First Over-the-Counter Birth Control Pill Approved By FDA

The first birth control pill in the US to be distributed without a prescription was approved by the Food and Drug Administration on Thursday.

Federal officials have made a groundbreaking decision by approving the progestin-only pill, known as Opill, which is manufactured by French pharmaceutical company HRA Pharma and its parent company Perrigo.

This spring, an independent advisory group determined that the medication was safe for the majority of patients. Progestin-only tablets, often referred to as the “mini-pill,” are thought to carry fewer risks than combination pills that also contain 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. “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.”

FDA advisors expressed concern about customers’ ability to effectively screen themselves for potential medical risks, especially young teens.

Despite those risks, FDA advisers believe they are outweighed by the significant benefits of removing obstacles to unplanned pregnancies, especially for younger women and those facing financial challenges.

Many states have already passed laws enabling pharmacists to dispense hormonal birth control themselves or obtain standing orders from doctors.

The FDA’s most recent action takes things a step further by allowing customers to buy oral contraceptives from pharmacies, convenience stores, and grocery stores without going through a pharmacist. Even internet purchases are permitted.

Increasing access is a well-liked concept. According to KFF, if research demonstrates that birth control tablets are safe and effective, an estimated 77% of women under 50 want access to them without a prescription.

The FDA predicted that making Opill available over-the-counter will lower the 3 million annual unplanned pregnancies that now occur in the country every year.

Currently, there is no information about the exact release date of the pill.

According to the FDA, the “timeline for availability and price” will be up to the manufacturer.