Ex-FDA Chief Would Not Aid Plan B Inquiry

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.
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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. [emphasis added by me] 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. [emphasis added by me] 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.
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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.
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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.
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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.”

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