CHPA Statement on FDA Announcement of Public Meeting on Over-the-Counter Monograph User Fees

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Press Releases and Statements | May 10, 2016

(WASHINGTON, D.C.)  The Consumer Healthcare Products Association (CHPA) issued the following statement following the Food and Drug Administration’s (FDA) announcement of a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs.

“The Consumer Healthcare Products Association (CHPA) welcomes the opportunity to participate in a public meeting on the potential development of a user fee program for nonprescription Monograph drugs. We look forward to participating in this meeting.

“Over-the-counter (OTC) medicines provide an enormous benefit to public health by providing convenient, accessible, and affordable relief to consumers suffering from a wide range of common ailments and conditions. OTC medicines are highly prevalent in our healthcare system – approximately 60 percent of all pharmaceuticals consumed are OTC medicines. We agree with FDA’s assessment that ‘FDA is critically under-resourced in this regulatory area’ and look forward to discussing whether a targeted user fee program could spur innovation and provide a more flexible and responsive Monograph system.

“However, as FDA points out in the Federal Register notice, the regulatory system for nonprescription Monograph drugs is very different from that of other drugs currently under other user fee programs. Fees can create certain incentives and disincentives for activity subject to the fee. A public discussion on the concept of user fees for the OTC Monograph products will shed more light on the pros and cons of trying to apply a user fee system to these products.”

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.