Two manufacturers of contraceptive pills have been jockeying for FDA clearance to sell their medications over the counter for more than half a decade. Now, against the backdrop of an intense debate over reproductive rights, one of those drugmakers is officially in the running for an approval.
HRA Pharma has applied to the FDA for approval of what could be the first over-the-counter birth control pill in the U.S., the Perrigo-owned company said Monday. The move comes shortly after the Supreme Court’s decision to overturn Roe v. Wade, which has ignited a nationwide clash over reproductive rights.
HRA’s application specifically seeks to convert the prescription approval for the so-called mini pill or non-estrogen pill, dubbed Opill, into an over-the-counter approval.
At the same time, Cadence Health, another maker of birth control pills that’s been in talks with the FDA about converting its med’s approval into an over-the-counter one, said it hopes to move closer to submitting its application in the coming year, The New York Times reports.
HRA’s Opill won FDA approval way back in 1973. Unlike “combination pills,” which are more popular in the U.S. and include both progestin and estrogen, mini pills only contain the hormone progestin, which plays a role in the menstrual cycle and pregnancy, The New York Times explains.
"More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant,” Frédérique Welgryn, chief strategic operations and innovation officer at HRA, said in a statement. “Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers."
Almost half of the more than 6.1 million pregnancies in the U.S. each year are unplanned, HRA pointed out. The likelihood of a patient using effective birth control hinges on a range of methods and ways to access contraception, the company stressed.
HRA argues that by removing Opill’s prescription barrier, patients would enjoy improved access to a contraceptive method “that is well tolerated and notably more effective at preventing pregnancy than all current methods available [over the counter].”
Irish over-the-counter specialist Perrigo closed its roughly $1.9 billion acquisition of HRA in May. At the time, Perrigo pegged the buyout as a means to return to its “self-care roots.”
Cadence, for its part, has also been petitioning the FDA for an over-the-counter approval of its combination birth control pill, the NYT reports. Cadence still hasn’t received FDA backing to run its “actual use trial”—the study to determine how women use the pill in a real-world setting—which means it may be another year or two before the company can lodge its application with the FDA, the news service added.
On the heels of the Supreme Court’s recent abortion decision, supporters of reproductive rights have called on President Joe Biden to push the FDA to hasten its review of over-the-counter contraceptives, the NYT points out. Separately in March, scores of House Democrats inked (PDF) a letter to FDA Commissioner Robert Califf, M.D., petitioning for the “timely review” of any applications to take birth control pills over the counter, the newspaper reports.