Consumer Healthcare Products Association member companies are no longer advertising or promoting their cough/cold products for use by children under the age of 2, CHPA says.

A CHPA spokesperson told "The Tan Sheet" on Oct. 4 the change was already under way before House Committee on Oversight and Government Reform Chairman Henry Waxman sent the association a letter asking why the industry had not already removed the products from the market.

CHPA says member companies are individually working on transition plans to address the recommendations in the group's background materials released Sept. 27 for the upcoming advisory panel on pediatric cough/cold products scheduled for Oct. 18 and 19 (¹ Also see "FDA Floats Eliminating Multi-Ingredient Pediatric Cold Products" - Pink Sheet, 1 October, 2007., p. 3).

The advisory committees meeting will address concerns raised by public health officials and pediatricians regarding the safety and efficacy of pediatric cold products for young children (² Also see "FDA Review Of Children’s Cough/Cold OTCs Has Broader Implications" - Pink Sheet, 5 March, 2007., p. 3).

CHPA recommends changing instructions on pediatric cough/cold product labels from "Ask a Doctor" to "Do Not Use" in children under 2, and adding "Do not use to sedate children" or similar language for the antihistamine monograph.

Companies can make some voluntary label changes without regulatory approval, but CHPA advises members to work with FDA. CHPA says its members plan to make the changes as soon as possible.

Former FDA Nonprescription Drug Advisory Committee Chairman Randy Juhl told "The Tan Sheet" that firms could benefit from voluntarily removing from their product labels language or images referring to infants (³ Also see "Pediatric Cough/Cold Packaging No Place For Babies – Former NDAC Chair" - Pink Sheet, 3 September, 2007., p. 9).

Briefing Materials Spark Coverage

Waxman contacted CHPA as widespread reports drew attention to recommendations made by FDA offices as well as by CHPA in briefing materials prepared for the joint meeting of the NDAC and Pediatric Advisory Committee.

CHPA's report cites incidents where injuries occurred due to misuse of pediatric cough/cold medicines, while also stating that when used as directed, the medicines are safe and effective.

Multiple FDA reports also recommend labeling for OTC cough/cold drugs should indicate their use is not safe for children under 2.

Additionally, the agency's reports recommend adding "prominent language to describe the risk of overdose in children" to labeling of both prescription and OTC cough/cold products.

Waxman, D-Calif., commends CHPA for its labeling recommendations in an Oct. 3 letter to association President Linda Suydam.

However, he says evidence and information in the report suggest some currently available products should be removed from the market immediately and that the marketing of other products should be modified substantially.

Waxman highlights products including Novartis' Triaminic Instant Thin Strips Decongestant Plus Cough as examples of CHPA member products still being marketed for use by children under 2.

A Novartis spokesperson said the firm began the process of halting its advertising and promoting of infant products on Oct. 1.

Novartis supports the recommendations CHPA made to the FDA, which will be discussed further by an expert panel at the advisory committees meeting, the spokesperson said.

Waxman's letter asks what steps CHPA will to take to cease the marketing of pediatric formulations for children under 2 and why CHPA has not recommended marketing of these products is discontinued.

He also asks how the industry will explain to consumers why the medicines they have already purchased should not be given to infants.

Waxman asked CHPA to respond to his letter by Oct. 12. CHPA said it would respond on or before that date.

- Katie Stevenson (k.stevenson@elsevier.com)

Firms Stop Cough/Cold Product Promotions For Use By Infants – CHPA

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