Update on Oct. 26 at 9:15 a.m. PT: The FDA announced it is postposting the meeting to review advocates’ application for over-the-counter birth control. The agency had previously scheduled the advisory committee meeting for Nov. 18.
“We are frustrated and deeply disappointed by this delay of the advisory committee meeting,” said Ibis Reproductive Health in a statement. (Ibis operates the Free the Pill campaign.) “Increasing access to birth control 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.”
“We are in a healthcare crisis,” said Monica Simpson, executive director of SisterSong. “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.”
Reproductive justice advocates recently achieved a major milestone: the U.S. Food and Drug Administration (FDA) received its first-ever application for an over-the-counter birth control pill. On July 11, HRA Pharma announced that it has submitted an application to the FDA to switch their progestin-only, daily birth control pill, called Opill, from prescription to over-the-counter status. If approved, this would be the first over-the-counter birth control pill available in the United States.
“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,” said Victoria Nichols, director of Free the Pill, a project of global nonprofit research organization Ibis Reproductive Health. “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.”
The FDA approved the birth control pill for distribution in the United States by prescription in 1960, but it is only available by prescription from a doctor or pharmacist. If the OTC application is granted, Opill would be available on the grocery shelf next to tampons and condoms.
“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 Nichols. “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’s 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.
“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. “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.”
Young people spoke out in favor of this important step closer to over-the-counter access to birth control.
“Now more than ever, young people need birth control that’s accessible, affordable and over-the-counter,” said Angela Maske, Strategic Projects manager and coordinator of the #FreethePill Youth Council. “We need tools to help us plan our lives and our futures. And we need policies that move us forward, not backward.”
Other young people agreed.
“As a young person, I’ve experienced first-hand the stress and pain caused by poor access to birth control. Often, as a young person, your healthcare is up to your provider *and* your guardian,” said #FreethePill Youth Council member Bex Heimbrock. “By making birth control over-the-counter, there will be no more undue stress or prejudice involved in getting basic healthcare.”
“In the midst of everything else going on it is so exciting and hopeful to see that the first application for an over-the-counter birth control pill has been submitted to the FDA,” said #FreethePill Youth Council member Lauren Schenck. “It is now more important than ever to have safe and affordable access to birth control for people of all ages, and making it over-the-counter will eliminate so many barriers to access. We will not stop until birth control is over-the-counter and accessible for all people regardless of age, race, gender, class or sexuality!”
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 American Medical Association passed a resolution on June 15 this year in support of removing the prescription requirement to birth control pills without an age restriction. The American College of Obstetricians and Gynecologists and the American Academy of Family Physicians also support over-the-counter access to birth control pills.
Some health care providers, however, warn that the progesterone-only birth control pill may not be the best option for most women. Reproductive expert Dr. Sophia Yen says personalized birth control options based on age, race, body mass index, lifestyle, etc. are necessary for the highest protection rate for many women.
Affordability is also a concern. Senator Patty Murray (D-Wash.) in June introduced the Affordability is Access Act, which would require insurance coverage of over-the-counter oral contraceptive and ensure retailers provide these contraceptives without a prescription.
“It’s not enough for an over-the-counter birth control pill to be available to women—it has to be affordable, too, and that’s why we need to pass my Affordability is Access Act,” said Senator Murray. “Once the FDA determines an over-the-counter option to be safe and effective for use without a prescription, it should be approved without delay and must be fully covered by insurance just like other FDA-approved birth control—and that’s exactly what my bill will do.”
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.”