(NEW YORK) — The Food and Drug Administration approved the first birth control pill in the United States that can be sold without a prescription Thursday.
The progestin-only pill, called Opill, is made by French drugmaker HRA Pharma and its parent company Perrigo and the approval is a first-of-its-kind move by federal regulators.
It comes after an independent advisory panel agreed this spring that the drug was safe for most patients. Doctors say progestin-only pills, also known as the “mini pill,” pose fewer medical risks than combination pills that rely on estrogen.
“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 Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, 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.”
One concern raised by FDA advisers had been whether consumers, particularly young teens, will adequately screen themselves for potential medical risks.
But FDA advisers agreed those risks were minimal compared to the significant benefits in removing hurdles to prevent unwanted pregnancies, particularly for younger women or those facing financial or child care constraints.
More than a dozen states have already passed laws expanding access to hormonal birth control by allowing pharmacists to dispense the drugs themselves or rely on a standing order from a doctor.
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