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

Kathryn J. Aikin, Amie C. O’Donoghue, Claudia M. Squire, Helen W. Sullivan, and Kevin R. Betts
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Key Takeaways
Inclusion of the MedWatch statement did not adversely impact comprehension or perceptions of product risks or benefits.

Presenting the MedWatch statement in both text and audio resulted in better memory for the statement compared to text alone.

Presenting the MedWatch statement before the major statement of risks resulted in poorer memory for the statement than placing it during or after the risks.

Article Snapshots: Executive Summaries from the Journal of Public Policy & Marketing

We investigated how inclusion of a “toll-free statement” for reporting side effects in DTC TV ads affects risk and benefit comprehension; findings suggest it can be added without significantly affecting comprehension, and select presentations are preferable for communicating the statement.


"​The appropriate inclusion of the toll-free statement in DTC television ads may increase the visibility of the adverse event reporting system, without cost to the understanding of benefits and risks."


Research

This study was motivated by a requirement in the Food and Drug Administration Amendments Act of 2007 that a study be conducted to determine whether the inclusion of the “toll-free statement” for reporting side effects to the FDA (MedWatch statement) would interfere with viewers’ comprehension of risk information in DTC TV ads and, if it is appropriate, the length of time the statement should be displayed in the ads.

Method

We randomly assigned 4,961 adult participants to view one of nine mock DTC television ads. We simultaneously examined three independent variables in three separate designs: (1) the placement of the MedWatch statement, (2) the duration of time the statement was presented on screen, and (3) the prominence of the statement in the ad. We assessed participants' comprehension and perception of product risks and benefits, and compehension, memory, and clarity for the MedWatch statement.


"Our data suggest that the toll-free statement itself is well understood. Participants found the toll-free statement understandable and clearly recognized its intent to encourage reporting of side effects to FDA."
Findings

Inclusion of the MedWatch statement did not adversely impact comprehension or perceptions of product risks or benefits.  Presenting the MedWatch statement in both text and audio resulted in better memory for the statement compared to text alone.  Presenting the MedWatch statement before the major statement of risks resulted in poorer memory for the statement than placing it during or after the risks. Over 60% of participants in all conditions rated the statement as "very clear," and there were no differences in clarity ratings by placement, prominence, or duration.

Implications

The appropriate inclusion of the toll-free statement in DTC television ads may increase the visibility of the adverse event reporting system, without cost to the understanding of benefits and risks.  DTC TV ads are widely dispersed and highly visible. Thus, this could translate to thousands of extra eyes and increased usage of the MedWatch system. Creating awareness of this outlet for reporting negative side effects of prescription drugs may empower and encourage consumers to contribute their voice in ensuring the safe use of prescription drugs.


Full Article
Kathryn J. Aikin, Amie C. O’Donoghue, Claudia M. Squire, Helen W. Sullivan, and Kevin R. Betts (2016) An Empirical Examination of the FDAAA-Mandated Toll-Free Statement for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements. Journal of Public Policy & Marketing: Spring 2016, Vol. 35, No. 1, pp. 108-123.
doi: http://dx.doi.org/10.1509/jppm.14.077

Kathryn J. Aikin is Senior Social Science Analyst, U.S. Food and Drug Administration (e-mail: Kathryn.Aikin@fda.hhs.gov).

Amie C. O’Donoghue is Social Science Analyst, U.S. Food and Drug Administration (e-mail: Amie.Odonoghue@fda.hhs.gov).

Claudia M. Squire is Research Health Analyst, RTI International (e-mail: cms@rti.org).

Helen W. Sullivan is Social Science Analyst, U.S. Food and Drug Administration (e-mail: Helen.Sullivan@fda.hhs.gov).

Kevin R. Betts is Social Science Analyst, U.S. Food and Drug Administration (e-mail: Kevin.Betts@fda.hhs.gov).


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Kathryn J. Aikin, Amie C. O’Donoghue, Claudia M. Squire, Helen W. Sullivan, and Kevin R. Betts
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