FDA to rewrite cold medicine ad rules
The Food and Drug Administration is set to rewrite old regulations that dictate how cold and cough medicines can be marketed for children.
An estimated 95 million packages of children’s over-the-counter cold and cough medicines are sold each year in the U.S. under a range of brand names, including Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic and Wyeth’s Robitussin, according to industry estimates.
John Jenkins, the FDA’s office of new drugs director, said the system that currently governs over-the-counter cold and cough products was really designed to grandfather the over-the-counter medicines that were on the market in the 1960s. The system allowed certain active ingredients (such as those in decongestants) to be legally marketed without obtaining prior FDA approval for each individual product. The studies used to establish the safety of those ingredients were mostly done in adults; current dosing recommendations for kids are simply reduced from adult doses.
Information from: http://online.wsj.com/article/SB12229540...
