FDA to consider application for first over-the-counter birth control pill
Pharmaceutical company HRA Pharma submitted an application to the Food and Drug Administration on Monday asking to sell a birth control bill over-the-counter, rather than via prescription.
Why it matters: If approved, it would be the first ever birth control pill to be available over-the-counter in the U.S.
- The application was submitted just weeks after the Supreme Court overturned Roe v. Wade, putting contraception access back into the spotlight.
What they're saying: "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 the press 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," Welgryn added.
Welgryn noted that the timing of the company's application was unrelated to the Supreme Court ruling last month, calling it "a really sad coincidence," per the New York Times.
- “Birth control is not a solution for abortion access,” Welgryn told the Times.
State of play: FDA approval could come some time next year and would only apply to HRA Pharma's pill, Opill, per AP.
- Another pill manufacturer, Cadence Health, aims to get closer to submitting an application to the FDA to move its birth control pill to over-the-counter in the coming year as well, the Times reported.
The big picture: Last month, the American Medical Association called on the FDA to make birth control pills available over-the-counter to Americans, without an age restriction.
- In late June, the Biden administration put insurers on notice, reminding them of their obligation to cover at least one form of contraception within each FDA-approved category of birth control at no cost to members under the Affordable Care Act.