Based in Paris HRA-Pharma announced last week that it had applied to the FDA for approval to replace Opill, a progestin-only daily oral contraceptive cleared for prescription use in 1973 for over-the-counter use. If approved, it would be the first time Americans would have access to birth control pills without needing to get a prescription from a medical professional. Another pill maker, Cadence Health, has been talking to the FDA about moving its progesterone-estrogen combination to over-the-counter sales in hopes of submitting an application as well.
About half of all pregnancies in the United States are unintended, according to the Guttmacher Institute. Requiring a prescription can create barriers for women who do not have easy access to a health care provider due to cost, lack of transportation or child care, and privacy issues. Making the pill available without a prescription could be particularly helpful for women in rural, poor and marginalized communities.
Oral contraceptives have been used safely by millions of women in the United States for six decades. They are available over the counter in over 100 countries and clinical trials have shown them to be safe and reliable. The main health risk – blood clots in the veins – is rare, occurring within 1 in 1,000 pill takers per year. Major medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, have expressed support for making birth control pills available without a prescription.
Birth control is certainly not a substitute for access to abortion care, but it is essential for people to make choices about their bodies and can help prevent unwanted pregnancies and thus reduce abortions. There should be a speedy review of this request, as House Democrats urged in a letter to the FDA sent even before the court’s erroneous ruling in Dobbs v. Jackson Women’s Health Organization. And if the application passes the scientific test, we hope the FDA won’t repeat the mistake it made in approving the over-the-counter use of the emergency contraceptive pill, Plan B, when it imposed age limits.
Another issue will be affordability. A spokesperson for HRA Pharma promised that the company would manufacture Opill”very affordable for consumers— although it’s unclear what that would mean. Insurance companies are now required under the Affordable Care Act to cover expenses related to prescription contraceptives, and a invoice before Congress would require insurance companies to cover the cost of over-the-counter pills as well. As states race to cut off abortion access and birth control looms as a potential battleground in the war for reproductive rights, it’s important that the FDA make this issue a priority.