FDA advisers vote unanimously in favor of over-the-counter birth-control pill

By Eleanor Laise

The nonbinding vote recommends that the agency approve Perrigo's oral contraceptive for use without a prescription, with a final FDA decision possible late this summer

U.S. Food and Drug Administration advisory committees meeting jointly on Wednesday voted unanimously to recommend that the agency approve the first daily over-the-counter birth-control pill.

The 17 panel members all said that the benefits of making Perrigo Co.'s (PRGO) Opill available for use without a prescription would outweigh the risks. The joint committee's vote is not binding, but the FDA often follows advisory committee recommendations.

The recommendation came despite some safety and data concerns that the FDA had raised in advance of the meeting. "The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out over the counter," Dr. Katalin Roth, a member of the FDA's nonprescription drugs advisory committee, said at the meeting after casting her vote in favor of over-the-counter availability. "The history of women's contraception is a struggle for women's control over their reproduction, and we need to trust women," Roth said.

If ultimately approved by the FDA, over-the-counter availability of birth-control pills would remove barriers that often prevent people from accessing a highly effective form of contraception, some doctors and health policy experts say. "As a physician, birth-control pills are one of the safest medications I can prescribe to my patients," Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health, a research program based at the University of California San Francisco, said in a statement. He added that "removing the medically unnecessary prescription requirement will mean that more people can get care without barriers."

The FDA could make a final decision by late this summer, experts say, and if given the green light, Opill could be on drugstore shelves at some point next year. Cost remains a potential barrier to access, because many private health-insurance plans aren't required to cover FDA-approved contraceptives without a prescription.

More than three out of four women age 18 to 49 favor making birth-control pills available without a prescription if research shows the pills to be safe and effective, according to a 2022 survey by health-policy nonprofit KFF.

Opill, first approved for prescription use in the U.S. in 1973, was marketed by Pfizer for more than 30 years. HRA Pharma, a French drugmaker acquired by Perrigo last year, acquired the rights to the pill in 2015 with the intention of applying for over-the-counter approval. Considering the pill's long track record, "it would therefore take a very high bar of concern to justify nonapproval of over-the-counter status, given what we know about this medication," Dr. Eve Espey, a professor at the University of New Mexico and an FDA panel member, said at the meeting Wednesday.

One question raised by the FDA was whether women who currently have or previously had breast cancer would appropriately avoid taking the pill. Given the various concerns raised by the FDA, "I was surprised it was unanimous," with no panel members abstaining from the vote, said Michelle Long, a senior policy analyst at KFF. Several panel members expressed confidence that the groups at risk would understand that the pill isn't recommended for them.

The Opill over-the-counter development program, conducted over the last eight years, included studies demonstrating that consumers could understand the over-the-counter label, use it correctly based on the label and follow the dosing instructions, Perrigo said in a statement Wednesday.

The vote is "a new, groundbreaking chapter in reproductive health," Perrigo president and CEO Murray Kessler said in a statement. Perrigo's stock gained 4.5% on Wednesday, while the S&P 500 gained 0.4%.

-Eleanor Laise

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05-10-23 1634ET

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