The pill can reduce the chance of pregnancy if taken within 72 hours of unprotected sex. It is currently available by prescription only to people under 17 in the United States.
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CDER found "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential," she said in a statement.
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"It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said in a statement.
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"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application."
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"The availability of Plan B over-the-counter for all ages would have bypassed necessary routine medical care for sexually active girls," she said, citing the risk of STDs and sexual abuse.
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Kirsten Moore, president of the Reproductive Health Technologies Project, an advocacy group that had supported drugstore shelf access for all ages, expressed anger at President Barack Obama's administration.
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"And we are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion."
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The pill contains 1.5 milligrams of levonorgestrel, a higher level of a hormone found in birth control pills.
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Plan B One-Step was first approved in 2009 for use without a prescription in those aged 17 and over, but was available to younger girls with a doctor's prescription.