Plan B Over-the-Counter Application is Filed, But CRR Says FDA has Enough Evidence

(PRESS RELEASE) Teva, the manufacturer of the emergency contraceptive Plan B, announced that they filed an over-the-counter application for Plan B One-Step with the Food and Drug Administration this week. The application requests that the agency make the emergency contraceptive available without a prescription for women of all ages.

This development comes on the heels of the Center for Reproductive Rights filing a motion for contempt against the FDA for failing to follow a 2009 federal court order regarding Plan B. 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 prior decision to limit over-the-counter access to Plan B to women over 16 was based on politics rather than science. He ordered the agency to reconsider that decision.
 
"We certainly support any actions that will increase women's access to emergency contraception, but Teva's application does not absolve the FDA of its responsibility to comply with the court order," said Nancy Northup, president of the Center for Reproductive Rights. "There's enough scientific evidence before the agency to decide whether to make Plan B available over-the-counter, and there has been for ten years."
 
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. As a result, the Center argues that the FDA has continued the same pattern of steady and repeated inaction seen during the previous administration.