Scientific Publications by FDA Staff

Ther Innov Regul Sci 2015 Jul;49(4):493-502

Communicating benefit and risk information in direct-to-consumer print advertisements: a randomized study.

Sullivan HW, O'Donoghue AC, Aikin KJ

BACKGROUND: Previous research demonstrated that providing qualitative and quantitative information in a drug facts box may help individuals understand prescription drug information in print-based direct-to-consumer advertisements. The authors sought to determine whether qualitative, quantitative, or a combination thereof best communicates benefit and risk information. METHODS: To replicate and extend previous research, the authors used simple quantitative drug information. A randomized controlled study was conducted with 5067 Internet panelists with heartburn. Participants viewed a drug facts box with benefit and risk information that varied the presence or absence of qualitative summaries and absolute frequencies, percentages, and absolute differences. Measures included knowledge of drug benefits and risks, perceptions, and intentions. RESULTS: Providing absolute frequencies and percentages most improved participants' drug knowledge and affected perceptions and intentions. CONCLUSIONS: The study findings suggest that, for simple drug information, adding absolute frequencies and percentages to direct-to-consumer advertisements may benefit consumers. Absolute differences and qualitative labels may not be needed.