An FDA study looking at 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 that the major statement in TV and radio ads “be presented in a clear, conspicuous and neutral manner.” FDA was particularly concerned with companies' use of benign music and visuals – drug ad clichés like patients hoisting grandchildren, playing fetch with their dogs or strolling along a shoreline – to offset the grim warnings of possible side effects.
“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,” said the agency, giving as examples “visuals, images, graphics or background music, sound effects or other noises.”
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 mages with the risk info. Researchers confirmed that presenting risk info in text and audio simultaneously improves understanding, but found that the tone and consistency of background images with risk info did not impair understanding, as the agency had expected.
The agency's original public comment period closed June 28, 2010. As a result of the study data, the agency is reopening the docket to electronic or written comments through February 27.