Almost two years ago, the Food and Drug Administration (FDA) issued proposed guidance for direct to consumer television (DTC) and radio ads as directed by the Food and Drug Administration Amendments Act of 2007 (FDAAA). The guidance called for clear, conspicuous and neutral standards.
In addition, FDA launched a “Distraction Study” 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.
Ruth Day, of Duke University, began to study DTC ads in the late 1990s by recording hours of television every day to isolate drug commercials, and systematically measuring their “cognitive accessibility. Her research, which was not funded by either the industry or the FDA, analyzed ads for their linguistic complexity, speed of voiceovers, visual distractions and the timing of when information is given about drug benefits and side effects — all to help determine how easy it is to understand and remember the information presented.
Day even testified to congressional committees about her study of 29 drug ads that she conducted in 2000 and 2001. Her research found that, on average, benefit information required a sixth-grade level of language comprehension, while side effect information required a ninth-grade level.
One of the DTC ads she studied and raised concerns over was Schering-Plough’s Nasonex ads, featuring a talking bee voiced by Antonio Banderas. (I challenge you to watch the ads to see if you can tell the difference Nasonex Bee Nasonex Bee #2). In addition to Nasonex, she also studied Ambien, Lunesta, and Enablex.
Consequently, after these “issues” were raised, FDA announced an opportunity for the public to comment on the Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements (ads). Specifically, the study was designed to test different ways of presenting benefit and risk information in the brief summary in DTC print ads.
Results of FDA DTC Study
Interestingly, this month, the results of this study were published. As reported by MM&M, the 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.
Specifically, FDA concluded that, “The results of the Distraction Study indicate that presenting risk information at the same time in text and in audio improves consumers’ understanding of the risk information.”
Moreover, “The results of the Distraction Study did not find support for the idea that consumers’ understanding of the risk information is influenced by the emotional (affective) tone of visual images or the consistency of the visual images with the risk information on the screen during the major statement.”
“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.
You may submit comments, identified by Docket No. FDA–2009–N–0582 and/or RIN 0910–AG27 through www.regulations.gov.