New Draft Guidance on Presentation of Risk Information

By: Chris Didizian, CIS Senior Associate
chrisdidizian@cis-partners.com

Preface: Based on the title you may already know the contents of this blog entry, but it must be said that the following is not a full summary of the guidance. For the full document (and it is worth the read!) please click here.

On May 26, 2009 the FDA issued a draft guidance titled Presenting Risk Information in Promotion. In the past, manufacturers relied on Warning and Untitled Letters to determine the most current “focus” areas regarding promotional materials. In other words, it is safe to say that manufacturers often had to “guess” whether a promotional piece would be approved or not. While the actual process is more complicated than that, the lack of guidance was costing companies a significant amount of money, and forcing them to incessantly request some sort of direction in an effort to save money and remain compliant. This absence of this type of guidance for the past few years begs the question: how consistent is the FDA in assessing the accuracy/completeness of a promotional piece without “standard” guidelines? Undoubtedly, the draft is a step in the right direction toward providing the manufacturer with specific guidelines and ensuring a sense of consistency in the approval process. But is the guidance comprehensive?

The twenty-seven page draft details exactly the level of information (and even formatting) that will be approved, while also highlighting the standard for reviewing advertisements. This “reasonable consumer standard” maintains efforts to protect the safety of the consumer by providing the appropriate information in an educational manner. However, while much of the guide is useful, it fails to address unique technical issues concerning the Internet, which houses a significant amount of promotional material. These situations are unique because, for example, information that appears on one browser/computer may not show on another browser/computer. It goes without saying that there are a number of problems with the previous example, but to find a solution the agency will have to delve deep into this advertising technology, so it is understandable that this guidance does not yet address that type of issue.

As stated, the guidance is just a step in the right direction. By not addressing the technical issues for advertising via the internet, the FDA is leaving out a huge area of advertising/promotion. In any event, the guidance will be far more useful to manufacturers than reading warning and untitled letters in order to figure out a standard for what to (and not to) advertise.
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