The FDA’s Morning-After Pill Decision, Explained
On Tuesday afternoon the Food and Drug Administration issued a press release about the approval of Plan B One-Step, a brand-name emergency contraceptive — aka the “morning after pill” — manufactured by the pharmaceutical manufacturer Teva. Essentially, the FDA approved the contraceptive drug to be sold, without a prescription, to teenagers 15 years and older:
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.
(The over-the-counter version will go on sale sometime this summer.)
The FDA’s approval of the lower age range — previously, you needed to be at leat 17 years old — came nearly a month after a federal judge ordered the agency to remove age and prescription requirements from the sale of all emergency contraceptives. (Health Secretary Kathleen Sebelius had overruled Teva’s approved application to sell Plan B One-Step over-the-counter in 2011, an action that no Health Secretary had ever taken before.) The Department of Justice, whose lawyers argued on behalf of Sebelius, has not yet appealed the order, which goes into effect on May 5.
Though the approval goes a long way to opening access to emergency contraception, the FDA emphasized that it was not related to the federal judge’s order. Which makes sense: the agency’s new regulation simply lowers an existing age threshold by two years for one brand-name drug. The judge’s orders require the FDA to eliminate every age threshold for all emergency contraceptives, like generic Plan B and brand-name alternatives like Ella and Next Choice One Dose.
Still, today’s reaction — like this breathless AP tweet — offer a preview of what will happen when May 5 rolls around.