FDA Designation of Prevor’s Chemical Skin Wash as ‘Drug’ was Arbitrary, Court Finds

WASHINGTON, D.C. — A federal judge has concluded that the Food and Drug Administration’s decision to designate a skin wash used to alleviate workplace chemical exposure as a drug, rather than a device, was arbitrary and needs to be reconsidered.

Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia did not order the agency to reclassify Prevor’s Diphoterine™ Skin Wash, which would allow different standards and costs for approvals, but concluded that the FDA failed to adequately explain its rationale.

Judge Collyer commented in her Sept. 25 opinion that the FDA’s post-decision issuance of …