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OTC Oral Contraceptive: In U.S. by Year’s End?

Americans could have access to a nonprescription, progestin-only oral contraceptive later this year if FDA follows the recommendation of an advisory committee. In a May 10 meeting, advisors voted unanimously “that the benefits of providing a progestin-only birth control pill over-the-counter outweighed the risks,” according to a JAMA news article.

“The agency is expected to act on the matter later this summer, and, if approved, Perrigo’s Opill (0.075 mg norgestrel) could be on drugstore shelves by the end of the year or the first quarter of 2024, Frédérique Welgryn, MS, global vice president for women’s health at Perrigo, told JAMA in a statement,” a reporter writes. “Perrigo already sells a 0.075-mg norgestrel pill, under the brand name Hana, without a prescription in the UK. The UK Medicines and Healthcare products Regulatory Agency approved switching progestin-only pills from prescription to nonprescription status in 2021. But the UK has a nonprescription category that requires consulting with a pharmacist before purchasing a drug, so technically, nonprescription progestin-only pills are available there from behind the pharmacy counter, not over-the-counter.…”

Source: JAMA