Sex, Politics, and Lessons Learned from Plan B: A Review of the FDA’s Actions and Future Direction

23 Pages Posted: 25 Jan 2012

See all articles by Roseann B. Termini

Roseann B. Termini

Widener University Delaware Law School

Miranda Lee

Widener University - Delaware Law School

Date Written: January 19, 2012

Abstract

Plan B, an emergency contraceptive pill available in the United States, acts in a similar manner as regular hormonal contraception; however, Plan B is a strong, concentrated dose of a synthetic progesterone used to prevent pregnancy in the event of unplanned and/or unprotected sex or the failure of other contraception such as condoms or a birth-control pill. Plan B became the first drug in ten years to be rejected by the Food and Drug Administration (FDA) after the agency’s own panel and research teams recommended OTC approval. Women’s Capital Corporation, manufacturer of Plan B (now Duramed Pharmaceuticals, Inc.), had applied to have Plan B’s status changed from prescription only to over-the-counter (OTC) back in 2003. Throughout Plan B’s application process, there was evidence of strong political interference. Due to the FDA’s denial of the switch to OTC status for those under eighteen years of age, Congress requested an investigation by the Government Accountability Office (GAO). Finally, in 2009, a federal judge ordered the FDA to approve OTC use for ages seventeen and older and remanded the case back to the FDA to re-review the application of OTC use for all ages. This Article discusses the past, present, and future implications and directions for the FDA regarding Plan B and other emergency contraceptives.

Keywords: plan b, birth control, FDA, Food and Drug Administration, emergency contraceptives

JEL Classification: K32, I18

Suggested Citation

Termini, Roseann B. and Lee, Miranda, Sex, Politics, and Lessons Learned from Plan B: A Review of the FDA’s Actions and Future Direction (January 19, 2012). Oklahoma City University Law Review, Vol. 36, 2011. Available at SSRN: https://ssrn.com/abstract=1988526

Roseann B. Termini (Contact Author)

Widener University Delaware Law School ( email )

4601 Concord Pike
Wilmington, DE 19803-0406
United States

Miranda Lee

Widener University - Delaware Law School ( email )

4601 Concord Pike
Wilmington, DE 19803-0406
United States

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