In his 59-page ruling, Korman stated that the government’s more than decade-long refusal to lift restrictions was “arbitrary, capricious, and unreasonable,” and he accused the FDA of "bad faith" dealings:
“More than 12 years have passed since the citizen petition was filed and 8 years since this lawsuit commenced,” the judge wrote. “The F.D.A. has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster.”In 2011, HHS Secretary Kathleen Sebelius overturned an FDA decision to make the pill available to all ages, a decision backed by President Barack Obama, who said at the time:
I will say this, as the father of two daughters. I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine. And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old go into a drugstore, should be able—alongside bubble gum or batteries—be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way.That stirred a lot of objections among feminists and reproductive rights advocates who said his point of view encouraged a greater risk of pregnancy.
In his ruling, Korman wrote:
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. [...]Even if there is no appeal, that doesn't mean the pill will be immediately available to all who seek it. A study in January 2012, Research Letter: Access to Emergency Contraception for Adolescents, found that when callers posing as 17-year-olds phoned pharmacies, 20 percent of them "did not have emergency contraception available on the same day that the patient called.” The situation was worst in low-income neighborhoods.
As I have previously observed, the obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptives unavailable without a doctor’s prescription. Consequently, the decision of the FDA denying the Citizen Petition is reversed, and the case is remanded to the FDA with the instruction to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days. On remand, the FDA may determine whether any new labeling is reasonably necessary.