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FDA okays RU486 after years of controversy NEW YORK Sep 28 Reuters Health - After 4 years of controversy and negotiation the US Food and Drug Administration FDA on Thursday approved the abortion drug mifepristone more commonly known as RU-486 The approval comes with some but not all of the prescribing restrictions originally discussed as conditions for getting the drug onto the market Mifepristone which will be sold under the trade name Mifeprex will be available to doctors within about 4 weeks according to Danco Laboratories the New York City-based pharmaceutical company that will distribute and market the drug The procedure for obtaining mifepristone is more burdensome than for other drugs but the FDAs requirements surrounding the abortion drug are far less restrictive than they might have been As recently as June it appeared that prescribing of the drug might have been limited to doctors who were trained to perform surgical abortions had facilities to monitor patients using ultrasound and were located within an hour of emergency facilities Dr Carole Joffe a professor at the University of California-Davis who studies abortion policy in the US called the fact that the FDA will allow doctors who do not currently perform surgical abortion to prescribe Mifeprex a tremendous victory The major premise of this drug is to increase access to abortion services because in the United States we are in a serious crisis of access she told Reuters Health If the tiny pool of present abortion providers could not be increased the approval would have been a much more limited gain The FDAs major restriction on Mifeprex is that the drug will not be available through pharmacies even with a prescription Instead it will be distributed directly to doctors offices or clinics and doctors will need to sign a statement certifying that they have met certain requirements before they may place an order A Danco spokesperson stressed that information about which doctors have ordered the drug will
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