In EC Case, U.S. District Court Judge Rejects FDA’s Request for More Time


See all our coverage of over-the-counter emergency contraception here and of Kathleen Sebelius’ EC decision here.

A federal court judge Friday refused to grant an extension of time to the U.S. Food and Drug Administration (FDA) in a long-running case concerning access to emergency contraception.

The decision relates to an April order in which U.S. District Court Judge Edward R. Korman ordered the FDA to make emergency contraception—commonly known as the morning-after pill—available over-the-counter to people of all ages. The government had until today to comply with that order but has announced its intention to appeal.

“In my view, the defendants’ appeal is frivolous and is taken for the purpose of delay,” Judge Korman wrote. Nevertheless, the judge granted a temporary extension, called a stay, giving the government until noon Monday to lodge its request for an extension with the court of appeal.

Today’s decision follows a fiery hearing on May 7, during which Judge Korman accused the government of playing politics with the rights of young women, and likened the Obama administration’s policies on access to emergency contraception to voter suppression.

One of the key issues on appeal would be whether Judge Korman had the authority to order the FDA to make emergency contraception freely available. The FDA argued that drug approvals involve scientific decisions which require specialist knowledge, and that those decisions should not be made by a judge.

“The agency alone has the necessary information and scientific expertise to assess the data and information required to make a determination that a drug is safe and effective,” the FDA wrote in its court filings.

However, it was precisely those scientific decisions that had been disregarded by the Obama administration, Judge Korman said. In particular, the judge referred to a 2011 incident in which the administration overturned a decision by the FDA to make emergency contraception available over-the-counter, without age restrictions. Despite what Judge Korman called her “lack of competence in this area,” Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s decision.

“In something out of an alternate reality, the defendants seek a stay to pursue an appeal that would vindicate the Secretary’s disregard of the very principle they advocate,” Judge Korman wrote.

The Center for Reproductive Rights, which has represented the plaintiffs in the case, welcomed today’s decision.

“In a country where nearly half of all pregnancies are unintended, there is a tremendous public interest in expanding access to safe and effective birth control methods, including emergency contraception, to as many women as possible,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement.

“Judge Korman’s sound ruling simply orders the government to do what the experts at FDA have been trying to do for years: to put politics aside and let science guide us to a policy that makes emergency contraception readily accessible to all women when they need it most urgently,” Northup said.

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