New FDA Denial Holds Emergency Contraceptives to Unfair Standard, says Center for Reproductive Rights

(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.