FDA Warning to Diovan on Banner Ad ... will there be more?

FDA Issues Warning Letter to Novartis for Diovan Banner Ad

 

I am sure this is not the first time the FDA issues a warning letter to a pharmaceutical company regarding a banner ad for a prescription product (http://www.fda.gov/CDER/warn/2008/Diovan_Letter.pdf), but what I find particularly interesting in this letter is that the FDA explicitly states that despite the links to the PI and PPI in the banner they feel the banners "fail to communicate any risk information".  As far as I can recall, this is the first time I have seen the agency take a specific stance on the use of a link to the safety info VS actually including the extensive (and often difficult to comprehend) verbiage in the content of the banner (oftetimes we see companies address this in the way of adding additional frames to a banner or include the copy in a scrolling text box).  Upon careful review of the words in the FDA's letter, it appears they are insisting on the inclusion of risk information, warnings, precautions, and the most frequently reported adverse events INSIDE the actual banner -- at least in this particular case (which will probably set a precedent).  I think publishers might need to rethink their banners specs if they expect pharma to stay in compliance.  Fortunately, adding an additional :15 seconds in the online channel doesn't have the same cost implications as :15 seconds on TV.  On the other hand, it means less rotations which reduces impressions (aka "ad inventory").  So perhaps pharma banner ads cost will end up costing more in the long run.  We probably won't see the impact of this much in the next 6-12 months as the general state of the economy is affecting media spends across the board (the first time we have actually seen an overall decline in several years).  This would probably not be a good time to hike prices.

FDA Writes: "... The banners, however, entirely omit all risk information, including the warnings, precautions,and the most frequently reported adverse events from the PI. We note that a link to the PI and Patient Product Information (PPI) is included at the bottom of the banners. However, this does not mitigate the misleading omission of risk information from the banners. For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any effectiveness or safety claims made in that part. By omitting the most serious and frequently occurring risks associated with the drug, the banners misleadingly suggest that Diovan is safer than has been demonstrated."

This letter came in late August 2008.  More recently, we recently have seen a warning letter on Shire's Adderral video on YouTube. Is this going to be a growing pattern?  It will be interesting to see if the FDA begins to more actively monitor the Internet (beyond Web sites).  How will the agency review more complex platforms like social networks, widgets, and other Web 2.0/syndicated technologies?  Will someone at the FDA function in this dedicated role?

This is definately worth keeping an eye on.

Fabio Gratton
Chief Innovation Officer
Ignite Health