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.
Chief Innovation Officer