The French company that has asked for permission to sell birth control pills over the counter in the United States says the timing of its request to the Food and Drug Administration, coming soon after the Supreme Court’s decision overturning Roe v. Wade, is coincidental. That might be, but the court’s decision eliminating the constitutional right to abortion makes more urgent than ever the imperative of easily accessible birth control. As with any drug, the FDA must follow the science. But if over-the-counter birth control makes sense — and for years it has worked safely in other countries — the agency should approve it as soon as possible.
Paris-based HRA Pharma announced last week that it has applied to the FDA for approval to switch Opill, a progestin-only daily oral contraceptive licensed for prescription use in 1973, to over-the-counter use. If approved, it would be the first time Americans would have access to oral contraceptives without the need to obtain a prescription from a health professional. Another pill manufacturer, Cadence Health, has been discussing with the FDA switching its progesterone-estrogen combination to over-the-counter sales in hopes of also submitting an application.
About half of all pregnancies in the United States are unintended, according to the Guttmacher Institute. The requirement for a prescription can create barriers for women who don’t have easy access to a health-care provider because of cost, lack of transportation or child care, and privacy and confidentiality concerns. Making the pill available without a prescription could be particularly helpful to women in rural, poor and marginalized communities.
Oral contraceptives have been safely used by millions of women in the United States for six decades. They are available over the counter in more than 100 countries, and clinical trials have shown them to be safe and reliable. The chief health risk — blood clots in veins — is rare, occurring in less than 1 in every 1,000 pill takers per year. Major medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, have voiced their support for making birth control pills available without prescription.
Birth control is certainly no substitute for access to abortion care, but it is key to people making choices about their bodies, and can help in preventing unintended pregnancies and thereby reducing abortions. There should be timely review of this request, as House Democrats urged in a letter to the FDA sent even before the court’s misguided ruling in Dobbs v. Jackson Women’s Health Organization. And if the application passes scientific muster, we hope the FDA doesn’t repeat the mistake it made in its approval of over-the-counter use of the emergency contraception pill, Plan B, when it imposed age limits.
Another issue will be affordability. A spokesperson for HRA Pharma promised the company would make Opill “very affordable for consumers” — though it is unclear what that would mean. Insurance companies are now required under the Affordable Care Act to cover the expense of prescription contraceptives, and a bill before Congress would require insurance companies to cover the cost of over-the-counter pills as well. With states rushing to cut off access to abortion, and birth control looming as a potential battleground in the war over reproductive rights, it is important that the FDA make this matter a priority.