The Politics of Emergency Contraception

On December 7, Health and Human Services Secretary Kathleen Sebelius overruled an FDA decision to approve over-the-counter sales of Plan B One-Step. Although the drug can be used safely without medical supervision, it apparently poses unacceptable political risks. On December 7, 2011, Health and Human Services (HHS) Secretary Kathleen Sebelius instructed Food and Drug Administration (FDA) Commissioner Margaret Hamburg not to approve the application for over-the-counter sales of Plan B One-Step, a single-dose emergency contraceptive. 1 Dr. Hamburg issued her own public statement 2 in which she made it clear that she had intended to approve the application. This is the first time that an HHS secretary has publicly overruled an FDA regulatory decision of this nature, and Sebelius's action has drawn extraordinary attention. First, the facts: Plan B One-Step, a single 1.5-mg tablet of the progestin levonorgestrel, is intended . . .