Back to Annual Meeting Page		American Public Health Association 133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA

Abstract #114620

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

• Identify the FDA’s mandate to protect the public health in its review of drug applications.
• Articulate common policy arguments made for and against OTC access to EC, and assess the extent to which those arguments are evidence-based.
• Discuss the role that public health professionals can play in the ongoing debates about emerging reproductive health care technologies and medications.

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.