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FDA makes morning-after pill available over the counter for girls 15 and older

Plan B is one of two emergency contraceptives available in the U.S.

UPI/Landov

Plan B is one of two emergency contraceptive pills available in the U.S. In early April, a federal judge ruled that the Food and Drug Administration couldn't put point-of-sale or age restrictions on it.

The Food and Drug Administration announced Tuesday that it has approved Plan B One-Step, often referred to as the morning-after pill, for use without a prescription for girls who are 15 or older.

The emergency contraceptive's manufacturer, Teva Women's Health, Inc., originally submitted an application for it to be made available over-the-counter to all women and girls of reproductive age in December 2011, which the FDA rejected.

Teva then submitted an amended application to make Plan B available over-the-counter for girls who are 15 or older, which is what the federal agency approved on Tuesday.

That amended application was pending when Judge Edward Korman of New York's Eastern District ruled – in a strongly-worded opinion – that the FDA must make Plan B available without a prescription, and without point-of-sale or age restrictions, within 30 days.

That ruling came down on April 5, which means the deadline is quickly approaching. But the FDA's Tuesday announcement regarding Plan B doesn't mark full compliance with the court's ruling – the agency said the product will now carry a label that forbids sale to anyone who can't prove she is at least 15 years old.

That's not in violation of the law quite yet because the court's deadline hasn't passed, but when asked about whether the FDA planned to fully comply with the court's decision, an FDA spokeswoman said the Department of Justice "is considering next steps in the litigation."

As of press time, the Department of Justice hadn't returned a request for comment detailing what that meant or what the FDA's options are.

In a news release, the FDA described its approval of Teva's application as "independent action."

Emergency contraception is defined by the World Health Organization as a method "that can be used to prevent pregnancy in the first days after intercourse," especially in cases of unprotected sex, contraceptive failure (like a torn condom) or rape.

Plan B is one of two emergency contraceptives available in the U.S., and its road to accessibility hasn't been an easy one. In 2011, FDA Commissioner Margaret Hamburg said the morning-after pill was safe enough for the agency to recommend that it be made available without a prescription to "all females of childbearing potential."

The agency did make that recommendation, but virtually in the same breath, Hamburg said U.S. Secretary of Health and Human Services Kathleen Sebelius disagreed, and so was overruling the FDA's recommendation.

That earned Sebelius a skewering from Judge Edward Korman in early April, who in his opinion decried the delay in making the contraception more accessible and called Sebelius' decision "arbitrary, capricious and unreasonable."

Jim Mangia, the president and CEO of St. John's Well Child and Family Center in South Los Angeles, called Korman's decision "an extremely important" one that would "put more power in the hands of women with regard to their reproductive health."

That's especially true in South L.A., he added, which has the highest teenage pregnancy rate in the county.

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