FDA Approves First Over-the-Counter Daily Birth Control Pill
The FDA on Thursday approved the country’s first-ever daily hormonal contraceptive pill for sale without a prescription, a move that could dramatically expand access to birth control for the uninsured and reduce unwanted pregnancies at a time abortion access is evaporating in much of the country. Opill is a daily pill made by the company Perrigo. 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.
Expert Recommendation and Safety
Two independent panels for the the FDA comprised of 17 experts voted unanimously in May to recommend the agency approve Opill without a prescription. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, stated that “when used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
According to the FDA, there are about 3 million unintended pregnancies in the U.S. annually. These pregnancies come with higher risks of negative health outcomes, including preterm birth. Reproductive rights advocates and medical groups praised the announcement, saying it will meaningfully expand contraception access for the uninsured, teenagers and other groups who face barriers to obtaining a prescription.
Availability and Retail
Perrigo’s president and CEO Patrick Lockwood-Taylor called the decision “a truly momentous day for women’s health nationwide” and said the drug “has the potential to radically transform women’s access to contraception.” Opill will be available in stores and online in early 2024. CVS, one of the nation’s largest pharmacy chains, has already pledged to carry the drug in its 10,000 locations.
Key Facts about Opill Approval
| Drug Name | Opill |
| Manufacturer | Perrigo |
| Expert Panel Vote | Unanimous (17-0) |
| Expected Launch | Early 2024 |
Affordability and Insurance Coverage
Perrigo has pledged to make the pill “accessible and affordable to women and people of all ages.” However, in a call with reporters, Perrigo declined to share a retail price for Opill. Frédérique Welgryn, Perrigo’s Global Vice President for women’s health, added that the company was working on a patient assistance program for those who may not be able to afford it and is working to get Opill included in Medicaid coverage.
It’s not clear whether health insurance plans will cover Opill, as most insurance coverage doesn’t cover over-the-counter products. Greer Donley, an associate professor at the University of Pittsburgh law school, noted that while the Affordable Care Act requires coverage of certain over-the-counter products, it still would require a prescription, and that may put the same burden on patients that previously existed.