An Empirical Examination of the FDAAA-Mandated "Toll-Free Statement" for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements.

We investigated how inclusion of a "toll-free statement" for reporting side effects to FDA in prescription drug direct-to-consumer (DTC) television ads affects comprehension of product risks and benefits, and comprehension of and memory for the toll-free statement itself. Participants viewed one of nine mock prescription drug television ads that varied elements of the toll-free statement, and then responded to a questionnaire. Presenting the statement in both text and audio resulted in better processing of the statement compared to only text. When shown in text alone, presenting the statement during the entire advertisement or after the statement of risks resulted in better processing of the statement compared to placement before the presentation of risk information. The placement, duration, or prominence of the statement did not affect comprehension of product risk and benefit information. Our findings suggest that the toll-free statement can be added to DTC television ads without significantly affecting comprehension of product risk and benefit information, and that select presentations are preferable for communicating the toll-free statement. The appropriate inclusion of the toll-free statement in DTC television ads may increase the visibility of the adverse event reporting system, without any apparent cost to the understanding of benefits and risks.