FDA refuses to act on 'morning after' contraception pill.The Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has refused to grant approval for over-the-counter sales of an emergency oral-contraceptive pill, and critics say the reason is pressure from the Religious Right. The drug, synthetic progestin progestin /pro·ges·tin/ (-jes´tin) progestational agent. pro·ges·tin n. 1. A natural or synthetic progestational substance that mimics some or all of the actions of progesterone. levonorgestrel levonorgestrel /le·vo·nor·ges·trel/ (-nor-jes´trel) the levorotatory form of norgestrel; used as an oral or subdermal contraceptive. le·vo·nor·ges·trel n. , 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 Lester Mills Crawford (born March 13, 1938) is a former Commissioner of the United States Food and Drug Administration (FDA). Dr. Crawford resigned from the FDA in September, 2005 - just two months after his approval by the Senate. 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 Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. , 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 Emergency Contraception Definition Emergency contraception or emergency birth control uses either emergency contraceptive pills (ECPs) or a Copper-T intrauterine device (IUD) to help prevent pregnancy following unprotected vaginal intercourse. , 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 o·ver·rate tr.v. o·ver·rat·ed, o·ver·rat·ing, o·ver·rates To overestimate the merits of; rate too highly. overrate Verb to have too high an opinion of: 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 CNN or Cable News Network Subsidiary company of Turner Broadcasting Systems. It was created by Ted Turner in 1980 to present 24-hour live news broadcasts, using satellites to transmit reports from news bureaus around the world. 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 Concerned Women for America is a conservative Christian political action group active in the United States. The group was founded in 1979 by Beverly LaHaye, wife of Christian Coalition co-founder Timothy LaHaye, as a response to activities by the National Organization for Women and and other Religious Right groups. U.S. Sen. Patty Murray (D-Wash.) was infuriated in·fu·ri·ate tr.v. in·fu·ri·at·ed, in·fu·ri·at·ing, in·fu·ri·ates To make furious; enrage. adj. Archaic Furious. 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." |
|
||||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion