The Food and Drug Administration has indefinitely postponed a joint meeting between two outside panels to review the first application for over-the-counter birth control.
The meeting, which was initially scheduled for Nov. 18 between the FDA’s Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee, was set to decide whether to recommend Opill, a once daily oral contraceptive, for over-the-counter use.
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“FDA postponed the meeting in order to review additional information requested related to the Opill Rx-to-OTC switch,” said Perrigo, which owns drugmaker HRA Pharma, which sought over-the-counter approval for Opill in July. “The Company will continue to work collaboratively with the FDA to ensure a timely and thorough review.”
A new date for the meeting has not been set, and the FDA extended a timeline to make a final decision on the drug’s approval by 90 days.
It’s unclear how the setback will affect the drug’s application, though typically reviews of such drugs take 10 months. The FDA told Axios that it remains “committed to a timely review” of the application.
If Opill is approved, it would be the first daily birth control pill available without a prescription.
The meeting between two of the FDA’s advisory committees was highly anticipated because proponents claim that easier access to contraceptives is critical as some states implement more restrictive abortion laws following the Supreme Court decision in June to overturn Roe v. Wade.
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“The FDA has an opportunity to make this change and reduce barriers by prioritizing the timely review of the first-ever application for an over-the-counter birth control pill. This change is urgent, long overdue, and would enable people to have greater control over their health and futures,” said Victoria Nichols, project director of Free the Pill.
