New FDA Denial Holds Emergency Contraceptives to Unfair Standard, says Center for Reproductive Rights
12.12.11 - (PRESS RELEASE) Late today, the U.S. Food and Drug Administration (FDA) denied the Center for Reproductive Rights' 2001 Citizen Petition to make levonorgestrel-based emergency contraception available over the counter to women of all ages on the grounds the agency needs additional data-which a federal court decided two years ago was not necessary to make a sound decision.
"On the eve of a contempt hearing, the FDA has once again come up with an excuse to treat the approval of contraceptives differently from any other drug," said Nancy Northup, president and CEO of the Center for Reproductive Rights. "It is truly stunning the lengths to which the agency will go to deny women access to emergency contraceptives that have been proven safe and effective for years."
The Center is back in federal court tomorrow afternoon to argue the FDA has been in contempt of court for failing to appropriately address the Citizen's Petition and not place politics over science, as ordered by the judge in 2009.
This decision and tomorrow's court hearing comes on the heels of a stunning and unprecedented decision by the U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius to intervene and block the FDA's expected approval of Plan B One-Step for over-the-counter unrestricted sale.
The Center filed Tummino v. Hamburg along with attorneys Andrea Costello of Florida Institutional Legal Services and Natalie Maxwell of Southern Legal Counsel on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, grassroots activists, and parents who seek over-the-counter access for their daughters.
Tummino v. von Hamburg (NY)