The U.S. government asked a federal appeals court to delay a trial judge’s ruling that would grant women of all ages over-the-counter access to the so-called morning after birth-control pill.
A delay is necessary to prevent confusion among consumers, the government wrote in a brief filed today in Manhattan.
“If the status of these drugs is changed and later reversed, some women may mistakenly believe that they can obtain the drug without a prescription after they are no longer able to do so,” lawyers for the government wrote.
The U.S. is appealing an April 5 order by U.S. District Judge Edward R. Korman in Brooklyn, New York, requiring that the medication be made available without a prescription to all women and girls regardless of age.
Last week, Korman denied the government’s initial request to delay the ruling, which was set to go into effect this month, while his decision is being challenged.
In his order last month, Korman directed the U.S. Food and Drug Administration to lift age restrictions for obtaining levonorgestrel-based contraceptives without a prescription and said the agency was influenced by political pressure.
The FDA in December 2011 was set to approve sales of Teva Pharmaceutical Industries Ltd. (TEVA)’s Plan B One-Step, a branded version of the pill, without a prescription. Health and Human Services Secretary Kathleen Sebelius overruled the action, marking the first time an FDA decision was reversed by a presidential administration.
Currently, the FDA allows women 17 and older to obtain generic and non-generic versions of the morning-after pill without a prescription. Last month, the agency approved Teva’s application to sell Plan B One-Step over-the-counter to girls as young as 15.
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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