FDA Approves Over-the-Counter, Nonprescription Birth Control

After months of deliberation, the United States Food and Drug Administration (FDA) approved the first hormonal oral contraceptive for non-prescription over-the-counter (OTC) sale. This historical approval of Opill comes at the height of reproductive uncertainty in the US.

Opill, or norgestrel, is a progestin-only female contraceptive pill previously sold by prescription only. Under new approvals, the medication will be available OTC at drug, convenience, and grocery stores. Consumers may also be able to purchase the prescription online.

As the first and only form of oral contraceptives to be available over the counter in the US, Opill may improve access to reproductive resources. By removing the barrier of a doctor’s visit, patients can more readily access the medication.

The FDA and other major health organizations predict that increased availability of the drug may reduce the annual number of unintended pregnancies in the US, accounting for nearly half of the 6.1 million total pregnancies yearly.

Consistently high rates of unintended pregnancy have been of great concern as access to abortion and comprehensive reproductive healthcare was compromised by federal rulings.

Opill was first approved for prescription use in 1973 as a prescription medication. Since its original release, the drug has proven to be a safe and effective hormonal birth control method.

In June 2022, the American Medical Association (AMA) echoed multiple other reproductive health organizations urging the FDA to approve the OTC sale of oral contraceptives. Just one month later, in July 2022, HRA Pharma, the manufacturer of Opill, applied for the OTC sale of Opill.

Since that original submission, more data has come to light urging this transition. A KFF survey published in November 2022 noted that 77% of female-identifying individuals of reproductive age favored making birth control pills available over the counter.

As the FDA analyzed data on the Opill and assessed its potential for OTC sale, a joint FDA advisory panel, including individuals from the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drug Advisory Committee (ORUDAC), voted in favor of making the medication more readily available.

The unanimous vote of the advisory panel in favor of Opill’s OTC sale was revealed in May 2023; however, it did not act as a final ruling. Today’s final ruling on the pill is a significant milestone in reproductive health.

“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, MD, director of the FDA’s Center for Drug Evaluation and Research, in the FDA 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.”