In Major Step For Women's Health, FDA Approves First Over-the-Counter Birth Control Pill

In a historic move, the U.S. Food and Drug Administration has granted approval for the first over-the-counter birth control pill in the United States. The FDA announced on Thursday that Opill (norgestrel), a daily oral contraceptive, can now be purchased without a prescription.

Opill offers a new level of accessibility for consumers who can now buy the oral contraceptive in drug stores, convenience stores, grocery stores, and online. The timeline and pricing of this nonprescription product will be determined by the manufacturer. Other approved formulations and dosages of oral contraceptives will continue to be available by prescription only.

"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, M.D., director of the FDA’s Center for Drug Evaluation and Research. "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.”

The FDA said it hopes that the nonprescription availability of Opill will reduce barriers to access, allowing individuals to obtain an oral contraceptive without needing to see a healthcare provider first. This move is particularly significant considering almost half of the 6.1 million pregnancies in the U.S. each year are unintended. Unintended pregnancies can lead to negative maternal and perinatal outcomes, including a reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse impacts on neonatal, developmental, and child health outcomes.