U.S. regulators will hold a joint meeting in May to review whether Perrigo Co.’s birth-control product Opill can be sold without a prescription.
The Food and Drug Administration’s Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee will virtually meet on May 9 and May 10 to review the company’s application, according to a company statement on Tuesday.
The FDA did not immediately respond to a request for comment.
If approved, Opill would become the first daily, over-the-counter oral contraceptive in the U.S., removing a substantial barrier to access many Americans have faced. Reproductive-rights advocates have long argued that oral contraception should be available without a prescription, as it is in more than 100 other countries.
Perrigo’s HRA Pharma unit sought FDA approval in July 2022 after the Supreme Court overturned the landmark decision, Roe v. Wade.
Also called norgestrel, Opill is available via prescription. Other birth control options such as Plan B can be obtained over the counter. They are known as emergency contraceptives and not for daily use.
The meeting of outside advisers to the U.S. Food and Drug Administration was initially scheduled for mid-November, but was postponed to allow extra time for the agency to evaluate additional information about the product.
Shares of Perrigo, a generic-drug maker, were up 1.2% at 2:31 p.m. in New York.
