The Food and Drug Administration’s (FDA) joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee to review the application for the prescription (Rx) to over-the-counter (OTC) switch of Opill®, a progestin-only daily birth control pill, has been rescheduled for May 9 and 10, 2023.
Opill contains 0.075mg of norgestrel, a single active steroid ingredient. According to scientific evidence, progestin-only pills like Opill have been shown to be effective for the prevention of pregnancy and are safe for most women to use.
In 8 US clinical studies with Opill, 2173 women completed at least 1 cycle and 648 completed at least 13 cycles providing a total of 21,856 28-day cycles of exposure in women aged from 15 to 49 years. The pregnancy rate was reported to be approximately 2 per 100 women-years.
While not bound to the committees’ recommendations, the FDA does take them into consideration when making regulatory decisions. If the Rx-to-OTC switch is approved, Opill would be the first daily oral contraceptive pill available without a prescription.
Medical organizations, such as the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians have all expressed support of OTC access for oral hormonal contraceptives.
- Perrigo announces new date for joint FDA advisory committee meeting to review Opill® daily oral contraceptive for OTC use. News release. Perrigo. March 28, 2023. https://www.prnewswire.com/news-releases/perrigo-announces-new-date-for-joint-fda-advisory-committee-meeting-to-review-opill-daily-oral-contraceptive-for-otc-use-301783374.html.
- Opill®. Package insert. 2017. Accessed March 28, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf.