Citizens’s Petition (Supplement 2001): Food and Drug Administration

In 2001, the Center, along with the Reproductive Health Technologies Project and numerous women’s health organizations, filed a Citizen’s Petition to the Food and Drug Administration (FDA), urging the agency to switch emergency contraception drugs from prescription-only to over-the-counter status. Shortly thereafter, the manufacturer of the emergency contraceptive product Plan B^TM submitted its own application to the FDA seeking to make Plan B^TM available over-the-counter. The FDA responded to our Citizens Petition and to the Plan B^TM application with years of unexplained delay. After four years of waiting, the Center filed suit in federal court against the FDA, alleging that the agency’s failure to approve Plan B for over-the-counter use impermissibly denied women access to EC.

In July of 2006, the FDA finally acted on the Plan B^TM application and Citizen’s Petition, announcing that it would approve the distribution of emergency contraception without a prescription only at pharmacies and only for women 18 or older who could produce government-issued identification as proof of age.