Kids’ Cough/Cold Combos Need Label Comp, Actual Use Studies – AC Panel

Recommendations by advisory committees could lead FDA to require label comprehension and actual use studies for multi-ingredient nonprescription cough/cold products for children.

At a joint meeting in Silver Spring, Md., on Oct. 19, members of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee voted unanimously that label comprehension and actual use studies be done prior to allowing marketing of combination products.

In a press briefing following the meeting, Office of New Drugs Director John Jenkins said the recommendation by the joint panel, if followed, would apply to all multi-ingredient products.

"We've got to take back and think about all the advice we heard. We have to do this essentially in two contexts. One is what do we want to say in the immediate term versus the rulemaking process that we have to proceed through [under] the Administrative Procedures Act since these are regulated through notice and comment rulemaking," Jenkins said.

In briefing materials issued prior to the meeting the Office of Surveillance and Epidemiology in FDA's drug center recommended convening a meeting to discuss eliminating multiple ingredient cough/cold products for children (¹ (Also see "FDA Floats Eliminating Multi-Ingredient Pediatric Cold Products" - Pink Sheet, 1 Oct, 2007.), p. 3).

However, Jenkins explained the committees did not recommend pulling the products off the market. "They did in the end overall recommend that combinations be available."

The recommendation came with requests for improvements in labeling, standardization of dosing cups and comprehension and actual use studies.

"Of course all of these combination drugs are out there and that's what we have to think about and regulate currently because to do the studies that we're being asked to do will probably take clearly on the order of two or three years to get efficacy studies, assuming the companies are aggressive in going and doing those studies for all the different indications, all the different age groups and all the different active ingredients," Jenkins said.

"It's a fairly significant number of studies that would need to be done to address all those questions," he added.

In a statement following the meeting, the Consumer Healthcare Products Association acknowledged the need for studies.

"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," CHPA President Linda Suydam said.

However, during the meeting, Suydam told the committee she disagreed with their assessment of the safety of the combination cough/cold products.

"Combinations are 75 percent of the market share and I believe if you would look at the data that this percentage, both by the FDA and by industry, that the events actually are about equal, which means that combinations are safer," she said.

The panel conducted votes on three questions related to children's combination cough/cold products.

The committees voted 14-4 that combination products should be allowed to be marketed for children ages 2 to under 6, with the assumption the ingredients are safe and effective. They voted 15-3 to allow marketing the products for children ages 6 through 11.

However, the committees unanimously agreed label comprehension and actual use studies should be done prior to allowing marketing of combination products.

The committees also discussed improving the usage and indication language on product labeling.

They voted against the use of terms similar or related to "Dr. Recommended" on products' principle display panels, with only one member dissenting vote due First Amendment-related labeling issues.

"I find the use of 'Dr. Recommended' particularly egregious and I think from this day forward this has no validity and if it continues to be used it's used to mislead people. I would strongly recommend that that language not be used," said PAC Chairwoman Marsha Rappley, a neurology and psychiatry specialist and a dean's office officials at Michigan State University's College of Human Medicine.

- Jessica Lake ([email protected])