FDA Will Rewrite Rules For Marketing for Children

The Food and Drug Administration will rewrite decades-old federal regulations governing how over-the-counter cold and cough medicines are marketed to children amid concerns over whether the products are safe and effective.

[FDA to Rewrite Marketing Rules] 

The FDA is revisiting marketing rules.

As part of that effort the agency held a daylong hearing Thursday to solicit views about how the rules should be changed. While the effort is expected to take years, the end result could be a tougher regulatory environment for many over-the-counter cold and cough products — such as requiring drug makers to seek approval for their products in a manner similar to that for prescription drugs.

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.