Meet the pharma company bringing birth control pills over the counter for the first time

As women’s reproductive rights in the U.S. come increasingly under attack, Paris-based HRA Pharma, acquired by the multinational conglomerate Perrigo, scored a significant win in simplifying access to birth control with the July 2023 FDA approval of the first over-the-counter daily oral contraceptive pill available in the U.S.



About one-quarter of U.S. women ages 15 to 44 who currently use contraception report using the pill as their method of choice. Opill (norgestrel) is a daily tablet that contains progestin only, a synthetic form of the hormone progesterone, versus currently available prescription birth control pills that use a combination of progestin and estrogen.



Opill has been available by prescription for about 50 years via a different manufacturer and is over 90% effective at preventing pregnancy with normal use. To get approval for OTC sales, HRA had to submit data showing, among other things, that consumers could understand how to use Opill without supervision and could correctly identify whether they had any contraindications, such as a history of breast cancer, that would preclude them from taking the drug.



Oral contraceptives are already available over the counter in many other countries—Opill should be available for purchase in the U.S. in the coming weeks. Perrigo has said retailers will carry Opill in supplies of one month ($19.99) and three-months ($49.99). The company will sell a six-month supply on its website for $89.99. It’s not clear whether insurers will cover it, but Perrigo has said it will administer a cost-assistance program to help people afford Opill.



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