The U.S. Food and Drug Administration (FDA) approved an over-the-counter birth control pill for the very first time on Thursday.
Opill will be available without a prescription, the FDA said in a July 13 news release announcing its decision. It will likely be in stores and pharmacies in early 2024.
“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 Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, in a statement. “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.”
The company’s manufacturer Perrigo Company, based in Dublin, Ireland, has yet to say what the medication will cost.
Nearly all health insurance providers plan to pay for prescription contraception but not over-the-counter methods, raising the issue of affordability.
“If available equitably — meaning that they are priced affordably and fully covered by insurance — over-the-counter birth control pills will be a game-changer for communities impacted by systemic health inequities,” Dr. Daniel Grossman, director of the research program Advancing New Standards in Reproductive Health, told The New York Times (NYT).
An FDA panel of experts recommended in May that a safe and effective form of birth control be made available over the counter. Its availability outweighs any risks, it concluded, according to the NYT.
“The evidence demonstrates that the benefits clearly exceed the risks,” said advisory committee member Kathryn Curtis, a health scientist with the Centers for Disease Control and Prevention’s division of reproductive health, according to the NYT. “I think Opill has the potential to have a huge positive public health impact.”
Opill contains one hormone, progestin, giving rise to its “mini-pill” nickname. Other birth-control methods contain both progestin and estrogen. A combination pill from Cadence Health is also being evaluated for over-the-counter sales.
The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, and bloating, the FDA said.
