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Temporary stay of Plan B decision extended through May 28

NEW YORK — The Food and Drug Administration's temporary stay pending its appeal of a district court decision ordering all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions was extended through May 28 by the U.S. Court of Appeals for the Second Circuit on Monday. 

The Second Circuit will entertain the appeal on that day. 

"Although the district court rejected the government’s position in the strongest terms, the court plainly exceeded its jurisdiction in ordering FDA to take any action on the one-pill drug and to make any of these drugs available without a prescription or any other restriction without conducting a rulemaking," the appeal reads. "Because the district court plainly overstepped its authority, there is a substantial likelihood that the government will prevail in this appeal. The balance of harms and the public interest also strongly support a stay."

Senior United States District Judge Edward Korman on Friday had denied an FDA 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 had granted 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." It was a deadline that the FDA honored. 

In a 17-page decision, Korman noted he was not appeased by 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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