FDA approves the first-ever over-the-counter birth control pill
Opill, the first daily birth control pill taken without a prescription, has been approved by the Food and Drug Administration and will be available to consumers in drugstores early 2024.
Today, the Food and Drug Administration approved Opill – the first-ever daily oral contraceptive approved in the U.S. to prevent pregnancy without a prescription. Perrigo, which sought FDA approval for an over-the-counter version last summer after the Supreme Court’s ruling the overturned Roe v. Wade, expects to start shipping the mini pill early next year.
In May, Ireland-based Perrigo, a leading provider of consumer self-care products, gained a key recommendation from U.S. regulatory advisors, which paved the way for Opill to get clearance to be sold without a prescription. The FDA is not required to follow the advisers’ recommendations, but often does.
The American Medical Association and the leading professional society for obstetricians and gynecologists backed Opill’s application for over-the-counter status.
Approval of this progestin-only oral mini-pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online. Perrigo did not announce a price for Opill, however, it is likely to be much cheaper than prescriptions, since they aren’t covered by insurance.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider. There will be no age restrictions on sales of Opill.
Related: More than 75% of females favor over-the-counter birth control pills
“Today marks a truly momentous day for women’s health nationwide,” said Perrigo President and Chief Executive Officer Patrick Lockwood-Taylor. “Opill has the potential to radically transform women’s access to contraception and is a true testament of Perrigo’s unwavering commitment to deliver impactful solutions that truly make lives better.”