The U.S. Food and Drug Administration approved Opill (norgestrel) for nonprescription use to prevent pregnancy. This is the first daily oral contraceptive approved for use in the U.S. without a prescription. Consumers will be able to purchase the oral contraceptive 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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, 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.”
Governor Jared Polis praised the decision in a tweet. “In Colorado, we respect individual freedoms and protect people’s right to safe reproductive healthcare,” he said. “I applaud the FDA for taking this step and ensuring more people nationwide will have the opportunity to access safe contraceptive options like Opill. By expanding affordable reproductive health care options we can improve health outcomes and save people money on their health care.”
Nonprescription availability of Opill will allow individuals to obtain an oral contraceptive without the need to first see a health care provider. According to the FDA, almost half of the 6.1 million pregnancies in the U.S. each year are unintended, and 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. Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.
Dr. Jesse Ehrenfeld, president of the American Medical Association, noted the impact this decision will have on lower income and rural 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,” said Ehrenfeld in a news release. “It is important patients have options when choosing which type of birth control works best for them. 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. We must continue to remove barriers to affordable care for those in underserved, high-poverty, and rural communities. We know barriers to oral contraceptives can lead to inconsistent or discontinued use. While it is important patients maintain relationships with their physician to stay up to date on screenings, requiring an office visit to begin birth control is an unnecessary hurdle for patients who must take time off work, find childcare, and travel to appointments. The AMA remains committed to ensuring patients have access to the entire spectrum of reproductive health care services, including safe and affordable oral contraceptives. We look forward to continuing work with the FDA to support patients’ right to access essential health care services.”
Since last year’s Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade, a number of states have passed legislation to ban or restrict access to abortion, and four states — Arkansas, Mississippi, Missouri, and Texas — have moved to limit access to contraceptives. In response, Senators Michael Bennet (D-CO) and John Hickenlooper (D-CO), alongside others, introduced the Right to Contraception Act last month, which would codify and strengthen the legal right to contraceptives.
“Since the fall of Roe v. Wade, and the criminalization of abortion provision in Missouri, anti-abortion actors have been working overtime to confuse and deceive Missourians about their reproductive healthcare options,” said Abortion Action Missouri executive director Mallory Schwarz in a news release. “In 2023, our state leaders pushed legislation intentionally conflating abortion and birth control, and directed millions of dollars on false advertising to push people towards fake anti-abortion centers instead of supporting their access to essential healthcare. These attacks have done exactly what they were intended to do: cause fear and confusion for patients and providers. … Today’s news out of the FDA is an important victory. Birth control is safe, and this move to make a daily birth control pill available over-the-counter will increase direct access to essential preventive healthcare for so many. Birth control is not a solution to the abortion access crisis, but in the absence of abortion care available in our communities, birth control access has never been more critical.”