May 1 (Bloomberg) -- The U.S. is appealing a federal judge’s ruling allowing the “morning after” pill to be made available nationwide to girls under 17 without a prescription.
Lawyers for the government filed a notice today in federal court that it’s appealing the April 5 order issued by U.S. District Judge Edward R. Korman in Brooklyn, New York.
In his ruling, Korman directed the U.S. Food and Drug Administration to abolish age restrictions for purchasing the emergency contraceptive over the counter. The judge also criticized the agency for what he called a 12-year delay in broadening access to the pill.
Yesterday, the agency approved over-the-counter sales of Teva Pharmaceutical Industries Ltd.’s Plan B One-Step to girls as young as 15, saying its decision was “independent” of the court case and wasn’t intended to respond to the judge’s order.
“The public interest will not be served by a reclassification of drugs as non-prescription by order of a court, without appropriate agency decision-making procedures being followed,” lawyers for the government said in a letter filed with the notice. The government also requested that Korman’s order be put on hold while it is appealed.
Korman’s decision followed a reproductive-rights group’s request to reopen a lawsuit over access to the contraceptive, claiming the FDA acted in bad faith when it placed restrictions on the drug.
The FDA in December 2011 was set to approve sales of Plan B One-Step to women of all ages without a doctor’s prescription, when Health and Human Services Secretary Kathleen Sebelius overruled the decision. The action was the first such reversal of an FDA decision by a presidential administration.
“We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions,” Nancy Northup, president of the Center for Reproductive Rights, said today in a statement.
The case is Tummino v. Hamburg, 12-cv-0763, U.S. District Court, Eastern District of New York (Brooklyn).
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