On July 13, 2023, the Food and Drug Administration (“FDA”) approved the first daily contraceptive for use without a prescription.[i] Opill® (norgestrel) tablet, .075 mg has been approved to prevent pregnancy in individuals of all ages and can be available for consumer purchase at pharmacies, grocery and convenience stores, and online.

Opill® History

Opill® was originally approved in 1973 as a prescription-only daily oral contraceptive. In contrast to many other oral contraceptives, Opill® is progestin-only. The process for the prescription to non-prescription switch was initiated in 2015 when Laboratoire HRA Pharma (“HRA”) (now owned by Perrigo Company plc. (“Perrigo”) met with the FDA for guidance on a nonprescription development program. In 2022, HRA submitted a supplemental application and major amendment to the supplemental application for a full prescription to nonprescription (“Rx-to-OTC”) switch. Earlier this year, on May 9-10, 2023, the FDA held a Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (“Advisory Committee”) after which the panel of advisers unanimously voted that the potential benefits of nonprescription Opill® outweighed the risks.

Opill® Rx-to-OTC Switch

In order to market a prescription drug product as nonprescription, a sponsor may initiate the change under the New Drug Application (“NDA”) process. An Rx-to-OTC switch may be full or partial. After a full switch, a drug is only available as a nonprescription drug. A full switch requires an efficacy supplement to an approved NDA or a 505(b)(2) application. Alternatively, in a partial switch, some indications of a drug retain prescription status while other indications are nonprescription. A partial switch requires a new NDA. An Rx-to-OTC switch requires efficacy and safety data demonstrating that the drug is safe to use in a nonprescription setting, consumer behavior data demonstrating that consumers can understand how to use the drug without the intervention of a healthcare professional, and post-marketing safety surveillance data.

Opill® was approved for a full Rx-to-OTC switch, after overcoming some challenges in the application. Although the FDA highlighted uncertainty caused by improbable results in the Actual Use study, it ultimately reached the approval decision based upon the totality of evidence and a favorable benefit vs. risk determination. Additionally, final labeling of the nonprescription drug may change as pre-specified thresholds for comprehension were met for all but two endpoints in the Label Comprehension Study for the Drug Facts Label.[ii]

Key Takeaways

The FDA’s approval decision is notable for many reasons. First, the decision to approve the request reflects the FDA’s commitment to reproductive health as the Advisory Committee’s vote is non-binding and the FDA is not required to follow the vote of the Advisory Committee. The approval has also been met with support from a variety of medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists. Second, as noted by the FDA, nonprescription availability of Opill® will likely reduce barriers to contraception access and significantly impact the number of unintended pregnancies, which are linked to negative maternal and perinatal outcomes. Perrigo has stated that it is committed to making the pill accessible and affordable, and that it is establishing a consumer assistance program to provide Opill® free of charge to some individuals. Opill® is expected to be available online and in retail stores in early 2024. Finally, this landmark approval may also pave the way for other contraception methods, such as pills with estrogen or contraceptive patches, to be available without a prescription.

FOOTNOTES

[i] FDA, “FDA Approves First Nonprescription Daily Oral Contraceptive” (July 13, 2023), available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive.

[ii] Full FDA Decisional Memorandum available here.