Center for Reproductive Rights Prepares New Legal Challenge to Lift FDA Restrictions on Emergency Contraception

Center will reopen its 2005 lawsuit against FDA and add HHS Secretary Kathleen Sebelius as a defendant in the case
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(PRESS RELEASE) The Center for Reproductive Rights announced today it will reopen its 2005 lawsuit against the Food and Drug Administration (FDA) for imposing unnecessary age restrictions on emergency contraceptives, and seek immediate relief to allow broader access to available drugs. The Center also plans to add U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius as a defendant in the reopened case for her role in overruling the FDA’s approval of Plan B One-Step last week.

“This fight is far from over. We intend to take every legal step necessary to hold the FDA and this administration accountable for its extraordinary actions to block women from safe, effective emergency contraception,” said Nancy Northup, president and CEO for the Center for Reproductive Rights. “It has been ten years of battling to bring emergency contraception out from behind the pharmacy counter. The FDA cannot simply continue moving the goal posts down the field for women’s reproductive health care.”

While U.S. District Court Judge Edward Korman found the contempt motion moot because late last night, the FDA decided to deny the 2001 Citizen Petition to lift age restrictions on emergency contraceptives— two years after the judge had ordered the agency to fairly reconsider the petition— he proceeded to invite the Center to reopen its 2005 lawsuit and agreed that the Center could add Secretary Sebelius as a defendant.

During the hearing, Judge Korman repeatedly noted the striking similarities between recent events —including last night’s denial of the Citizen Petition and Secretary Sebelius’ unprecedented decision to intervene and block the unrestricted sale of the drug—and the findings in 2009 that the FDA under the Bush Administration had “acted in bad faith and in response to political pressure.”

“The FDA has essentially been holding women’s reproductive health hostage to political calculations,” said Suzanne Novak, senior staff attorney who argued for the Center for Reproductive Rights today.

According to the Center, by denying women of all ages access to emergency contraception without a prescription, and by failing to follow its own procedures and statutory and regulatory mandates, the FDA violated the Administrative Procedures Act and the U.S. Constitution. 

The Center filed Tummino v. Hamburg in 2005 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.