Judge Orders FDA to Make Plan B Contraception Available Over-the-Counter Without Age Restrictions

This morning, a federal district court judge overturned the Department of Health and Human Services’ decision to maintain limits on access to Plan B contraception by girls under the age of 17.  As I noted here, the Food and Drug Administration had initially decided to grant a petition urging a removal of the age restrictions but was overruled by HHS Secretary Kathleen Sebelius.  Today’s decision overrules the Secretary’s decision on the grounds that it was “arbitrary, capricious, and unreasonable,” and the judge accuses HHS of “bad faith” and “intolerable” delays in considering the initial petition that prompted this litigation. The opinion is here and a related order is here.  The opinion’s conclusion summarizes the case as follows:

The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable. I decline to direct a remedy comparable to that which I directed in my 2009 opinion, such as directing that emergency contraception be made available without a prescription  but with the current point-of-sale restrictions to women whom studies have demonstrated are capable of understanding the label and using the product appropriately. 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. Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product.

The question now is when, if ever, will the FDA make all contraception available over-the-counter?

UPDATE: More from Wonkbook here.

Powered by WordPress. Designed by Woo Themes