FDA approves Opill, first nonprescription daily oral contraceptive in U.S.

© Perrigo Company plc

The first nonprescription daily oral contraceptive has been approved by federal regulators.

The U.S. Food and Drug Administration (FDA) announced approval of Opill (norgestrel) tablets to provide “an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.”

“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,” FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni, MD, said in a news release. “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 timeline for availability and price of this nonprescription product is determined by manufacturer. Perrigo Company plc in May acquired drug creator HRA Pharma, which sought the change from prescription use to over-the-counter use.

"Today marks a truly momentous day for women's health nationwide," Perrigo President and CEO Patrick Lockwood-Taylor said in a news release. "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."

Other approved formulations and dosages of other oral contraceptives will remain available by prescription only, according to FDA.

The FDA’s announcement said almost half of the 6.1 million pregnancies in the United State each year are unintended.

“Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes,” the FDA announcement said. “Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.”

American Medical Association (AMA) President Jesse M. Ehrenfeld, MD, MPH, issued a statement praising the FDA’s nod as “a monumental step in providing broader access to safe and effective reproductive health care for millions of patients.”

“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” Ehrenfeld’s statement said, referring to the U.S. Department of Health and Human Services.

“It is important patients have options when choosing which type of birth control works best for them,” Ehrenfeld said. “We hope this is just the first of several to be approved, and we urge the FDA to consider applications from the full range of available oral contraceptives for over-the-counter access.”

Perrigo said the company’s request also had support from the American College of Obstetricians and Gynecologists, the Society for Adolescent Health and Medicine, and the American Academy of Family Physicians.

While the FDA approval for nonprescription use is new, norgestrel’s efficacy was established with the original approval for prescription use in 1973. HRA Pharma applied to change the drug from prescription to over-the-counter use, and showed consumers understood of the Opill drug facts label and instructions for use.