FDA Ruling on Generic OTC Plan B Sales to Girls Due Tomorrow

The U.S. Food and Drug Administration will rule by tomorrow on whether girls under 17 can get generic versions of an emergency contraceptive at drugstores without a prescription.

The FDA “expects to issue a decision on the citizen petition on or before Dec. 13,” Assistant U.S. Attorney Scott R. Landau wrote Dec. 9 to U.S. District Judge Edward R. Korman in Brooklyn, New York.

Kathleen Sebelius, the U.S. secretary of health and human services, last week ordered FDA Commissioner Margaret Hamburg to reject an application by Teva Pharmaceutical Industries Ltd. to approve the branded drug, Plan B One-Step, as the first over-the-counter emergency contraceptive.

Korman is presiding over a 2005 lawsuit by the New York-based Center for Reproductive Rights to force the FDA to relax the rules for obtaining generic versions of the drug. The center wants the Obama Administration held in contempt for ignoring an order to reconsider the FDA’s rejection of the application. A hearing on the contempt request is set for tomorrow.

“If they are to follow the court’s order, the FDA must follow science,” Nancy Northup, president and chief executive officer of the Center for Reproductive Rights, said in an e-mailed statement. “Which means finally -- after ten years -- granting the citizen petition to make the generic two-pill emergency contraceptive available over the counter to women of all ages.”

Next Choice

Watson Pharmaceuticals Inc., based in Parsippany, New Jersey, makes a generic version of the drug called Next Choice.

Sebelius, citing potential harm to girls under 17 in her Dec. 7 memo, overruled the FDA on Petach Tikva, Israel-based Teva’s request. Hamburg, in a statement on the FDA website, said she was ready to approve over-the-counter sales based on “well-supported” and “science-based evidence.”

Plan B One-Step and the generic version are kept behind pharmacy counters and sold without prescription only to women 17 and older. Younger girls may get the drug with a doctor’s order. Plan B One-Step reduces pregnancy risk if taken within three days of sex.

The FDA last week said science requires granting the petition “for Plan B One-Step, and that’s exactly what the science requires for the generic drug,” Northup said in her statement. “The Obama administration has a second chance to live up to its promise that science will not be overruled by politics as it was in the Bush administration.”

Three-Year Debate

The original Plan B was cleared in 1999 for U.S. sales with a prescription. Barr Pharmaceutical’s application to sell the pills over the counter in 2003 ignited a three-year debate between people who wanted more timely access to the drug and those who argued that it might promote sexual promiscuity among teenagers. Teva now owns Barr.

The Center for Reproductive Rights sued the FDA in January 2005 over its failure to act on the request for over-the-counter sales. In 2006, the FDA granted Barr permission to sell the pill without a prescription only to women 18 and older.

Plan B One-Step is made with levongestrel, an ingredient found in birth-control pills, and is linked with side effects that can include nausea, dizziness, changes in menstrual periods and fatigue.

Sales of Plan B more than doubled when it became available without prescription to women 18 and older in 2006, Teva said.

The case is Tummino v. Hamburg, 05-cv-366, U.S. District Court, Eastern District of New York (Brooklyn).

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