FDA approves the first-ever over-the-counter birth control pill in the United States

July 2023

July 13, 2023 - Today, in a historic move for reproductive health that could transform contraception access, the United States Food and Drug Administration (FDA) approved Opill, a progestin-only birth control pill (POP), for over-the-counter (OTC) use. After a comprehensive review of the data and a unanimous advisory committee vote to recommend Opill for over-the-counter status, the FDA followed the science and made a decision that will expand contraceptive access for those who face the greatest barriers to care. The United States will now join over 100 countries where birth control pills are available without a prescription.

This victory would not be possible without 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, youth activists, health care providers, researchers, medical and health professional associations, and others working toward more equitable access to contraception. Decades of data demonstrate that birth control pills are safe and effective for over-the-counter use and this transformative change will help ensure more people can access the contraception they need without unnecessary barriers. The Free the Pill coalition's commitment to a reproductive justice framework and adoption of a youth-adult partnership approach were critical to this win.

We also congratulate HRA Pharma and Perrigo on this momentous achievement. We are grateful for their support of the Free the Pill's vision of an OTC birth control pill that is affordable, covered by insurance, and available to people of all ages, and we look forward to seeing Opill on the shelves.

This moment is a victory for equity, human rights, public health, and evidence-based research–and especially in light of the ongoing attacks on reproductive health and rights, it is a reason to celebrate. As we celebrate this win, we must also ensure that this decision leads to improved access for everyone – regardless of background or income. This means that we must ensure OTC birth control pills are priced affordably and covered by insurance. To achieve this goal, we will continue our critical work to advocate at the federal and state levels to expand insurance coverage of OTC birth control pills and ensure everyone who wants to can walk into their local pharmacy and pick up a pack of birth control pills right off the shelf. 

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 –  

“Over-the-counter birth control pills will help bridge gaps in access and give people greater control over their reproductive health and lives. This is a movement win led by a coalition that recognized the potential of over-the-counter birth control pills and worked for nearly two decades to build the evidence, support, and partnerships necessary to make them a reality in the United States. FDA approval is an important step forward, but we must ensure that over-the-counter birth control pills are equitably accessible to all. To ensure equitable access, we must continue to advocate for over-the-counter birth control pills to be priced affordably and fully covered by insurance.” 

Lupe M. Rodríguez, executive director of the National Latina Institute for Reproductive Justice and Free the Pill coalition steering committee member, released the following statement –  

“We’re thrilled by the FDA’s historic decision to approve Opill as the first ever over-the-counter birth control pill. Over-the-counter access to birth control will greatly reduce the barriers that prevent Latinas/xs from getting the care they need, including barriers due to transportation, cost, language, and documentation. If this is implemented correctly, expanding access to birth control will allow our communities the freedom to make meaningful decisions about our lives and futures. Now we must ensure that this safe and effective birth control pill is affordable and covered by insurance. 

At the Latina Institute, we believe that everyone should have access to the full range of sexual and reproductive healthcare, including birth control. This important and long overdue victory means that we can make decisions for ourselves and take care of our families with dignity.” 

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 FDA followed the science and the unanimous decision of its advisory committee, and has authorized Opill for sale over the counter. Having an OTC option for birth control pills is incredibly important and long overdue. 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."

Dyvia Huitron, a 19-year-old organizer with Advocates for Youth, released the following statement – 

"This monumental moment of over-the-counter approval gives thousands of young people across the United States access to a vital piece of health care. I am so glad to know that I, and many others, can now take charge of our health and pick up birth control on our own terms and in our own time."

Dr. Lin-Fan Wang (she/her), a family physician at QueerDoc and Free the Pill coalition steering committee member, released the following statement –  

“An over-the-counter birth control pill marks a groundbreaking advancement for contraceptive access nationwide. Today’s decision by the FDA reflects decades of data that show progestin-only birth control pills like Opill are safe and effective for use without a prescription. As a health care provider, I want my patients to have access to care that helps them plan their reproductive lives and futures without medically unnecessary barriers. An over-the-counter birth control pill has the potential to transform the way people access contraception, especially those who face the most barriers in our health care system, including LGBTQIA+ folks, people of color, and those working to make ends meet.”

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

“Today’s FDA decision is a critical victory for reproductive health and freedom. Studies I have led demonstrate that over-the-counter birth control pills are safe and effective, and I’m eager for my patients and people across the country to benefit from increased access to birth control. If available equitably—meaning that they are priced affordably and fully covered by insurance—over-the-counter birth control pills will be a game-changer for communities impacted by systemic health inequities. We’re one step closer to ensuring contraceptive access is a reality for all.” 

Jamie L. Manson, MDiv (she/her), president of Catholics for Choice, released the following statement –  

“The FDA’s decision to approve Opill, the first-ever over-the-counter birth control pill in the United States, is an historic victory for the 98% of sexually active Catholic women who have used contraception. In a time when reproductive rights are constantly under threat from misinformation and attacked by religiously motivated extremists, the approval of this safe and highly effective medication is also a victory of science over scare tactics and doctors over doctrine. I was proud to testify at the hearing to recommend that contraception be made available without a prescription, and Catholics for Choice will continue to advocate for policies that equip every person to make their own sexual and reproductive healthcare decisions, without undue interference from church or state.” 

We are grateful to the funders of Free the Pill, whose belief in our vision and support of our approach to partnership were instrumental in helping us achieve this victory.