Center requests addition of HHS Secretary Kathleen Sebelius as defendant, seeks immediate and unrestricted OTC status
(PRESS RELEASE) Seeking immediate relief that would allow emergency contraception over-the-counter access for women of all ages, today the Center for Reproductive Rights asked a federal court to reopen the Center’s 2005 lawsuit against the Food and Drug Administration (FDA) for imposing unnecessary age restrictions on the drugs, also known as the “morning-after pill.”The Center also requested the addition of U.S. Department of Health and Human Services Secretary Kathleen Sebelius as a defendant in the reopened case for her role in recently overruling the FDA’s decision to approve Plan B One-Step for over-the-counter status in December 2011.“After 10 years of stalling and putting politics before science, it is time to bring emergency contraception out from behind the pharmacy counter,” said Nancy Northup, president and CEO for the Center for Reproductive Rights. “While we applaud the Obama Administration for recognizing that no-copay birth control is a vital preventive healthcare service, HHS’s actions on emergency contraception have been arbitrary and legally unjustifiable.” Northup also emphasized the benefits of increasing access to emergency contraception to women of all ages. Currently, levonorgestrel-based emergency contraceptives (such as Plan B One-Step) are available to women 17 and older without a prescription, with young women under 17 required to obtain a prescription from a physician. Even for women 17 and older, however, the medication is available only at pharmacies upon request and with adequate identification. If the drugs were granted unrestricted access, they could be sold at stores other than just pharmacies and identification would not be required “Some women don’t have the identification they need to get emergency contraception. Others may find their local pharmacy counters closed late at night or on weekends. They all need better access to this safe and effective method of contraception when emergencies happen,” said Northup.The new suit asks U.S. District Court Judge Edward Korman to issue a preliminary injunction that would allow all levonorgestrel-based emergency contraceptives —both the single-dose Plan B One-Step and the two-dose generic brands — to be immediately approved for unrestricted over-the-counter sale.“The FDA has continually treated emergency contraception completely different than it has any other medication,” said Suzanne Novak, senior staff attorney for the Center for Reproductive Rights and lead counsel on this case. “We are asking the court to recognize that the FDA has failed to meet its obligation to the public and make decisions based on science, rather than politics.”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 over-the-counter status to all emergency contraceptive products available at the time. Based on the way the FDA failed to respond appropriately to both the Citizen Petition and applications from manufacturers of emergency contraception, the Center filed a lawsuit in 2005 in federal court. According to the Center’s lawsuit, 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 has violated the Administrative Procedure Act and the U.S. Constitution.
In 2009, the federal court ordered the FDA to immediately grant over-the-counter status to Plan B for 17 year olds, and also ordered the agency to reconsider the Citizen Petition because it concluded that the agency had based its decision to restrict access to Plan B 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 and rule on the Citizen Petition.
In February 2011, Plan B One-Step’s drug manufacturer filed a supplemental new application 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 on December 7, 2011, Secretary Sebelius blocked that approval, asserting that the data submitted with the application “do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.” The FDA denied the 2001 Citizen Petition a week later on the eve of the contempt motion hearing.While Judge Korman found the contempt motion moot because the FDA did finally rule on the petition—two years after it was ordered to do so—he noted that these recent events drew striking similarities to the findings in 2009 that the FDA under the Bush Administration had “acted in bad faith and in response to political pressure.” The Center filed Tummino v. Hamburg along with Andrea Costello of Florida Institutional Legal Services on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, grassroots activists with National Women’s Liberation, and parents who seek over-the-counter access for their daughters.