CHPA Statement on Part 15 Public Hearing on OTC Monograph System

Makers of OTC medicines say system can be improved without overhaul

Washington, D.C. (March 25, 2014) —Consumer Healthcare Products Association (CHPA) issued the following statement in response to the Food and Drug Administration’s (FDA) public hearing and request for comments on the Over-the-Counter (OTC) Drug Review (the Monograph System): 

"The Consumer Healthcare Products Association welcomes the opportunity to take part in today's public hearing at FDA about the future of the OTC Monograph System," CHPA President and CEO Scott Melville said. "The way OTC products are currently regulated has been demonstrably effective for more than 40 years. While the rulemaking process has slowed in recent years, we believe it can be improved without undermining an effective, sensible system that has served the public well for more than four decades.

"Most OTC medicines available to consumers today are regulated under the OTC Monograph System and include nearly 300 ingredients and several hundred thousand products, ranging from antacids to diaper rash creams, from analgesics to cough/cold products.  Consumers should be confident that these products are safe and effective when used as labeled and are strictly regulated by FDA."

"We look to FDA to provide a clearer understanding of the challenges to completing the unfinished Monographs, and we remain committed to working with FDA to identify and implement these improvements."

For CHPA’s recommendations to FDA, see CHPA’s testimony overview.

Contact: Jenni Terry, 202.429.9260 


The Consumer Healthcare Products Association (CHPA) is the 133-year-old trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system $6-$7, contributing a total of $102 billion in savings each year. CHPA is committed to promoting the increasingly vital role of over-the-counter medicines and dietary supplements in America’s healthcare system through science, education, and advocacy.