In a landmark first today, the Food and Drug Administration (FDA) approved the first over-the-counter hormonal contraceptive. This oral birth control pill, Opill (norgestrel), is a once-daily tablet that will be available in commercial drug stores for purchase without a prescription or age restriction.
Perrigo, the pharmaceutical company that owns and markets Opill, will begin distribution in early 2024 and has yet to announce a price. Perrigo first FDA over-the-counter sought approval just over a year ago. Back in May, two FDA committees voted unanimously that the benefits of making Opill OTC outweighed the potential risks, speaking to an internal consensus on the decision.
“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, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”
While some hormonal birth control pills contain a combination of synthetic estrogen and progestin (known as combination pills), Opill is progestin-only. Some users must avoid synthetic estrogen because they’re at increased risk for blood clots, making Opill a readily accessible choice for many. The drug works by preventing the release of an egg from the ovary, so there’s nothing for sperm to fertilize. It also thickens cervical mucus, which slows down sperm, and it thins the uterine lining so it can’t cultivate a fertilized egg.
This decision comes more than a year after the Supreme Court overturned Roe v. Wade, effectively leaving the fate of legal abortion up to individual states. In the time since then, states like Missouri, Oklahoma, Tennessee, and Texas have implemented near-total bans on legal abortion.
Birth control pills serve other primary purposes besides contraception. It can regulate periods and control acne, for example. Medical professionals from groups like the American Medical Association and American College of Obstetricians and Gynecologists have advocated OTC birth control. Even though a vast body of research demonstrates oral contraceptives are safe and effective for most users, the prescription remains a barrier.
According to a 2018 survey of over 72.5 million menstruating people between ages 15 and 49, 65 percent used contraceptives; twenty-one percent of these contraceptive users took the pill.
