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

Abstract

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.

Acknowledgments

The Center for Drug Evaluation and Research, Food and Drug Administration (FDA) provided research funding for this study. The OMB Control No. for this study is 0910-0695. Use of actual product ads implies neither endorsement nor approval by the Food and Drug Administration. The authors acknowledge and thank Claudia Squire, Jennifer Hayes, Suzanne Dolina, Alex Breslav, Scott Riggan and John Bollenbacher for research assistance.

Notes

¹ We did not find significant effects of disclosure on our key outcomes, so we combined the disclosure and no disclosure conditions for analysis.

² Use of brand names does not imply endorsement by FDA.