Prevor v. United States Food and Drug Administration

OPINION

ROSEMARY M. COLLYER, District Judge.

PREVOR, a French company, developed a product called DiphoterineTM Skin Wash (“DSW”) to mitigate chemical burn injuries in the industrial workplace. PREVOR sues the Food and Drug Administration for declaratory and injunctive relief to change FDA’s designation of DSW as a drug-device combination product with a “drug” primary mode of action. PREVOR claims that FDA erred and thereby violated the Federal Food, Drug, and Cosmetic Act and the Administrative Procedure Act. FDA maintains that its determination was based on the clear language of its governing…