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FDA lifts age restrictions for emergency contraception

The US Food and Drug Administration (FDA) [official website] announced Thursday that it has officially approved the brand-name emergency contraceptive Plan B Onestep [product website] for all women of child-bearing potential without a prescription, regardless of age [press release]. This approval comes following an order [text, PDF; JURIST report] issued last week by Judge Edward Korman of the US District Court for the Eastern District of New York [official website], who has been overseeing the Plan B litigation [JURIST news archive] for more than six years. Korman ruled that the FDA's plan to approve Plan B was acceptable despite the fact that opposing parties argued it was not broad enough [text, PDF]. Women's rights groups argued that the FDA restricted access to only the name-brand, one-pill product, leaving generic and two-pill options unavailable to women of lesser means. In his approval of the FDA's plan, the judge reiterated several times that he expects alternative emergency contraceptives to be approved without delay.

Originally, when the judge ruled [JURIST report] in favor of increasing the availability of Plan B, Katherine Sebelius, Secretary of the Department of Health and Human Services [official website], intervened to block the sale of such pharmaceuticals to minors. Birth control, especially emergency contraceptives like Plan B, has been the target of social stigma, which the judge found to be the only cause [JURIST report] for the Department's intervention. Only days before the FDA's presentation of its approval plan to the judge, it announced that the Department of Justice would not seek to appeal the judge's decision, despite the Obama administration's renewed promises [JURIST reports] to restrain minor's access to emergency contraceptives.

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