How we got here: A timeline of the movement to free the pill.
On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill as the first-ever over-the-counter (OTC) birth control pill in the United States! This historic advancement in contraceptive access was the result of a decades-long, movement-driven effort led by the Free the Pill coalition—a group of reproductive justice advocates, youth activists, providers, researchers, and many others. The timeline below outlines the key events and milestones that led to this moment.
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Our History
1993 – 2006: EARLY BEGINNINGS
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A groundbreaking research paper advocating for OTC oral contraceptives is published in the American Journal of Public Health.
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Ibis Reproductive Health convenes the first meeting of the Oral Contraceptives Over-the-Counter (OCs OTC) Working Group (now the Free the Pill coalition) to strategize and build support for OTC birth control pills.
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The Border Contraceptive Access Study finds that participants in Mexico with OTC access to birth control pills had a 60% higher continuation rate than those in the US with prescription-only access, and that both groups sought preventive reproductive health screenings at similar rates.
1993 – 2006: EARLY BEGINNINGS
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While remaining committed to bringing all forms of OTC birth control pills over the counter, the OCs OTC Working Group decided to focus on the progestin-only pill (POP) first, due to its safety for most people. The group also revises its statement of purpose to include a focus on addressing disparities in reproductive health care access.
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The coalition holds its first Reproductive Justice meeting where advocates emphasize the importance of insurance coverage and access for people of all ages for an OTC pill.
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The first nationally representative survey on women’s opinions about OTC access, conducted by Ibis Reproductive Health, finds that 62% of respondents at risk of unintended pregnancy support OTC birth control pills, with 37% likely to use them.
2014 – 2016: BUILDING PUBLIC AWARENESS AND SUPPORT
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The Free the Pill campaign is launched to build public support for OTC birth control pills that are affordable, fully covered by insurance, and accessible to all ages.
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The David and Lucile Packard Foundation awards a $12 million grant to grow the coalition and incentivize a pharmaceutical company to submit an OTC-switch application to the FDA.
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HRA Pharma (now Perrigo) is selected as the coalition’s partner after committing to working with the coalition, developing the necessary research for an OTC application, and supporting insurance cov erage and affordability of a future OTC pill.
2016 – 2022: CENTERING REPRODUCTIVE JUSTICE AND YOUTH LEADERSHIP AND ENGAGING POLICYMAKERS
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The OCs OTC Working Group engages in a coalition-wide training on reproductive justice, led by SisterReach, reflecting its commitment to a reproductive justice approach.
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Free the Pill expands its work with state advocates to push for insurance coverage of OTC contraception and Maryland passes the Contraceptive Equity Act, becoming the first state to pass a law including a provision that requires OTC coverage.
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The Native American Women's Health Education Resource Center collaborates with Free the Pill to conduct educational talking circles with Native women and girls in Oklahoma, New Mexico, and South Dakota to understand gaps in reproductive health care access and highlight the unique needs of Native American women for OTC birth control, leading to a supportive resolution from the National Congress of American Indians.
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The OCs OTC Working Group engages in a coalition-wide training led by Advocates for Youth, commits to adopting a formal youth-adult partnership model, and begins the process of recruiting and onboarding youth leaders to its Steering Committee.
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The first Free the Pill Hill Education Day is held to engage policymakers in advocacy for OTC birth control pills.
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The first Free the Pill Day is celebrated on May 9 as a movement-wide event to commemorate the date the FDA approved the first birth control pill in 1960.
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HRA Pharma (now Perrigo) launches its actual use trial for an OTC POP, with support from the Free the Pill coalition for recruitment of adolescent participants.
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Ibis Reproductive Health and its partners develop an OTC drug facts label for a combined oral contraceptive (COC) and conduct a pilot label comprehension study.
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The OCs OTC Working Group Steering Committee releases a statement on racial justice highlighting the need to center communities that face the most barriers to access in the movement to bring birth control pills over the counter. They also host a webinar acknowledging the history of experimentation on Puerto Rican women who, without consent, compensation, or subsequent access to the product, were included in clinical trials that resulted in the FDA approval of the first birth control pill.
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The OCs OTC Working Group convenes a series of meetings with clinical and regulatory experts and reproductive justice leaders to develop evidence-based recommendations on blood pressure screening for future OTC COCs.
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The OCs OTC Working Group transitions to the Free the Pill coalition and updates its statement of purpose to emphasize its commitment to reproductive justice values, youth-adult partnerships, and broader work to center the leadership of those who face the greatest barriers to contraceptive care, and who could benefit the most from easier access to birth control pills.
2022 – 2024: BRINGING THE FIRST DAILY BIRTH CONTROL PILL OVER THE COUNTER AND ADVOCATING FOR AFFORDABLE ACCESS
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After years of rigorous research, HRA Pharma (now Perrigo) announces that it has submitted an application to switch a progestin-only, daily birth control pill called Opill from prescription to OTC status.
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On May 9, the 5th annual Free the Pill Day is celebrated and the first day of the two-day FDA Advisory Committee meeting begins. The meeting includes presentations by FDA and Perrigo staff followed by powerful public testimony from over 30 coalition partners (including six Free the Pill Youth Council members) who speak on the research, clinical evidence, and lived experience that demonstrates the need, interest, and appropriateness of OTC birth control pills. This meeting ends with a unanimous vote from the advisory committee recommending that Opill be approved for OTC status without age restrictions.
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The FDA approves Opill for OTC use without an age restriction, making it the first-ever OTC daily birth control pill in the United States. This achievement would not have been possible without the two decades of advocacy and research led by Free the Pill coalition partners and the seven years of collaborative work with HRA Pharma and Perrigo to conduct the research needed to submit a successful application to the FDA.
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Free the Pill, Advocates for Youth, and partners launch a letter-writing campaign advocating for insurance coverage of OTC birth control. With over 168,000 letters submitted, this campaign demonstrates broad interest in and need for OTC coverage to support affordable access. In addition, the Free the Pill coalition sends a letter to the Departments of Health and Human Services, Treasury, and Labor, urging the Administration to require insurance plans to cover all FDA-approved OTC birth control without a prescription or cost-sharing.
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The Biden Administration opens a Request for Information regarding insurance coverage without a prescription or cost-sharing requirement for over-the-counter preventive services, which includes OTC contraceptives like Opill. Over 390 comments—most positive—are submitted to the docket, including comments from the Free the Pill coalition and partners.
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Perrigo launches Opill online and in stores nationwide. The first phase of Opill’s cost assistance program goes live to provide free or discounted products to those who qualify.
TODAY
The approval of the first OTC birth control pill is a significant milestone, yet the work continues. Free the Pill continues to advocate for equitable access to OTC birth control pills by calling for full public and private insurance coverage of OTC contraceptives without a prescription requirement, advocating for the expansion of cost assistance programs, and working with advocates and community partners to educate and empower communities that face the most barriers with resources and more avenues of access. We are also working with coalition members to lay the groundwork for future OTC birth control options, including for combined oral contraceptives (COCs), to ensure everyone can access the contraceptive care they want and need, free from barriers and stigma.
