McNeil, Whitehall object to FDA studies of alcohol warnings for OTC analgesics.
This article was originally published in The Tan Sheet
Executive Summary
ALCOHOL WARNING ON ANALGESICS: McNEIL QUESTIONS RATIONALE, METHODS OF FDA STUDY to examine consumer comprehension of several possible versions of the label warning in Sept. 29 comments to FDA on the agency's Feb. 27 proposed revisions to OTC product labeling. McNeil points out the agency "routinely issues rules containing warnings for OTC drug products without consumer surveys," and questions "why FDA deems it necessary to conduct consumer research on this issue."