FDA asked to lift ban on birth control pills

The United States Food and Drug Administration has received its first application to supply birth control pills over the counter rather than by prescription, weeks after the Supreme Court overturned the Roe v. Wade ruling.

Paris-based pharmaceutical company HRA Pharma submitted an application to the FDA on Monday. It said the timing of its application is unrelated to the June 24 Supreme Court decision.

The contraceptive is currently a prescription drug sold under the brand name Opill. If approved, Opill would become the first daily hormonal birth control pill sold over the counter in the US, broadening access to millions of people.

"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the US," Frederique Welgryn, the company's chief strategic and innovations officer, said in a statement.

Oral contraceptives have been widely used in the US since the 1960s. The FDA is expected to make a decision next year, according to HRA Pharma. The approval will apply only to the company's Opill drug, which has been used with a prescription since FDA approval in 1973.

"More than 60 years ago, prescription birth control pills in the US 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," Welgryn said.

Before submitting its application, HRA Pharma had been studying thousands of subjects for more than six years to prove to the FDA that people could understand a drug's label and use it properly without a doctor's guidance, Politico reported.

The timing of HRA Pharma's FDA submission shortly after the Supreme Court decision is "a really sad coincidence", Welgryn told The New York Times.

Cadence Health, another pill manufacturer that has been in close dialogue with the FDA about switching its pill to over-the-counter status, said it hopes to move closer to submitting an application in the coming year.

Globally, more than 100 countries provide oral contraceptives without a prescription, making the US one of the few countries to require one.

Last month, the American Medical Association called on the FDA to make birth control pills available over the counter without age restriction.

In March, more than 50 House Democrats wrote to FDA Commissioner Robert Califf to urge the agency to approve over-the-counter birth control pills.