Administration Withdraws Appeal, Allows Plan B Contraception Over the Counter Without Restrictions

On June 10, 2013, the Obama administration notified the district court that it would withdraw the appeal of its decision in Tummino v Hamburg, which ordered the Food and Drug Administration (FDA) to approve a form of emergency contraception for purchase over-the-counter (OTC) without any restriction as to age. The FDA will approve Plan B One Step (One Step) for OTC use rather than the original form of Plan B, which required the user to take two doses 12 hours apart. The administration determined that there was sufficient patient data showing that even young adolescents can use One Step safely and effectively.

The administration’s action will put to rest a controversy that has been brewing since 2001, when the first citizen petition seeking OTC approval was filed with the FDA. In 2006, the FDA approved the drug for use without a prescription by women 18 years of age and older, but required anyone 17 and younger to have a prescription. A lawsuit was filed challenging the FDA’s prescription requirement.

In 2009, the court ordered the FDA to reevaluate the citizen petition and to lower the age for OTC purchase of Plan to 17. The court found that the agency had delayed its action without cause, disregarded the scientific findings of staff and panel, and made its decision solely for political reasons.

The FDA reconsidered the petition and, based on the scientific evidence, the Commissioner decided to grant it in December 2011. However, HHS Secretary Kathleen Sebelius overruled the Commissioner; she found that the evidence did not “conclusively” establish that ten-year-old girls would understand and follow the instructions.

The plaintiffs returned to court. On April 4, 2013, Judge Edward Korman granted the plaintiffs summary judgment in a 59-page opinion and ordered the FDA to make both the original Plan B and One Step available without a prescription. The opinion criticized the FDA for bad faith and the obvious political nature of the decision, comparing the safety of Plan B with other drugs that children may buy over the counter. Judge Korman further noted that Secretary Sebelius’ action, overruling the FDA Commissioner without notice to the parties or an opportunity to be heard, was inconsistent with standard principles of administrative law.

The government appealed and asked the district court for stay of its order. On May 10, 2013, Judge Korman denied the request for the stay, although as a courtesy to the Court of Appeals, he stayed the order until noon the following Monday to allow the government to file a motion there.

On June 5, 2013, the Court of Appeals granted the stay in part and denied it in part. To the extent that the district court ordered the FDA to make One Step available, the stay was granted; but the stay was denied with respect to the order to make the two-dose version of Plan B available. The effect was to make the more complex dosage available but not the variant that would be easiest for the youngest adolescents to understand. It also ordered that the appeal be heard on an expedited schedule.

The administration’ withdrew its appeal five days later. The agency will comply with the order by making One Step available immediately.