Justice Department files appeal to keep age restrictions in place for emergency contraceptives

The U.S. Department of Justice filed a notice on May 1 to appeal New York Judge Edward R. Korman’s decision last month to make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions.

On April 5, Judge Korman of the United States District Court for the Eastern District of New York struck down the restrictions on these emergency contraceptives and ordered the FDA to make the drugs available over the counter without point-of-sale or age restrictions within 30 days.

In his ruling, Judge Korman said that the decisions made by the secretary of the U.S. Department of Health and Human Services with respect to Plan B One-Step and by the FDA to deny the Citizen Petition with respect to availability of emergency contraceptives to patients of any age without a prescription “were arbitrary, capricious, and unreasonable.”

In its letter to Judge Korman yesterday, the Justice Department says that it is not in the public interest to have drugs reclassified as non-prescription by a court order, and it is the FDA that must make those decisions.

Two days ago, FDA did change the age and point-of-sale restrictions for one of the levonorgestrel-based emergency contraceptives, Plan B One-Step (Teva Women’s Health Inc.), making it available to women 15 years and older as an over-the-counter medication. This decision was independent of Judge Korman’s April 5 ruling.

Nancy Northup, president and CEO of the Center for Reproductive Rights, said her organization was disappointed with the Obama and Bush administrations for their actions on denying access to obtain emergency contraceptives for women of all ages. The Center for Reproductive Rights was one of the original groups to file the Tummino v. Hamburg suit to make these drugs available over-the-counter.

“Women who urgently need emergency contraception have been delayed in getting it or denied access for more than a decade because of political maneuverings of the last two presidential administrations,” Northup said in a May 1 press statement. “The federal court [New York Judge Korman] has made clear that these stalling tactics were based purely on politics, not science.”