The fight over whether versions of the emergency contraceptives Plan B and Plan B One-Step (collectively “Plan B”) should be available without a prescription to all women continued yesterday. Lawyers for FDA appeared before Judge Edward Korman of the Eastern District of New York urging him to stay his April 4 Order requiring the Agency to lift age restrictions on access to emergency contraceptives by May 10. FDA has appealed that ruling to the Second Circuit. The Agency has yet to implement the court’s directive, but in late April it approved a supplemental new drug application (“sNDA”) that lowers the age at which women can obtain these drugs without a prescription from 17 to 15. Judge Korman expressed skepticism as to the timing of the approval and criticized the Agency for not following his order. A ruling on the stay is expected by the end of this week.
FDA’s actions have received mixed reviews. Last week, President Barack Obama reiterated his support of FDA’s and the Department of Health and Human Services’ (“DHHS’s”) determination that the age-restriction should be fifteen. He said that he was “very comfortable with the decisions they’ve made.” Others have been more critical. Nancy Northup, President and CEO of the Center for Reproductive Rights, speaking after the Department of Justice’s appeal to the Second Circuit said, “We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions.”
The approval of Plan B has a long history. Originally approved in 1999 for prescription-only use, Plan B became the United States’ first emergency contraceptive. In February 2001, sixty-six organizations filed a Citizen Petition with FDA urging the Agency to switch Plan B, as well as any other emergency contraceptives, from a prescription-only drug to an over-the-counter (“OTC”) drug and remove all age and point-of-sale restrictions. Despite repeated claims that it would address the outstanding petition, the Agency waited over five years to rule–denying the Petition in June 2006. FDA claimed that the petitioners had failed to provide sufficient data or information to meet the statutory and regulatory requirements of an OTC switch to any age group.