Ibis celebrates the first-ever application for an OTC birth control pill in the United States

July 2022

For nearly two decades, Ibis Reproductive Health has led a coalition-driven effort involving more than 100 reproductive health, rights, and justice organizations, research and advocacy groups, youth activists, health care providers, prominent medical and health professional associations, regulatory experts, and others to build the evidence base and grow support for bringing birth control pills over the counter (OTC) in the United States for people of all ages. Ibis and coalition partners conducted critical research and built consensus on the need for an OTC birth control pill for a decade and in 2016 partnered with HRA Pharma to conduct the research needed to submit an Rx-to-OTC switch application to the Food and Drug Administration (FDA).

Today, HRA Pharma announced that it has submitted the first-ever application to the FDA to switch Opill, a progestin-only, daily birth control pill from prescription to over-the-counter status. Ibis Reproductive Health celebrates this important milestone and looks forward to continuing to work with coalition members to ensure that future OTC birth control pills are affordable, fully covered by insurance, and accessible to people of all ages in the United States.

Victoria Nichols (she/her), project director of Free the Pill, a project of Ibis Reproductive Health focused on bringing birth control pills over the counter in the United States, released the following statement – 

This FDA submission marks the culmination of decades of work by reproductive justice organizers, advocates, providers, and researchers to bring a birth control pill over the counter in the United States. More than 60 years since the birth control pill was first approved by the FDA, it’s past time for an over-the-counter birth control pill—one that’s also affordable, fully covered by insurance, and available to people of all ages.  

Research has documented that the prescription requirement is a barrier for many people and can push birth control out of reach because it means a potentially costly health care provider’s visit, taking time off school or work to get to the appointment, and more. These barriers are even more challenging for people already facing obstacles to accessing essential health care because of systemic racism and other oppressions, including Black folks, Indigenous peoples, Asian American, Native Hawaiian, and Pacific Islanders, Latinx folks and other people or color as well as LGBTQ+ folks, young people, and people working to make ends meet. Over-the-counter birth control pills would reduce many of these barriers and advance health equity. 

Kelly Blanchard (she/her), president of Ibis Reproductive Health, a global nonprofit research organization which operates the Free the Pill coalition released the following statement – 

After years of rigorous research and partnership supported by a 100+ member strong coalition, we are thrilled that an application for an over-the-counter birth control pill is now before the FDA. Decades of research and experience of millions of people using birth control pills show they are safe and effective, and we can safely expand access to them by removing the prescription requirement.

This historic moment wouldn’t be possible without leaders in the reproductive justice movement who continue to ensure sexual and reproductive health and rights are part of an intersectional understanding of what it means to access abortion, contraception, and the full range of health care as well as the right to parent the children we have in safe, healthy communities. Our work to support this over-the-counter switch centers the voices of and access for Black folks, Indigenous peoples, Asian American, Native Hawaiian, and Pacific Islanders, Latinx folks and other people of color, young people, LGBTQ+ folks, and those working to make ends meet – communities that bear the brunt of barriers to birth control. 

Monica Simpson (she/her), executive director of SisterSong and Free the Pill coalition Steering Committee Member, released the following statement  – 

This is a powerful moment in our movement to bring birth control pills over the counter in the United States. Together we are working to advance reproductive justice by removing barriers to access to give people more control over their own bodies, lives, and futures. We are in a health care crisis in this country and there is no better time than now to get behind this because it addresses a real-time need. We must work intentionally to ensure that the intersectional perspectives and needs of Black, Indigenous, Asian American, Native Hawaiian, and Pacific Islanders, Latinx folks and other people of color, LGBTQ+ communities, young people, those in rural communities, and people working to make ends meet have equitable access to the reproductive health options they want and need without stigma or barriers. Making birth control pills OTC will help us move closer to the liberation that we all want.

This submission is a critical step towards our goal—an FDA-approved over-the-counter birth control pill that is affordable, fully covered by insurance, and available to people of all ages. We look forward to the FDA following the science as they review the application and we will continue our work to ensure the policies are in place to ensure access for all.