FDA approves OTC birth control pill.

FDA approves OTC birth control pill.

The First Over-the-Counter Birth Control Pill in the U.S. Is Approved: Breaking Barriers for Contraception Access


The U.S. Food and Drug Administration (FDA) has made a groundbreaking decision by approving the first over-the-counter birth control pill in the nation. This move is expected to significantly increase access to contraception for Americans, marking a significant step forward in reproductive health.

As early as January or February, women will be able to purchase the progestin-only oral contraceptive, known as Opill, at drug stores, convenience stores, and grocery stores with no age restrictions. This exciting advancement is expected to eliminate many of the barriers and challenges that individuals face when seeking birth control options.

Opill, manufactured by Perrigo and originally approved by the FDA in 1973, will soon be available without a prescription. While other types of birth control pills will still require a prescription, the availability of Opill over-the-counter opens new possibilities for individuals seeking a safe and effective contraceptive method.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, expressed the significance of this approval. She stated, “Today’s approval marks the first time a non-prescription 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.”

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Clearing the Path: Support from Medical Organizations and Advocacy Groups

It is essential to highlight that prominent medical organizations, such as the American Medical Association, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists (ACOG), have long endorsed over-the-counter access to hormonal contraception without age restrictions. These organizations recognize the importance of removing barriers to contraception and promoting reproductive health.

Additionally, advocacy groups, including the Free the Pill coalition, have tirelessly advocated for over-the-counter status for birth control pills since 2004. The coalition, consisting of numerous organizations committed to expanding access to birth control, emphasizes the necessity of this transformative change in contraceptive access and reproductive health.

Victoria Nichols, the project director of Free the Pill, expresses the significance of this milestone, stating, “It’s a transformative change in contraceptive access and reproductive health.” The accomplishment of making birth control pills available without a prescription is a significant step toward breaking down barriers, particularly for marginalized communities.

FDA’s Thoughtful Decision: Addressing Concerns

The FDA’s approval is based on careful consideration and extensive research. An advisory panel, whose members voted unanimously in favor of the over-the-counter pill, recommended the FDA’s decision in May.

The FDA acknowledges concerns that consumers may not use the pills appropriately when available over-the-counter. However, studies have shown that a high proportion of consumers understand the Opill label instructions, supporting their ability to use the drug correctly without prescription oversight.

The one major contraindication for Opill is having active breast cancer. While this limitation is crucial, Dr. Kristyn Brandi, an obstetrician/gynecologist and ACOG’s Darney-Landy Fellow, explains that individuals with active breast cancer are likely already under the care of multiple healthcare providers who can guide them regarding birth control options.

Another concern raised by the FDA is the potential decreased effectiveness of the pill in people who are overweight or obese. However, Dr. Brandi states that this should not be an issue, as no alterations are currently made for patients who are obese and take the pill via prescription.

The approval of an over-the-counter birth control pill carries immense significance, particularly considering recent legal changes surrounding reproductive rights. In the wake of the U.S. Supreme Court ruling that overturned Roe v. Wade, individuals’ access to reproductive healthcare has faced additional barriers.

Dr. Brandi highlights the importance of increasing access to contraception in this context, emphasizing that over-the-counter availability is not a solution to abortion bans. However, it holds the potential to empower individuals to prevent unintended pregnancies and promote reproductive autonomy. The value of this expanded access to contraception cannot be overstated.

Final Words

The FDA’s approval of the first over-the-counter birth control pill in the United States marks a monumental shift in contraceptive accessibility. This decision will undoubtedly pave the way for greater access to contraception for millions of individuals. By breaking down barriers and increasing options, the Opill and future over-the-counter contraceptives have the potential to transform reproductive health and empower individuals to make informed decisions about their bodies and futures.


  • U.S. Food and Drug Administration, news release, July 13, 2023; May 8, 2023, media briefing with Victoria Nichols, project director, Free the Pill, Cambridge, Mass.; Kristyn Brandi, MD, Darney-Landy Fellow, American College of Obstetricians and Gynecologists, obstetrician/gynecologist, Newark, N.J.; Washington Post

  • For more information on choosing the best birth control method, visit The American College of Obstetricians and Gynecologists website.