FDA urged advice on meds

By The Associated Press Comments 0
Published: October 11, 2008

WASHINGTON — When drugmakers made a surprise announcement this week that they no longer recommend cough and cold remedies for youngsters under 4, they didn’t let on that it was the government’s idea.

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Taking precautions

The industry has taken other precautions as well. Drugmakers are advising parents not to give their children antihistamines to make them sleepy. The companies also are adopting better child-resistant packaging, and they are expanding an educational campaign aimed at parents.

Food and Drug Administration officials proposed the cutoff earlier this year in private discussions with the industry, government and industry officials confirmed Friday. The companies agreed, and this week announced they were "voluntarily” changing their advice to parents.

The maneuvering is an example of how government health officials and the industries they regulate seek to come to an accommodation behind the scenes on tricky issues.

In this case, there is scant evidence that the widely used over-the-counter medicines really do work in children. Emergency-room data shows that they sicken some 7,000 kids a year, mostly because of overdoses.

"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 compromise,” said Dr. Joshua Sharfstein, Baltimore’s health commissioner.

Sharfstein and other pediatricians have asked the FDA to ban cold products for children under 6. A panel of independent advisers to the FDA strongly seconded that recommendation. But the agency took a different approach.

"The analysis that led to the under-4 cutoff was performed by FDA,” said Rita Chappelle, a spokeswoman for the agency.

The FDA says it settled on age 4 after a data review and vigorous debate. The agency says it intends to revise rules for OTC cough and cold medicines and may eventually require changes that affect teens.