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

Abstract

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 directto-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.

Attention to and Distraction from Risk Information in Prescription Drug Advertising: An Eye-Tracking Study

“…Exposing more consumers to the statement via multiple DTC television ads could increase consumers’ knowledge of the MedWatch information, even if distraction is present in other parts of the ad, thus having a positive effect on consumers’ ability to report drug safety concerns. Similar to Aikin et al (2016), we find that attention to the MedWatch statement did not decrease risk retention, supporting the inclusion of the MedWatch statement in DTC television ads.…”

“…In addition, results from a study required by FDAAA suggested that the following statement about FDA's MedWatch reporting program for adverse events is appropriate for inclusion in DTC television ads: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088” (Aikin et al 2016).…”

“…Also relevant to DTC advertising is the question of whether distracting elements during one segment of the ad can interfere with attention to and retention of information presented in a following segment. A study on the inclusion of the MedWatch statement in DTC television ads shows that when the statement was presented in text only, approximately 15% of participants noticed it and could report what it said (Aikin et al 2016). However, that study did not test distraction or include a direct measure of attention.…”

Communicating Risk Information in Direct-to-Consumer Prescription Drug Television Ads: A Content Analysis

“…Finally, many ads used the superimposed text during the major statement to convey non-risk information. The effects of presenting non-risk information during the major statement is unclear, with one study showing a decrease in risk retention (Wogalter et al, 2014) and another study not finding a significant effect on risk retention (Aikin, O'Donoghue, Squire, Sullivan, & Betts, 2016). Given that the presence of non-risk information is unlikely to increase consumers' understanding of the risk information, it would be prudent to avoid it during the major statement.…”

The dance between darkness and light: a systematic review of advertising’s role in consumer well-being (1980–2020)

“…Sullivan et al (2017) found superimposed risk text led to greater visual attention to, and recall of, the risk information, but attention was impeded by distracting visual elements when the text was presented in the DTC pharmaceutical ad. However, including both text and audio in a DTC ad produced better processing of the FDAAA-mandated tollfree statement (Aikin et al 2016).…”