CHPA Applauds Progress as FDA Moves Forward on First-Ever Switch Application for OTC Oral Contraception “Opill”

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(WASHINGTON, DC) — Consumer Healthcare Products Association (CHPA) President and CEO, Scott Melville, today released the following statement in response to the U.S. Food and Drug Administration’s (FDA) announcement of a joint meeting between its Advisory Committees on Nonprescription Drugs and Obstetrics and Reproductive and Urologic Drugs. The meeting has been scheduled for Nov. 18, 2022.

“CHPA’s mission is to empower self-care by preserving and expanding choice and availability of beneficial consumer healthcare products​,” said CHPA CEO and President, Scott Melville, “and pathways like Rx-to-OTC switch are instrumental in carrying out that mission on behalf of our member companies and American consumers. We are pleased to see FDA evaluating broadened access to oral contraception and we look forward to sharing industry perspectives at this joint Committee meeting in November. Should the sponsor’s application ultimately be approved, based on the additional scientific data provided, this switch will pave the way for women to have increased access to healthcare products that meet their reproductive health needs.”

Background:

According to survey results released by Data for Progress in July 2022, an overwhelming majority of adults across the U.S. consider birth control to be a basic and essential part of women’s health care. Providing OTC access to daily oral contraception is a long-sought objective for women’s health advocates, care providers, and policymakers that is also supported by more than 70 percent of voters in the U.S.

On July 11, 2022, HRA Pharma, a Perrigo Company, applied for the first-ever Rx-to-OTC switch for a daily birth control pill.

Rx-to-OTC switches have had a tremendously positive impact on U.S. healthcare over many decades by increasing consumer access to safe, effective, and less expensive treatment options. With more than 120 ingredients, indications, or dosages making the switch from Rx to OTC status since 1976, eight occurring within the past five years, CHPA hopes to see even more applications for switch before the FDA. OTC access has proven to greatly enhance the availability and affordability of healthcare.

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.