The FDA has identified a date for its long-awaited advisory committee meeting to discuss whether Perrigo’s birth control medication Opill can be used without a prescription.
The joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee has been set for May 9-10, Perrigo said in a release.
The meeting was originally scheduled for Nov. 18, 2022, before the FDA decided to delay the process. Perrigo had been hoping for an approval in the first half of 2023.
The regulatory process for the contraceptive has been closely watched after the U.S. Supreme Court’s decision in June of last year to overturn the 1973 Roe v. Wade case that legalized abortion nationwide. Since then, 14 states including Texas, Wisconsin and Georgia have banned most abortions.
If the FDA signs off on allowing over-the-counter use, Opill would become the first daily contraceptive drug available. It has been in use with a prescription for 50 years and is widely considered “safe and effective,” according to the American Academy of Family Physicians (AAFP).
In addition to support from the AAFP, the switch of Opill to nonprescription use is endorsed by the American College of Obstretricians and Gynecoologists and the American Medical Association (PDF), Perrigo points out.
Typically, an Rx-to-OTC switch application must include efficacy and safety data to show that the drug works in the nonprescription setting. In some cases, new clinical trials may be necessary. Drugmakers must also provide data demonstrating consumers understand how to use the drug properly without the supervision of a healthcare professional.
Perrigo acquired Opill in May of last year when it bought out HRA Pharma in a $1.9 billion deal. In its most recent financial report, Perrigo created a new “women’s health” category, which also includes HRA Pharma’s ellaOne, an emergency contraceptive.
Another company hoping to gain an over-the-counter nod for its birth control pill is Cadence Health.