- HRA Pharma is seeking FDA approval for a nonprescription birth control pill in the US.
- The progestin-only pill, also known as the minipill, has been prescribed since it was first approved in 1973.
- Approval would improve access to reproductive health in the wake of the Supreme Court's Roe v. Wade decision.
HRA Pharma, a Paris-based pharmaceutical company, is seeking approval from the Food and Drug Administration to sell an over-the-counter birth control pill in the US.
It would be the first of its kind, since the US currently requires a prescription to get birth control pills.
"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the US," Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma, said in an announcement on Monday.
HRA Pharma is hoping to get approved a progestin-only daily birth control, named Opill, also known as a mini pill or non-estrogen pill. Opill was first approved by the FDA in 1973.
Company officials said they expect a decision from the US agency in about 10 months, according to The New York Times.
HRA Pharma did not immediately respond to a request for comments from Insider.
The move to make an oral contraceptive available without a prescription comes just weeks after the Supreme Court overturned the Roe V. Wade decision that granted women the constitutional right to an abortion.
Birth control remains legal in the US, but the recent SCOTUS decision has sparked concerns from experts that access to contraceptives could be next.
In his concurring opinion to the Dobbs V. Jackson Women's Health Organization that overruled Roe, Justice Clarence Thomas suggested that the court should also use the same approach to overrule, among other cases, Griswold v. Connecticut, which protected access to contraceptives. Welgryn, the HRA Pharma official, told The Times that the timing of the company's application was "a really sad coincidence."
In March, House Democrats signed a letter to FDA Commissioner Robert Califf, hoping to apply pressure on the agency to review applications for any over-the-counter birth control pills "without delay."
Cadence Health, another company that makes oral contraceptives, is also hoping to submit an application for an over-the-counter pill to the FDA later this year, according to The Times.
More than 100 countries sell oral contraceptives without prescriptions, according to the American Academy of Family Physicians Foundation. This includes China, India, South Korea, Egypt, and Sudan, among other countries.
If HRA Pharma's pill is approved, it would be the first to be available in the US without a prescription since oral contraceptives were approved in the country in 1960.