Washington, DC -- Research released today supports the contention that the leadership of the federal Food and Drug Administration (FDA) shortchanged and underestimated women last year by failing to approve over-the-counter (OTC) status for the emergency contraceptive Plan B.

Although the FDA typically follows the recommendations of its scientific committees, the May 2004 "not approved" decision by Steven Galston, acting director of the FDA's drugs division, ignored the nearly unanimous recommendations of FDA advisory panels and the advice of FDA staff that Plan B was safe for OTC use. His decision was wrong then, and it's still wrong today.

A study of 2,117 young women ages 15 to 24, reported in today's Journal of the American Medical Association (JAMA), concludes that providing young women with access to emergency contraception (EC) did not lead them to engage in more risky sexual behavior. (See TR Raine et al, Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs, JAMA, 2005; 293:54-62, at www.jama.com.) The study demonstrates that ready availability of EC does not negate the ability of women to act responsibly, despite erroneous claims to the contrary by some EC opponents.

These new data clearly add to the existing body of evidence previously reviewed by two FDA expert advisory panels. They overwhelmingly had recommended OTC approval of Plan B by a 23-to-4 vote, after reviewing more than 15,000 pages of clinical data from approximately 40 studies submitted with the OTC application. The JAMA study confirms they were correct: EC does not increase promiscuity or unprotected sex among women, nor does it cause women to abandon their regular birth control methods.

ACOG and other organizations have estimated that greater access to emergency contraceptives could cut the US unintended pregnancy and abortion rates in half. FDA leaders bear significant responsibility for a public health failure to reduce these rates if they fail to consider sound scientific evidence.

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