Generic morning-after pills will finally be available over-the-counter. Nora Caplan-Bricker explains why the cheaper generic version will come with an age warning, while the brand-name version, Plan B One-Step, does not:
The logic behind the distinction wasn’t scientific: It was commercial. FDA protocol grants three years of exclusivity every time a drugmaker conducts new clinical studies that result in a major change to the product—it’s an incentive for companies to bankroll costly research to improve their wares. In this case, since [Teva Pharmaceuticals, maker of Plan B] was behind the studies that made the case for allowing girls under 17 to buy the morning-after pill without a prescription, the FDA was looking for a way to protect Teva’s share of the market.
Now, according to a letter to the makers of generics from Kathleen Uhl, acting director of the Office of Generic Drugs, the FDA has decided that “the exclusivity is too broad,” so it’s letting the generics out from behind the counter. But it’s requiring generic drug makers to include the special label, in order—as Uhl’s letter puts it—to “carve out” some exclusivity for Teva.
Irin Carmon zooms out:
Until getting rid of most of its age restrictions on the drug, the U.S. was one of the few countries to have age restrictions at all.
Confusingly, the FDA’s most recent letter says the generics will be repackaged to say they are “for use by women ages 17 and up.” It appears that provision won’t actually be in force, since now no one is required to show proof of age, and that the new label is, according to the letter, intended to “appropriately carve out Teva’s exclusivity” per an earlier agreement. But the wording could still sow confusion in pharmacy aisles.
The drug has repeatedly been shown to be safe for women and girls of all ages, but the specter of adolescents having sex has haunted American politicians. In 2005, the top FDA official for women’s health, Susan F. Wood, quit in protest of the Bush-era politicization of the agency, particularly around emergency contraception.
Back in August, Tara Culp-Ressler reported that existing regulations had already caused mass confusion about the drug:
Aside from medical misconceptions about the contraceptive, moving Plan B out from behind the counter has not been without its own complications. Outside investigations have found that not all pharmacies may be stocking their shelves with Plan B yet. Some are still choosing to keep emergency contraception under lock and key because they’re worried that people might try to shoplift the expensive product — Plan B One-Step, which is manufactured by Teva Pharmaceuticals, generally costs between $40 and $50. That means that people who want to purchase the morning after pill may still have to ask a pharmacist about it, something that can make some customers feel too uncomfortable or give pharmacists an opportunity to turn them down.
Another point of confusion is the fact that the FDA currently has a “sweetheart arrangement” with Teva Pharmaceuticals when it comes to over-the-counter emergency contraception. Until 2016, Teva’s Plan B One-Step is the only type of emergency contraception that young women or men under the age of 17 are allowed to purchase. Other generic versions — which tend to be cheaper — still require older customers to show an ID to prove that they’re old enough to buy it. The cost barrier may prevent some of the people who need emergency contraception from being able to purchase it, whether or not it appears on their local pharmacy shelves.
The Dish 