June 13, 2013 — A federal judge on Wednesday approved the government's plan to make the emergency contraceptive Plan B One-Step available without age or point-of-sale restrictions, the New York Times reports.
U.S. District Judge Edward Korman's approval of the Department of Justice's plan is the latest development in a long-running lawsuit that seeks to make all EC products available over the counter (Belluck, New York Times, 6/12). In his original ruling in April, Korman said restrictions should be lifted on all EC drugs, but the government responded that it only plans to allow OTC sales of Plan B One-Step (Women's Health Policy Report, 6/12).
Objections From Plaintiff
Earlier Wednesday, the Center for Reproductive Rights -- the plaintiff in the case -- urged Korman to reject the government's plan, arguing that the "[d]efendant's claim that they have complied with the court's order rings hollow."
CRR said DOJ's plan does not go far enough because it fails to address restrictions on older, two-pill EC products. Additionally, it remains unclear if manufacturers of generic versions of EC would be granted OTC status.
DOJ's plan "deprives women of more affordable [EC], creating an improper financial barrier to access for poor women," CRR said in its letter to Korman.
CRR also argued that the government did not provide enough details about how and when it will make Plan B One-Step available OTC (Smith , Politico, 6/12).
In his April ruling, Korman said FDA could maintain restrictions on the two-dose versions of the drugs if the agency "actually believed there was a significant difference" from the one-pill version (New York Times, 6/12).
However, he said on Wednesday that DOJ's plan "is sufficient to comply with [his] order" (Smith , Politico, 6/12). He explained that restrictions could continue on the two-dose versions "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" (New York Times, 6/12).
Korman urged the government not to grant market exclusivity to Teva Pharmaceuticals -- the manufacturer of Plan B One-Step -- 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."
CRR President and CEO Nancy Northup in a statement on Wednesday evening said, "We are tremendously gratified that this lawsuit has resulted in an historic victory to bring [EC] out from behind the pharmacy counter for millions of women across the United States."
Northup stressed that CRR believes "women deserve the full range of available [EC], including lower cost generic options," adding that the organization "will continue our advocacy on all fronts to ensure widespread availability of affordable birth control for all women" (Smith , Politico, 6/12).