Federal Court Orders FDA To Expand Access To Emergency Contraception
Calls On FDA To Reconsider Making Plan B Available To All Women Without a Prescription
WASHINGTON – The American Civil Liberties Union today heralded a federal court decision ordering the Food and Drug Administration (FDA) to expand access to emergency contraception — also known as Plan B or the "morning after" pill. Today's decision orders the FDA to make Plan B available within 30 days without a prescription to women 17 and older. Moreover, it calls on the FDA to reconsider whether to approve Plan B for over-the-counter status without age restrictions.
"Today's decision is an important victory that will help increase women's access to contraception," said Louise Melling, Director of the ACLU Reproductive Freedom Project. "It is the first step toward ending years of political interference by the FDA regarding Plan B and will give more women the opportunity to prevent an unintended pregnancy."
In May 2004, the FDA denied over-the-counter status to the emergency contraceptive, Plan B, disregarding the near-unanimous recommendation of a panel of FDA advisors to allow the drug to be sold without a prescription. FDA staff as well as the American College of Obstetricians and Gynecologists, the American Public Health Association, and other medical organizations also supported the recommendation.
After public outcry, in August of 2006, the FDA decided to allow pharmacies to sell Plan B without a prescription, but only to women 18 and older with government-issued proof of age. At the time, the ACLU warned that the age restriction was arbitrary and the proof-of-age restriction infringed on privacy rights.
In today's decision the court repeatedly criticizes the FDA for allowing politics to interfere in its decision-making process and notes that "the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use." The court also states that "the FDA's denial of non-prescription access without age restriction went against the recommendation of a committee of experts it had empanelled to advise it on Plan B; and the Commissioner – at the behest of political actors –decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews."
"We are hopeful that the FDA under President Obama will respect the scientific evidence and act in a timely manner to make Plan B available to all women without a prescription," said Vania Leveille, ACLU Legislative Counsel. "Today's decision is a welcome sign, putting health care needs and scientific evidence above political machinations."
The lawsuit Tummino v. von Eschenbach was filed on January 21, 2005, by the Center for Reproductive Rights in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals, National Latina Institute for Reproductive Health, and individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy.