CHPA Statement Regarding FDA’s Proposed Rule for Additional Conditions for Nonprescription Use

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CHPA’s President and CEO, Scott Melville, today released the following statement in response to the FDA releasing a proposed rule on "Nonprescription Drug Product with an Additional Condition for Nonprescription Use" (ACNU):

CHPA is pleased the FDA has issued this long-awaited proposed rule. Prescription to over-the-counter switches for certain pharmaceutical ingredients (“Rx-to-OTC switch”) have positively impacted U.S. healthcare over many decades by increasing consumer access to safe, effective, and affordable treatments and driving down healthcare costs for individuals and systems.

“Creating a modernized framework that allows more prescription medicines to be safely switched using innovative approaches has the potential to reduce healthcare costs even further, provide greater efficiency, and encourage more consumer self-care by increasing the availability of certain products that would otherwise be available only by prescription.

“CHPA looks forward to reviewing the proposed rule and submitting comments to FDA.”

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.