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American Public Health Association
133rd Annual Meeting & Exposition
December 10-14, 2005
Philadelphia, PA
APHA 2005
3307.0: Monday, December 12, 2005 - 2:30 PM

Abstract #114620

Over-the-Counter Access to Emergency Contraception: Why did the FDA Delay its Response?

Priscilla Smith, JD, Nan Strauss, JD, and Simon Heller, JD. Domestic Legal Program, Center for Reproductive Rights, 120 Wall Street, 14th Floor, New York, NY 10005, 917-637-3600, nstrauss@reprorights.org

This presentation will discuss the FDA's continuing refusal to grant over-the-counter access to Plan B, an Emergency Contraception (EC) product, and the lawsuit brought by the Center for Reproductive Rights to challenge the FDA's actions. When taken within 72 hours of unprotected intercourse, EC reduces the risk of pregnancy by approximately 89 percent, according to a study published in Obstetrics and Gynecology.

The lawsuit was filed within hours of the FDA's announcement on January 21, 2005 that it would delay deciding whether Plan B should be made available over-the-counter to women 16 and older. In May 2004, the FDA had denied a request to make the product available over-the-counter to women of all ages, citing a lack of information on whether EC could be taken safely by women under 16 or whether easier access would promote risk-taking sexual behavior among teens. The lawsuit alleges that the FDA's continuing refusal to grant OTC access to EC even for adult women -- violates federal law and the U.S. Constitution. The FDA has violated its statutory and regulatory mandate to protect the public health by ignoring the advice of its own advisory committee, the positions of major medical groups, such as the APHA, and by treating EC differently from other over-the-counter applications without compelling scientific reasons for the differential treatment. The presentation will discuss the extent to which arguments made to oppose OTC approval are evidence-based, ideological, or both.

Learning Objectives: Upon completion of this session, the participant will be able to

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.

Emergency Contraceptives: Practices and Issues

The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA