Abstract
BackgroundThe 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.ObjectiveThis study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media.MethodsA 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.ResultsEvery 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.ConclusionsIn 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.
Highlights
Direct-to-consumer advertising (DTCA) of prescription drugs has skyrocketed since the late 1990s
This rise was due to regulatory changes made by the Food and Drug Administration (FDA) in the late 1990s that clarified and relaxed the existing direct-to-consumer advertising (DTCA) guidelines
The purpose of this study is to investigate the degree to which one form of online prescription drug promotion, Internet banner ads, comply with adequate provision and fair balance FDA guidelines
Summary
BackgroundDirect-to-consumer advertising (DTCA) of prescription drugs has skyrocketed since the late 1990s. Prior to 1997, all consumer-directed prescription drug ads broadcasted were required to provide a brief summary of a drug’s risks and side effects to consumers. In 1999, the FDA released a final guidance [2] allowing drug manufacturers advertising on television and radio to include a “major statement” identifying the drug’s major risks in lieu of the brief summary. This statement, which must be spoken, is relevant only to broadcast ads. The FDA should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads
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