HRA Pharma submitted an application to the FDA for the first over-the-counter birth control pill in the U.S. The Paris-based company announced its plans to offer daily birth control pills in the U.S. without a prescription. The birth control pill called Opill was first approved in 1973. In 2014, HRA Pharma acquired the drug from Pfizer, but it’s currently not marketed in the U.S. According to the company, the FDA will decide on the application next year.
Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, released a statement:
“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S. More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they wanted 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.”
Last week, President Joe Biden signed an executive order to protect and expand reproductive healthcare services, including access to contraceptives and abortions, following the overturn of Roe.
