Commentary: Arcoxia panel signals new FDA mind-set on drugs

04/17/2007 | Wall Street Journal, The

A former deputy commissioner at the FDA writes the advisory panel recommendation against Merck's Arcoxia has "dramatic implications" for the U.S. drug industry. Scott Gottlieb said the effect of that meeting was to establish new rules for approving drugs for conditions already served by other therapies, adding that it will "ultimately deny patients needed choices and it reflects a dangerous way of looking at drug development, safety, and, more importantly, the practice of medicine."

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