FDA Lowers Age for Over-the-Counter Access of EC and Approves New One-Pill Version
On July 13 2009, the U.S. Food and Drug Administration (FDA) approved Emergency Contraception for over-the-counter sale to 17 year-olds. Prior to this decision, the FDA had only approved EC for sale over-the-counter to women ages 18 and older (it remained available to younger women by prescription). At the same time, Teva Pharmaceuticals, the company that makes Plan B, the only EC brand currently on the market, released Plan B One-Step, a new single-pill version of Plan B.[i]
The new one-pill version of Plan B is expected to be a more convenient form of emergency contraception than the original Plan B, which required women to take two doses. Because it is easier to use, healthcare professionals expect that the new version will be used more effectively. Jennifer Rogers, the acting executive director for Reproductive Health Technologies Project stated, "It makes intuitive sense that the one dose would be an obvious way to increase compliance. Sometimes, with two doses, women would delay taking their first pill. If you buy it at 2 p.m., but don’t want to wake up at 2 a.m., you may wait another six hours to begin the course of treatment."[ii] The efficacy of emergency contraception reduces every hour after unprotected sex, thus any delay increases the chance of an unintended pregnancy. Teva said the Plan B One-Step would be available in pharmacies next month.[iii]
“SIECUS applauds the FDA’s decision to make emergency contraception more widely available over the counter. We hope that in the future the FDA will ensure that all young women have the option to access to EC as a safe and effective form of contraception.” said William Smith, the Vice President for Public Policy at SIECUS.
Plan B and the new Plan B One-Step are both sold by Duramed Pharmaceuticals, a unit of Teva Pharmaceuticals Industries Ltd. Duramed loses market exclusivity on the traditional Plan B pill in August, thus allowing generic versions to be made available. The availability of generic brands is expected to lower the price of Plan B, which currently has an average sale price of $50 dollars.
[i] Jennifer Corbett Dooren, “FDA Approves New Plan B Labeling,” Wall Street Journal, 14 July 2009, accessed 16 July 2009, <http://online.wsj.com/article/SB10001424052970203739404574288451581882622.html?mod=googlenews_wsj>.
[ii] Kate Dailey, “Preventing Pregnancy ‘One-Step’ easier: FDA approves simpler Plan B”, Newsweek, 15 July 2009, accessed 16 July 2009, <http://blog.newsweek.com/blogs/thehumancondition/archive/2009/07/15/preventing-pregnancy-one-step-easier-fda-approves-simpler-plan-b.aspx>
[iii] Jennifer Corbett Dooren, “FDA approves new Plan B labeling.”
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