In Brief: SmithKline Beecham
This article was originally published in The Rose Sheet
Executive Summary
SmithKline Beecham: Marketer of Aquafresh Sensitive requests FDA "OTC feedback" meeting to discuss "consumer confusion over the four-week limitation warning statement" on hypersensitivity toothpastes and the company's consumer marketing survey, methods and raw data on the subject. FDA required the warning in the September 1991 tentative final monograph for OTC oral health care drug products. SmithKline initially requested a feedback meeting in April 1993. However, FDA declined the company's request and asked SmithKline to submit raw data from the survey ("The Rose Sheet" June 21, 1993, p. 11). SmithKline submitted the survey data last July...