FDA to Review Perrigo’s Birth Control Pill for Over-the-Counter Use

By Reuters
September 14, 2022 Updated: September 14, 2022

Perrigo Co. Plc. said on Monday that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of external experts on Nov. 18 to review the application of its daily birth control pill for over-the-counter (OTC) use.

Contraception access has taken the spotlight since the U.S. Supreme Court’s decision in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide.

The FDA meeting for Perrigo’s prescription drug, Opill, is set to happen about four months after unit HRA Pharma’s application to the health agency. If approved, it will be the first daily OTC birth control pill in the United States.

“While this [the review] is moving quickly, FDA confirmed this is still within timelines of a standard review,” a spokesperson for HRA said. Perrigo’s unit had earlier said a period of about 10 months is typical for such requests and that it was expecting a decision from the health regulator in the first half of 2023.

Pro-abortion activists have also stepped up calls to make abortion drug mifepristone available without a prescription. Mifepristone in combination with misoprostol induces an abortion up to 10 weeks into a pregnancy.

Opill, a non-estrogen contraceptive, has been used with prescription since its approval in 1973.