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 is 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 (OTC) birth control pill. It also comes amid legal battles over women’s reproductive rights.
"This is a monumental decision," said Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University. "OTC birth control is available in over 100 countries, so we've been behind in availing safe, effective methods such as this oral contraceptive pill to individuals who are trying to avoid pregnancy."
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.
Almost half of the 6.1 million pregnancies in the U.S. each year are unintended, according to the FDA.
“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.
Opill was found to be 93% effective in preventing pregnancy with typical use, similar to prescription oral contraceptives. Opill must be taken at the same time every day. If it isn't taken within a three-hour window, experts advise a backup method, like a condom, for the next two days.
The medication is expected to be available at drug stores, convenience stores, grocery stores and online, according to the FDA. People who want to grab the medication off store shelves will have to wait a little longer, however. 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 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.
At the time, scientists at the FDA had expressed concerns about whether women with breast cancer or a history of breast cancer would know not to use the drug. But FDA committee members said they didn’t expect that to be a problem because they said many women with breast cancer are aware they should not use hormonal contraceptives.
Another concern was side effects, such as vaginal bleeding, and whether users, particularly teenagers, would know to seek the help of a health care provider.
Still, ultimately, the FDA committee agreed most women could make their own decisions whether the medication was appropriate for them.
"There are no good scientific reasons to keep them from being as accessible as possible," said Dr. Sarah Prager, an obstetrics and gynecology specialist in Seattle.
Over-the-counter birth control pills are already in more than 100 other countries, according to Free the Pill, an advocacy group dedicated to educating about birth control.
A 2022 survey from KFF, formerly known as the Kaiser Family Foundation, found more than three-quarters of women of reproductive age were in favor of making birth control pills available without a prescription. The leading reason for supporting the switch from prescription to over-counter was convenience, according to the survey.