Judge: FDA Arbitrary in Calling Product a Drug

A U.S. district court judge concluded the FDA “acted arbitrarily and capriciously” in designating a drug-device combination product as one in which the drug is the primary mode of action, scoring a win for French devicemaker Prevor. The product, Diphoterine Skin Wash, is a first aid spray used to stop the progress of chemical burns. It was submitted for FDA review in 2009, at which time the Office of Combination Products assigned it to the Center for Drug Evaluation and Research.
International Medical Device Regulatory Monitor