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 (Q&A; with headings framed in the form of questions), highlights (a summary section from revised professional labeling), and prescription drug facts box (similar to the current over-the-counter drug facts label). Results . The format had several effects. For instance, participants who viewed the drug facts format were better able to recall risks ( P