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FDA eases Plan B restriction

Wed., May 1, 2013

15-year-olds can buy drug without prescription

The U.S. Food and Drug Administration announced Tuesday that it has approved a request to allow the emergency contraceptive pill, Plan B One-Step, to be sold to customers as young as 15 without a prescription.

The action comes roughly three weeks after a federal judge harshly criticized regulators from the Department of Health and Human Services for their handling of the drug’s approval process, calling their actions “politically motivated and scientifically unjustified.”

FDA officials said their decision was based on an amended application submitted by the drug’s manufacturer, Teva Pharmaceutical Industries of Israel.

It was not, they said, intended to address a recent court order requiring the FDA to make the drug available over the counter to all customers without age restrictions.

Until now, the drug was available without a prescription but could only be sold to people who were at least 17.

“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” FDA Commissioner Margaret Hamburg said.

“The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly and that it does not prevent the transmission of sexually transmitted disease,” she said.

The product can be sold in family planning or female health aisles but must carry a label stating that the buyer must prove they are at least 15.

The decision is at odds with an order issued by U.S. District Judge Edward Korman of New York. On April 5, Korman ruled that all levonorgestrel-based contraceptives like Plan B One-Step be made available to buyers of all ages, without a prescription, in 30 days’ time.

That ruling was the result of a lawsuit brought by the Center for Reproductive Rights, which complained that federal regulators were unfairly limiting access to a safe drug.

On Tuesday, the center’s president said the FDA was still ignoring “clear and challenging barriers” for women seeking emergency birth control.

“Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women - but it does nothing to address the significant barriers that far too many women of all ages will still find,” Nancy Northup said in a statement. The drug, a synthetic hormone, prevents pregnancy by blocking ovulation and impeding the mobility of sperm. It does not cause an abortion in women who are already pregnant, nor does it harm a developing fetus.

The pills are most effective when taken immediately after intercourse, and preferably within 24 hours, although they are sometimes effective even after 72 hours.

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