Statement from the Consumer Healthcare Products Association on Today's Joint FDA Advisory Committee Recommendations Regarding Pediatric Over-the-Counter Cough and Cold Medicines

Washington, D.C.—Following is a statement by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), regarding the recommendations issued today by the U.S. Food and Drug Administration’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee. At a meeting this week, the joint committee addressed the use of over-the-counter cough and cold medicines in children.

“For decades, parents and other caregivers have relied upon and trusted pediatric cough and cold medicines to relieve symptoms of the common cold in children and provide real comfort to children with runny noses, congestion and coughs.

“We believe that some of today’s advisory committee recommendations support and confirm the risk-management efforts we have proposed. However, other recommendations – notably the split vote to make single active ingredients no longer available for use in children under six years old – if adopted by FDA, would unduly limit parents’ access to medicines that work and are safe when taken as directed. The committee’s split majority vote on this matter clearly did not reflect a consensus of opinion, and we hope the FDA will weigh this recommendation with great caution. Adoption of this recommendation would leave parents with no over-the-counter medicinal relief when their children are suffering from cold symptoms.

“The data clearly show that these medicines are very safe when used as directed and that harm to this age group, while very rare, is attributable in most cases to accidental ingestion – an issue of safekeeping that is best addressed through education.

“Over-the-counter cough and cold medicines with multiple ingredients play an important role in relieving suffering from the common cold. It is easier and more practical to treat a child with a multiple symptom relief product. And the data presented at the advisory committee meeting show that multiple-ingredient products are as safe if not even less susceptible to misuse.

“Today, the advisory committee decided that there was insufficient evidence in pediatric populations to support efficacy. This is an issue we will address with FDA. We are already planning pharmacokinetic studies in children, which are the first step toward confirming correct dosing, and we will work with FDA to design appropriate pediatric clinical efficacy studies.”

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CHPA is the 126-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.

www.chpa-info.org

07-20/EA