Plan B Contraceptive and the Role of Politics in Medicine: A Comparative Analysis of the "Switch" of Emergency Contraception from Prescription to Non-Prescription in the United States, France, the United Kingdom, and Canada


Of the approximately 6 million pregnancies in the United States each year, almost half are unintended. Of these unintended pregnancies, approximately four in ten will end in abortion. Plan B emergency contraception is a drug that has the potential to reduce the number of abortions performed each year in half. Despite contentions from various religious and political sects, Plan B is not an abortifacient. It acts by preventing a pregnancy from starting rather than terminating a pregnancy that is already established. On December 16, 2003, a panel of medical and scientific experts gathered by the Food and Drug Administration (FDA), voted overwhelmingly to approve over-the-counter (OTC) status for Plan B emergency contraception for child -bearingwomen of all ages. In an unprecedented move, high level FDA officials rejected the panel’s recommendation and issued a Not Approvable letter citing a lack of data concerning the safety of Plan B for younger adolescents. In a subsequent application for Plan B OTC status with age restrictions, the FDA again rejected OTC approval noting various marketing, enforcement, and labeling concerns. To illustrate the level of political interference in what should have been a medical and scientific decision, this manuscript compares the “switch” of Plan B from prescription to OTC status in the United States with the process in France, the United Kingdom, and Canada. The governmental, political, and social forces affecting the switch are analyzed. Examination of survey results from the studied countries reveal that non-prescription emergency contraception can be safely self-administered in reproductive females of all ages, and does not result in an increase of risky sexual practices among those women. Although, on August 24, 2006, the FDA finally granted approval for OTC access to Plan B for women aged eighteen years and older, adolescent women, arguably the group who could most benefit from OTC access, was once again denied. In the realm of female reproductive health, conservative politics continues to trump sound medical and scientific judgment.


Health Law and Policy | Sexuality and the Law

Date of this Version

September 2006