May 14, 2013 — A federal appeals court on Monday placed a temporary hold on an order from a lower court judge who said emergency contraception must be made available without age or point-of-sale restrictions, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 5/13).
Earlier Monday, the Department of Justice asked the 2nd U.S. Circuit Court of Appeals to stay the order by U.S. District Judge Edward Korman while an appeal is argued, which could take weeks. A panel of judges will consider the request on May 28; until then, limits on the sale of EC will remain in place, the appeals court said.
DOJ's request was expected after Korman last week refused to stay his April 5 ruling that ordered FDA to lift restrictions on EC sales (CQ HealthBeat, 5/13). DOJ attorneys had argued that "substantial market confusion" could result if Korman's ruling were enforced during the appeals process (Long, AP/USA Today, 5/13).
Details of Monday's Filing
Government lawyers argued that Korman's order "exceed[ed] the court's authority in compelling FDA to act outside the required statutory procedures by changing a drug's status from prescription to nonprescription without undertaking rulemaking steps."
Instead, Korman should have remanded the decision to FDA and ordered the agency to reconsider its decision, DOJ argued. Korman had said that doing so would be "futile" because HHS Secretary Kathleen Sebelius previously overruled FDA's recommendation that EC be available without age restrictions.
Additionally, DOJ argued that a stay should be granted because FDA recently lowered the age limit on one EC product -- Plan B One-Step -- from 17 to 15. Because all of the plaintiffs in the case are older than 15, a temporary hold would not cause them any harm, DOJ lawyers argued (Smith, Politico, 5/14).
The Center for Reproductive Rights, which filed the lawsuit that resulted in Korman's decision, has 10 days to respond to the federal government's latest filing (AP/USA Today, 5/13).