As researchers that have supported building evidence around contraceptive safety, effectiveness and interests, we were thrilled when the U.S. Food and Drug Administration (FDA) announced they had approved Opill - a progestin-only pill (POP) - for over-the-counter use.
Finally, after decades of advocacy and research, birth control pills will soon be accessible without a prescription for people of all ages in the United States. As we mark World Contraception Day, we're closer than ever to breaking down barriers to contraception. Opill is expected to be on the shelves in early 2024 at pharmacies, retail stores and available online — and it will be a gamechanger for contraceptive access nationwide.
This accomplishment would not have been possible without the hard work and expertise of the Free the Pill coalition, a group of over 200 reproductive health, rights, and justice organizations, youth activists, health care providers, researchers, medical and health professional associations and others – all dedicated to improving and expanding contraceptive access. Ibis Reproductive Health established this coalition in 2004 to build evidence in support of over-the-counter oral contraceptives and in 2016, through an open process, partnered with HRA Pharma (now Perrigo) to submit an application to the FDA to make a POP available over-the-counter.
Research has also shown that people can accurately self-screen for contraindications to POPs and make the correct decision about whether or not a POP is safe and appropriate for them to use.
It is about time that people in the US have more equitable access to birth control pills. Providers understand and research shows that the prescription requirement has made it difficult to obtain and consistently use birth control, as many people encounter challenges scheduling or getting to an appointment and have trouble paying for a visit to a providers' office.
Due to systemic inequities, these barriers to accessing contraception are disproportionately experienced by certain populations, including Black, Indigenous, Latina/x, Asian American, Native Hawaiian, and Pacific Islanders, young people, immigrants, LGBTQ+ folks, people living in rural communities, and those working to make ends meet. But now, with Opill approved for over-the-counter access, people of all ages across the country will soon be able to get an oral contraceptive without a prescription and we hope that individuals and communities that have found it difficult to obtain contraceptive care will benefit the most.
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Although medical organizations have noted that all types of birth control pills should be available over the counter, the coalition decided to pursue a POP as the first pill to move OTC in the US because it is appropriate for almost anyone who may need contraception. Since they do not contain estrogen, POPs are safe for nearly all people, including those who are breastfeeding, are over 35 and smoke, or have certain health conditions like migraines with aura, blood clots, or heart disease.
Research has also shown that people can accurately self-screen for contraindications to POPs and make the correct decision about whether or not a POP is safe and appropriate for them to use. Beyond their strong safety record, POPs are also highly effective at preventing pregnancy. If used correctly and consistently (perfect use), it is estimated that POPs are about 99% effective and when taken incorrectly or inconsistently (typical use), it is estimated that POPs are about 93% effective. A recent review found that POPs may be even more effective than previously believed, estimating that only two pregnancies would occur if 100 people took the pill for a year compared to the seven pregnancies that have previously been estimated with typical use.
And though current guidance for POPs calls for them to be taken at the same time each day within a three-hour window, recent research suggests that for some POP formulations, including Opill, there is likely a wider window of time for maintaining efficacy if a pill is missed or delayed.
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Birth control pills are already available over the counter in over 100 countries and we're thrilled the U.S. will finally be joining that list. An over-the-counter birth control pill will help ensure more people can access the contraception they need without unnecessary barriers. And as we work towards a more equitable health care system, we hope the availability of an over-the-counter POP will pave the way for other types of hormonal methods to move over the counter, increasing accessibility and reproductive health care options for people in the US.
Carmela Zuniga and Katherine Key are Associate Research Scientists at Ibis Reproductive Health, which operates Free the Pill, a campaign to educate and engage in support of over-the-counter birth control pills in the United State.