The U.S. government lost a bid to delay a ruling that abolished age restrictions for buying the two-pill version of the emergency morning-after contraceptive over the counter.
A federal appeals court in New York agreed to stay part of a lower-court’s ruling making the one-pill version, such as Teva Pharmaceutical Industries Ltd. (TEVA)’s Plan B One-Step, available to all women over-the-counter. The government didn’t obtain a delay of the two-pill version because it “failed to meet the requisite standard,” the court said in an order filed today without elaborating.
“After more than a decade of politically motivated delays, women will no longer have to endure intrusive, onerous and medically unnecessary restrictions to get emergency contraception,” Nancy Northup, president of the Center for Reproductive Rights, said in a statement.
A lawyer for the government, F. Franklin Amanat, didn’t immediately return a call seeking comment on the decision.
The U.S. is challenging an April 5 order by U.S. District Judge Edward R. Korman in Brooklyn, New York, requiring the medication to be made available without a prescription to all women and girls regardless of age.
Korman said the U.S. Food and Drug Administration kept restrictions on obtaining levonorgestrel-based contraceptives without a prescription for political reasons.
Currently, the FDA allows women 17 and older to obtain generic and non-generic versions of the morning-after pill without a prescription. In April, the agency approved Teva’s application to sell Plan B One-Step over the counter to girls as young as 15.
FDA spokeswoman Stephanie Yao said in an e-mailed statement that the agency is “reviewing the decision, and we will determine the next steps.”
Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s decision in December 2011 to approve sales of Plan B One-Step without a prescription. The action was the first time an FDA finding has been reversed by a presidential administration. Sebelius said at the time that her decision to overrule the agency was merited by “cognitive and behavioral” differences in girls of the youngest reproductive age.
Separately, Sebelius is also facing criticism over her refusal to sign a waiver that would allow a 10-year-old girl who needs a lung transplant to receive one from an adult donor. A policy prevents children younger than 12 from being added to the list for adult transplants because of the differing biological needs of children and adults.
The family of the girl, Sarah Murnaghan, sued Sebelius today in federal court to prevent her from enforcing the regulation.
In a May 10 order regarding the morning-after pill, Korman called Sebelius’s overruling of the FDA “politically motivated, scientifically unjustified, and contrary to agency precedent.”
At a hearing also in May, Korman said the approval of Teva’s application to sell its one-step pill over-the-counter to younger teens offered little benefit to women because they would still be subject to age restrictions, requiring photo identification that some might not possess.
Younger teens lacking prescriptions would also only be able to obtain Teva’s branded drug, costing as much as $60 per dose, rather than less expensive generics, Korman said during the hearing.
The morning-after pill, which contains a larger amount of the hormone levonorgestrel than found in other birth control pills, prevents pregnancy by inhibiting fertilization. The drugs are most effective when taken within 24 hours of intercourse.
Anti-abortion groups have alleged that the pill can kill embryos by preventing implantation. In April, Charmaine Yoest of Americans United for Life called the pill “a potent and potentially life-ending drug” that young girls should need medical supervision to take.
The government argued to the appeals court that a delay of Korman’s ruling was necessary to prevent confusion among consumers in the event that the status of the drug changes. The appeals court hasn’t yet considered whether it will ultimately reverse Korman’s decision.
The case is Tummino v. Hamburg, 12-cv-00763, U.S. District Court, Eastern District of New York (Brooklyn). The appeal is Tummino v. Hamburg, 13-1690, U.S. Court of Appeals for the Second Circuit (Manhattan).
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