The Food and Drug Administration did not follow its usual procedures in rejecting an application for over-the-counter sales of the emergency contraceptive pill Plan B, the investigating arm of Congress found today.
The General Accounting Office also said in its 57-page report that there were questions about whether top officials of the F.D.A. made the decision to reject the application for over-the-counter sales of the drug, which is opposed by some religious conservatives, even before its own advisory committee had issued its recommendation on the matter.
We are deeply opposed to this subversion of science.
US Rep Henry Waxman
Several legislators and scientists have complained that the F.D.A. was putting politics ahead of science in its handling of the contraceptive, which can be used as emergency, morning-after contraception.
The G.A.O. said in its report that "the Plan B decision was not typical of the other 67 proposed" changes from prescription to over-the-counter sales that the agency received from 1994 through 2004.
The agency, which was charged with examining how the decision to reject the application was made, and how it compared to the decisions of other requested changes from prescription to over-the-counter sales, does not make recommendations about what action the F.D.A. or Congress should make in the matter.
But critics of the decision used the report as the basis to ask that the F.D.A. decision be revisited.
"We are deeply opposed to this subversion of science," Representative Henry Waxman, Democrat of California, wrote to Health and Human Services Secretary Mike Leavitt, in a letter signed by 17 other lawmakers.
They urged Mr. Leavitt, who oversees the F.D.A., to intervene to assure that a pending reconsideration of the pill's status "is based on the best available science instead of ideology."
In May 2004, the F.D.A. rejected an application by Barr Laboratories to sell its Plan B contraceptive over the counter without restrictions, saying the company's studies did not include enough girls younger than 16.
This came after the agency's own nonprescription drugs advisory committee and its review staff recommended approval.
Last month, a consultant to that advisory panel, Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine, resigned in protest of the agency's handling of the Plan B contraceptive, saying it was putting politics over science. In August, the top women's health official at agency, Susan Wood, also quit in protest over the Plan B decisions.
The G.A.O. report suggested that top F.D.A. officials had discussed turning down the application for over-the-counter sales of Plan B as early as December 2003, even though its advisory panels had not yet weighed in.
It also said that in Barr's application to switch Plan B from prescription to over the counter sales, or O.T.C,, as the agency calls it, "F.D.A.'s high level management was more involved in the review of Plan B than in those of other O.T.C. switch applications."
In its response to the G.A.O.'s draft report, Jane Woodcock, deputy commissioner for operations at the F.D.A., said it was "inaccurate" to suggest that a decision had already been made to reject the application before the review committees weighed in. She said, however, that "it was entirely normal" for top officials "to convey to the review division their concerns regarding the application."
She also said the Plan B case had attracted a high level of "public interest," including two citizen petitions. Top level officials were involved in the review process, she said, but only to the extent that it was "typical for high-profile, controversial applications."
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