The Food and Drug Administration (FDA) has recently issued proposed guidance for direct to consumer television and radio ads as directed by the Food and Drug Administration Amendments Act of 2007 (FDAAA). The guidance calls for clear, conspicuous and neutral standards.
Back in 2005, Ruth Day of Duke University, presented a study to the FDA showing that when drug ads listed benefits, the images on the screen matched the voiceover and moved slowly. But when side effects were listed, the images often became mismatched to the voiceover and moved much faster or were more distracting.
Along with her small staff at Duke's Medical Cognition Laboratory, Day has been studying drug commercials since the late 1990s by recording hours of television every day to isolate drug commercials, and systematically measuring their "cognitive accessibility." Her research, which is not funded by either the industry or the FDA, analyzes 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’s infamous example was of 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) She has also testified to congressional committees about her study of 29 drug ads that Day 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. In addition to Nasonex, she also studied Ambien, Lunesta, and Enablex.
Eventually, her research and PowerPoint presentation, turned into the Food and Drug Administration (FDA) issuing a proposal to amend its regulation concerning direct-to-consumer (DTC) advertisements of prescription drugs.
Overall, FDA’s new proposed guidelines on drug advertising will require companies to produce materials that are more comprehensible to the “reasonable consumer;” that are more overt about risks; and warn that the FDA will judge them by their “net impression” “as a whole,” not simply whether they are technically accurate. They control font size, white space, context, contrast, placement, background and the use of sections in ads
Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act (the act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. To evaluate advertisements, FDA is proposing standards, in which a major statement would be considered to be presented in this manner if:
1. Information is presented in language readily understandable by consumers;
2. Audio information is understandable in terms of the volume, articulation, and pacing used;
3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.
The language used to communicate risks in the major statement needs to use everyday words or terms that are understandable to consumers, and must also avoid the use of vague terms or explanations that are readily subject to different interpretations. Risk information must be presented at a pace that allows the audience to hear and process it. If it is presented in a manner that is too quick for the audience to process or is otherwise inarticulate, it would not be considered to be clear and conspicuous.
When information from the major statement is conveyed in the visual as well as the audio portion of a television ad, this information must be placed in a manner that allows it to be easily read, such as parallel with the base of the ad. This information must also be placed such that it appears concurrently with any directly related audio information. There must also be sufficient contrast between visually-presented text and the background to highlight the risk information.
Advertisements must be designed so that the risk information can be easily seen and read. Furthermore, the text must remain on the screen for sufficient time to allow for consumers to identify and read and process the information. Font size and type style are additional factors that FDA will consider when evaluating whether the major statement is communicated in the required manner. Visual risk presentations must be in a type size and style that allows them to be easily read by viewers.
The major statement must not be presented in competition with other elements if these elements would arrest the attention and distract consumers from the presentation of the risk information. Examples of these elements may include, but are not limited to, visuals, images, graphics or background music, sound effects, or other noises.
Accordingly, FDA will continue to evaluate these standards to ensure that they result in consumer-directed ads that effectively communicate necessary risk information in a clear, conspicuous, and neutral way. The agency is requesting any comments on standards to establish.
Conclusion
Ultimately, the FDA does not intend to prescribe a set formula for clear, conspicuous, and neutral major statements because there is more than one way to achieve these standards in a television or radio ad. Instead, FDA intends to be flexible enough to consider the variety of techniques sponsors may use to appropriately convey required risk information in prescription drug ads. This flexibility is important because as an article in the New England Journal of Medicine (NEJM) stated, “drug ads can be helpful to consumers, prompting patients to seek new treatments, ask better questions of their doctors and solicit advice for medical conditions that might have gone untreated.”