Federal Judge Strikes Age Restriction on Morning-after Pill

The “morning after” pill can be made available to women of all ages and without a prescription, a federal judge ruled yesterday, dealing a blow to U.S. restrictions on access to the contraceptive.

U.S. District Judge Edward Korman in Brooklyn, New York, excoriated the Food and Drug Administration for what he called a 12-year delay in making the emergency contraceptive, Teva Pharmaceutical Industries Ltd.’s Plan B, available over-the-counter. While acknowledging opponent contentions that increased access to contraception may encourage sexual conduct by minors, Korman said the case isn’t about “the potential misuse of Plan B by 11-year-olds.”

“These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be minuscule,” Korman wrote. “The invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”

Korman, 70, ordered the FDA make the drug available without limits in 30 days. His ruling followed a reproductive rights group’s request to reopen a lawsuit over access to the contraceptive, claiming the FDA acted in bad faith when it placed restrictions on the drug.
Delay, Obstruction.

“The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction,” said Korman, a former federal prosecutor appointed to the bench in 1985 by President Ronald Reagan, a Republican.

Korman’s ruling expands on a 2009 decision in which he ordered the pill made available without a prescription to women as young as 17. The judge ruled then that the age restrictions were arbitrary and based more on political pressure than safety.

The pill and generic versions of it are now kept behind pharmacy counters and sold without prescription only to women 17 and older.

“Today science has finally prevailed over politics,” Nancy Northup, president and chief executive for the Center for Reproductive Rights, said in a statement. “This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods.”

Erica Jefferson, a spokeswoman for the FDA, declined to comment on the ruling or the possibility of an appeal to the U.S. Court of Appeals in New York.

The 2005 case was reopened after Northup’s group petitioned Korman in February 2012 claiming it was the most efficient way for the group to overturn the FDA’s age restraints on the drug.

Lawyers for the group accused the FDA of persistently treating emergency contraception different from other medicines.

The group previously supported Israel-based Teva in a failed bid to make the emergency contraceptive, Plan B One-Step, available in stores to all ages.

U.S. Secretary of Health and Human Services Kathleen Sebelius ordered the FDA to reject that application in December 2011 because of the “cognitive and behavioral” differences in girls of the youngest reproductive age. The reproductive rights group asked to add Sebelius as a defendant in the case.

The FDA’s rules for approving drugs for over-the-counter sale are the same for aspirin as they are for contraceptives, Korman said. The standard for determining whether any drug should be made available over-the-counter turns solely on the ability of the consumer to understand how to use that drug safely and effectively, Korman said.

Korman rejected the FDA’s request that he remand the case for administrative rulemaking proceedings. The agency has engaged in “intolerable” delays since an initial citizen petition was filed more than 12 years ago, Korman said.