August 1, 2014 — Emergency contraception became available over-the-counter without proof-of-age requirements one year ago this week, but federal and state policies continue to limit access to it, according to a new paper from the Reproductive Health Technologies Project, Politico's "Pulse" reports (Villacorta, "Pulse," Politico, 8/1).
History of OTC EC
Teva Pharmaceuticals began OTC sales of its EC product Plan B One-Step on Aug. 1, 2013. The move came after U.S. District Judge Edward Korman ruled in April 2013 that age and point-of-sale restrictions should be lifted on all EC drugs, although Korman in June of that year approved an FDA plan of compliance to allow OTC sales only for Plan B One-Step (Women's Health Policy Report, 8/23/2013).
However, FDA this spring said that generic drugmakers also may sell approved versions of the drug OTC without a requirement that consumers provider proof of age. FDA decided to lift the market exclusivity because Teva's "interpretation of the scope of its exclusivity was too broad," an agency official said at the time (Women's Health Policy Report, 3/3).
In a two-page paper, RHTP outlined several suggestions for improving access to OTC EC. The group called for contraceptive coverage requirements under the Affordable Care Act's (PL 111-148) preventive services provision to include EC when it is obtained without a prescription, wider access to EC at retail pharmacies, protections from state-level restrictions on EC access and further research into the efficacy of EC in women of higher weights.
RHTP added that the Supreme Court's recent ruling on contraceptive coverage should serve as a reminder "that the fight for unfettered access to safe and effective reproductive health products, like EC, is far from over" ("Pulse," Politico, 8/1).