Pharmaceutical Company Seeks FDA Approval for First Over-the-Counter Birth Control Pill
Getty
A French pharmaceutical company has submitted an application to the Food and Drug Administration for the first-ever over-the-counter birth control pill in the United States.
HRA Pharma, a Paris-based company, announced plans Monday to try to offer its daily birth control pill in the U.S. without a prescription.
The birth control pill, called Opill, was first approved for use in 1973 — if prescribed. HRA Pharma acquired the drug in 2014 from Pfizer but it is currently not marketed in the United States. The FDA is expected to make a decision on the application next year, according to the company.
"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.," Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma, said in a release. "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."
Never miss a story — sign up for PEOPLE's free daily newsletter to stay up-to-date on the best of what PEOPLE has to offer, from juicy celebrity news to compelling human interest stories.
"As a doctor, I am dedicated to empowering people to make decisions about pregnancy prevention. For many, a birth control pill may be the best option for them but requiring a prescription is an unnecessary obstacle that can put it out of reach," Dr. Melissa J. Kottke, an OB-GYN, added in the company's statement. "Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health."
HRA Pharma's application comes two weeks after the Supreme Court's decision to overturn Roe v. Wade, sending women nationwide scrambling for better access to contraceptives.
However, Welgryn admits the application is unrelated to recent events and the timing is "a really sad coincidence," telling The New York Times, "Birth control is not a solution for abortion access."
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.
