FDA Receives First Application For Over-The-Counter Birth Control Pill
The Opill, from French company HRA Pharma, is a progestin-only pill that has already been available with a prescription since it was approved by the FDA in 1973. Approval for OTC sales wouldn't be expected until next year.
The New York Times:
F.D.A. To Weigh Over-The-Counter Sale Of Contraceptive Pills
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)
AP:
Over-The-Counter Birth Control? Drugmaker Seeks FDA Approval
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)
Reuters:
Perrigo Unit Submits Approval Application To FDA For OTC Birth Control Pill
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)
