AER label comprehension study
This article was originally published in The Tan Sheet
Executive Summary
FDA has proposed a consumer comprehension study be conducted on labeling statement alternatives relating to AERs for Rx and OTC drugs, the agency announces in the Federal Register Feb. 2. The idea for the study came about as a result of an FDA proposed rule in 2004 which required all OTCs approved under an NDA or ANDA to add a toll-free number and other statements to product labeling for adverse event reporting purposes (1"The Tan Sheet" April 26, 2004 p. 14). FDA conducted focus groups to narrow the field of potential labeling statement alternatives in response to comments recommending changes to the statements. The experimental study the agency now plans will require participants to view a statement on an Rx or OTC bottle and then answer a series of questions. The information will be gathered via the Internet by an external research organization...