WASHINGTON — The Food and Drug Administration on Thursday approved the oral contraceptive Opill for over-the-counter sales, making it the first hormonal contraceptive pill available in the U.S. without a prescription.
The approval marks a major win for medical groups, including the American Medical Association and the American College of Obstetricians and Gynecologists, which have been pushing for years for an over-the-counter birth control pill. It also comes amid legal battles over women’s reproductive rights.
Opill, also known as the “mini-pill,” contains one hormone, progestin, and is taken daily. It was first approved by the FDA as a prescription in 1973.
The FDA said it is approving the over-the-counter version for all users of reproductive age, including teenagers, a move that is expected to remove barriers to access and reduce the risk of unintended pregnancies.
“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a release.
Almost half of the 6.1 million pregnancies in the U.S. each year are unintended, according to the FDA.
The maker of the Opill, Perrigo’s HRA Pharma, said it doesn’t expect it will be available until “early 2024.”
HRA Pharma hasn’t yet disclosed how much the over-the-counter pill will cost. The price will need to be very low, experts say, because over-the-counter medications typically aren’t covered by insurance.
The FDA’s move comes about two months after an outside advisory committee voted unanimously to recommend making Opill available without a prescription.
Consumer Healthcare Products Association (CHPA) president and CEO Scott Melville said: “Today’s historic action by the FDA is a major step forward in helping American women meet their reproductive health needs. More than 40 million U.S. women are at risk of experiencing an unexpected pregnancy each year, and this landmark approval removes barriers and increases access to a safe and effective contraceptive option. This Rx-OTC switch, and other first-in-class switches, provide groundbreaking public health benefits by empowering consumers to take greater control over their own health.”