Stephanie Sober

Birth control pills revolutionized women’s reproductive health when they first became available in the U.S. in the 1960s. But they’ve required a prescription, which has made access difficult for many. After advocates pushed companies for years to ask the U.S. Food and Drug Administration (FDA) to switch from prescription to over-the-counter pills, the agency approved the first nonprescription oral contraceptive, Opill, in July 2023. 

Dr. Stephanie Sober, medical liaison at Perrigo, which makes Opill, co-led the study that her company submitted to request the switch. The process began nearly a decade ago, first with studies showing that people could successfully read the label on the medication and decide whether it was appropriate for them or not; women with a history of breast cancer, for example, should not take the pill. Then came a study involving 880 women who chose to use Opill and were monitored to see if they could take the pills as directed daily, and whether they took the right steps if they missed a dose. Those studies all showed that making the medication available without a prescription did not affect the way women took it, says Sober. And because the pill includes progestin and not estrogen, there are fewer side effects. And to be safe, the FDA required the company to include teens as young as 11 years old in the study, since adolescents are at higher risk of unintended pregnancies. “The data demonstrated that people of all ages were able to successfully read the label and use the product according to the directions,” says Sober.

The first pills arrived in 65,000 pharmacies in April 2024, and are also available to order online. “I hope this is the first step to lead to other contraceptives having successful switches to over-the-counter as well,” says Sober. “We know the impact that having access to effective contraception can have on people’s lives.”