FDA Approves First Nonprescription Oral Contraceptive

The FDA has approved a nonprescription version of the contraceptive Opill (norgestrel). It is the first daily oral contraceptive approved for use in the United States without a prescription. Developed by HRA Pharma, a Perrigo company, the nonprescription Opill consists of 0.075 mg norgestrel and is a progestin-only daily birth control pill, which is also referred to as a mini pill or non-estrogen pill. The prescription Opill is not currently marketed.

Opill will be available in stores and online at leading retailers early in the first quarter of 2024. Pricing information is not yet available; pricing will be available in advance of availability, a company spokesperson said.

Last year, a survey by KFF found that 77% of almost 5,000 respondents support a nonprescription contraceptive but those likely to use an over-the counter product are price sensitive. Only 16% would pay more than $20. One in 10 (11%) say they are unwilling or unable to pay anything for OTC birth control pills.

“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,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a press 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 contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973, the FDA said in its press release. OTC oral contraception has support from major medical organizations including the American College of Obstetricians and Gynecologists, the American Medical Association, the Society for Adolescent Health and Medicine and the American Academy of Family Physicians.

“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. 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," Jesse M. Ehrenfeld, M.D., M.P.H., president, American Medical Association, said in a statement.

In May 2023, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) voted unanimously 17 to 0, with no abstentions, that the benefits of making Opill available for OTC use, outweigh the risks.

After the vote, committee member Deborah Armstrong, M.D., a professor of oncology, gynecology and obstetrics at Johns Hopkins, said she voted yes because the risks of unintended pregnancy are lower with this approach than other available contraceptives that a woman would have without seeing a doctor.

Kathryn Curtis, Ph.D., an epidemiologist with the CDC, said: “The evidence demonstrates that the benefits clearly exceed the risk. The benefits of moving Opill over the counter include increased access to contraception, especially those who face multiple barriers that we heard about: reduction in unintended pregnancy, associated risk, approved reproductive autonomy and improved equitable access to contraception. I think Opill has the potential to have a huge positive public health impact.”

HRA Pharma applied in July 2022 to switch norgestrel from a prescription to an over-the-counter product. For an Rx to OTC switch, the FDA requires that that company demonstrate the product can be used by consumers safely.

In its briefing document for the advisory committee meeting, HRA indicated it had conducted an iterative label development program. The proposed OTC labeling was tested over the course of a seven-year development program with 14 consumer studies. Feedback from the FDA was incorporated throughout the development program in both the design of studies and content of the labeling.

Additionally, a study published online last year in Perspectives on Sexual and Reproductive Health found that study participants understood the label information required for safe use without clinician involvement. Investigators surveyed 63 adults and teens aged 12 to 49 years of age. They found that 10 of the 11 primary endpoints were understood by more than 95% of participants. The remaining primary endpoint on use with prior blood clots was understood by 89% of participants.