FDA Panel Meeting Scheduled to Discuss Rx-to-OTC Switch of Oral Contraceptive Opill

The Food and Drug Administration (FDA) has scheduled a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) on November 18, 2022, to review the application for the prescription to over-the-counter (OTC) switch of Opill^®, a progestin-only daily birth control pill.

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.

The contraceptive works by suppressing ovulation in approximately half of the cycles in users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.

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.

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.

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