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DoJ appeals Plan B ruling

May 2, 2013 1:35 AM UTC

The U.S. Department of Justice on Wednesday filed an appeal in the U.S. District Court for the Eastern District of New York of an April order compelling FDA to make emergency contraceptives containing levonorgestrel available OTC without any age restrictions. The DoJ also requested a stay of the order, pending the appeal. The April order overturned a 2011 decision by HHS Secretary Kathleen Sebelius that overruled FDA's approval of unrestricted OTC sales of the emergency contraceptive Plan B One-Step levonorgestrel from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) (see BioCentury, April 8).

In its appeal, the DoJ asserts the district court overreached its authority, which DoJ claims was limited to vacating HHS's decision to restrict the OTC sale of Plan B to those 17 and older. ...