A panel of advisors to the U.S. Food and Drug Administration (FDA) unanimously voted on Wednesday to recommend the FDA approve the first over-the-counter birth control pill in the United States: Opill, a progestin-only birth control pill. The advisory panel decided the pros of making the pill available over the counter—including a significant increase in birth control access, especially for young women—outweigh any of the cons. Once approved, Opill would be available without an age restriction.
The decision does not mean the pill is available over the counter—yet. But the decision from the influential advisory panel marks a significant step toward making birth control more widely available.
“Opill is a safe and effective birth control pill that people of all ages should be able to access without the unnecessary barrier and delay of needing a prescription and mandated visits to a provider,” said Dr. Jamila Perritt, president & CEO of Physicians for Reproductive Health.
Opill, which is made of progestin, is not recommended for people who have had breast cancer. FDA scientists said their reservations about making the progestin-only birth control pill available without a prescription are whether women with medical conditions that should preclude them from taking the pill—mainly, breast cancer and undiagnosed vaginal bleeding—would self-select and avoid the product.
The FDA panel also raised questions about whether young people and people with limited literacy would be able to follow the directions.
Opill should be taken at the same time every day—even more so than when taking combination birth control pills, which contain both estrogen and progestin. Dr. Sophia Yen, co-founder and CEO of Pandia Heath, echoed this point during a Ms. webinar on contraception in August: “It’s not a very forgiving pill, but if you can take the pill at the exact same time every day plus or minus two hours, then you’re good.”
Even still, the FDA document also said the government body “does realize how very important women’s health is and how important it is to try to increase access to effective contraception for U.S. women.” The report emphasized how the value of making the oral contraceptive more readily available outweighed concerns like these.
“The people we care for are smart, savvy and resilient,” said Perritt, who is also a practicing board-certified ob-gyn. “They are aware of their needs and their goals regarding decisions about if, when and how they build their families, plan or prevent pregnancy.”
This recommendation from the FDA Advisory Committee is not only historic—it is simply the right thing to do.NARAL Pro-Choice America president Mini Timmaraju
The Feminist Fight for Over-the-Counter Birth Control
The FDA approved the birth control pill for distribution in the United States by prescription in 1960, but it is currently only available by prescription from a doctor or pharmacist.
“The prescription requirement is a barrier for many and can push birth control out of reach due to a potentially costly healthcare provider’s visit, taking time off school or work to get to the appointment and more,” said Victoria Nichols, director of Free the Pill, a project of global nonprofit research organization Ibis Reproductive Health. “These barriers are even more challenging for people who already face difficulties accessing essential healthcare because of systemic racism, including BIPOC, 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.”
For nearly two decades, Ibis Reproductive Health has spearheaded the campaign for over-the-counter birth control access. Its Free the Pill project is a coalition of over 100 national, state and local reproductive health, rights and justice organizations working to remove unnecessary doctor visits for prescriptions and give more people greater control over their reproductive health.
In 2016, Ibis partnered with the French pharmaceutical company HRA Pharma to conduct the research needed to submit the OTC application to the FDA.
On July 11, 2022, HRA Pharma announced it had submitted an application to the FDA to switch their progestin-only, daily birth control pill, called Opill, from prescription to over-the-counter status.
“After years of rigorous research, we are thrilled that an application for an over-the-counter birth control pill is now before the FDA,” said Ibis president Kelly Blanchard in July. “Decades of research and the 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.”
“As reproductive freedom in our country faces an unprecedented crisis, expanding access to proven, safe and effective contraception has never been more important. This recommendation from the FDA Advisory Committee is not only historic—it is simply the right thing to do,” said NARAL Pro-Choice America president Mini Timmaraju.
Almost half of the more than 6.1 million pregnancies in the U.S. each year are unintended. Research shows close to one-third of women have had trouble obtaining a prescription or refill for contraceptives. With a 99 percent success rate if taken properly, the pill is safer than many drugs already available over-the-counter.
“As a doctor, I am dedicated to empowering people to make decisions about pregnancy prevention. For many, a birth control pill may be the best option for them but requiring a prescription is an unnecessary obstacle that can put it out of reach,” said Dr. Melissa J. Kottke, an ob-gyn and professor at Emory University. ”Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health.”
The pill is already available without a doctor’s prescription in many countries around the world, including the United Kingdom as of July 2021.
“We look forward to the FDA following the science as they review the application,” said Blanchard, “and we will continue our work to ensure the policies are in place to ensure access for all.”
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