March 3, 2014 — FDA in a letter last week authorized two generic drugmakers to sell their one-pill emergency contraceptives over the counter without a requirement that consumers provide proof of age, the Boston Globe reports (Kotz, Boston Globe, 2/28).
Previously, only the brand-name version of the pill was approved for OTC sales without age restrictions (Rovner, "Shots," NPR, 3/2). In July, FDA granted three years of market exclusivity to the brand-name drugmaker, Teva Pharmaceuticals, to sell its EC product Plan B One-Step OTC without age restrictions because the company had paid for and conducted the research demonstrating the drug is safe for teenagers (Women's Health Policy Report, 7/24/13).
According to NPR's "Shots," women's rights groups were "disappointed" in last year's decision because the brand-name version is more costly than its generic counterparts ("Shots," NPR, 3/2).
Erica Jefferson, FDA's acting assistant commissioner for media affairs, said last week that the agency had lifted the market exclusivity because Teva's "interpretation of the scope of its exclusivity was too broad."
However, FDA said the generic options will have to be packaged with new labels that state they are intended for use among women ages 17 and older, although consumers will not be required to provide proof of age. According to the Boston Globe, the requirement means that it might take a few months for the generic options to become available OTC.
Jefferson added, "Once a company submits its revised labeling to market a generic version of Plan B One-Step, the agency will work to approve it as soon as possible" (Boston Globe, 2/28).
Jessica Arons, president and CEO of the Reproductive Health Technologies Project, said the decision "is a significant leap forward in obtaining full, [OTC] status for [EC] and we commend the FDA for this decision" ("Shots," NPR, 3/2).
Planned Parenthood League of Massachusetts President Martha Walz also praised the decision, saying that it "means lower-cost [EC] will be available to women of all ages" and could help "reduce the number of unintended pregnancies." However, Walz added that she is "puzzled" over the age specifications on the label and expressed concern that young consumers would purchase the more expensive, brand-name product, even though the generic and brand-name versions are identical (Boston Globe, 2/28).