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  Audit Faults FDA on Morning-After Pill
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Last EditedRP  Nov 15, 2005 05:34pm
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MediaWebsite - Yahoo News
News DateTuesday, November 15, 2005 08:15:00 PM UTC0:0
DescriptionLawmakers are again accusing the Food and Drug Administration of putting politics over science in the long-running saga over whether the morning-after pill should sell without a prescription.

A congressional audit released Monday cited "unusual" steps in the FDA's initial rejection of over-the-counter emergency contraception, including conflicting accounts of whether top officials made the decision even before scientists finished reviewing the evidence.

The FDA is reconsidering the decision on the pill, sold under the brand Plan B. While the report by the Government Accountability Office, Congress' investigative arm, doesn't say that FDA made the wrong decision, it does raise the most serious questions to date about agency credibility — and increases pressure to settle the issue.

"Regardless of how you feel about whether Plan B should be available in the community, the fact is the FDA decision should be based on science, not cultural controversy," said Sen. Barbara Mikulski (news, bio, voting record), D-Md.

In December 2003, FDA's scientific advisers overwhelmingly backed over-the-counter sales of the Plan B brand for all ages. They cited assessments that easier access could halve the nation's 3 million annual unintended pregnancies.

Top-ranking FDA officials have acknowledged they overruled their own scientists' decision that nonprescription sales would be safe, and the women's health chief resigned in protest.
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