May 8, 2013

Plan B Battle Continues Despite FDA's Decision to Lower Age Restriction

plan b.pngThe 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.

During the Citizen Petition review, Women's Capital Corporation, the original sponsor of Plan B, submitted a number of sNDAs seeking an OTC switch. The first--submitted in April 2003--sought OTC access without any age restriction. FDA denied this application in May 2004. The next sNDA--submitted in July 2004--sought OTC access for women sixteen and older. Another sNDA--submitted in August 2006--sought OTC approval for women eighteen and older. FDA approved this application on August 24, 2006 but required that the drug be kept behind the counter.

Unhappy with FDA's denial of the Citizen Petition, a number of individuals, organization, as well as minors and their parents seeking wider distribution and access to emergency contraceptives, sued FDA under the Administrative Procedure Act and the U.S. Constitution. See Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y. 2009). Judge Korman agreed that the Agency had not acted properly in deciding the Citizen Petition. He found that FDA "repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons." Additionally, he felt that FDA's actions concerning Plan B had significantly departed from how the Agency had historically handled other applications seeking prescription-to-nonprescription switches. Judge Korman vacated the Citizen Petition denial and instructed FDA to reconsider whether Plan B should be approved without age and/or point-of-sale restrictions. But FDA did not receive unfettered remand authority; Judge Korman told the Agency that it could not make the cutoff age lower than seventeen.

It took FDA almost three years to rule on the remanded Citizen Petition. During the review, FDA considered another sNDA that sought approval of an OTC Plan B without age restrictions. This time the FDA agreed to approve the application. But Kathleen Sebelius, Secretary of DHHS, disagreed and ordered FDA to deny the sNDA. The Secretary's directive regarding the application also brought a death knell to the remanded Citizen Petition, which FDA denied in December 2011. The citizen petition denial brought further litigation, as the petitioners again appealed to Judge Korman asking to have Plan B and all related emergency contraceptives be made available without prescription to all ages. See April 4, 2013 Order above. And again Judge Korman disagreed with FDA's actions. He found that Secretary Sebelius's intervention in the sNDA application was unprecedented, represented a deviation from traditional policy that was politically motivated, and resulted in the Citizen Petition's denial. Judge Korman held that FDA's actions in denying the citizen petition were arbitrary, capricious, and unreasonable; he reversed the denial and remanded the petition to FDA. But this time he did not remand with instructions to reconsider. Instead, he told the Agency to grant the Petition and make Plan B and all related emergency contraceptives available without prescription and without age or point-of-sale restrictions within thirty days.