Dodd calls for FDA to restrict pediatric cough-cold medicines

WASHINGTON Sen. Chris Dodd, D-Conn., who is currently campaigning for president, last week added his voice in calling for the Food and Drug Administration to err on the side of caution in restricting the marketing of pediatric cough and cold medicines for use in children under the age of six.

“I write today to urge the Food and Drug Administration to take swift and comprehensive action on the recommendations of the recent joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee which discussed the safety and efficacy of over-the-counter cough-and-cold products marketed for pediatric use,” Dodd wrote in a letter addressed to FDA commissioner Andrew von Eschenbach. “As the author of the Best Pharmaceuticals for Children Act, an initiative that has generated more data about the safe and effective use of medications in children than any other in history, I am deeply concerned for the safety of children using these products when their efficacy has not been adequately established and safety has been called into question.”

Safety, however, is not necessarily an issue, argued the Consumer Healthcare Products Association in the aftermath of the October FDA meeting. “The data clearly show that these medicines are very safe when used as directed and that harm to this age group [children under six], while very rare, is attributable in most cases to accidental ingestion—an issue of safekeeping that is best addressed through education,” stated Linda Suydam, CHPA president. “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,” she said. “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.”

Dodd criticized the FDA for recommending that parents continue to follow the directions on their kids cough-cold medicines despite a majority vote by a pair of FDA advisory committees against marketing kids cough/cold medicines to children under six. “In response to the strong votes by the FDA’s advisory committees, officials at the FDA are quoted in press reports as merely urging parents to continue following directions on these products. I find FDA’s comments deeply troubling as it is these very directions that have been identified as misleading to parents,” Dodd wrote.

Dodd called on FDA to keep him updated on “the FDA’s plan for acting.”