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FDA Approves Plan B One-Step for Over-the-Counter Sales

FDA Approves Plan B One-Step for Over-the-Counter Sales

June 21, 2013 — FDA on Thursday approved Teva Pharmaceutical's application to sell the emergency contraceptive Plan B One-Step over the counter without age restrictions, in compliance with a federal ruling requiring the agency to do so, the Wall Street Journal reports.

A Teva spokesperson said Plan B One-Step likely would be available OTC "in the next month or so" (Corbett Dooren, Wall Street Journal, 6/20). The drug's packaging will have to be redesigned to reflect the change. In the meantime, existing stock at pharmacies must be sold according to the former restrictions, the Los Angeles Times reports (Morin, Los Angeles Times, 6/20).

The approval applies to Plan B One-Step but not generic versions of EC or Teva's two-dose version of the product. An FDA spokesperson said the agency has not decided whether to grant Teva a period of market exclusivity (Wall Street Journal, 6/20).

FDA's Plan of Compliance

U.S. District Judge Edward Korman in April ruled that restrictions should be lifted on all EC drugs, but in June he approved FDA's proposed plan of compliance to allow OTC sales of only Plan B One-Step.

Korman explained in his June decision that restrictions could continue on two-dose versions of the drug "because off-brand versions of the one-pill product are available, [and] it is at best speculative whether the two-pill product will provide a significantly cheaper alternative." However, he urged FDA not to grant Teva market exclusivity, arguing that doing so could create "a near-monopoly that will only result in making a one-pill [EC] more expensive and thus less accessible to many poor women."

At the time, the Center for Reproductive Rights -- a plaintiff in the case -- urged Korman to reject the government's plan, arguing that it did not go far enough (Women's Health Policy Report, 6/13).

Comments From FDA, CRR

Janet Woodcock -- director of FDA's Center for Drug Evaluation and Research -- said in the announcement that OTC "access to [EC] products has the potential to further decrease the rate of unintended pregnancies in the United States" (Los Angeles Times, 6/20). The announcement also noted that FDA in its approval has "fulfilled its commitment to the court by promptly completing its review and approval" of the drug (Norman, Politico, 6/20).

CRR spokesperson Chris Iseli praised the announcement, adding, "It's taken too long to bring [EC] out from behind the pharmacy counter" (Los Angeles Times, 6/20).