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GAO: FDA ruling on 'morning after pill' was unusual

Agency overrode bid to relax curbs

WASHINGTON -- Former Food and Drug Administration commissioner Mark McClellan voiced strong doubts about a proposal to make the ''morning after pill" more easily accessible months before the agency overrode the advice of its staff and an expert panel and rejected the application, government investigators reported today.

The Government Accountability Office report said the apparent involvement of McClellan and other top officials was one of four unusual aspects of FDA's handling of the politically sensitive decision. The investigators reported that several key FDA officials told colleagues that the application to allow over-the-counter sales of the emergency contraceptive would be rejected months before the decision was announced.

The proposal for nonprescription sales of the ''Plan B" contraceptive was actively supported by FDA staff and by a joint advisory panel of experts, and the decision caused considerable internal dissent.

In a letter responding to a GAO request for information, McClellan noted that the decision to reject the Plan B application was made after he left FDA to run the Centers for Medicare and Medicaid Services, and said his actions had been ''consistent with his usual practices."

The report's finding that McClellan may have played a major, early role in forming FDA policy on the issue provoked an immediate and angry response from some Democrats.

In a letter to Health and Human Services Secretary Mike Leavitt, US Representatives Henry Waxman, a California Democrat, and John Dingell, a Michigan Democrat, said the GAO was unable to fully understand McClellan's role because he would not speak with the investigators and because the agency provided no documents reflecting his communications with other officials. The FDA told the investigators that e-mails to and from McClellan had been deleted and that written memos were routinely destroyed.

Raising the possibility that the practice was a violation of federal record-keeping law, the lawmakers wrote: ''This potential violation of records management laws and regulations is not a mere technicality. On the contrary, as the Plan B decision makes clear, retaining the documents of the agency head is essential for the transparent operation of government."

Plan B, manufactured by Barr Laboratories, is an emergency contraceptive that can prevent pregnancy if taken within 72 hours of unprotected sex. The drug was approved by the FDA in 1999 as a prescription medication, but advocates say the time needed to get a doctor's appointment and prescription often makes emergency contraception far less effective.

The bid to make the drug available over-the-counter was opposed by some conservatives, including almost 50 members of Congress who wrote a letter to President Bush asking him to ensure that the application was rejected.

Many proponents of easier access to Plan B charge that political considerations had intruded into the FDA decision-making, which is by law supposed to be based solely on scientific evidence.

The key findings of the GAO report were that the FDA did not employ its usual procedures and scientific standards in weighing the Plan B application. GAO investigator Marcia Crosse said it was unusual for top FDA officials to get actively involved. The decision to reject the application was signed by Steven Galson, the senior officer of the Center for Drug Evaluation and Research, because lower-ranking officials disagreed with his conclusion.

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