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

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Press Releases and Statements | Jul 12, 2016

(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.

Founded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system more than $7, contributing a total of $146 billion in savings each year. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products.