July 24, 2013 — FDA on Monday granted Teva Pharmaceuticals market exclusivity for the next three years to sell the emergency contraceptive Plan B One-Step over the counter and without age restrictions, the New York Times reports (Belluck, New York Times, 7/23). Plan B One-Step has begun to appear in some drugstore aisles alongside other contraceptive methods. Teva's updated packaging for One-Step specifies that it can be taken by women of all ages to prevent pregnancy within three days of unprotected sex (Kotz, "Daily Dose," Boston Globe, 7/23).
FDA's announcement follows U.S. District Judge Edward Korman's April ruling that age restrictions should be lifted on all EC drugs. However, in June, he approved FDA's proposed plan of compliance to allow OTC sales of only Plan B One-Step.
According to Korman, restrictions would 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" (Women's Health Policy Report, 6/21).
In his April decision, Korman also warned against such exclusivity, explaining, "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" (McDonough, Salon, 7/23).
Teva's Market Exclusivity
FDA said it gave Teva market exclusivity for One-Step because the company had paid for and conducted the research demonstrating the drug was safe for teenagers. "There were no other data available that could support approval of the product for nonprescription use first for women age 15 and 16 and subsequently for women age 14 and below," FDA spokesperson Erica Jefferson said (Cheney, Politico Pro, 7/23).
Generic drug manufacturers who obtain FDA approval can sell one-dose versions or two-dose versions without a prescription. Because of Teva's market exclusivity, in both instances, women will have to verify with an ID that they are age 17 or older ("Daily Dose," Boston Globe, 7/23).
According to Salon, Plan B One-Step sells for about $50, while generic versions typically sell for $10 or $15 less (Salon, 7/23). After Teva's market exclusivity expires in April 2016, age restrictions will be lifted for generic versions of the one-dose drug and prices likely will drop, according to "Daily Dose" ("Daily Dose," Boston Globe, 7/23).
Andrea Costello -- the lead attorney in the lawsuit that last month forced the administration to permit EC sales without age or point-of-sale restrictions -- said that FDA's exclusivity grant could make it difficult for low-income women to purchase the drug. "The FDA's grant of exclusivity to a single drug company is going to really allow that company to push the price up higher," Costello said, adding, "The fact that the FDA made this decision now really just shows that it's unjustifiably giving a reward to one drug company at women's expense" (Politico Pro, 7/23).