Randomized Trial of Risk Information Formats in Direct-to-Consumer Prescription Drug Advertisements:

Background. Federal regulations specify that print advertisements for prescription drugs and biological products must provide a true statement of information “in brief summary” about each advertised product’s “side effects, contraindications, and effectiveness.” Some of the current approaches to fulfilling the brief summary requirement, although adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion. Objective. To explore ways in which the brief summary might be improved. Design. The authors conducted an experimental study that examined 300 consumers’ (mall visitors ever told that they were overweight) understanding of and preference for 4 different brief summary formats: traditional (a plain-language version of the risk sections from professional labeling), question and answer (QA with headings framed in the form of questions), highlights (a summary section from revised professional labeling), and prescription drug fac...