FDA Reviewing Application For OTC Contraceptive

If approved, Perrigo’s Opill would be the first nonprescription birth control pill ever.

The FDA has rescheduled1 a joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee for May 9 & 10, 2023, to review the Perrigo’s application for Opill. The nonprescription Opill consists of 0.075 mg norgestrel and is a progestin-only daily birth control pill, which is also referred to as a mini pill or non-estrogen pill. The prescription Opill is not currently marketed.

HRA Pharma, a Perrigo company, had submitted its application in July 2022, and the advisory committee meeting was originally scheduled for Nov. 18, 2022, but in October 2022, the FDA postponed the meeting in order to review additional information requested related to the Opill Rx-to-OTC switch.

“The days of the current prescription requirement – a barrier that disproportionately impacts Black, Indigenous, Latina/x, Asian Americans, Native Hawaiian and Pacific Islander communities, LGBTQ+ folks, young people, people with disabilities, and those working to make ends meet – are numbered,” Victoria Nichols, project director of Free the Pill, a project of Ibis Reproductive Health, said in a statement.2

Over-the-counter birth control has support from major medical organizations including the American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians.

“Over 100 countries round the world currently provide oral contraceptive pills over the counter without a prescription. The AAFP supports over-the-counter access to oral contraception without a prescription,” the American Academy of Family Physicians said in a statement.

Officials from the American College of Obstetricians and Gynecologists said access barriers are one reason why women may not use contraception. They support OTC use without age or cost restrictions. One national survey of 1,385 women reported that among the 68% of people who had ever tried to obtain a prescription for hormonal contraception, 29% had problems accessing the initial prescription or refills.

Perrigo has indicated the application includes an indication that has no age restrictions.

For Rx-to-OTC switches, the FDA requires sponsors to conduct two pivotal trials that demonstrate consumers can understand the label and how to use the drug safely.

While Perrigo has not released its data, a study3 published online last year in Perspectives on Sexual and Reproductive Health found that study participants understood the label information required for safe use without clinician involvement. Investigators surveyed 63 adults and teens aged 12 to 49 years of age. They found that 10 of the 11 primary endpoints were understood by more than 95% of participants. The remaining primary endpoint on use with prior blood clots was understood by 89% of participants.

1. Perrigo Announces New Date for Joint FDA Advisory Committee Meeting to Review Opill® Daily Oral Contraceptive for OTC Use. Press release. Perrigo. March 28, 2023. Accessed March 29, 2023. https://investor.perrigo.com/2023-03-28-Perrigo-Announces-New-Date-for-Joint-FDA-Advisory-Committee-Meeting-to-Review-Opill-R-Daily-Oral-Contraceptive-for-OTC-Use
2. https://freethepill.org/latest/fda-schedules-advisory-committee-meeting-for-over-the-counter-birth-control-pill-to-take-place-may-9-10. Free The Pill. Press release. March 28, 2023. Accessed March 29, 2023. https://freethepill.org/latest/fda-schedules-advisory-committee-meeting-for-over-the-counter-birth-control-pill-to-take-place-may-9-10
3. Grindlay K. Key K. Bradford RD. Amato C. Blanchard K. Grossman D. Pilot label comprehension study for an over-the-counter combined oral contraceptive pill in the United States. November 9, 2022. Accessed March 29, 2023. https://doi.org/10.1363/psrh.12214
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