CHPA Statement on FDA Notice of Part 15 Public Hearing on OTC Monograph System

Washington, D.C. (February 21, 2014) — The Consumer Healthcare Products Association (CHPA) issued the following statement in response to the Food and Drug Administration’s (FDA) notice of a public hearing and request for comments on the Over-the-Counter (OTC) Drug Review (the Monograph system):

“Each day, consumers rely on the more than 100,000 OTC products for convenient, real-time relief of symptoms associated with pain, colds, allergies, heartburn, skin conditions, and other ailments. CHPA members strongly support the OTC Monograph system, which effectively and efficiently regulates the majority of OTC medicines on the U.S. market.  The system ensures consumers have access to a wide variety of safe and effective medicines, while at the same time providing FDA with access to important information on safety and quality.

“Since 1972, the OTC Monograph system has provided a regulatory structure for FDA to evaluate the safety and efficacy of thousands of OTC products by category rather than face a review of tens of thousands of individual New Drug Applications. However, the rule-making process has slowed in recent years, and we’re hopeful FDA will share its perspective on why that is the case at the public hearing.

“CHPA welcomes an opportunity to highlight the consumer and public health benefits of the OTC Monograph system, as well as the opportunity to provide suggestions for improving it."

Contact: Elizabeth Funderburk, 202.256.5677 or Jenni Terry, 703.380.2764


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. @CHPA