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FDA approves first OTC birth control pill

Parent company says Opill will be on store shelves early next year

External advisers recommended the approval of Opill over-the-counter birth control in May, even though the FDA voiced concerns about the company’s data.
External advisers recommended the approval of Opill over-the-counter birth control in May, even though the FDA voiced concerns about the company’s data. (Al Drago/CQ Roll Call file photo)

The Food and Drug Administration on Thursday approved HRA Pharma’s progestin-only birth control medication Opill, making it the nation’s first over-the-counter birth control pill.

“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 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.”

The daily pill is approved for all ages, though questions about coverage still exist — including coverage under insurance plans. Parent company Perrigo Co. did not announce a price but said the pill will be available in stores early next year.

“Today marks a truly momentous day for women’s health nationwide,” said Perrigo CEO Patrick Lockwood-Taylor. “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.”

The decision is a major victory for advocacy groups that have stepped up efforts to expand contraceptive access in the wake of the Supreme Court overturning the abortion-rights ruling Roe v. Wade in 2022.

“Amid nationwide attacks on reproductive rights, we celebrate this victory for equity, evidence-based research and reproductive freedom,” said Kelly Blanchard, president of Ibis Reproductive Health, which manages the Free the Pill Coalition.

More than 100 countries already offer birth control pills over the counter, according to the group.

External advisers recommended the approval by a vote of 17-0 in May, even though the FDA voiced significant concerns about the company’s data.

Officials questioned the reliability of the clinical trials after one-third of participants over-reported the number of pills they took. The agency also expressed concerns about the number of patients with irregular bleeding who did not consult a doctor. The problems nearly undid HRA Pharma’s application.

Opill has a better safety profile than combination pills that contain both progestin and estrogen. But the drug still carries a high risk for women with a history of breast cancer.

More over-the-counter birth control pills are likely on the horizon, though it’s unclear how soon. Cadence OTC previously announced plans to pursue over-the-counter clearance for its combination pill, though the FDA has yet to finalize the regulatory pathway the company is planning to use.

The news follows a June executive order from President Joe Biden to protect and expand contraceptive access. One provision directed the departments of Health and Human Services, Treasury and Labor to consider new ways to broaden access to affordable over-the-counter contraception.

Sandhya Raman contributed to this story.

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