The US Food and Drug Administration (FDA) has approved the country’s first birth control pill for use without a prescription. The decision, announced on 13 July, will significantly increase access to contraception in the US.
Currently, hormonal contraceptives can only be obtained in the US with a prescription, which usually requires visiting a doctor. This can be difficult for those who lack health insurance, live in rural areas or don’t have time to go to a clinic. A 2016 survey found that nearly a third of women in the US who report trying to obtain a prescription or refill for hormonal birth control have had trouble doing so.
A daily birth control pill called Opill will be available in the US early next year at drug stores, convenience stores and online retailers. The approval does not apply to other hormonal birth control options.
The administration first approved Opill for use with a prescription in 1973. With typical use, it prevents 93 per cent of pregnancies, whereas condoms, spermicides and other over-the-counter contraceptives are only about 79 to 87 per cent effective.
“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,” said Patrizia Cavazzoni at the FDA in a statement.
Almost half of the 6.1 million pregnancies each year in the US are unintended, according to the FDA. Compared with planned pregnancies, unintended pregnancies are associated with poorer maternal and childhood health outcomes, including higher rates of pre- and postpartum depression, domestic violence and preterm birth.
“Today’s approval is a groundbreaking expansion for women’s health in the US, and a significant milestone towards addressing a key unmet need for contraceptive access,” said Frederique Welgryn at Perrigo Company, the drug’s Dublin-based manufacturer, in a statement.
Over-the-counter hormonal contraception is supported by medical groups such as the American Medical Association and the American College of Obstetrician and Gynecologists. But the issue has received extra attention since last year, when the US Supreme Court overturned Roe v Wade, a ruling that had protected the right to an abortion.
A 2022 survey found that more than 77 per cent of reproductive-age women support over-the-counter birth control so long as it safe and effective, and about 40 per cent say they would probably use it if approved.
Perrigo has not announced how much the pill will cost, but Welgryn said the company is committed to ensuring it is affordable for people of all ages.