August 12, 2010 » Novartis’s Most Recent Letter: Social Media—Facebook—is the Channel Not the Issue

So at this point most folks have heard about the Novartis letter regarding the Tasigna.com Facebook Share feature; in the event that you didn’t, here is what happened:

On July 29, 2010 the FDA issued a warning letter to Novartis for the Facebook share button and sharebar on the Tasigna product website – both consumer and HCP sides. The issue was that when a user clicked the share button, it displayed a post on the user’s Facebook wall. The post was a statement (that varied by page) that typically included the brand name and the indication. It was a brief statement with a link to the website, so of course it did not include fair balance. Further, language within the statement used on some of the pages used superiority language that FDA had previously told them not to use.

So, what does this mean?

First, just as in the instance of the Gleevec unbranded letters this spring, it actually changes nothing. Novartis, for the second time this year, simply violated known and understood DDMAC policies. It’s shocking, actually, that after the unbranded letters, that they did not do a better job following well established rules in the rest of their communications (particularly interactive communications).

This letter is certainly NOT a new FDA policy prohibiting the use of share tools or social media in branded pharma. It does reinforce the FDA policies regarding claims and balance and that channel and format does not change the rules. As with all things, the devil is in the execution.

What concerns us, is that, as with the unbranded Gleevec letters, the industry will overreact and start pulling back on their investments or efforts within social media. This should not be our response; we should take this as confirmation that DDMAC sees the internet and social media the same as every other channel and applies the same rules. We as an industry just need to accept that fact and follow the rules!