GRAND RAPIDS — Perrigo Co. plc is now scheduled to make a pitch in May to federal regulators who will decide whether to approve an over-the-counter daily birth control pill for the U.S. market.
The company said today that the U.S. Food and Drug Administration rescheduled a joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee for May 9 and 10 to review an application seeking approval for the Opill daily oral contraceptive.
Last fall, the FDA delayed consideration of Perrigo’s over-the-counter Opill application to review additional information requested from the company.
If the FDA approves, Opill would become the first daily birth control pill available in the U.S. without a prescription. Perrigo would produce Opill as part of its Women’s Health division that the company seeks to build as a strategic growth pillar.
In announcing the re-scheduled FDA review, Perrigo said it “believes access to affordable birth control is an important next step” for the Women’s Health division and that it “will work diligently with the FDA to gain its approval.”
“Women’s needs are nuanced, and it’s about time their health options reflect that,” Frederique Welgryn, global vice president for Perrigo Women’s Health division, said in a statement. “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.”
Perrigo’s Women’s Health division in 2022 generated sales of $32 million, an increase of 155 percent that was driven primarily by the addition of brands from affiliate HRA Pharma, a European maker of over-the-counter self-care products. Perrigo bought HRA nearly a year ago for $1.9 billion.
HRA Pharma last July filed an application with the FDA to switch the Opill daily birth control pill to OTC status in the U.S. In an investor presentation in February, the company estimated the U.S. market for daily oral contraceptives at $3.7 billion.
President and CEO Murray Kessler said last summer that he believes Opill “has the potential to be huge for the company,” especially after the 2022 U.S. Supreme Court decision that overturned the landmark Roe v. Wade decision on abortion. He cited consumer studies that indicate 30 percent of consumers “still say it is very difficult to get access to birth control pills, and we will be providing access at an affordable price with an everyday birth control pill, and giving everything else that’s happening in the world, especially the U.S. right now, I think the timing is right for it.”