Meet Opill: The first FDA-approved over-the-counter birth control pill in the U.S.

The Food and Drug Administration (FDA) approved the first non-prescription birth control pill in the United States on Thursday, greatly expanding access to contraception around the country. 

The medication, Opill (norgestrel), is a hormonal contraceptive in the form of oral tablets to be taken at the same time every day. It was found to be 93% effective in preventing pregnancy with normal use, which is comparable to prescription oral contraceptives.

For decades, hormonal pills have been the most prevalent form of birth control in the United States, but all have required a prescription—posing challenges, such as paying for doctors’ appointments and taking time off from work. Opill’s pioneering status as the first over-the-counter birth control pill will allow Americans to purchase contraceptives at grocery stores and online retailers alike, reducing logistical hurdles and alleviating barriers of time and costs for people across the country. 

“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said 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.”

According to the FDA, nearly half of the 6.1 million pregnancies in the U.S. each year are unintended. Unintended pregnancies have been associated with adverse maternal and child health outcomes, as well as an increased risk of preterm delivery. Opill will reduce the possibility of unintended pregnancies more effectively than any other over-the-counter contraceptive, including condoms and spermicides.

Medical societies like the American Medical Association and the American College of Obstetricians and Gynecologists have for years been advocating for a nonprescription birth control pill, alongside women’s health groups and nonprofit organizations. According to Free the Pill, an advocacy group dedicated to birth control education, contraceptive pills are already available over the counter in more than 100 other countries. Come early 2024, when Opill is expected to hit store shelves, the United States will join other nations in expanding access to contraception for all.