


The FDA on Thursday approved the country’s first-ever daily hormonal contraceptive pill for sale without a prescription.
Though the drug itself and the campaign for its approval go back decades, pressure on the Biden administration to approve a hormonal over-the-counter birth control option increased after the fall of Roe v. Wade last year. Perrigo, the pill’s manufacturer, has pledged to make the pill “accessible and affordable to women and people of all ages,” but did not give a timeline for its release. CVS, one of the nation’s largest pharmacy chains, has already pledged to carry it in its 10,000 locations.
Opill is a progestin-only birth control pill from Perrigo. It works by thickening cervical mucus and disrupting ovary activity. Several progestin-only birth control pills are currently available with a prescription. According to the CDC, they are about 93 percent effective at preventing pregnancy.
Two independent panels for the the FDA comprised of 17 experts voted unanimously in May to recommend the agency approve Opill without a prescription. HRA Pharma, which has since been acquired by Perrigo, submitted data from its study of more than 880 participants showing that the vast majority correctly took the pill at the same time every day — or used an alternative form of birth control if they didn’t.
At that meeting in May, however, FDA scientists expressed concern that the study’s findings on the pills’ effectiveness were based on 50-year-old data that didn’t reflect the current demographics of those able to become pregnant in the U.S. today. The staffers also flagged that the company’s data indicated that users may have taken more pills than they were given. Company representatives said that this was more likely a result of the study design, rather than participants actually taking more pills.
What’s next: Perrigo has yet to disclose how much Opill will cost at point of sale. Other retailers haven’t yet revealed whether they will stock the drug.