The US Food and Drug Administration decided late Monday night to grant exclusive rights to Teva Pharmaceuticals to put its brand name one pill form of emergency contraception on drugstore shelves without any age restrictions for the next three years. Plan B One-Step, Teva’s product, has started to appear this week on shelves next to spermicides and pregnancy tests.
It has new packaging saying it can safely be taken by women and girls of all ages to prevent pregnancy within 72 hours of unprotected sex. That decision could mean that the brand name product might be the only one women can purchase over the counter without showing proof of their age until the exclusive rights expire in April 2016.
The product retails for about $50—considerably more than generic two pill products that usually cost about $20 to $35. Drug companies won’t be allowed to make a generic one pill version while the exclusivity agreement is in effect.
“Companies seeking approval of generic versions of Plan B One-Step or those who wish to continue marketing approved versions before Teva’s exclusivity expires, must obtain approval of labeling that does not contain prescription labeling or impinge on Teva’s exclusivity for nonprescription use in women age 16 and below,” according to a statement released by the FDA.
The FDA decided last month to comply with a federal judge’s court ruling forcing the agency to make emergency contraception available over-the-counter to women and girls of all ages. Before then, products were kept stocked behind the pharmacy counter and dispensed withthout a prescription only to those who were age 17 or older with the proper form of identification.
Emergency contraception is available to younger teens with a doctor’s prescription.
In his April ruling, US District Judge Edward Korman of New York stated that females of all ages be given unfettered access to the Plan B One-Step product, and any generic versions, but left it up to the FDA to decide whether to continue to restrict access to two-pill products, which require girls to space the pills out 12 hours apart.
That same judge, however, warned the FDA not to enter into exclusivity agreements with Teva when he accepted the agency’s decision to comply with his ruling. He cited concerns he’d heard from women’s health groups that such agreements would make the over-the-counter product unaffordable to younger teens and poorer women.
Teva Pharmaceuticals submitted clinical trial data to the FDA in June showing that the product could safely be taken by young teens. FDA spokesperson Erica Jefferson said the decision was made to grant exclusive rights after the agency determined that the only research data they had supporting the safe over-the-counter use of emergency contraception in teens under age 17 was supplied by Teva for its One-Step product.
