FDA approves first birth control pill for use without prescription

(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.

The latest move by the FDA goes further and means consumers can bypass a pharmacist and purchase the oral contraceptive from drug stores, convenience stories and grocery stores. It can even be purchased online.

Expanding access is a popular idea. According to KFF, an estimated 77% of women under 50 say they want birth control pills available without a doctor’s prescription if research shows it’s safe and effective.

The FDA said the ability to buy Opill over the counter will reduce the number of unintended pregnancies in the U.S., with about three million occurring every year.

Unintended pregnancies are linked to negative health outcomes for both mothers and newborns, including lower likelihood of receiving prenatal care and increased risk of premature birth.

It’s not immediately clear how soon the pill will become available. The FDA said the “timeline for availability and price” will be up to the manufacturer.

The agency also clarified that Opill is the only oral contraceptive that will be available for over-the-counter purchase for the time being. All other formulations and dosages will only be available by prescription.