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Ex-FDA Chief Would Not Aid Plan B Inquiry

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By Marc Kaufman
Washington Post Staff Writer
Friday, October 14, 2005

The former commissioner of the Food and Drug Administration declined to cooperate with an inquiry by the Government Accountability Office into the agency's controversial decision to reject nonprescription sales of an emergency contraceptive.

According to congressional staffers who have read the draft GAO report but were not allowed to copy it, the document has several footnotes indicating Lester M. Crawford did not respond to requests for an interview.

During the period examined by the GAO, the investigative arm of Congress, Crawford was deputy FDA commissioner and then acting commissioner of the agency. He was confirmed as permanent FDA commissioner in July and then abruptly resigned last month.

The draft report, which is being reviewed by the FDA and members of Congress, describes the agency's decision-making process on Plan B as highly unusual because officials in the commissioner's office were directly involved and the FDA office directors who normally rule on applications refused to sign the rejection letter. An FDA advisory panel earlier voted overwhelmingly in favor of the proposal.

In addition, the GAO report indicates that the decision to reject the application was made months before it was announced in May 2004 by Steven Galson, then acting director of the FDA's Center for Drug Evaluation and Research. The report says the rejection was discussed at a January 2004 staff meeting when Mark B. McClellan, now head of the Centers for Medicare and Medicaid Services, was FDA commissioner. It was unclear yesterday whether McClellan spoke with the GAO.

Many social conservatives oppose any efforts to make emergency contraception more easily available, saying that it can encourage sexual promiscuity, especially among teenagers.

GAO spokesman Paul Anderson said the office can demand documents from federal agencies but cannot compel an official to speak with investigators. He declined to comment on whether Crawford had cooperated or on the contents of the draft report.

The FDA also declined to respond to the GAO report. The agency has until Oct. 26 to comment on the findings, which are scheduled to be released next month.

Galson and other FDA officials have said they rejected the application because of concerns that the "morning-after pill," called Plan B, could lead young girls to become more sexually active. The GAO report says that FDA scientific staff provided studies that indicated the concern was unwarranted but that Galson was not convinced.

The drug is a concentrated form of a standard contraceptive and can generally prevent a pregnancy if taken within 72 hours of unprotected sex.

Galson has said that their Plan B decision was made within the FDA, without input or pressure from the White House. But advocates of emergency contraception say the draft report indicates that the rejection was made for political reasons.

"The draft GAO report appears to confirm what we have suspected for some time: Science was compromised in the FDA's decision-making process on Plan B," Sen. Hillary Rodham Clinton (D-N.Y.) said in a statement.

In its draft report, the GAO says FDA advisory panels had reviewed 23 applications to switch a prescription drug to over-the-counter status, and that the Plan B application was the only one where the agency did not follow the experts' recommendation.

Congress requested the investigation in the summer of 2004, and many have waited impatiently for it. Sen. Patty Murray (D-Wash.) said yesterday that she was "very disturbed" by the draft report and by Crawford's refusal to answer GAO's questions.

"We need an FDA commissioner who is willing to go before the public and explain how agency decisions are made," she said. "Refusing to explain his role in this decision is not acceptable."

The maker of Plan B, Barr Laboratories, later submitted a revised application. Under pressure from Clinton and Murray, Crawford promised to decide on the second application by September but instead put it on indefinite hold in August.


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