CRR Blasts Health and Human Services Secretary’s Intervention to Block FDA Approval of Plan B One-Step for Over-the-Counter, All-Ages Use

(PRESS RELEASE) The Center for Reproductive Rights strongly criticizes U.S. Department of Health and Human Services Secretary Kathleen Sebelius’ decision to intervene and block the Food and Drug Administration’s expected approval of emergency contraceptive Plan B One-Step for over-the-counter sale to women of all ages.

“Six years ago, we sued the Bush administration for rejecting science and playing politics with women’s health by denying emergency contraception for over-the-counter sale,” said Nancy Northup, president of the Center for Reproductive Rights. “We are stunned to see the same behavior from the Obama administration.

“It is unacceptable that the approval for drugs supporting women’s reproductive health is held to a completely different standard.”

Since 2009, the FDA has continually ignored a federal judge’s order to reconsider and rule on the Citizen Petition filed by the Center in 2001 to make all brands of levonorgestrel-based emergency contraception available over-the-counter and to all ages-and the Center will be back in federal court on Tuesday, December 13 arguing the agency is in contempt of court for failing to do so.

The Center initially filed a Citizen Petition with the FDA in 2001 on behalf of over 70 medical and public health organizations, asking the agency to grant emergency contraception over-the-counter status to the original two-pill version of Plan B. When the FDA refused to rule on the petition, the Center filed a lawsuit in 2005 in federal court.

In 2009, the federal court ordered the FDA to reconsider its decision to limit over-the-counter access to Plan B for women over 16 after it was discovered the agency’s decision was based on politics rather than science. The Center filed a motion for contempt against the FDA in November 2010 for continually failing to follow that order.

In February 2011, Teva filed a supplemental new drug application for Plan B One-Step asking the FDA to allow unrestricted over-the-counter distribution of the product. According to the FDA, the agency was poised to approve Plan B One-Step for over-the-counter, unrestricted use based on a “body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed to specifically address the regulatory standards for nonprescription drugs.”

But today, Secretary Sebelius has blocked that approval, citing the data submitted by Teva “do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.”

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.