D.C. CIRCUIT CORRECTS FDA’S ABUSE OF DISCRETION IN DRUG VS. DEVICE DETERMINATION

Citing agency experience and expertise, courts have long afforded federal agencies discretion in administering their respective statutes.  But, in Genus Med. Techs., LLC v. United States FDA, 2021 U.S. App. LEXIS 10928, 994 F.3d 631 (D.C. Cir. 2021), the U.S. Court of Appeals for the District of Columbia Circuit decided that the Food and Drug Administration had taken that leeway too far. Sarah Koblitz writes more about it at the article linked above.