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FDA delays review of over-the-counter Perrigo contraceptive COURTESY PHOTO

FDA delays review of over-the-counter Perrigo contraceptive

BY Wednesday, October 26, 2022 06:01pm

Federal regulators have delayed a planned review for Perrigo Co. plc’s birth control pill to “review additional information requested,” company officials announced today.

The U.S. Food and Drug Administration postponed a scheduled Nov. 18 meeting of the joint Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee. The FDA wants to “review additional information requested” for the contraceptive, Opill, which is switching from prescription to over-the-counter use, the company said.

“The company will continue to work collaboratively with the FDA to ensure a timely and thorough review,” Perrigo said today in a statement.

Perrigo affiliate HRA Pharma in July this year filed an application with the FDA to switch the Opill daily birth control pill to over-the-counter status. If approved, the switch would allow Perrigo to bring to market in the U.S. the first daily birth control pill available without a prescription.

The FDA also extended a decision on Opill by 90 days, Perrigo said.

Perrigo has high hopes for Opill. The company’s filing to the FDA came soon after a June U.S. Supreme Court ruling that overturned the landmark Roe v. Wade decision that legalized abortion 50 years ago.

Perrigo President and CEO Murray Kessler said in a June investor presentation that Opill “has the potential to be huge for the company.”

“This filing represents a tremendous amount of work done by our HRA colleagues, and our commitment and their commitment to women’s health. It’s a meaningful step forward to expanding affordable access (to) daily birth control products for women in the U.S. at a time when it is most needed,” Kessler said in an August conference call with brokerage analysts to discuss second quarter results.

The “outcry of support for this filing was overwhelmingly positive,” Kessler said. Perrigo at the time had hoped to launch Opill in the U.S. in 2023, pending FDA approval.

A Raymond James analysts in June wrote in a note to investors that the Supreme Court ruling “is likely the catalyst needed to put (over-the-counter) access to oral contraceptives on the front page” and that there “is simply no company that could benefit more than (Perrigo) from a potential shift towards more accessible contraception options that could be catalyzed by the decision and the resulting financial impact could be significant.”

Perrigo reports results for the third quarter on Nov. 8.

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