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 BTM submitted its own application to the FDA seeking to make Plan BTM available over-the-counter. The FDA responded to our Citizens Petition and to the Plan BTM 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 BTM 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.