As you may have seen, the newly minted pharma “Social Media Working Group” accepted the FDA’s invitation for comments on its recent public hearing on social media.  The group consists of representatives from Amgen, Bristol-Myers Squibb, AztraZeneca, Millennium Pharmaceuticals and sanofi-aventis.

First off, let me start off by saying that I applaud the efforts of this group to make a concerted effort to offer solutions. Throughout this public discourse on the use of social media for pharmaceutical companies, there has been a noticeable lack of proposed solutions; replaced instead by unintelligible noise.  This group of five pharmaceutical companies has taken the opportunity to separate itself from the noise and help move the conversation forward.  Bravo!

Take one look at the document submitted by the Social Media Working Group and it is painstakingly clear how complicated of a problem this really is.  Clearly, the individuals that drafted this document went to great lengths to consider every FDA rebuttal before proposing an action plan.  I shudder at the effort it must have required to get this document through the appropriate channels at each company and out the door.  The fact that this document did make it to the final stages speaks volumes as to how seriously the pharma industry takes social media.  In addition, the very measured approach to this document illustrates that marketers view this as a strategic imperative—not a “shiny new object.”

When things like this emerge, it is important that we not only spend time criticizing—but also building off the base that was provided.  For starters, the SMWG makes it clear that its goal in social media is to ensure the accuracy and completeness of information as an authoritative source.  There’s no doubt that pharma’s primary role is as an information broker.  These companies are taking a patient-centric view that is imperative in any social media engagement.  This is a base that all pharma and bitotech companies must have before moving forward with social media.

The letter to the FDA also attempts to tackle possibly the two most difficult issues facing pharmaceutical marketers when it comes to social media: discussion around off-label usage and adverse events.  In my opinion, the trickier of the two issues is how to handle the discussion of off-label usage so we’ll start there.

Off-label usage is a very important part of medical care.  Doctors routinely prescribe medication for uses other than its approved list of indications.  In many cases, this type of prescribing can have a profound impact on a patient’s quality of life.  Naturally, patients are eager to share that type of information online and with communities of people they trust.  But as stipulated by the FDA, pharmaceutical companies are not permitted to promote off-label usage (and with good reason).  That leaves the question, what happens if a pharmaceutical company becomes aware of off-label usage discussion through social media channels?

The SMWG breaks this down into two buckets: sites maintained by the pharma company and those that are not.  The group suggests that on a company’s own site, it should clearly post rules of engaging in conversation (such as no discussion of off-label usage) but anticipate some community members will step out of bounds.  They are right on that part.  The group then suggests that if and when an off-label comment does appear, the pharmaceutical company should quickly notify the community the nature of that discussion is related to off-label discussion and direct the commenter to the right outlet inside the company.

I’m not sure that is viable.  At face value it makes sense.  Responding to the commenter in a public fashion ensures that transparent engagement remains intact and helps to ensure the community sees the pharma company is taking action.  But the speed at which social media spreads is going to make it nearly impossible to contain off-label discussion once it begins to occur.  That one comment is likely to spur another, and another, and another.  You get the picture.  Many of those comments are likely to take place off your own site.  Then what?  If they originated from your site, are you then responsible for every subsequent comment that spread throughout the vast social media landscape?

It’s an impossible task.  Instead, why not hold ALL comments for moderation and reserve the right to not publish those that refer to off-label usage.  You could even respond directly to that commenter offline with the appropriate channel within the company.  This way you still engage with the individual but spare the community of the discussion.  Sure, in a perfect world you wouldn’t have to moderate every comment, but this isn’t a perfect world.  And yes, this does introduce problems of scale, but doesn’t the alternative as well?  Ultimately, pharma companies cannot hope to moderate off-label discussion on a company site without approving comments.

As you can see, I have only begun to scratch the surface of the Social Media Working Group’s response in an attempt to expand on their recommendations.  In the coming days, I’ll dig a bit deeper into other aspects of the document and offer my two cents.

But what about you?  How would you have expanded or changed the document?  What would you add to complete this response to the FDA?