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.

Paid Search May Need Different Standards

Once the letters were posted, Pharma ads began disappearing from the results of searches as companies pulled their ads to re-tool and re-submit to their internal teams. The end result being that two types of ads seemed to be acceptable based on the FDA letters:

Branded ads – These are ads with the use of the branded name of the product and the established name following the brand name, at least once in the ad, but not necessarily the first instance. In such an ad there would be no mention of the disease-state or indication of the usage of the product mentioned.

Disease-State ads – These are ads where the disease state or indication may be described. There can be no mention of the brand name or established name of the product. This included the URL of the ad.

The end result of this is to reinforce to the marketing community that online advertisement is no different from other marketing media. It is not the media but the message. And this would result in a better experience for the consumer.

But has it?

Are the Consumers Really Being Protected?

It has been fully two months since the letters were posted by the FDA and what is the result? Of the 48 products mentioned in the letter, only 35% of them have returned to sponsored advertising. Many other companies, presumably fearful of receiving their own warning letters, have also stopped their paid search campaigns. And what remains? Canadian pharmacies, class-action lawyers, untested miracle-cure ads and holistic products.  Is this the better consumer experience? This has created an environment where the consumer is protected from the only entities that are providing a worthwhile and efficacious treatment for their illness. In fact, as everyone else except the Pharma industries are not regulated by the FDA, everyone except the owner, creator and provider of the branded product, may use the product name as they will.

It is apparent that rules and regulations, designed for television, print and billboards, may not be applicable or in the best interests of the consumer when speaking of sponsored ads. Copyright laws, as an example, are very difficult to implement in an age of electronic file sharing, because no one had conceived, at that time, of easily copyable electronic files. At the same time, the search engine industry should further develop technologies that add risk information where possible on the results page. Mouse-over pop-ups, for instance, with scrollable content might work.

It might have been a better option to discuss what the marketing industry can or could do before stating that they were doing it wrongly. As my Grandfather always told me, “never bring a problem to the table, unless you also have at least one solution”.

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