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March-24-09

Court Rules that FDA Reconsider Restrictions on Sale of Plan B

Edward Korman, a New York District Court Judge ruled yesterday that the FDA must reconsider its 2006 ruling that allowed emergency contraception (EC), also known as Plan B, to be sold without a prescription to women 18 and older. The ruling (see PDF) also specifically orders Barr Pharmaceuticals, which distributes Plan B, to make EC available over-the-counter to women as young as 17 within 30 days.

Emergency contraception is effective up to five days (120 hours) after unprotected sex, birth control failure, or rape, but it is most effective (95 percent) if taken within 24 hours. Because of the time-sensitive nature of EC, over-the-counter access is crucial to its effective use.

In the ruling, Korman wrote: "These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making. Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use, referred to as a 'switch application' or an 'over-the-counter switch'. the matter is remanded to the FDA for reconsideration of whether to approve Plan B for over-the counter status without age or point-of-sale restrictions. While the FDA is free, on remand, to exercise its expertise and discretion regarding the proper disposition of the Citizen Petition, no useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription."

A recent study found that access to EC has improved since the 2006 ruling by the FDA allowing the morning after pill to be sold without a prescription to women 18 and older. The FDA approved over-the-counter sales of EC after a massive campaign, during which the Feminist Majority Foundation sent tens of thousands of petitions to the FDA asking for approval of EC over-the-counter.

Media Resources: Feminist Daily Newswire 8/24/06, 12/8/08; United States District Court Eastern District of New York 3/23/09

   

     

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