(NEW YORK) — Advisory committees of the U.S. Food and Drug Administration are meeting Tuesday and Wednesday to review the first-ever application for an over-the-counter birth control pill.
At a joint meeting, the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee will discuss whether pharmaceutical company Perrigo can make its oral contraceptive Opill, which currently requires a prescription, to be available on store shelves.
First approved by the FDA in 1973, Opill is type of hormonal birth control pill known as the “minipill,” which some experts say poses fewer risks than combination pills that rely on estrogen.
Still, buyers would have to screen themselves for any health risk factors, much as they would other OTC medications.
During the meeting, the FDA will hear from the company as well as speakers who will advocate for the need of nonprescription birth control.
Committee members will debate the results of a study Perrigo conducted and there will be an opportunity for open public comment. A vote from the advisory committees is expected to come Wednesday.
If the advisory committees do recommend approval, the next step is approval from the FDA. Although the agency is not bound to follow the advisory groups’ recommendations, the FDA typically does not go against their guidance.
The FDA is expected to make a decision by the summer. If the OTC pill does get greenlit, it would not become available as quickly as COVID-19 vaccines, which were speedily rolled out after the advisory committee meeting to approve them due to the global emergency.
Perrigo, which filed the application in July 2022, argued that changing its pill from prescription to OTC use will improve access to affordable birth control.
“Women’s needs are nuanced, and it’s about time their health options reflect that,” Frederique Welgryn, global vice president for the Women’s Health initiative at Perrigo, said in a statement in March. “At Perrigo, we’re not only committed to prioritizing women’s health — we’re committed to being active champions for it. We’re reimagining a new world where people are empowered to determine their own sexual health journey and access the solutions they want.”
Groups such as the American Medical Association and the American College of Obstetricians and Gynecologists support making OTC birth control available to improve access, such as for those living in contraceptive deserts, where access to birth control is lacking.
“We know that barriers to accessing contraception contribute to non-use or inconsistent use of contraception,” Dr. Raegan McDonald-Mosley, CEO of nonprofit group Power to Decide, said a statement. “For people to achieve reproductive well-being and have the power to decide when and whether to become pregnant, we need to dismantle those barriers.”
She added, “As a practicing OB-GYN, I know that people can safely and effectively use a birth control pill without a prescription and without a doctor’s visit.”
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