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FDA urged to act on cough/cold medicines

This article was originally published in The Tan Sheet

Executive Summary

Sen. Chris Dodd, D-Conn., has urged FDA Commissioner Andrew von Eschenbach to provide an update on FDA's plan for acting on the recommendations of its advisory committees regarding a "no use" suggestion for cough and cold medicines for children under the age of 6 due to safety concerns. In a letter dated Nov. 1, Dodd asks FDA to take "aggressive action" on the issue, suggesting "at a minimum, these products should be immediately relabeled to reflect the recommendations" of the advisory committees. A senior Democrat on the Senate Committee on Health, Education, Labor and Pensions and the chairman of its Subcommittee on Children and Families, Dodd notes he is "troubled" that agency officials have been quoted in press reports as "merely urging parents to continue following directions on these products" when the panels found the labels to be misleading. He also expresses concern FDA will act slowly on the issue, citing its regulatory approach on issuing a final monograph for sunscreen UVA/UVB protection...

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