FDA approves Opill, the nation’s first over-the-counter birth control pill
Last week, the U.S. Food and Drug Administration approved Opill (norgestrel) tablets for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription.
Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider. This comes amid the legal and political battles over reproductive health as well as the reversal of Roe v. Wade, which ended abortion access across much of the U.S.
The approval of the nation’s first over the counter birth control pill is hailed as a landmark decision as it will soon allow American women and girls to obtain contraceptive medication as easily as they buy aspirin and eye drops.
Consumers can purchase the progestin-only oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
The move is being applauded by medical societies and women’s health groups who pushed for wider access. The timeline for availability and price of this nonprescription product is determined by the manufacturer. Other approved formulations and dosages of other oral contraceptives will remain available by prescription only.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research said, “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. When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non prescription contraceptive methods in preventing unintended pregnancy.”Experts believe that the availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts. They say almost half of the 6.1 million pregnancies in the U.S. each year are unintended and 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.
Kelly Blanchard, president of Ibis Reproductive Health, a nonprofit group that supported the approval said, “This is really a transformation in access to contraceptive care. Hopefully this will help people overcome those barriers that exist now.”
When it comes to pricing, concerns have turned to the cost for Opill. The exact price is unknown at this time, but experts say that over-the-counter medicines are generally much cheaper than prescriptions, however, they typically aren’t covered by insurance. Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government which many women’s advocate groups are urging the Biden administration to implement.