Perrigo Company
"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity," HRA's chief strategic and innovations officer Frédérique Welgryn said. "More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers."
The Paris-based pharmaceutical firm does not appear to have planned its application filing to have coincided with the aftermath of the Supreme Court's gutting of Roe v. Wade. Welgryn told The New York Times the timing was a "really sad coincidence," and that "birth control is not a solution for abortion access."
The company's birth control medicine, Opill, is current available throughout the United States through a doctor's prescription. FDA approval to go OTC would make Opill the first birth control pill to do so; however, HRA Pharma isn't the first company to have tried, with previous attempts becoming stuck in regulatory limbo. The approval of the emergency contraceptive Plan B for use by teens was initially blocked in 2011 by Health Secretary Kathleen Sebelius, with the reversal taking years of litigation.
While the FDA has remained quiet on the application, the growing political pressure on the agency from Democrats on Capitol Hill in the wake of the controversial SCOTUS decision is a factor that hadn't been in play before.
Advocates of reproductive rights have called on the White House to press the FDA to move more quickly in reviewing OTC birth control. Some advocates, like the nonprofit Contraceptive Access Initiative, have pointed to the agency's rapid response to applications during the COVID-19 pandemic to illustrate how the agency is more than capable of working with urgency.
