FDA refuses to act on 'morning after' contraception pill.
The drug, synthetic progestin levonorgestrel, is currently available by prescription only. It can prevent pregnancy if taken within 72 hours after intercourse. Called "Plan B" by its manufacturer, Barr Pharmaceutical, the drug works by blocking fertilization of the egg. If the woman is already pregnant, it has no effect.
Religious Right groups have opposed Plan B, arguing that it is a form of abortion. In December of 2003, an FDA advisory panel voted 23-4 to approve over-the-counter sales for the drug. But nothing has been done, and on Aug. 27, the FDA announced another delay.
FDA Commissioner Lester Crawford claimed there are unresolved safety questions about the pill's use by teenage girls. He announced a 60-day period to solicit public comments.
Susan Wood, director of the FDA's Office of Women's Health, was so upset by the move that she resigned. In a parting statement, Wood charged that ideology had trumped science.
"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," Wood wrote in a letter to her colleagues. "The recent decision announced by the Commissioner about emergency contraception, which continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advancing women's health."
Critics charge that the FDA ignored its own advisory panel due to pressure from the Bush administration's fundamentalist allies. One member of the panel, Dr. W. David Hager, was apparently instrumental in blocking Plan B.
Hager, a strong opponent of abortion, left the panel in June. In an interview with the Lexington, Ky., Herald-Leader, he tried to downplay his input, insisting, "People overrate my significance. I carry a very small role."
But the newspaper noted that in fall of 2004, Hager, addressing a conservative audience in Wilmore, Ky., took a different view. Noting that the Plan B decision was only the second time in 50 years that the FDA has disregarded the advice of its advisory panel, Hager said, "You don't have to wave your Bible to have an effect as a Christian in the public arena. Once again, what Satan meant for evil, God turned into good."
Hager, who cast one of the dissenting votes against over-the-counter status for Plan B, later sent a letter to the commissioner of the FDA outlining his concerns about the drug. In the letter, Hager stuck to medical concerns, but speaking on CNN he was more frank about his moral agenda, asserting that the pill might lead to more sexual activity by teens.
"I'm opposed to any effort that may potentially increase adolescent sexual activity outside of marriage," he said.
Hager currently serves as chairman of the Physicians Resource Council, a group sponsored by James Dobson's Focus on the Family. He also worked with Concerned Women for America and other Religious Right groups.
U.S. Sen. Patty Murray (D-Wash.) was infuriated by the FDA's action. In June, Murray and Sen. Hillary Clinton (D-N.Y.) agreed to withdraw a block they had placed on Crawford's nomination to head the FDA after receiving assurances the agency would act on Plan B by Sept. 1.
"The FDA is redefining birth control as abortion," Murray said. "The FDA is setting the bar higher for this kind of drug. I'm outraged, disgusted, furious. I'm running out of words to express how upset I am."
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|Title Annotation:||Food and Drug Administration|
|Publication:||Church & State|
|Date:||Oct 1, 2005|
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