08212017Headline:

Charlottesville, Virginia

HomeVirginiaCharlottesville

Email Greg Webb Greg Webb on LinkedIn Greg Webb on Facebook
Greg Webb
Greg Webb
Attorney • (800) 451-1288

Drugmakers Issue Warning on OTC Cold Medicines for Children – After the FDA Prompts the Move

Comments Off

Drugmakers recently announced that they did not recommend over-the-counter cough and cold medicines for children under 4 years of age. What they did not say in the announcement was that one year before, pediatricians and a panel of independent advisors to the Food and Drug Administration strongly recommended that the FDA ban cough and cold remedies for all children under the age of 6. In private discussions with the pharmaceutical industry, however, the FDA recommended the cutoff be age 4. The drugmakers have apparently claimed the idea as their own.

The FDA chose to recommend age 4 instead of age 6 after an internal debate and an investigation of emergency room data; according to the data, most problems involve children under the age of 4, but the FDA would not release the figures. In a letter to Commissioner Andrew C. von Eschenbach, Senator Christopher J. Dodd (D-Conn.) stated that he was “disappointed that the FDA has not followed the recommendations of its own advisory panel.”

Though the doctors recommending bans on pediatric cold and cough medicines are pleased with the progress, many believe the FDA should make further restrictions. According to some doctors, the medicines are not effective in, nor should they be available over-the-counter for, children under the age of 12.

A cynic might view this announcement by the drug companies as an attempt to show what good corporate citizens they are, when in fact they merely made the move before they were forced to do so. Thus, they could turn the announcement into a public relations and marketing strategy. In reality, this announcement may take money out of the already substantial cash coffers of the drug industry.