The US Food and Drug Administration has granted exclusive rights to Teva Pharmaceuticals to put its Plan B One-Step emergency contraceptive on drugstore shelves without any age restrictions for the next three years.
The decision late Monday night means the brand-name product will be the only version available to younger teenagers, and the price — about $50 for a one-pill dose — is unlikely to drop until 2016. Critics of the decision said that will make the drug unaffordable for many teens.
The FDA action comes as Plan B One-Step has started to appear in some drugstores in Boston 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 three days of unprotected sex.
The FDA will allow generic manufacturers of the one-pill form of emergency contraception — which contains high doses of the female hormone progestin — to place their products directly on drugstore shelves. But those products will still have age restrictions: Only women ages 17 and over can purchase them after their age is verified on an ID.
The price — about $50 for a one-pill dose — is unlikely to drop until 2016. Critics say it will make the drug unaffordable for many.
Two-pill generic products will remain behind the pharmacy counter and dispensed without a prescription, but also only to those who are at least 17.
After exclusive rights expire for the One-Step product in April 2016, age restrictions will be lifted for generic one-pill versions, and the competition is likely to drive down the price of the brand-name drug.
The generic products now sell for $35 to $40.
“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, One-Step and other products were kept stocked behind the pharmacy counter and dispensed without a prescription only to those who were age 17 or older with the proper form of identification.
Other forms of emergency contraception are available to younger teens with a doctor’s prescription.
“The FDA should have left open the option for all generic and potentially more affordable brands of emergency contraception to be made widely available, without delay,” said Janet Crepps, senior counsel at the Center for Reproductive Rights. The nonprofit organization filed a lawsuit with other women’s rights groups against the FDA in an effort to force the agency to make emergency contraception available on store shelves without any age restrictions.
In his April ruling on that lawsuit, US District Judge Edward Korman of New York stated that females of all ages must be given unfettered access to the Plan B One-Step product, but left it up to the FDA to decide whether to continue to restrict access to two-pill products, which recommend spacing the pills out 12 hours apart.
Teva Pharmaceuticals submitted clinical trial data to the FDA in June showing that the product could safely be taken by young teens. FDA spokeswoman Erica Jefferson said the decision was made to grant exclusive rights after the agency determined that the only research data it 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.
But Susan Wood, former FDA assistant commissioner of women’s health, said FDA drug reviewers felt confident a decade ago that the use of two pills for emergency contraception — each pill contains a half dose of the single-pill product — was safe and appropriate for teens to buy over-the-counter regardless of their age.
“The rationale behind exclusivity is that if a company does essential new research to get their product approved over-the-counter, they should get protection from generics for a little bit longer,” said Wood who resigned from the FDA in 2005 after the agency initially decided not to allow Plan B to be sold over-the-counter for adult women.
“But the data Teva was asked to collect wasn’t actually essential, and now we’re left in a confusing situation that makes it more expensive for women to get full access to emergency contraception.”