
On April 3 2009 the FDA, in a very surprising move, posted 14 untitled-letters on their web page that covers Division of Drug Marketing and Communications (DDMAC) and Headquarters Warning Letters. These letters covered 48 different products and were related to situations where the FDA felt that the advertisers had failed in supplying sufficient risk information.
The question is, 60 days after the postings, cui bono, who benefits? Has anything changed for the better?
The issuance of a warning letter is well within the purview of the FDA and DDMAC and would not, in and of itself be special, except that the ads discussed were sponsored paid search ads appearing in Google or Yahoo.
Search marketing agencies and Pharma advertisers had long been aware that paid search ads were limited in the portrayal of risk information. After all, with 25-characters in the Title and 35-characters each in the subsequent three lines, there is not a lot of text for a message, much less an involved risk information statement. Thus, for many years, with lack of direction from the FDA, the marketing community adopted a self-created policy known as the One-Click Rule. That being that risk information was no more than one click away from the ad, much in the way that risk information is one turn of the page away in a magazine or newspaper. And, for years, this seemed to meet with the FDA’s, if not approval, well, lack of overt disapproval; until April 3, 2009, that is.
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