A Paris-based pharmaceutical company on Monday asked the U.S. Food and Drug Administration to authorize its birth control pill for over-the-counter purchase, multiple outlets have reported. It's the first such request the FDA has ever received.
The company, HRA Pharma, said the timing of its application is unrelated to the recent Supreme Court decision to overturn landmark abortion rights case Roe v. Wade (1973). The pill in question — known as Opill — has not been sold in the U.S. for over a decade, per The Washington Post. The company's request, meanwhile, "sets up a high-stakes decision for health regulators amid legal and political battles over women's reproductive health," The Associated Press contends.
Securing over-the-counter status "will provide another option for managing reproductive health," HRA Pharma's Frédérique Welgryn told the Post. "But it is not the solution for abortion access." The company expects the FDA's review of its application will take roughly 10 months, she added.
The push for over-the-counter birth control access is not new, notes the Post. For example, in March, a group of House Democrats wrote to FDA Commissioner Robert Califf imploring regulators to move on the option.