Federal judge approves FDA emergency contraceptive plan

[JURIST] Judge Edward Korman of the US District Court for the Eastern District of New York [official website] on Wednesday approved [order, PDF ] the Food and Drug Administration (FDA) plan to make the Plan B [JURIST news archive] emergency contraceptive available over-the-counter to women of all ages. In an effort to comply with the judge's April ruling [JURIST report], the FDA has approved the brand name version of Plan-B OneStep [product website] for women of all ages without retail restrictions. However, opposing parties argued [letter, PDF] Wednesday that limiting the approval to the one-step version of the brand name hormone would increase pricing, thus limiting availability to women of lesser means. While Korman agreed that such a spike in price was theoretically possible, he maintained that the FDA has only to approve the same hormone produced by generic pharmaceutical companies in order to avoid the problem. He expressed a firm belief that the FDA would do so as quickly as possible. As for the two-pill alternative, the judge emphasized that making the two-pill option as readily available as its alternative was in the discretion of the FDA. On the other hand, the language of the ruling reiterated the court's dismay at the FDA's "unjustifiably political" history of restricting access to the drugs, evincing the judge's longstanding conviction [SCOTUSblog report] that access to emergency contraceptives should be as least-restrictive as possible.

In 2005 organizations and individuals concerned with women's health filed suit in the Eastern District of New York, in pursuit of expanded access to the drugs, including over-the-counter availability regardless of age. It was heard before Korman, who ruled in their favor, but in December 2011 the Secretary of the Department of Health and Human Services (HHS) [official website], Kathleen Sebelius [HHS profile], intervened to block the ruling as it related to minors, citing inadequate evidence concerning adverse health effects. In April Korman overruled Sebelius' "unprecedented," decision, calling the prior requirement for adolescents under age 16 "unjustified and burdensome." The US Department of Justice (DOJ) [official website] initially appealed [JURIST report] the decision in, stating that the judge had overstepped his legal authority. The DOJ announced that it would drop the appeal [JURIST report] on Monday.

 

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