September 19, 2005
Monday

WASHINGTON - After nearly 14 years in the Senate, Patty Murray thought she had seen just about everything.

But the Washington Democrat said she had never been lied to by a cabinet secretary until Health and Human Services Secretary Michael Leavitt broke a promise and again delayed a final decision on whether to allow over-the-counter sales of a morning-after contraceptive known as Plan B.

"This is a blatant slap in the face," Murray said in an interview. "I've never had a handshake deal and a signed letter in which they lied."

The usually mild-mannered senator had agreed to lift her hold on the nomination of Lester Crawford to head the Food and Drug Administration after Leavitt assured her and other senators in July that a decision on the controversial drug would be made by Sept. 1. FDA is part of the Department of Health and Human Services. Crawford was confirmed by the Senate.

However, in late August as the deadline approached, Crawford announced he had indefinitely postponed a decision on Plan B. While Crawford said science supported over-the-counter sales to women over age 17, the agency had not determined how to avoid having younger teenagers get hold of the pills.

Crawford said the public would have 60 days to comment before the FDA would make a decision, but he gave no indication when the agency would act.

Murray said Crawford's decision was politically motivated because of conservative opposition to over-the-counter sales. The postponement, she said, had seriously undermined the credibility of an independent agency that had always based its decisions on science. The senator also said the agency's call for public comment was unprecedented.

"I was floored when they broke their word," she said. "It's unbelievable they would seek public comment. Their (the FDA's) decisions have always been scientifically based. Soliciting public comment to me means it is political."

A Leavitt spokesman declined comment and referred questions to the FDA. A spokeswoman for the FDA did not return repeated phone calls and e-mails seeking comment.

Leavitt was quoted as saying the FDA action represented a "step forward" in the process.

"Sometimes action isn't always yes and no," Leavitt said. "Sometimes it requires additional thought."

Murray dismissed Leavitt's explanation as semantics and said it was time for the FDA to "stop playing games."

Plan B has become one of the focal points in the national debate over abortion. Abortion supporters and women's rights groups say making the drug more readily available would reduce unwanted pregnancies and abortions. Anti-abortion activists say over-the-counter sales would increase promiscuity and the spread of sexually transmitted diseases.

The pill, which contains a higher dose of the hormone progestin than birth control pills, can reduce the risk of pregnancy by nearly 90 percent if taken within 72 hours of unprotected sex.

The FDA approved prescription-only sales of Plan B in 1999, but in May 2004 it rejected an application to sell the drug over-the-counter. The rejection came even though an FDA scientific advisory panel had voted 24-3 that such sales be allowed.

Barr Pharmaceuticals, which manufactures the drug, filed an application in July 2004 that would have placed an age limit on who could purchase the drug over the counter. The application has been pending since then.

Murray said she is frustrated by the delay. In a phone conversation with Leavitt, Murray said she told the HHS secretary he had not been honest with her.

"He thanked me for my input," she said.

Unless the drug is sold over the counter, Murray said it would be ineffective.

"If you have to call the doctor for an appointment, get the prescription and go the pharmacy, it's too late," she said.

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