CRR Takes FDA Back to Court Over Morning-After Pill
Says Obama FDA is Still Ignoring Science and Playing Games with Women's Health Like Bush FDA
11.16.10 - (PRESS RELEASE) Today, the Center for Reproductive Rights filed a motion for contempt against the Food and Drug Administration for failing to follow a court order regarding access to emergency contraception for women of all ages. On March 23, 2009, Judge Edward Korman of the U.S. District Court for the Eastern District of New York found that the FDA's decision to limit over-the-counter access to the emergency contraceptive Plan B to women over 18 was based on politics rather than science. He ordered the agency to reconsider that decision.
"The FDA has had ample time, countless opportunities, and overwhelming scientific evidence put before it to make a decision on Plan B," said Nancy Northup, president of the Center for Reproductive Rights. "The President promised that his administration would reverse the Bush policy of politics trumping science. But when it comes to emergency contraception, it's a new administration playing the same old games."
The Center argues that the FDA has continued the same pattern of steady and repeated inaction seen during the previous administration. The Center originally 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. When the FDA refused to rule on the petition, the Center filed a lawsuit in 2005 in federal court. In 2009, the court ruled that the agency had acted in "bad faith and in response to political pressure," not science, when it repeatedly and unreasonably delayed making a decision on Plan B, and that the agency had departed in significant ways from its normal procedures. Soon after the ruling, the FDA acknowledged its obligation to reconsider making Plan B available over-the-counter to all ages and said that it intended to make a final decision on the drug's availability to women under the age of 17. But this year, the agency admitted that it does not plan to reconsider the Citizen Petition, as the court ordered.
"All of the scientific facts are there and FDA experts agree—emergency contraception has proven safe and effective to be sold over-the-counter to all ages," said Suzanne Novak, lead counsel in the case. "It's time for the FDA to stop the stonewalling, follow the science, and make emergency contraception available without a prescription to women of all ages."
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.