First OTC Pill for Birth Control Significantly Advances Health Equity

Due to a collective movement led by a coalition, approval of the first oral contraceptive pill (OCP) offered OTC was found to significantly improve health care equity, according to a study in Contraception.¹ Because of the movement’s success, they believe similar ideas can be explored to further transform health care access while simultaneously improving OTC contraceptive coverage.

“Oral contraceptives are the most commonly used method of reversible contraception in the US,” according to KFF.² “OCPs were first approved for prescription use by the FDA in 1960. Over 60 years later, on July 13, 2023, the FDA approved Opill (norgestrel), the first daily OCP to become available OTC without a doctor’s prescription.”

Opill first became available to US patients on March 4, 2024, following its approval.³ Since its launch, birth control use rates have increased significantly, rising 31.8% between approval in 2023 and August of 2025, according to NPR.⁴

As authors of the current study noted, there have been a plethora of events and decisions leading to Opill’s approval.

READ MORE: How PBMs, Pharmacists Can Team Up to Improve Women's Health

One of them was the introduction of emergency contraception (EC) accessed OTC, such as the Plan B One-Step (levonorgestrel). However, there have since been reports of consumer challenges when accessing EC from the front-end of a pharmacy, leading to studies like the current one that further explore the impact of contraceptive approvals and access.

“This paper captures lessons learned from the movement-driven effort leading to the FDA approval of the first OTC daily OCP in the US,” wrote authors of the Contraception study.¹

Free the Pill

The advocacy group, or coalition as researchers stated, was originally called the Oral Contraceptives Over-the-Counter Working Group and later changed to just “Free the Pill” around 2016.

Created by the Ibis Reproductive Health group in 2004, this campaign has since grown extensively as it continues to incite change in the women’s health space. Running the gamut of key stakeholders in this discussion, the campaign included researchers, providers, reproductive health advocates, and young leaders looking to advocate for their peers’ long-term health.¹

After the monumental approval of OTC EC in 2006, the coalition decided to place its focus on the progestin-only pill (POP) around the year 2009, as opposed to the progestin and estrogen combined oral contraceptive. And after almost 15 years of researching, debating, advocating, and additional efforts, Free the Pill—in partnership with HRA Pharma—saw the approval of OTC POP after a 17-0 vote from the FDA.

Lessons Learned, Future Considerations

In the study, coalition participants identified 5 specific lessons learned throughout the movement: proactive and inclusive coalition building, shared equity values, navigation of power dynamics, funding to “win” and partnerships that sustain, and evidence-based communications and research.¹

First, owing to the variety of stakeholders involved with Free the Pill, campaigners believe they have been successful in forming the coalition proactively and ensuring an inclusive but diverse group of advocates. They’ve also deeply aligned on equity values, shared goals, and the expectations for the future.

Among all 5 lessons elucidated throughout this study, no one seems to be more important than another. This shows that a well-established coalition like this will only entice federal change if it continues to target the most pressing issues regarding medication and health care access in the US.

In this case, Free the Pill was a huge success throughout the 21st century, and they’re not slowing down. The coalition continues to call for change while also encouraging industry leaders outside of contraceptive care to be doing the same.

“Now more than ever, it is critical that people have equitable access to contraception,” they concluded.¹ “In building trust-based partnerships, aligning on shared values, conducting rigorous research, and funding to win, we can advance equitable access for all.”

READ MORE: OTC Resource Center

REFERENCES

1. Nichols V, Maske A, Elliott R, et al. Lessons learned from the movement behind the first over-the-counter daily birth control pill in the United States and recommended strategies for implementing full insurance coverage. Contraception. December 20, 2025:111348. https://doi.org/10.1016/j.contraception.2025.111348

2. Over-the-counter OCPs. KFF. September 27, 2024. Accessed January 9, 2026. https://www.kff.org/affordable-care-act/over-the-counter-oral-contraceptive-pills/

3. First over-the-counter daily contraceptive pill released. American College of Obstetricians and Gynecologists. March 2024. Accessed January 9, 2026. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2024/03/first-over-the-counter-daily-contraceptive-pill-released

4. Riddle K. Birth control use is up since FDA approved over-the-counter pill. NPR. August 18, 2025. Accessed January 9, 2026. https://www.npr.org/2025/08/18/nx-s1-5503963/birth-control-use-is-up-since-fda-approved-over-the-counter-pill