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Emergency Contraception Access Curtailed Yet Again

The FDA's approval of over-the-counter access to emergency contraception without age restrictions was recently blocked at the federal level.

In 2003, an FDA advisory committee endorsed over-the-counter (OTC) access to levonorgestrel emergency contraception (EC). Nonetheless, under federal pressure, the FDA instead placed this medication "behind the counter," which required women who sought EC to obtain prescriptions or to prove that they were at least 18. In 2009, a federal judge ruled that this policy did not reflect scientific evidence and required that, at minimum, EC must be made available without prescription to all women who could prove they were at least 17. In addition, further studies that involved adolescents as young as 12 were reviewed by the FDA. In December 2011, the FDA again recommended OTC access to EC without age restrictions, and the FDA commissioner indicated her intent to approve OTC access to EC. However, the Secretary of Health and Human Services took the unprecedented step of blocking the FDA's recommendation.

Amidst this political conflict, we can easily lose sight of medical facts. Although one of every three U.S. women has undergone an induced abortion by the time she reaches age 45, fewer than 10% have ever used EC. Clinical counseling is one of the strongest predictors of EC use, yet few clinicians routinely advise patients about EC or other forms of contraception (e.g., IUDs, implants) that preclude the need for EC. Now, new data show that pharmacists in low-income communities provide misinformation about EC more commonly than do those in wealthier communities. Other facts about EC are as follows:

• Levonorgestrel EC is available without prescription in >50 countries and has not been associated with serious adverse effects.
• Many randomized controlled trials have shown that improving access to EC does not raise incidence of sexual risk taking or sexually transmitted infections.
• Levonorgestrel EC delays ovulation and has no effect on established pregnancies. This medication should not be confused with the antiprogestin mifepristone (Mifeprex; RU-486).
• Levonorgestrel EC is effective as long as 5 days after unprotected sex (although EC is more effective the sooner it is used).
• Two types of oral EC are now available in the US: levonorgestrel (Plan B One-Step or the generic Next Choice) and ulipristal acetate (ella). The latter requires a prescription for women of all ages but is more effective than levonorgestrel, especially for obese women.
• The most effective EC is placement of a copper IUD within 5 days of unprotected sex. This is also the only emergency method that provides ongoing contraception.

— Eleanor Bimla Schwarz, MD, MS

Published in Journal Watch Women's Health January 12, 2012

Citation(s):

Wilkinson TA et al. Access to emergency contraception for adolescents. JAMA 2011 Dec 19; [e-pub ahead of print]. (http://dx.doi.org/10.1001/JAMA.2011.1949)

Steinbrook R. Science, politics, and over-the-counter emergency contraception. JAMA 2011 Dec 19; [e-pub ahead of print]. (http://dx.doi.org/10.1001/JAMA.2011.1957)

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