For Birth Control Access in the US, a 'Groundbreaking Moment'

HRA Pharma submits application to FDA for nation's first over-the-counter birth control pill
By Jenn Gidman,  Newser Staff
Posted Jul 11, 2022 8:57 AM CDT
FDA Gets Application for US' First OTC Birth Control Pill
A one-month supply of hormonal birth control pills is displayed in Sacramento, Calif., on Aug. 26, 2016.   (AP Photo/Rich Pedroncelli, File)

Ever since the Supreme Court overturned Roe v. Wade last month, effectively banning abortion in states that choose to, reproductive rights advocates have worried that contraception might be the next target of conservative activists and lawmakers. One company is now trying to dismantle at least some of the barriers to contraception access, filing an application with the Food and Drug Administration to sell an over-the-counter birth control pill, the nation's first, per Axios. The application submitted Monday by HRA Pharma, owned by Perrigo, "marks a groundbreaking moment in contraceptive access and reproductive equity in the US," says Frederique Welgryn, HRA Pharma's chief strategic operations and innovation officer, in a release.

She adds: "Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers." The AP notes that hormone-based birth control pills have been prescription-only to allow doctors to monitor patients who might be at risk for rare but dangerous blood clots. In its application, however, HRA Pharma is said to have included "years of research" suggesting women can screen themselves for such risks. The filing comes after the American Medical Association last month urged the FDA to allow for OTC birth control, with no age restrictions.

Birth control pills are already available over the counter throughout much of Asia, Africa, and South America. An OK from the FDA could emerge by next year, and it would be applicable only to the French drugmaker's pill—sold under the brand name Opill—which has been FDA-approved since the early 1970s. HRA Pharma may not remain alone in this venture for long: The New York Times notes that pill manufacturer Cadence Health has indicated it hopes to submit its own application to the FDA for OTC birth control pills, though the paper notes that could take up to two more years. As for how HRA Pharma's application ties to the Roe v. Wade decision, Welgryn tells the Times it's a "sad coincidence." "Birth control is not a solution for abortion access," she says. (More contraceptive stories.)

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