Reuters: Regulatory News: UPDATE 1-U.S. judge strikes restrictions on 'morning-after' pill

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UPDATE 1-U.S. judge strikes restrictions on 'morning-after' pill Apr 5th 2013, 13:08 Fri Apr 5, 2013 9:59am EDT By Jessica Dye NEW YORK, April 5 (Reuters) - A federal judge on Friday ordered the U.S. Food and Drug Administration to make "morning-after" emergency contraception pills available without a prescription to all girls of reproductive age. The ruling is a victory for reproductive-rights groups that had sought to remove age and other restrictions on emergency contraception. Currently, only women age 17 or older can obtain emergency contraception pills without a prescription. Point-of-sale restrictions require that all women present identification to a pharmacist before obtaining the drug. In his ruling, U.S. District Judge Edward Korman said the FDA's rejection of requests to remove age restrictions to obtain the pill was "arbitrary, capricious and unreasonable." FDA spokeswoman Erica Jefferson declined to comment on the ruling, saying it was an ongoing legal matter. The Center for Reproductive Rights and other groups had petitioned the FDA to strike down age and access limits on all emergency contraceptives, saying there was no scientific proof that girls younger than 17 could not safely use the drug without supervision. Nancy Northup, president of the Center for Reproductive Rights, hailed the ruling. "Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception," she said. Teva Pharmaceuticals Ltd's Plan B in 1999 became the first emergency contraceptive available for prescription use in the United States. The company also markets Plan B One-Step, a one-pill version of Plan B. Teva had also petitioned the government to allow sales of Plan B One-Step over the counter without restrictions. In 2011, the FDA said it had concluded Plan B One-Step could be safely used in girls of child-bearing age. But U.S. Department of Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled the FDA and said that there was insufficient evidence to support removing the restrictions. Several days later, the FDA also rejected the petition to lower restrictions on all emergency contraceptives. In Friday's ruling, Korman blasted the agencies' justification for their decisions, calling it "an excuse to deprive the overwhelming majority of women of their rights to obtain contraceptives without unjustified and burdensome restrictions." Link this Share this Digg this Email Reprints

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