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Feds Drop Opposition To OTC Sales Of Morning-After Pill

Posted: June 10, 2013

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NPR's Julie Rovner Explains The Decision

U.S. agencies move to comply with U.S. District Court Judge Edward Korman's order that a one-dose version of emergency contraception, such as the Plan B One-Step, be made available for purchase without an age restriction or prescription.

The federal government says it will withdraw its appeal of a court order allowing girls of any age to buy emergency contraception, as U.S. agencies move to comply with U.S. District Court Judge Edward Korman's order that "morning-after" pills be made available for purchase without an age restriction, and without a prescription.

The development is the latest in an extended process of shifting emergency contraception to being over-the-counter medication instead of requiring a prescription and being restricted by age.

NPR's Julie Rovner last week explained recent developments in the current case, after a federal appeals court refused the Department of Justice's request to place a stay on Korman's order that "at least some medications must be made available over the counter immediately."

In that ruling, a three-judge panel for the U.S. Court of Appeals for the 2nd Circuit enforced Korman's order to permit "two-step" versions of levonorgestral drugs such as Next Choice and Plan B.

But the government said Monday it will withdraw its appeal, with U.S. Attorney Loretta E. Lynch writing the court to say the Food and Drug Administration and the Department of Health and Human Services "have complied with the Court's April 10, 2013, judgment ... making Plan B One-Step (PBOS) available over-the-counter (OTC) without age or point-of-sale restrictions as described below."

Monday's court filing also said that the FDA had asked Teva Pharmaceutical, the makers of Plan B One-Step, to submit a new supplemental new drug application, which the FDA promises to approve "without delay."

The shift in approach — allowing a one-dose variant of the medication, instead of the two-dose product — was necessary, the Justice Department letter says, because documentation that accompanied the Plan B One-Step product application included "actual use data specifically addressing the ability of adolescents, including younger adolescents, to understand and follow the directions for safe and effective use as a nonprescription product; there are fewer data available regarding the actual use of Plan B as a nonprescription product by younger adolescents."

Copyright 2014 NPR. To see more, visit http://www.npr.org/.

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