush administration or both, Woodcock testified.

Simon Heller, a staff lawyer at the Center for Reproductive Rights, said in a statement that the testimony of Woodcock and Galson bolstered the lawsuit's claim that the FDA departed from its own standard practices and violated the rights of women.

But David Christensen, director of congressional affairs at the conservative Family Research Council, criticized the Center for Reproductive Rights for ignoring the impact of over-the-counter sales on teenage girls. "They don't care about the safety of young women," said Christensen, who has not seen the testimony.

The new details about Crawford's role are the latest revelations to emerge from the suit, filed in January 2005 in New York federal court. Last month, Crawford's lawyer asked to delay his deposition because of federal investigations into statements he made on his financial disclosure forms and to Congress about Plan B. Van Gelder said Crawford answered all questions yesterday.

Democratic senators have blocked the nomination of President Bush's choice to replace Crawford, Dr. Andrew C. von Eschenbach, until the agency takes action on Plan B. The drug is designed to prevent pregnancy if taken within 72 hours after sex.

jonathan.rockoff@baltsun.com

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