An FDA study on the power of background visuals to distract viewers from the often-ominous risk info read in the “major statement” section of TV drug ads found no evidence that consumer understanding of risk info is affected by the “emotional (affective) tone of images.”

The agency’s “Distraction Study” was initiated as part of a proposed rule, mandated by the 2007 FDA Amendments Act, that would require the major statement in TV and radio ads to “be presented in a clear, conspicuous and neutral manner.”

“When elements of the advertisement such as images, text, graphics or sounds are presented in such a way as to significantly detract from the major statement, consumers are likely to be deterred from attending to and comprehending the risk information being presented,” said FDA in a March 29, 2010 Federal Register announcement. “To achieve a ‘neutral,’ unbiased presentation of the major statement and to avoid undercutting its effectiveness, the major statement must not be presented in competition with other elements if these elements would arrest the attention and distract consumers from presentation of the risk information.”

The study, a summary of which ran in the January 27th Federal Register, looked at three factors which might compromise understanding of risk info in the audio portion of the major statement: Presence or absence of superimposed text; the emotional/affective tone of visual images; and the consistency of the visual images with the risk info. Researchers found that the tone and consistency of background images running with risk info did not impair understanding, as the agency had expected.

The FDA has been concerned about the use of distracting visuals during presentation of risk information since 2005, when a study by Duke University’s Ruth Day reported that background images often became more agitated or asynchronous with the voiceover during the presentation of the major statement. Day used the example of Schering-Plough’s animated, Antonio Banderas-voiced Nasonex bee, whose wings beat faster during the major statement.

The agency’s original public comment period closed June 28, 2010. As a result of the study data, the agency reopened the docket to electronic or written comments through February 27.

From the March 01, 2012 Issue of MM+M - Medical Marketing and Media