FDA must file Plan B appeal by noon on May 13 or remove age restrictions from all OTC EC products

NEW YORK — Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions. 

However, Korman did grant a stay "pending the hearing or submission of the defendants’ motion for a stay in the Court of Appeals on the condition that the motion for a stay be filed by noon on May 13, 2013."

In a 17-page decision, Korman noted he was not appeased by the FDA's decision regarding Plan B One-Step. "Plan B One-Step aside, the effect of my [original] decision was to make levonorgestrel-based emergency contraceptives available without a prescription and without any point-of-sale or age restrictions," he wrote. "The only practical difference between my decision and the decision of the FDA that the Secretary reversed was that the FDA’s decision was arguably directed towards the one-pill version of the drug, and my decision applied to both versions." 

 

 

 

 

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