CHPA Statement on Status of Industry Efforts to Modernize the OTC Monograph System, Including Discussions on a User Fee Program

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(WASHINGTON, D.C.) —  Since the Food and Drug Administration’s (FDA) March 25, 2014 Part 15 public hearing on the OTC Drug Monograph, the Consumer Healthcare Products Association (CHPA) has been in discussions with FDA and relevant committees in Congress to identify potential enhancements that would update and modernize this regulatory framework for most nonprescription medicines.

CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive, and accommodating to innovation. We recognize that resource constraints would affect the ability of FDA to implement any potential monograph reforms, and we are open to discussing ways of adequately funding reforms, including consideration of a user fee program for OTC drugs.

Following the FDA Public Meeting on OTC Monograph User Fees on June 10, 2016, we have entered the stage of discussion that will include detailed talks about the parameters of a potential user fee framework. Any such framework would require Congressional action. The FDA will post public minutes of these meetings on its website.

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.