From Peter Hopper, VP, Account Services, Palio

Just the other day, in my local newspaper, there was a front page story about how the local police authorities are stepping up patrol of a main expressway heading into the city due to a significant increase in “aggressive driving.” Not to suggest that aggressive driving is appropriate behavior in any context, but obviously drivers are on notice: this particular stretch of road is going to be that much more on the radar screen, so to speak.

The appropriate response is to be mindful of the increased vigilance and ensure you are extra cautious to avoid getting pulled over and suffer the consequences: a ticket, extra points on your license, increased insurance, legal fees, perhaps even your name in the newspaper.

What about the duck?

For our industry, the name in the paper was Novartis, its oncology product Gleevec, and two disease-awareness Web sites actually registered to Novartis AG. The two sites’ disease-state content and clinical data were specific to the Gleevec indication. The FDA Warning Letter cited, along with other evidence, that the unbranded Web sites were “perceptually similar” to the Gleevec brand by look and feel, each included the Novartis Oncology logo, and each presented well-known facts that the medical community would easily recognize as referring to the branded product: if it looks like a duck….

In addition to blurring the lines between disease awareness and product promotion, the letter noted the omission of risk, as well as the inclusion of unsubstantiated dosing claims.

It is not news that DDMAC has substantially increased its resources to scrutinize branded and unbranded communications in the marketplace, and that those resources are good at their job. The FDA has posted over 30 letters specific to promotional materials to date in 2010, already eclipsing the entire count for 2008. This latest letter demonstrates the agency’s prowess, and every letter posted reinforces its determination, regardless of anyone’s opinion about how clearly defined, or not, the rules are.

One of our jobs as professional marketers is to seek out the appropriate opportunities and venues for our clients’ communications plans – and to offer sage advice on how best to leverage those opportunities – and, just as importantly, to keep our clients out of the unfortunate headlines.