Reuters: Regulatory News: UPDATE 1-Judge denies FDA bid to stay 'morning-after' pill ruling

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UPDATE 1-Judge denies FDA bid to stay 'morning-after' pill ruling May 10th 2013, 16:19 Fri May 10, 2013 12:19pm EDT By Jessica Dye NEW YORK May 10 (Reuters) - A federal judge in New York on Friday declined to temporarily halt a court order directing the U.S. Food and Drug Administration to make emergency contraception available over the counter to girls of all ages. However, U.S. District Judge Edward Korman in Brooklyn said he would give the FDA until May 13 to ask a federal appeals court in Manhattan to stay the order, which had been scheduled to take effect on Friday. Korman ordered the FDA on April 5 to lift age and point-of-access restrictions on all levonorgestrel-based emergency contraception, also known as the "morning-after" pill or "Plan B," to prevent unwanted pregnancies. The FDA has appealed that ruling. "In my view, the defendants' appeal is frivolous and taken for the purposes of delay," Korman wrote in Friday's decision. The case stems from a 2005 lawsuit filed by a coalition of reproductive rights advocates who sought to lift age and access restrictions on emergency contraception. At the time of Korman's original April ruling, emergency contraception was available without a prescription to women 17 years and older who presented identification at a pharmacist's counter. Late last month, the FDA said it would allow girls as young as 15 to buy a one-pill version of emergency contraception, Plan B One-Step, made by a unit of Teva Pharmaceutical Industries Ltd without a prescription. The agency said its decision was unrelated to the court ruling and based on data from Teva showing teens that age could take the drug safely. In the April 5 ruling, Korman called the agency's restrictions on emergency contraception "arbitrary, capricious and unreasonable," and gave it 30 days to make the drug available over the counter to women of all ages. If taken up to 120 hours after unprotected sex, emergency contraception is designed to prevent pregnancy. FDA and Teva officials declined to comment. Link this Share this Digg this Email Reprints

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