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Fair Balance and Adequate Provision in Direct-to-Consumer Prescription Drug Online Banner Advertisements: A Content Analysis.

ABSTRACT: The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements.This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media.A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug's risks and side effects or of a "major statement" identifying the drug's major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of "fair balance," the FDA's requirement that prescription drug ads balance information relating to the drug's risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information.Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug's risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks facts. When benefit facts were being presented, 7% (5/68) showed only positive images. No ads showed negative images when the benefit facts were being presented.In the face of ambiguous regulatory guidelines for online banner promotion, drug companies appear to make an attempt to adapt to regulatory guidelines designed for traditional media. However, banner ads use various techniques of presentation to present the advertised drug in the best possible light. The FDA should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads.

SUBMITTER: Adams C

PROVIDER: S-EPMC4777882 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Project description:Background. Previous research found that adding a single piece of quantitative information about prescription drug benefits to direct-to-consumer (DTC) ads helps consumers understand how well the drug works. However, drug information often includes quantitative information on multiple benefit outcomes and risks. Thus, we examined whether consumer understanding was similarly improved when DTC television ads include varying amounts of quantitative information. Methods. We randomly assigned participants (945 Internet panelists ≥ 60 years old) to view 1 of 9 fictitious prescription drug television ads that varied the presentation of quantitative information for benefits (none, single outcome, 2 outcomes) and risks (none, 1 risk category, 3 risk categories) and then measured gist and verbatim recall/estimation and drug perceptions. Results. Adding a single benefit outcome and a single risk category replicated past results. Compared with an ad containing no quantitative information, presenting 2 benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions. Compared with presenting a single benefit outcome, presenting 2 benefit outcomes increased verbatim recall for the second outcome but decreased verbatim recall for the first outcome. Likewise, compared with presenting a single risk category, presenting multiple risk categories increased gist and verbatim recall for the multiple risk categories but decreased gist recall for a concept more closely associated with the single risk category. Adding multiple risk categories decreased risk perceptions even more than did the single risk category. Limitations. This study may have limited generalizability because it examined an ad for only 1 medical condition. Conclusions. There are tradeoffs to adding multiple quantitative benefit outcomes in DTC ads. However, presenting multiple quantitative risk categories helps consumers better understand a drug's risks.

Project description:BACKGROUND:US Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug's risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device. OBJECTIVE:The objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence. METHODS:We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. RESULTS:Of the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages with both benefit and risk information, 71% (25/35) presented benefits before risks and 51% (18/35) used a bigger font for benefits than for risks. CONCLUSIONS:These results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not equally prominent and accessible. This has implications for compliance with FDA fair balance regulations.

Project description:The main challenge of advertising is to catch consumers' attention and evoke in them positive attitudes to consequently achieve product preference and higher purchase intentions. In modern advertising, visual metaphors are widely used due to their effects such as improving advertising recall, enhancing persuasiveness, and generating consumers' positive attitudes. Previous research has pointed out the existence of an "inverted U-curve" that describes a positive relationship between the conceptual complexity of metaphors and consumers' positive reactions to them, which ends where complexity outweighs comprehension. Despite the dominance of visual metaphors in modern advertising, academic research on this topic has been relatively sparse. The inverted U-curve pattern has been validated regarding ad appreciation, ad liking, and purchase intention by using declarative methods. However, at present, there is no evidence of consumers' neurophysiological responses to visual metaphors included in advertising. Given this gap, the aim of this research is to assess consumer neurophysiological responses to print advertisements that include visual metaphors, using neuroscience-based techniques. Forty-three participants (22W-21M) were exposed to 28 stimuli according to three levels of visual complexity, while their reactions were recorded with an electroencephalogram (EEG), eye tracking (ET), and galvanic skin response (GSR). The results indicated that, regardless of metaphor type, ads with metaphors evoke more positive reactions than non-metaphor ads. EEG results revealed a positive relationship between cognitive load and conceptual complexity that is not mediated by comprehension. This suggests that the cognitive load index could be a suitable indicator of complexity, as it reflects the amount of cognitive resources needed to process stimuli. ET results showed significant differences in the time dedicated to exploring the ads; however, comprehension doesn't mediate this relationship. Moreover, no cognitive load was detected from GSR. ET and GSR results suggest that neither methodology is a suitable measure of cognitive load in the case of visual metaphors. Instead, it seems that they are more related to the attention and/or emotion devoted to the stimuli. Our empirical analysis reveals the importance of using neurophysiological measures to analyze the appropriate use of visual metaphors and to find out how to maximize their impact on advertising effectiveness.

Project description:Background: Direct-to-consumer (DTC) prescription drug advertisements are thought to induce "boomerang effects," meaning they reduce the perceived effectiveness of a potential alternative option: non-pharmaceutical treatment via lifestyle change. Past research has observed such effects using artificially created, text-only advertisements that may not adequate capture the complex, conflicting portrayal of lifestyle change in real television advertisements. In other risk domains, individual "problem status" often moderates boomerang effects, such that subjects who currently engage in the risky behavior exhibit the strongest boomerang effects. Objectives: We aimed to assess whether priming with real DTC television advertisements elicited boomerang effects on perceptions of lifestyle change and whether these effects, if present, were moderated by individual problem status. Methods: We assembled a sample of real, previously aired DTC television advertisements in order to naturalistically capture the portrayal of lifestyle change in real advertisements. We randomized 819 adults in the United States recruited via Amazon Mechanical Turk to view or not view an advertisement for a prescription drug. We further randomized subjects to judge either lifestyle change or drugs on three measures: general effectiveness, disease severity for a hypothetical patient, and personal intention to use the intervention if diagnosed with the target health condition. Results: Advertisement exposure induced a statistically significant, but weak, boomerang effect on general effectiveness (p = 0.01, partial R2 = 0.007) and did not affect disease severity score (p = 0.32, partial R2 = 0.0009). Advertisement exposure elicited a reverse boomerang effect of similar effect size on personal intentions, such that advertisement-exposed subjects reported comparatively higher intentions to use lifestyle change relative to drugs (p = 0.006, partial R2 = 0.008). Individual problem status did not significantly moderate these effects. Conclusion: In contrast to previous literature finding large boomerang effects using artificial advertisement stimuli, real television advertisements elicited only a weak boomerang effect on perceived effectiveness and elicited an unexpected reverse boomerang effect on personal intentions to use lifestyle change versus drugs. These findings may reflect real advertisements' induction of descriptive norms and self-efficacy; future research could address such possibilities by systematically manipulating advertisement content.

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Fair Balance and Adequate Provision in Direct-to-Consumer Prescription Drug Online Banner Advertisements: A Content Analysis.

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