Drugmakers Warning was FDA's Idea

When drug makers made a suprise announcement that they no longer recommend cough and cold remedies for children under 4, they didn't let on that it was the governments idea. And why at age 4 rather than 6 like pediatricians wanted? Because the FDA suggested that, too. FDA officials proposed the cutoff this year in private discussions with the industry, government and industry officials confirmed Friday. The maneuvering is an example of how government health officials and the industries they regulate seek to come to an accommidation behind the scenes on tricky issues. In this case, there is scant evidence that the widely used over-the-counter medicines really work in children. "There is a delicate dance between how much legal authority the FDA has and their use of the bully pulpit for getting some sort of comprimise," said Dr. Joshua Sharfstein, Baltimore's health commisoner. He and other pediatricians have asked the FDA to ban the cold products for children under 6. A panel of independent advisers to the FDA strongly seconded the recommendation. But the agency took a different approach. The FDA says it settled on age 4 after a careful data review and a vigorous internal debate. Emergency-room data show that most of the problems involve kids under 4, but the FDA would not release the hospital data. Still, some of the FDA's independent advisers question the under 4 recommendation. "There was no data suggesting that the drugs were effective in kids under 12," said Sean Hennesey, a professor of epidemiology and biostatistics at the University of Pennsylvania. "I don't see how that's a fully rational approach to the problem."

Fort Worth Star-Telegram Sunday, 10-12-08