Perrigo Announces New Date for Joint FDA Advisory Committee Meeting to Review Opill® Daily Oral Contraceptive for OTC Use

Rhea-AI Summary

Perrigo Company plc (NYSE: PRGO) announced a rescheduled FDA meeting set for May 9-10, 2023, to review their application for the Opill^® daily oral contraceptive for over-the-counter (OTC) availability. If approved, Opill^® would be the first OTC daily birth control pill in the U.S. This initiative is supported by key medical organizations advocating for increased access to contraception. The establishment of a dedicated Women's Health strategic organization reflects Perrigo's commitment to addressing women's health needs, aiming to empower individuals with affordable contraceptive options.

Positive

• FDA meeting scheduled for May 9-10, 2023, to review Opill's OTC application.
• Opill could become the first OTC daily contraceptive in the U.S., expanding market opportunities.
• Strong support from major medical organizations enhances the potential for approval.
• Creation of a dedicated Women's Health strategic organization indicates focus on growth in this sector.

Negative

• No guarantee of FDA approval for OTC sale of Opill.
• Potential delays in meeting could impact the timeline for product launch.

DUBLIN, March 28, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, today announced that the U.S. Food and Drug Administration (FDA) has rescheduled a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) for May 9 & 10, 2023, to review the Company's application for Opill^® daily oral contraceptive for over-the-counter (OTC) use.

Perrigo announced in July 2022 that its HRA Pharma affiliate filed an application with the FDA for the Rx-to-OTC switch of Opill^®, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill). If approved, Opill^® would be the first ever daily birth control pill available OTC, without a prescription, in the U.S. 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.

Women's Health is one of Perrigo's strategic growth pillars. Having recognized its importance to society and its growth potential, the Company has recently created a dedicated global Women's Health strategic organization, with specific focus on the sexual health needs of women. From expanded contraceptive options, to products that help people understand and manage their fertility, to helping women adjust to perimenopause, the Women's Health strategic organization will partner with women and people as experts in their own bodies and sexual health to help provide them with support and solutions at every step. The Company believes access to affordable birth control is an important next step and will work diligently with the FDA to gain its approval.

"Women's needs are nuanced, and it's about time their health options reflect that," said Frederique Welgryn, Global Vice President for Women's Health. "At Perrigo, we're not only committed to prioritizing women's health – we're committed to being active champions for it. We're reimagining a new world where people are empowered to determine their own sexual health journey and access the solutions they want."

Perrigo Women's Health Strategic Organization's Purpose & Mission are available at here.

About Perrigo

Perrigo Company plc (NYSE: PRGO) is a leading provider of Consumer Self-Care Products and over-the-counter (OTC) health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at www.perrigo.com. 

Forward-Looking Statements

Certain statements in this press release relate to future events and may therefore be considered "forward-looking statements". Forward-looking statements involve known and unknown risks, uncertainties and other factors, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by such statements. Often such factors may be beyond our control, including risks and uncertainties regarding the occurrence and timing of regulatory activities, such as the FDA advisory committee meeting described above. While the Company believes that the FDA advisory committee meeting has been scheduled, there can be no assurances that such meeting will occur, or that it will not be postponed or otherwise rescheduled. Nor can the outcome of that meeting be predicted. In particular, there can be no assurance that the FDA will approve the sale of daily oral contraceptives without a prescription in the United States. The foregoing and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2022, as well as the Company's subsequent filings with the United States Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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SOURCE Perrigo Company plc

FAQ

What is the purpose of the FDA meeting scheduled for May 9-10, 2023, regarding Perrigo?

The FDA meeting aims to review Perrigo's application for the Opill daily oral contraceptive to be available over-the-counter.

What would the approval of Opill mean for Perrigo?

Approval would allow Opill to be the first daily oral contraceptive available OTC in the U.S., significantly expanding Perrigo's market presence.

Which medical organizations support the OTC availability of Opill?

Support comes from major organizations including the American College of Obstetricians and Gynecologists and the American Medical Association.

What strategic steps is Perrigo taking in women's health?

Perrigo has created a dedicated Women's Health strategic organization to focus on women's sexual health needs, including affordable contraceptive options.

What risks does Perrigo face regarding the FDA's decision on Opill?

Perrigo faces uncertainties as there is no assurance that the FDA will approve the OTC sale of Opill or that the scheduled meeting will not be postponed.