Could social marketing—a subject that pharma loves to talk about but hasn't been able to do much about—come to pass in 2014? Perhaps the new draft guidance from the FDA this past January paves the way for just that. At first glance, it's a fairly good clarification of how and where pharma can engage in a legally viable manner with interactive media and, in particular, real-time communications...a/k/a social marketing.
There are a few interesting twists within the guidance—but first the basics. In understanding the risks involved in social marketing, there are two core considerations: content and context. Social content, or user-generated content, generally comprises a primary stimulus and responses from users/members (much the same as threaded discussions on any article or video on cnn.com; the video is the stimulus, the discussions that follow are responses to it).
What the guidance says is that a company is only responsible for content generated by it or its agents, but not responsible for user-generated content that comes from users/members who are "truly independent" whereby there is no business relationship between the company and the author of such responses that comprise the context. Even more interesting is this understanding applies across sites owned, supported, or influenced by a company (such as brand.com or a paid promotion on third-party sites).
A few twisty details: content vs context
Now for the twists. There are a few areas left undefined that could add complexity in analyzing risk. First, let’s look at a content-oriented scenario that falls into the gray zone. Very often, social platforms don't force users to be personally identifiable; people could use a handle such as "jollyrancher25." In such cases, there isn’t an immediately identifiable way in which their affiliation with a company can be traced. There's a suggested solution in the guidance that mentions badges or self-declaration of an association with a company, if that's the case.
The question that then arises is that if a professional or consumer has been paid for a speaking engagement or an advocacy role (as the case may be), are all of their interactions on social media subject to scrutiny and part of the legal liability for pharma? Most key opinion leaders have relationships with multiple pharma companies. Would scrutiny around their social engagements be limited to brand mentions, or all related clinical topics?
Then there's the question of context. The FDA submission guidelines referenced within the guidance point to a higher degree of scrutiny for real-time communications that occur behind a login, which is almost always the case for any social-enabled site. In these cases, the company must submit the full context within which a company or its agents post any content on a monthly basis.
While not explicitly stated, this seems contrary to the fundamental direction the guidance provides in that a company is only responsible for what it says, not what others say. The requirement around monitoring all discussions taking place behind logged-in social sites where a company has engaged suggests that the FDA will in fact consider the broader context of the discussion, which increases its potential liability significantly.
There is hope! Separating minutiae from intent
In spite of my wedging apart the minutiae of the draft guidance and its implications on a real-world tactical context, I do believe there is much hope for pharma engagement on social channels within its framework. The central crux of the FDA's ruling suggests that a company’s responsibility is for content posted and not the entirety of the social context. And the intent, if I were to derive one, is to enable—if not empower—pharma to engage in social marketing.
In fact, I would suggest that it is the responsibility of pharma to engage and dispel inaccuracies regarding its products with a genuine intent in doing just so, in a responsible manner. And I imagine that the positive thinker on either side of the regulatory fence, whether at FDA or pharma, would see eye to eye on furthering the goal of legitimate information dissemination through the most powerful means of communications in our time—social engagement. Fingers crossed; here we come, 2014.