FDA approves first oral contraceptive for OTC sales

Consumers can soon purchase birth control pills from US retailers and online stores without a prescription, following the FDA’s approval of the first over-the-counter (OTC) oral contraceptive.

On Thursday, the agency greenlit nonprescription sales of Opill (norgestrel), a progestin-only daily tablet—expanding access to a form of birth control that has required physician oversight and a prescription for decades. Opill is expected to hit retail shelves in the first quarter of 2024, according to manufacturer Perrigo Company.

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that “daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy” when used as directed.

About half of the 6+ million pregnancies that occur in the US each year are unintended, according to the FDA.

Frederique Welgryn, Perrigo’s global VP for women’s health, called the FDA’s approval “a groundbreaking expansion for women’s health in the US, and a significant milestone toward addressing a key unmet need for contraceptive access.”

The FDA’s approval comes almost exactly one year after Perrigo-acquired HRA Pharma applied to make Opill available OTC—and one year after the Supreme Court’s reversal of Roe v. Wade reignited debate over birth control and abortion access in the US. A federal court is expected to soon weigh in on a legal fight over the FDA’s approval of abortion drug mifepristone.

Medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, have supported making oral contraceptives available without a prescription, citing access barriers as major reasons for inconsistent or nonuse of birth control.

Free the Pill, a project of Ibis Reproductive Health that has also pushed for OTC oral contraceptives, noted that the US now joins “over 100 countries where birth control pills are available without a prescription.” (In the US, pharmacists in close to 30 states and Washington, DC, can already prescribe and dispense self-administered hormonal contraception.)

“This is a movement win, led by a coalition that recognized the potential of over-the-counter birth control pills and worked for nearly two decades to build the evidence, support, and partnerships necessary to make them a reality,” Victoria Nichols, project director for Free the Pill, said in a statement. “FDA approval is an important step forward, but we must ensure that OTC birth control pills are equitably accessible to all. To ensure equitable access, we must continue to advocate for OTC birth control pills to be affordably priced and fully covered by insurance.”

Perrigo has not yet released a retail price for OTC Opill. Spokesperson Chrissy Faessen said in an email that “the company will release pricing and distribution plans in the coming months in advance of being on store shelves.”