On June 17, 2010 the FDA posted a warning letter that was sent out to Eisai Corporation regarding a consumer-targeted method-of-action video that had been posted to their website. This letter examined an interesting issue surrounding a common problem, presentation of risk information. In this letter, FDA criticized the placement of the risk information in the video and how that placement could lead to a minimization of the risk information. This warning adds new depth to layout considerations when developing videos, emails, or websites. Risk information in any medium must first be given the same creative emphasis as benefit information and second, it must be incorporated into the body of the media so that viewer’s attention is still held and the overall impact of the information is not minimized. The numerous warning letters over the last year and a half, makes it clear that the FDA is serious about ensuring guidelines are implemented according to the latest standards, and they are taking action against communications that don’t meet their standards.
For a more in-depth analysis of the Gliadel letter and implications for marketers:
RTCRM Perspectives Video Marketing FDA Warning Letter 6 23 10
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