Individual- and Ad-Level Predictors of Perceptions of Serious and Actionable Risks in Direct-to-Consumer Prescription Drug TV Advertising.

Prescription drug broadcast advertisements in the United States are required to present the product's major risks in at least the audio portion of the ad (21 CFR 202.1(e)(1)). This can result in a lengthy list of risks and side effects. The U.S. Food and Drug Administration has been studying the effects of limiting the major statement to those risks that are serious and actionable. We explore the level of agreement between consumers and experts regarding what risks and side effects are serious and actionable, and how variations in the content of major risk statement as well as other factors such as demographic variables, perceived accuracy of direct-to-consumer advertising, illness knowledge, and knowledge of prescription drug regulations, predict perceptions of risk and actionability. Participants (N = 1,000) self-diagnosed with depression or insomnia were randomly assigned to view a television ad for their respective condition that presented the full major statement or an edited version that included only serious and actionable risks. Results indicated consumers' perceptions of risk severity generally matched experts' assessment, but there was relatively less agreement about risk actionability. Results also varied as a function of income and gender.