WASHINGTON, D.C: The rules dictating how cough and cold medicines for children are marketed in the US are set to undergo a shake-up, as the Food and Drug Administration seeks to allay fears over the safety and efficacy of available remedies.
The regulator held a hearing last week to discuss how the system should change, particularly as the current rules allow children's over-the-counter brands with certain ingredients to advertise without prior permission from the FDA.
Another area of concern is that the recommended dosage amount for children is typically based on scaling-down the quantity found to be appropriate for adults - methodology that may not be accurate.
John Jenkins, the director of the FDA's office of new drugs, said that the current system was "very limited in its flexibility as to how rapidly we can deal with safety issues".
Some 95 million OTC children's cough and cold medicines are sold every year, and Jenkins warned that an across-the-board advertising ban on these products could lead to parents substituting adult brands instead.
Data sourced from Wall Street Journal Online; additional content by WARC staff