Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Receives First Application For Over-The-Counter Birth Control Pill
More than 60 years after the approval of oral contraceptives revolutionized women’s sexual health, the Food and Drug Administration has received its first application to supply a birth control pill over the counter — just as the Supreme Court’s decision to overturn Roe v. Wade has put access to contraception more squarely at the heart of the clash over reproductive rights. A Paris-based company, HRA Pharma, announced on Monday that it asked the F.D.A. to authorize its pill, which is available by prescription, for over-the-counter-sales in the United States. Cadence Health, another pill manufacturer that has been in close dialogue with the F.D.A. about switching its pill to over-the-counter status, said it hopes to move closer to submitting an application in the coming year. (Stolberg and Kelly, 7/11)
An FDA approval could come next year and would only apply to HRA’s pill, which would be sold under its original brand name, Opill. The company acquired the decades-old drug from Pfizer in 2014, but it’s not currently marketed in the U.S. (Perrone, 7/11)
The non-estrogen pill has been used with prescription since it was FDA-approved in 1973. Perrigo said scientific evidence has shown progestin-only pills like Opill are effective at preventing pregnancy and safe for most women to use. (7/11)
