Prevor v. United States Food & Drug Administration

OPINION

ROSEMARY M. COLLYER, United States District Judge

After five years, Prevor and the Food and Drug Administration (FI)A) continue to dispute whether Prevor’s Diphoteri-neTM Skin Wash (DSW) should be regulated as a “drug” or a “medical device.” By giving unduly expansive meanings to certain language in the Federal Food, Drug, and Cosmetic Act, FDA declared DSW to be a drug. On remand from this Court, FDA hardly changed its reading of the statute and relied on an arbitrary standard that contravenes the plain meaning of the law. Accordingly, the Court will deny FDA’s motion for summary…