Opill launches as the first OTC birth control pill in the US

This is a statement from Ibis Reproductive Health, which operates Free the Pill:

Today, in a historic step forward for contraceptive access, Perrigo announced that the first-ever over-the-counter (OTC) birth control pill, a progestin-only birth control pill (POP) called Opill, is now available for pre-order from select online retailers and is expected to be on store shelves at major retailers nationwide in the coming weeks. After a comprehensive review of the data and a unanimous advisory committee vote to recommend Opill for OTC status, the FDA approved Opill for people of all ages as the first OTC birth control pill in US history on July 13, 2023. Opill will soon be the most effective form of birth control available without a prescription in the United States and will impact countless people’s lives by allowing them the autonomy to take charge of their reproductive health without the unnecessary barrier of a prescription requirement. However, at a price of $19.99 per pack, there is more work to do to reduce cost barriers and ensure that Opill is equitably accessible. 

Opill’s FDA approval was a movement-driven win that comes after 20 years 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. The Free the Pill coalition, which is operated by Ibis reproductive Health, recognized the potential of over-the-counter birth control pills to expand equitable access to contraception and has continued working since 2004 to make this vision a reality. Ibis’s partnership with Perrigo (formerly HRA Pharma) in 2016 paved the way for this first-of-its-kind Rx-to-OTC switch application, and coalition members’ written and oral testimony were key factors that helped inform the FDA advisory committee’s unanimous recommendation in May 2023 to make Opill available OTC and FDA approval without an unnecessary age restriction. 

The coalition’s ongoing commitment to using a reproductive justice framework and its adoption of a youth-adult partnership approach were critical to this win. And this focus on equitable access for all requires us to ensure that those who face the most barriers to access can benefit from OTC birth control pills. At Perrigo’s suggested retail price of $19.99 per pack, many people—especially those who currently face the most barriers to access due to systemic inequities and other forms of oppression—may not be able to afford Opill nor benefit from OTC access. Research and polling found that half of adult and teen respondents interested in using OTC birth control pills would be able to pay only $10 or less per month for the product. A monthly cost of $20 per pack will leave many people without access and others to choose between getting birth control OTC and maintaining their monthly budget. No one should be denied access to basic health care due to cost barriers. 

As we work toward our vision of equitable access to OTC birth control pills, we will continue to advocate for affordable options. We are glad to see that Perrigo has announced a cost assistance program for Opill to help ensure access for those for whom this price is out of reach. We look forward to learning more about the program, and reiterate our call on Perrigo to ensure it meets the equity priorities the Free the Pill steering committee recommended, including to ensure it is inclusive of people of all ages and accessible to those who face the greatest barriers to contraceptive care. We also urge Perrigo to make every effort to reduce the price, and to find ways to work with community-based organizations, clinics, and other interested partners to make free or no-cost Opill available to those who cannot pay this price. We will also double down on our advocacy at the state and federal levels, as well as with private insurers, to expand public and private insurance coverage of OTC birth control without a prescription requirement or co-pay. Meanwhile, we call on retailers to stock Opill visibly and without barriers nationwide, and to price Opill as affordably as possible to ensure access for everyone. This OTC switch will not be successful until Opill is accessible and affordable to everyone who wants and needs it, and no one is left behind. 

Free the Pill’s steering committee released the following statement— 

Today we mark a new era for contraceptive access and celebrate as the US will soon join over 100 countries worldwide where birth control is available without a prescription. This accomplishment is a testament to the Free the Pill coalition’s decades of collective organizing, resilience, and grit. Opill being over the counter will benefit countless people who rely on contraception to help plan their lives and futures. Still, the current price will create barriers for some, as due to systemic inequities, cost barriers fall harder on young people and those working to make ends meet. It is essential that we continue our efforts to ensure that there are other lower and no-cost options for accessing Opill, and that OTC contraception is fully covered by insurance and available without barriers for all who need it. 

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 – 

The first-ever over-the-counter birth control pill, Opill, will be available online and on store shelves in the coming weeks in the United States. This is a landmark moment for public health nationwide that reflects two decades of research and advocacy led by the Free the Pill coalition! As we celebrate this pivotal advance, we recognize that there is still work to be done to ensure that contraception is accessible to every person who wants and needs it. At $19.99 for a one-month supply, Opill’s suggested retail price will create barriers to access, especially for young people and those working to make ends meet. Due to systemic inequities, cost can mean the difference between people getting effective contraception or going without. We urge Opill’s manufacturer to implement a robust consumer assistance program to ensure access to the most effective over the counter contraceptive option for people who face cost barriers. Further, we urge our policymakers at the state and federal level to act now to ensure that over the counter birth control is fully covered by insurance without a prescription or cost sharing.

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

Today we celebrate an important and historic milestone—the first-ever over-the-counter birth control pill is shipping to retailers this week. This is a long overdue breakthrough made possible in part by the amazing work of the Free the Pill coalition partners and backed by decades of science and research. This transformation in access has the potential to be a game changer, especially for people who face barriers to contraception due to the structural racism in our health care system. Yet, at $19.99/pack MSRP, Opill will remain out of reach for many people working to make ends meet. Our commitment to bringing a birth control pill over the counter has always centered on equity, and we are committed to ensuring that the company, retailers, and the Biden administration are doing everything in their power to guarantee access for everyone. Insurance coverage, a robust consumer assistance program, and getting OTC birth control into clinics and communities where people can access it at no charge are critical. We will continue our work to advocate for and test ways to make sure everyone has access to this amazing advancement in contraceptive availability.

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 are thrilled to see Opill become available over-the-counter and can’t wait for it to be stocked in pharmacies across the country. This is a long-overdue victory that gets Latinas/xs and other communities of color closer to being able to make meaningful decisions about whether and when to become parents. Over-the-counter access to birth control will greatly reduce the barriers like transportation, cost, language, and documentation that prevent Latinas/xs from getting the care they need. Now, we must ensure that all of our communities can benefit from this historic moment. We call on retailers nationwide to price Opill affordably and stock it on store shelves without barriers, and insurers to fully cover this without a prescription or cost-sharing.  

At the Latina Institute, we are committed to building power in Latino/x communities across the country so that everyone has access to the healthcare they need. We are proud to be a part of the Free the Pill coalition that advocated for Opill to be priced affordably, and we look forward to helping our communities learn more about this safe and effective birth control pill.

Maia Lopez, a 17-year-old organizer with Advocates for Youth and Free the Pill coalition steering committee member, released the following statement –  

After years of organizing for over-the-counter birth control, I’m thrilled that young people like me will finally be able to access Opill without a prescription. As a high school student in Texas who struggled to get on The Pill under the current system, and faced social stigma while trying, I know firsthand how important it is to ensure young people can walk into a store and easily access the contraception they need. While today is a huge step forward, the price is still steep for many teenagers I know. I don’t want Opill to be inaccessible to people who already face barriers from strict contraceptive policies. Our work is not done until every young person can afford and access Opill.

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 – 

This is a truly historic milestone for reproductive health in the United States. A robust body of evidence—including studies I have led—indicates that birth control pills can be taken safely and effectively without a prescription. Opill will help address the barriers to birth control that far too many people face far too often. Still, this price point could pose a financial barrier to some patients who need care. I look forward to learning more about Perrigo's consumer assistance program and supporting efforts to expand insurance coverage for over-the-counter contraception.

Rochelle Rodney (she/her), co-executive director of the New York Birth Control Access Project and Free the Pill coalition steering committee member, released the following statement –  

Birth control allows people to make informed decisions about their lives and futures. That’s exactly why we’ve been working for years to expand access to contraception for New Yorkers. Now, with Opill being available over the counter, people across the country will be able to access one more tool that helps them make informed decisions about their reproductive health.

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

Today, in a historic move for reproductive health that could transform contraceptive 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 coalition’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. FDA approval is an important step forward, but we must ensure that OTC birth control pills are equitably accessible to all. To ensure equitable access we must continue to advocate for OTC birth control pills to be affordably priced 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 a 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 health care 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.

Biden issues executive order on improving access to contraception

Last Friday, the Biden Administration issued an executive order on “Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services”. The executive order includes an explicit directive to the secretaries of the treasury, labor, and HHS to explore ways to improve access and affordability for over-the-counter (OTC) contraception. This is welcome news that we hope will help advance contraceptive equity. We look forward to the administration taking action to meet the president's directives and address the systemic barriers that have for too long kept people from accessing the care they want and need.

The order comes one month after a joint advisory committee’s unanimous vote recommending FDA approval of Opill as the first-ever over-the-counter birth control pill in the United States, and one year after the Supreme Court released its final decision in Dobbs vs. Jackson Women’s Health, which eliminated constitutional protections for abortion in the country. This is a critical time for the Biden Administration to take immediate action to ensure that the full range of sexual and reproductive health care is equitably accessible. Affordability is a key issue that prevents people from accessing the care they want and need, and for many people, insurance coverage is a direct path to ensuring that cost is not a barrier. Insurance coverage, coupled with no out-of-pocket cost for this critical preventive health service, will have an enormous impact on expanding access for OTC contraception methods for people of all incomes across the country. This is a health equity and reproductive justice issue, and timely action is needed to improve access for all. 

Immediate steps can be taken to improve access and affordability of OTC contraception. We look forward to working in partnership with the administration to support specific actions that they can take to ensure that current and future FDA-approved OTC methods are fully covered without a prescription and without out-of-pocket expenses.  

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 –  

“As we await an FDA decision on whether to approve Opill as the first-ever over-the-counter birth control pill, we are glad to see the Biden Administration issue an executive order to improve access to affordable over-the-counter contraception and affirm the importance of insurance coverage for OTC birth control. We know affordability and insurance coverage are systemic barriers to accessing birth control and removing these barriers is critical for advancing equitable access. Ensuring that future over-the-counter birth control pills–in addition to existing OTC birth control options–are fully covered by insurance, priced affordably, and available to people of all ages is essential to ensuring equitable contraceptive access.” 

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 –   

“Birth control pills are safe and effective, but there are currently too many barriers to access them and for many this includes issues related to affordability and insurance coverage. Increasing access to birth control pills is crucial to the health and well-being of women, people capable of pregnancy, and families. We need policymakers to take action to ensure and enforce comprehensive coverage of OTC contraception without a prescription and with no out-of-pocket cost.” 

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.” 

FDA schedules advisory committee meeting for over-the-counter birth control pill to take place May 9-10

The FDA announced today that an advisory committee meeting is scheduled for May 9 and 10 to review the first-ever application for an over-the-counter birth control pill. In July 2022, HRA Pharma announced it had submitted this application to the FDA to switch Opill, a progestin-only, daily birth control pill, from prescription to over-the-counter status.

The two-day advisory committee meeting will begin on May 9, which also marks Free the Pill Day, a movement-led celebration to commemorate the anniversary of the FDA approving the first birth control pill in 1960. This Free the Pill Day, we’re truly closer than ever to birth control pills being available without a prescription in the United States.

Free the Pill has long advocated for a timely, science-based review of an over-the-counter birth control pill. In January 2022, the coalition sent a letter to FDA Commissioner Robert Califf emphasizing the importance of and strong science behind an over-the-counter pill. While the FDA initially scheduled this advisory committee meeting for November 18, 2022, they announced in October that they would postpone that meeting. On March 17, the coalition sent a letter to the Commissioner urging the agency to reschedule the meeting and commit to a timely review of the application.

Victoria Nichols, 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 –

After nearly two-decades of coalition-driven efforts, we are on the cusp of making birth control pills more equitably accessible. It’s time to free the pill and ensure that those who have long faced the most barriers to care due to systemic inequities have access to an over-the-counter birth control pill that is priced affordably and covered by insurance. The days of the current prescription requirement – a barrier that disproportionately impacts Black, Indigenous, Latina/x, Asian Americans, Native Hawaiian and Pacific Islander communities, LGBTQ+ folks, young people, people with disabilities, and those working to make ends meet – are numbered. As the FDA convenes its Advisory Committee meeting this Free the Pill Day, we’ll truly be closer than ever to birth control pills being available over the counter.

Dr. Daniel Grossman, director of the Advancing New Standards in Reproductive Health (ANSIRH) program at the University of California, San Francisco and Free the Pill coalition steering committee member released the following statement –

It is past time for the FDA to follow the science and make birth control pills available over the counter. Oral contraceptives are one of the safest medications I can prescribe to my patients, and the science is clear that they are safe and effective for over-the-counter use. The prescription requirement serves as a medically unnecessary barrier that continues to keep care out of reach.

Janette Robinson Flint, executive director of Black Women for Wellness released the following statement –

We are glad to see the FDA taking a step forward towards making over-the-counter birth control pills a reality. For too long, barriers to contraception have fallen disproportionately hard on Black women and other communities of color. Access to the full range of reproductive health care, including affordable and accessible over-the-counter birth control pills, is crucial for Black women to control our lives and our destinies.

Maia Lopez, an organizer with Advocates for Youth released the following statement –

As a 17 year old in Texas, I am thrilled that FDA-approved, over-the-counter birth control pills could finally become an option In the United States. Young people like me were recently banned from getting confidential access to birth control from health care providers in Texas, yet our peers in more than 100 other countries around the world can walk into their local drug store and buy birth control pills over the counter. Using birth control is a responsible thing to do. We should make it easier, not harder, for young people to protect their health.  The prescription-only requirement is a relic of the past that puts up barriers for young people who want to do the right thing. Young people like me trust the FDA to do their job and follow the science. I look forward to watching the hearing in May.

Birth control shouldn’t be something that’s only available to people who live in certain states or whose parents happen to be open to it. It is essential healthcare that every single one of us should have access to, no matter our age, race, income, or life circumstance.

Ibis responds to FDA’s announcement to postpone advisory committee meeting for over-the-counter birth control pill

We are frustrated and deeply disappointed by the FDA’s delay of the advisory committee meeting to discuss the application to move a progestin-only birth control pill over the counter (OTC). Birth control pills are safe and effective, and over-the-counter availability would expand equitable access to care. Given the decades of evidence and science showing that oral contraception is safe and effective for over-the-counter use, coupled with the urgency of the need, this delay is unnecessary and unjustified.

Increasing access to birth control pills by removing the prescription requirement is a public health priority, and now, more than ever, we need to increase access to the contraception people want and need. Every day we wait is another day longer where barriers remain in place preventing people from getting access to the contraceptive care they need. The FDA must prioritize reviewing the first-ever application for an OTC birth control pill and ensure an evidence-based decision, on their typical 10-month timeline, that reflects the decades of safe use and research and the broad public health benefit.

We call on the agency to set a new date immediately and continue their scientific review of the application in a timely manner.

Victoria Nichols, 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 –

We have decades of evidence supporting the safety and efficacy of birth control pills and research shows that the prescription-only model involves too many barriers due to systemic inequities. Now, more than ever, it is time to change our systems and policies so that they reflect the science, advance health equity, and serve to benefit public health. The FDA has an opportunity to make this change and reduce barriers by prioritizing the timely review of the first-ever application for an over-the-counter birth control pill. This change is urgent, long overdue, and would enable people to have greater control over their health and futures.

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

Just the other week, Vice President Harris met with young advocates from around the country and urged them to continue fighting for reproductive freedom. With the delay by the FDA, we're left wondering how strongly the administration will support that fight. Young people are disillusioned by empty words and looking for the administration to act. We urge the FDA to convene the advisory committee as soon as possible and to approve an over-the-counter birth control pill without delay.

Dr. Krishna Upadhya, an adolescent medicine physician and Free the Pill coalition steering committee member released the following statement – 

As a medical provider, I have seen many patients who experience barriers to contraception—and especially younger patients—who could benefit from more ways to access birth control pills. I support making birth control pills over the counter because the evidence is clear—oral contraceptives are safe and effective. The FDA must make it a priority to review the application to bring a  progestin-only birth control pill OTC.

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

We are in a health care crisis. Black, Indigenous, Asian American, Native Hawaiian, and Pacific Islanders, Latinx folks, and other people of color have been hit the hardest by new barriers states have erected to prevent people from accessing the care they need. We cannot wait another day; people need access now to tools to control their reproductive lives. This includes over-the-counter birth control pills.

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

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.