First Over-the-Counter Birth Control Pill Gets FDA Approval

Birth control pills will soon be available over the counter in the United States, after the U.S. Food and Drug Administration (FDA) on Thursday approved the Perrigo Company’s daily birth control medication, Opill, to be sold without a prescription.

Opill is the first ever birth control pill to be approved for over-the-counter sales. The medication will likely become available at stores and online retailers in the U.S. in early 2024, according to Perrigo, which is based in Ireland.

In issuing its decision, the FDA panel cited the safety and efficacy of Opill, which was approved for prescription use 50 years ago. The company has not yet determined how much Opill will cost, but there will be no age restrictions on sales.

Reproductive and adolescent health experts and groups like the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians have long called for birth control to be available without a prescription for all ages in order to make it easier for women and teenage girls to access contraception.

A 2022 survey from KFF, a health care research organization, found that more than 75% of women of reproductive age said they preferred an over-the-counter pill, mostly because of convenience. Nearly 40% said they would be likely to use it.

Upon hitting store shelves, Opill will become the most effective birth control method available without a prescription, as it’s more effective at preventing pregnancy than condoms, spermicides, and other over-the-counter methods, though still not as effective as an intrauterine device (IUD) or implant.

Opill should be taken at the same time every day, according to the FDA’s guidance.

“Adherence to daily use at the same time of day is important for the effectiveness of Opill,” an agency press release reads. 

Planned Parenthood also notes the importance of taking Opill at the same time each day within a 3-hour window in order to ensure maximum effectiveness.

The FDA’s approval of Opill comes at a key time, as Republican-led states across the country implement strict abortion bans, with some right-wing officials and activists explicitly stating that they want to restrict access to birth control as well.

Currently in Pennsylvania, over-the-counter birth control is not permitted by law. Democratic lawmakers across the state, however, have been pushing for the commonwealth to expand access to contraceptives, especially since the fall of Roe v. Wade. When the FDA approves a medication, states no longer have the power to ban their sale or use, but if a Republican-led lawsuit to retroactively revoke the FDA’s approval of abortion medication mifepristone is any indication, it’s possible that the agency will face a lawsuit challenging its approval of Opill, which could create uncertainty about whether it will be available in Pennsylvania.

Alexis McGill Johnson, president and CEO, Planned Parenthood Federation of America, praised the FDA’s decision, but cautioned that it was not a cure-all for ongoing attacks on reproductive freedom.

“Birth control is essential health care,” McGill Johnson said in a statement. “We know that increasing access to birth control is not a solution to the ongoing attacks on abortion access and sexual and reproductive health. But it is a critical part of protecting our reproductive freedom, especially as states across the country continue to double down on their unpopular abortion bans and restrictions.”