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Plan B One-Step, morning-after pill, cleared for over-the-counter sale to young teens

Teva Pharmaceutical Industries Ltd. won U.S. approval to sell the Plan B One-Step emergency contraceptive without a prescription on pharmacy shelves to girls as young as age 15.

The Food and Drug Administration cleared Petach Tikva, Israel-based Teva to expand access of its so-called morning-after pill after previously denying the company's request to make it available to all females of reproductive ages, the agency said Tuesday in a statement. A federal judge on April 5 ordered the FDA to make emergency contraception available nationwide without limits within 30 days.

The pill and its generic copies have been kept behind drug store counters and sold without a prescription to women 17 and older. Government statistics show that more women are turning to emergency contraception, even as reproductive rights become embroiled in controversy after the 2010 Affordable Care Act required some employers to pay for preventive services.

"This is an important step forward," Planned Parenthood, a health-care provider and advocacy group for reproductive rights, said in a statement. "This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it."

Teva will make Plan B One-Step available at retail outlets that have a pharmacy on site and generally place it in the family planning or female health aisles, the FDA said. A code on the pill's package will prompt a cashier to verify a customer's age before it can be sold.


"For the past decade, emergency contraception has been available to millions of women to reduce the chance of an unplanned pregnancy following birth control failure or unprotected sex," Marty Berndt, a vice president at Teva Women's Health Inc., a U.S. subsidiary, said in a statement. "Today, we welcome the FDA's decision to provide extended and improved access to this important product, a significant milestone for women."

The FDA in December 2011 was set to approve sales of Plan B One-Step to women of all ages without a doctor's order, when Health and Human Services Secretary Kathleen Sebelius overruled the decision. The action was the first such reversal of an FDA decision by a presidential administration.

The contraceptives prevent pregnancy by inhibiting fertilization and are most effective when taken within 24 hours of intercourse.

"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the U.S.," FDA Commissioner Margaret A. Hamburg, said in the agency's statement.

The FDA said its decision to approve Teva's application is "independent" of the court case and not intended to respond to the judge's decision. The Justice Department is considering its next steps in the litigation, the agency said.

Teva's application for wider over-the-counter sales of Plan B was pending before the judge's ruling, the FDA said.

Planned Parenthood said it's still pushing for the FDA to lift all restrictions to emergency contraception.

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