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

This research investigates how the inclusion of the "toll-free statement" (a message about a toll-free number by which consumers can report drug side effects to the U.S. Food and Drug Administration) in direct-to-consumer (DTC) television advertisements for prescription drugs affects consumers' comprehension of product risks and benefits, as well as their comprehension and memory of the toll-free statement. Participants viewed one of nine mock television advertisements across which elements of the toll-free statement varied. Presenting the statement in both text and audio resulted in better processing of the statement than text-only presentations. When the statement was shown in text alone, presenting it during the entire advertisement or after the statement of risks resulted in better processing than a placement before the risk information. The placement, duration, and prominence of the statement did not affect risk or benefit comprehension. These findings suggest that the toll-free statement can be added to DTC television advertisements without significantly affecting risk and benefit comprehension and that certain presentations are preferable for communicating the statement. The appropriate inclusion of the toll-free statement in DTC television advertisements may increase the visibility of the adverse event reporting system, without cost to the understanding of benefits or risks.