A federal judge has ordered the government to allow the sale of emergency contraceptive pill Plan B One-Step without a prescription to any woman, no matter her age. The action effectively reverses a stunning decision by Heath and Human Services secretary Kathleen Sebelius, who, in 2011, overruled the Food and Drug Administration’s decision to make the pill more widely available over-the-counter. Sebelius’ intervention restricted over-the-counter sales of Plan B to women age 17 and older.
The judge’s order is the latest move in a long legal battle that has seemingly pitted scientists (including some working for the FDA) and sexual health advocates against government officials and others who see a controversy in making the pill more widely available. That’s despite significant scientific evidence that the pill is safe, does not encourage promiscuity, and does not cause an abortion. Judge Edward R. Korman’s opinion referenced and dismissed a specific concern cited by both Sebelius and President Obama at the time of the 2011 intervention, namely that the pill could be harmful to 10- and 11-year-old girls:
“This case is not 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 miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed. Instead, 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.”
Calling Sebelius’s action on the issue “arbitrary, capricious, and unreasonable,” Judge Korman ordered the government to lift age restrictions on Plan B One-Step (and generic versions) for over-the-counter sales within 30 days. Korman concluded, “The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster … 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.”
According to the New York Times, the FDA and the Department of Health and Human Services have not commented yet on whether they will appeal the decision.