FDA advisory committee votes unanimously to recommend Opill for over-the-counter use

Today, in a landmark step for reproductive health, a joint FDA advisory committee voted unanimously to allow a birth control pill to be offered over the counter (OTC). The advisory committee vote reflects the decades of science showing that birth control pills are safe, effective, and appropriate for over-the-counter use for people of all ages.  

The vote came at the end of a two-day advisory committee meeting to review an application to switch Opill, a progestin-only, daily birth control pill, from prescription to over-the-counter status. During the meeting, the FDA heard from reproductive health and justice advocates, health care providers, and young people about the broad benefits of bringing a birth control pill over the counter, particularly for those who currently face the most barriers to access. In July 2022, HRA Pharma announced it had submitted this application, the first of its kind, to the FDA. 

This significant milestone comes after nearly two decades of advocacy and research led by members of the Free the Pill coalition, comprised of over 200 reproductive health, rights, and justice organizations, research and advocacy groups, youth activists, health care providers, and prominent medical and health professional associations. Free the Pill, which is operated by Ibis Reproductive Health, supports over-the-counter (OTC) birth control pills that are affordable, fully covered by insurance, and available to people of all ages. Moving birth control pills over the counter as a safe and effective way to expand contraceptive access has been a key goal of Ibis since the organization was founded in 2002. 

We urge the FDA to follow the committee’s recommendation and approve an over-the-counter progestin-only birth control pill for all ages without any further delay. Every day we wait is another day longer where barriers remain in place preventing people from getting access to the contraceptive care they want and need. 

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 – 

“Today, in a historic step forward for reproductive health, a joint FDA advisory committee voted in favor of moving a progestin-only birth control pill over the counter. Decades of coalition-driven advocacy and research efforts that have centered the voices of those most impacted by barriers to contraception caused by systemic inequities have made this possible. It is past time for an over-the-counter birth control pill, which has the potential to advance reproductive justice and expand health equity. Now, we look to the FDA to follow the committee’s recommendation, in addition to the overwhelming data, and approve the first-ever over-the-counter birth control pill in the US. The days of the current prescription requirement are numbered.” 

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 –  

“I applaud the joint FDA advisory committee’s recommendation that progestin-only birth control pills should be approved for over-the-counter use. We have reached this significant milestone due to nearly two decades of research and coalition efforts by reproductive justice organizations, reproductive health advocates and researchers, health care providers and young people. The science is clear that an over-the-counter progestin-only pill is safe and effective and can advance public health and health equity, especially among communities who face the most barriers in our healthcare system. Following this historic vote, the FDA must follow the committee’s recommendation and remove the prescription requirement that prevents people from accessing the care they need.” 

Lupe M. Rodríguez (she/her), executive director of National Latina Institute for Reproductive Justice released the following statement – 

“We’re thrilled that a joint FDA advisory committee voted to allow a birth control pill to be available over the counter. Over the counter access to birth control is widely supported by Latinas/xs and would greatly reduce the barriers that prevent our communities from getting the care they need. We urge the FDA to follow the committee’s recommendation and immediately approve this safe and effective birth control pill for use over the counter by people of all ages. At Latina Institute, we believe that everyone should have access to the full range of sexual and reproductive healthcare, including birth control, regardless of their income, age, race, disability, im/migration status, or what state they call home. It’s time to protect and expand access to birth control to ensure that we can take care of ourselves and our families.”

Dr. Daniel Grossman (he/him), director of Advancing New Standards for Reproductive Health (ANSIRH) and Free the Pill coalition steering committee member released the following statement –  

“Today’s vote from the joint FDA advisory committee in favor of moving a progestin-only birth control pill over the counter is in line with what the science tells us. A large body of evidence indicates that progestin-only pills are safe and effective for over-the-counter use, and the experts on the advisory committee both recognized this evidence and strongly articulated the public health benefit of making Opill available over the counter. As a physician, birth control pills are one of the safest medications I can prescribe to my patients, and removing the medically unnecessary prescription requirement will mean that more people can get care without barriers. From a public health and equity perspective, this is a win-win. I urge the FDA to follow the committee’s sound recommendation and approve this progestin-only birth control pill for over-the-counter use.” 

Debra Hauser (she/her), president of Advocates for Youth and Free the Pill coalition steering committee member released the following statement – 

“I’m thrilled the advisory committee saw through myths, misconceptions, and condescension today, and recommended the FDA bring a birth control pill over-the-counter without age restrictions. The Biden Administration has pledged to ‘follow the science’ from the very beginning, so I’m certain the FDA will now follow this expert advice and finally give young people one more option for accessing life-changing birth control. We know that the far right will continue to attack and limit access to reproductive health care, and we need to ensure young people have everything they need to lead healthy lives and plan their futures.” 

Monica Simpson, executive director of SisterSong and Free the Pill coalition steering committee member, released the following statement – 

“Today’s vote from the FDA advisory committee is long overdue and brings us one step closer to a world with reproductive justice. For too long, barriers to birth control, including the prescription requirement, have prevented people from getting the contraceptive care they need, with the barriers falling hardest on Black, Indigenous, Asian American, Native Hawaiian, and Pacific Islanders, Latinx folks and other people of color. It’s time to free the pill and make birth control available over the counter – we can’t wait any longer.”