An increasing number of drugs once obtainable only by prescription are now becoming available over the counter. FDA is seeking input on OTC drug labeling to help better communicate information to consumers. In announcing the first of several public hearings on the subject, the agency said it believes a "standardized format" for OTC labels like the "Nutrition Facts" box on food labels would help consumers know what information to look for and where to find it on the label. FDA is particularly interested in what design features should be made consistent on all labeling, the terminology that should be used, the order of the information and type size. The hearings also will examine how consumers currently use label information, how labeling would affect consumer choice among competing products, and how labeling "influences consumer judgments and behaviors that are necessary for the safe and effective use" of drugs, particularly those that are switching from prescription to OTC status.
Standardized label redux: first food, now pharmaceuticals
We're becoming a nation of self-prescribed pill pushers, and FDA is concerned that consumers need sufficient information to avoid potential problems.
Sep 30th, 1995