FDA approves Opill, the first OTC birth control pill in the U.S.

The Food and Drug Administration approved Opill, the first daily over-the-counter (OTC) birth control pill in the U.S., on Thursday morning. 

The historic approval comes just over two months after FDA reviewers raised concerns about greenlighting the contraceptive manufactured by Perrigo, citing potential for inappropriate usage by consumers. 

Ultimately, external advisors to the FDA unanimously recommended Opill for OTC use and the agency followed suit.

The FDA originally approved the contraceptive efficacy of norgestrel in 1973, the same year the Supreme Court ruled in Roe v. Wade that Americans had a constitutional right to abortion. 

HRA Pharma, a subsidiary of Perrigo, applied to switch norgestrel from a prescription to OTC product in late June 2022, days after the Supreme Court overturned Roe in Dobbs v. Jackson Women’s Health Organization.

The emergence of Opill as an available OTC contraceptive is a major development in post-Roe America. The Supreme Court’s ruling last year reframed the national conversation around reproductive health and placed an outsized focus on access to birth control.

“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,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said 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.”

The FDA noted that Opill should be taken at the same time every day, emphasizing the importance of adherence to daily use for increased effectiveness.

Perrigo said in a press release following the announcement that Opill will be available in store and online at retailers across the country in Q1 2024. The company’s stock increased more than 6% in the early Thursday morning trading session after the FDA approved Opill.

“Today marks a truly momentous day for women’s health nationwide,” Perrigo CEO Patrick Lockwood-Taylor said in a statement. “Opill has the potential to radically transform women’s access to contraception and is a true testament of Perrigo’s unwavering commitment to deliver impactful solutions that truly make lives better.”

The decision was greeted by reproductive health advocates and healthcare associations as a welcome step towards broadening access to contraceptives nationwide.

“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,” Planned Parenthood Federation of America CEO Alexis McGill Johnson said in a statement.

Additionally, the American Medical Association applauded the move but also stated that it would continue to press FDA and the Department of Health and Human Services to consider a “variety of oral contraceptive options” for OTC use.

This story has been updated with additional commentary.