FDA may reevaluate policy on pediatric prescription drugs

WASHINGTON The recent announcement from the Food and Drug Administration’s Nonprescription Drugs and Pediatric Advisory Committees involving over-the-counter cough and cold medications could possibly call for the agency to reevaluate its policy on data concerning prescription medications.

The committees voted 21-1 that it was not appropriate to extrapolate data from adult clinical effectiveness studies to children between the ages of 2 and 12.

John Jenkins, director of the Office of New Drugs, said that many prescription antihistamines often are formulated in combination with such ingredients as antitussives and decongestants and the FDA does not require manufacturers to demonstrate that the combinations are effective. He apparently backed off from his statement during the meeting on Oct. 19 regarding the reevaluation of drugs that treat allergic rhinitis, saying the agency will have to look at the impact of the committees’ recommendations.

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