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Federal judge issues new ruling on emergency contraception

April 12, 2013

Plan B One StepA federal judge has ruled that the emergency contraception drug Plan B One- Step, a.k.a. the “morning-after pill,” must be made available over the counter to everyone. The decision, issued Friday, April 5, 2013, overturns a rule that required anyone 16 years old and younger to have a prescription in order to get the pill

In 2011, despite the Food and Drug Administration’s determination that Plan B is safe for all ages, the Department of Health and Human Services decided to block teenagers from buying the drug without a prescription. President Barack Obama endorsed HHS Secretary Kathleen Sebelius’ decision, arguing that the government “could not be confident that a 10-year-old or an 11-year-old going into a drugstore should be able—alongside bubble gum or batteries—be able to buy a medication that potentially, if not used properly, could end up having an adverse effect.”

But Judge Edward R. Korman of Federal District Court ruled Friday that this was not an acceptable reason to deny access, and that Sebelius’ decision “was politically motivated, scientifically unjustified, and contrary to agency precedent.” Nancy Northup, president of the Center for Reproductive Rights, hailed the ruling. “Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception,” she said.

Teva Pharmaceuticals Ltd’s Plan B in 1999 became the first emergency contraceptive available for prescription use in the United States. The company also markets Plan B One-Step, a one-pill version of Plan B.

Teva had also petitioned the government to allow sales of Plan B One-Step over the counter without restrictions.

In 2011, the FDA said it had concluded Plan B One- Step could be safely used in girls of child-bearing age. But U.S. Department of Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled the FDA and said that there was insufficient evidence to support removing the restrictions.

Several days later, the FDA also rejected the petition to lower restrictions on all emergency contraceptives.

In Friday’s ruling, Korman blasted the agencies’ justification for their decisions, calling it “an excuse to deprive the overwhelming majority of women of their rights to obtain contraceptives without unjustified and burdensome restrictions.”