The first over-the-counter (OTC) birth control pill has arrived in the U.S.
Nearly 50 years after norgestrel’s original green light, Perrigo’s oral contraceptive Opill has converted its prescription approval into an OTC nod. The FDA thumbs-up comes two months after the progestin-only tablet won unanimous backing at an FDA meeting of outside experts, paving the way for nonprescription use in patients of all ages.
“Today marks a truly momentous day for women’s health nationwide,” Perrigo’s chief executive officer Patrick Lockwood-Taylor said in a statement, adding that the OTC approval has the potential to “radically transform women’s access to contraception.”
Opill has been around since the early 1970s. With reproductive rights at an inflection point in the U.S., support for an over-the-counter birth control approval has been mounting. Backing has come from the likes of the American College of Obstetricians and Gynecologists, the American Medical Association, the Society for Adolescent Health and Medicine and the American Academy of Family Physicians, Perrigo highlighted.
The company added that some 45% of the 6 million pregnancies that occur each year in the U.S. are unintended. What’s more, nearly one-third of U.S. adult women who’ve ever tried to obtain a prescription or refill for a contraceptive pill, patch or ring reported difficulties doing so.
Perrigo plans to make over-the-counter Opill available online and on U.S. shelves early in the first quarter of 2024.
Back in May, a joint FDA meeting of outside experts voted 17 to 0 in favor of Opill’s over-the-counter pivot. The unanimous vote came despite a number of questions from the FDA about responsible nonprescription use of the hormonal contraceptive in the real world.
Nevertheless, many panelists argued that the risks of unplanned pregnancy are much higher than those posed by Opill.
The regulatory race for over-the-counter Opill has garnered much attention in the wake of the U.S. Supreme Court’s decision last June to overturn Roe v. Wade.
Meanwhile, Opill marks the second instance of a prescription drug winning over-the-counter approval in 2023. Back in March, Emergent BioSolution’s overdose reversal drug Narcan, also known as naloxone, made a historic pivot to nonprescription status.
That approval specifically covers 4mg Narcan nasal spray, which Emergent aims to make available in places like drug stores, convenience stores, supermarkets and gas stations by late summer.