U.S. FDA delays panel meeting on Perrigo's OTC birth control pill

[October 27, 2022]  WASHINGTON (Reuters) -The U.S. Food and Drug Administration has delayed a meeting of its advisory panel to discuss Perrigo Co Plc's over-the-counter (OTC) contraceptive, the drugmaker said on Wednesday.

The meeting, scheduled for Nov. 18, was delayed to review additional information, and no new date has yet been set, in a setback for what was expected to be the first approved daily OTC birth control pill in the United States.

Contraceptives have been in focus since abortion rights were sharply curtailed by the U.S. Supreme Court's decision about four months ago to overturn the landmark Roe v Wade ruling.

The health regulator had also extended the decision date for a possible approval decision by 90 days, Perrigo said.

"The meeting has been postponed to allow the agency additional time to review new information. The postponement does not indicate or affect any decision regarding the application," said an FDA spokesperson.

Birds are seen on the logo of generic drugmaker Perrigo Co outside their new factory in the city of Yeruham, in southern Israel March 2, 2016. REUTERS/Amir Cohen/File Photo

"The FDA will announce advisory committee meeting updates in the Federal Register and remains committed to a timely review of this application," the spokesperson added.

The drug, Opill, has been used with a prescription since its approval in 1973.

A spokesperson for Perrigo said the company still expects a decision in 2023.

(Reporting by Manas Mishra in Bengaluru, Trevor Hunnicutt, and Ahmed Aboulenein in Washington; Editing by Vinay Dwivedi, Sriraj Kalluvila and Cynthia Osterman)

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