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FDA grants exclusivity to One-Step Plan B product for next three years

This is the old packaging for Plan B One-Step which was changed before the product could move to drugstore shelves. (AP Photo/Barr Pharmaceuticals Inc., File)
This is the old packaging for Plan B One-Step which was changed before the product could move to drugstore shelves. (AP Photo/Barr Pharmaceuticals Inc., File) Credit:

The US Food and Drug Administration decided late Monday night to grant exclusive rights to Teva Pharmaceuticals to put its brand name 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 in some drugstores 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 it after their age is verified on an ID.

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The 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 its generic one-pill versions and likely the price will drop.

The brand name product retails for about $50—considerably more than generic products that usually cost about $20 to $35.

“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.

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.

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