The FDA Has Approved The First Over-The-Counter Birth Control Pill

For the first time in American history, the Food and Drug Administration (FDA) has approved an over-the-counter birth control pill. The medication, under the name Opill, is expected to be made available to purchase at stores and online in early 2024.

On July 13, an FDA advisory panel voted unanimously to approve a request from drug manufacturer Perrigo to sell Opill, the over-the-counter, once-a-day birth control medication. The decision came after two days of meetings to look into research on whether or not the drug would be safe to take the pill without a prescription. The FDA is expected to make a final decision based on the recommendation by the advisory panel regarding the sale of Opill later this summer.

“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,” Patrizia Cavazzoni, M.D., 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.”

Once the FDA puts its final stamp of approval on Opill, the contraceptive pill will be the first birth control medication to be made available without a prescription in the history of the United States. As it stands now, birth control medication still requires a prescription from a medical professional. While Perrigo has yet to announce how much the pill will cost, which could determine how accessible it would be, Frédérique Welgryn, Perrigo’s global vice president for women’s health, told The New York Times that the pill will be “accessible and affordable to women and people of all ages.” Welgryn also told the news outlet that Perrigo would offer a consumer assistance program to make the pill available at no cost to some women.

Opill has been available with a prescription for over 50 years, and has been proven to be 93% effective. The over-the-counter pill, which has been proven safe for ages 15 and up in a trial by the FDA, will be identical to the prescription Opill and “will be available in the aisles of most major retailers nationwide and will be available online,” according to the company. Reuters reports the pill expected to be in stores and online in the early quarter of 2024

The approval of an over-the-counter birth control pill comes at a time when reproductive rights across the country have been pulled back. The Supreme Court stripped away federal abortion rights when it voted to overturn Roe v. Wade in 2022, and there have been enough instances of pharmacies refusing to fill out birth control prescriptions that President Joe Biden himself has addressed the issue. Unintended pregnancies remain an important public health issue. Indeed, around half of all pregnancies reported in the United States every year have been deemed unintended.

Welgryn called the FDA’s approval of Opill “a giant leap for women's empowerment.”

“Today’s approval is a groundbreaking expansion for women’s health in the U.S.,” Welgryn added in a statement, “and a significant milestone towards addressing a key unmet need for contraceptive access.”