FDA Approves the First Over-the-Counter Birth Control Pill

Last week, the U.S. Food and Drug Administration approved the first daily oral contraceptive that can be obtained without a prescription.

Going forward, the progestin-only pill known as “Opill” will be available at drug stores, convenience stores, grocery stores and online, the agency said in a press release. The timeline for its availability will be determined by the manufacturer.

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

Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores, and grocery stores, as well as online.
— U.S. FDA (@US_FDA) July 13, 2023

“The pill” was first approved by the FDA in 1960, the American Medical Association reports.

In last week’s announcement, the FDA claimed that 6.1 million pregnancies in the United States each year are unintended.

“Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes. Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts,” it claimed.