The Food and Drug Administration is reviewing a first-of-its-kind application from HRA Pharma to sell its birth control without a prescription.
It has been 60 years since the FDA first approved oral contraceptives, and the decision revolutionized women’s sexual health care. The request comes on the back of the U.S. Supreme Court’s decision in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide.
A Paris-based company, HRA Pharma, announced on Monday that it had asked the F.D.A. to authorize its pill, which is available by prescription, for over-the-counter sales in the United States, according to the New York Times.
HRA Pharma expects the FDA to hold an advisory committee meeting and approve the application in the first half of 2023, which is typical for such requests, said Frédérique Welgryn, HRA Pharma’s chief strategic operations, and innovation officer.
“The timing is a bit coincidental. We have been working on that application for the last seven years,” Welgryn said, reports Reuters, adding the firm had been conducting consumer research and clinical trials, among other processes, before filing the application for the switch to OTC from prescription.
The company wants to prove to the FDA that women can understand the label on the drug and use it correctly without a doctor’s guidance. The non-estrogen pill, called Opill, was approved for use by the FDA in 1973.
Not only that, but the company is also arguing that there’s a public health case for its approval as there are millions of unintended pregnancies every year and abortion is becoming increasingly inaccessible, reports Politico.
HRA Pharma is also asking the FDA to not put an age limit on the birth control pills so that minors would be able to purchase them. “We believe people under 18 would benefit from better access to contraception and we included a number of adolescents in our studies,” Welgryn said.
Another company, Cadence Health, also plans to ask the FDA to approve its own application for over-the-counter birth control but still has more research to complete and its submission may still be years away.
