Judge approves FDA plan to drop limits on morning after pill

Reuters News
Posted: Jun 12, 2013 9:45 PM
Judge approves FDA plan to drop limits on morning after pill

By Karen Freifeld and Bernard Vaughan

NEW YORK (Reuters) - A U.S. district court judge on Wednesday approved a U.S. Food and Drug Administration plan to allow unrestricted sales of Plan B One-Step, a one-pill version of the emergency contraception drug.

Judge Edward Korman of the U.S. District Court in Brooklyn, New York, said the FDA proposal was "sufficient" to comply with his order to make emergency contraception widely available.

The Obama administration said on Monday that it would allow unrestricted sales of Plan B One-Step, the one-pill version of the drug made by Teva Pharmaceutical Industries.

The move followed an April 5 order by Korman for the FDA to make emergency contraception available without age or point-of-sale restrictions after finding it had been "arbitrary, capricious and unreasonable" in rejecting a citizen petition to do so.

Korman also said the FDA could lift restrictions on only the one-pill version if it believed there was a "significant difference" between that and an older two-pill version.

In a letter to Korman earlier Wednesday, Andrea Costello, a lawyer in the case, said the FDA had failed to comply with the order by not lifting restrictions on a two-pill version of the drug.

The morning-after pill has been the subject of a lengthy legal fight in the United States. Until recently, it was only available without a prescription to women 17 and older who presented proof of age at a pharmacist's counter.

Nancy Northup, president of the Center for Reproductive Rights, which helped bring the lawsuit, called the judge's decision a "historic victory" that will "bring emergency contraception out from behind the pharmacy counter for millions of women."

FDA spokeswoman Erica Jefferson declined to comment.

(Reporting By Karen Freifeld and Bernard Vaughan. Additional reporting by Jessica Dye; Editing by David Brunnstrom)