FDA grants Plan B exclusive marketing rights

A generic version of the pill won't be available until at least 2016, which could be a major barrier to access

Published July 23, 2013 8:45PM (EDT)

         (Reuters/Shannon Stapleton)
(Reuters/Shannon Stapleton)

The Food and Drug Administration on Tuesday granted Teva Pharmaceuticals, the manufacturer of Plan B One-Step, exclusive marketing rights for the next three years, meaning there will be no low-cost, generic versions of levonorgestrel-based emergency contraceptives available over-the-counter until 2016.

More from the New York Times on the decision:

Manufacturers of generic versions of the pill can apply to the F.D.A. for permission to sell their versions in drugstore aisles, instead of behind a pharmacy counter, but will have to continue requiring a prescription for those under age 17 until the three-year exclusivity period for Plan B One-Step ends.

Plan B One-Step retails for about $50; generics sell for at least $10 or $15 less. The F.D.A. decision Monday night follows the government’s decision last month to comply with a federal court order to lift age and sale restrictions on Plan B One-Step, which had been available without a prescription only for ages 17 and older.

In his April ruling, U.S. District Judge Edward Korman warned the FDA against such a decision, stating that exclusivity rights would allow Teva to exploit "its privileged marketing status and exclusivity to increase the cost of the drug," which would be a barrier to access for many women.

Korman went on to argue that "the price of Plan B One-Step under the new marketing regime is expected to be $60, significantly more than the one- or two-pill generic version, and could conceivably go higher, if only to accommodate the more expensive packing, age-verification tags, and anti-theft technology that the new marketing arrangement would require. The cost of all emergency contraception, particularly Plan B One-Step, which is the most expensive, is already an impediment to access for many women and adolescents."

Too bad, then, that the FDA didn't listen.

By Katie McDonough

Katie McDonough is Salon's politics writer, focusing on gender, sexuality and reproductive justice. Follow her on Twitter @kmcdonovgh or email her at kmcdonough@salon.com.

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Birth Control Edward Korman Plan B Reproductive Rights What Would Edward Korman Do? Women's Rights