Perrigo obtains FDA OK for Opill OTC daily oral contraceptive
Perrigo has received the Food and Drug Administration’s permission for Opill, a progestin-only daily oral contraceptive, for over-the-counter use for all ages. Opill is the first-ever birth control pill available over the counter in the United States.
In May 2023, the FDA's Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee voted unanimously 17 to 0, with no abstentions, that the benefits of making Opill available for OTC use, outweigh the risks.
Opill, which consists of 0.075 mg norgestrel, will be available in-store and online at major retailers across the United States early in the first quarter of 2024.
[Read more: Perrigo’s HRA Pharma submits FDA application for OTC birth control]
"Today marks a truly momentous day for women's health nationwide," said Patrick Lockwood-Taylor, president and CEO of Perrigo. "Opill has the potential to radically transform women's access to contraception and is a true testament of Perrigo's unwavering commitment to deliver impactful solutions that truly make lives better."
Nearly 50 years of use and scientific evidence demonstrate that progestin-only pills such as Opill are effective at preventing pregnancy and are safe for most women to use. OTC oral contraception has support from major medical organizations including 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 said.
"Today's approval is a groundbreaking expansion for women's health in the U.S., and a significant milestone towards addressing a key unmet need for contraceptive access," said Frederique Welgryn, global vice president for women's health at Perrigo. "Perrigo is committed to making Opill, which is now the most effective method available OTC at preventing pregnancy, accessible and affordable to women and people of all ages. I want to thank the FDA and its advisory panels, the Free The Pill coalition, the numerous medical organizations and advocacy groups, and all those who wholeheartedly supported this enormous undertaking that has made today a giant leap for women's empowerment."
Of the 6 million pregnancies in the United States each year, 45% are unintended. Nearly one-third of adult U.S. women who have ever tried to obtain a prescription or refill for a contraceptive pill, patch or ring reported difficulties doing so. Removing the prescription requirement for Opill improves access to a contraceptive method that is effective and well tolerated for all ages of women and people who can get pregnant, the company said.
"Today's approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States," said Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research. "When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy."
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“Today’s historic action by the FDA is a major step forward in helping American women meet their reproductive health needs. More than 40 million U.S. women are at risk of experiencing an unexpected pregnancy each year, and this landmark approval removes barriers and increases access to a safe and effective contraceptive option. This Rx-OTC switch, and other first-in-class switches, provide groundbreaking public health benefits by empowering consumers to take greater control over their own health,” said Scott Melville, president and CEO of the Consumer Healthcare Products Association.