Small Talk

January 25, 2012 »

Social Guidelines for Our Social World - Not Quite Yet….

I was honored to be contacted recently by the good folks at WOMMA to solicit my perspective on the draft guidelines issued by the FDA last month.  For those of you not familiar with WOMMA, it is the premier non-profit organization dedicated to advancing and advocating the discipline of credible word of mouth marketing, founded in 2004 by my friends Jonathan Carson, Dave Balter and Pete Blackshaw. WOMMA represents more than 350 member companies including brands, marketers, researchers, service providers, agencies, non-profits, and academic institutions - and the pharma sector is beginning to take note, more and more each year. 

This blog post was featured in today’s WOMMA’s newsletter that goes out to its membership. Enjoy.

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Many people in the pharma world have been champing at the bit for the FDA to provide guidance about how to use social media in the promotion of prescription products.

For what it’s worth, I tend to think that the use of social channels in the Rx space is widely over-hyped, and that the real opportunities lie in old fashioned, face-to-face word of mouth dialogue.  (Disclaimer: my company, HealthTalker, provides WOM services for life science companies).

Manufacturers and many of the agencies that support them have wondered how to avoid regulatory headaches but still tap the power of Facebook, Twitter and the like, hoping they’ll strike gold with some magic formula with these dynamic channels which will lead to noteworthy promotion and increased market share. 

I actually find the whole thing a bit laughable as it suggests that people in the industry have become too afraid to think on their own, to apply good judgment to marketing and promotion, and to push the envelope a bit further.  That statement might piss some people off and offend a few more, but at the end of the day, the FDA will never tell us exactly what to do; they will only provide draft guidance. 

The way the game works is that marketers will try to expand their reach; MLR teams will push back; and in the end, the most effective outcome will be finding the solid balance between appropriate promotion and persuasive marketing, no matter the medium.  But taking no action, standing on the sidelines, and waiting for permission will never be the winning approach.

So have all of the social marketing secrets for pharma been revealed with the arrival of this new document?   Not so fast.  When you take the time to review the guidance, there is actually very little here that will satisfy the curious and the hopeful. 

Perhaps even more upsetting is that there is a perception that the FDA actually provided guidelines for social media in this document - when in fact, the entire emphasis of the document is about off-label use of products and how companies can adequately and safely respond.  Should the FDA earn kudos because they made note of Twitter as a “microblogging tool”?  That was nearly the extent of their reference to social media!

Instead, the emphasis of the draft guidance is on the appropriate treatment of off-label inquiries associated with prescription products. Though the subject matter seems very narrow in its focus, the document does provide several good examples, indicating when and how a manufacturer might communicate with interested consumers. 

In the document, the FDA is saying it is ok for manufacturers to respond in a truthful and balanced fashion (one might have thought that even acknowledging an inquiry about off-label use might run afoul of what the FDA would permit).  However, that response needs to be done privately - in other words, the manufacturer firm cannot promote this information to the public at large.  Furthermore, sales and marketing personnel should have no input on the response, nor should the response be promotional in nature. 

Really?  An off-label response shouldn’t be promotional?  The FDA needed to issue this document to tell us that?

Forgive my frustrations here, but what people in our industry really want to know about - and where this draft document fell short - is guidance about how to address on-label uses of a product.  Had this document included that sort of information, I suspect that it would open a floodgate of social and WOM activity where pharma would finally know where they can step, and where they can’t. 

Right now, there is a paralysis that hinders pharma’s ability to engage with consumers in a natural and authentic manner.  It would have been great if companies were given a morsel of information about what they can do when someone makes a post about their medication’s effectiveness, inquires about a product’s known side effects, or even says that a certain drug has made a huge difference in their life.  The FDA could even call it “Social Guidelines for Our Social World.”  How catchy.

Unfortunately, those guidelines won’t be coming anytime soon – if ever.   And this latest document doesn’t get us any closer.

Looks like we’ll just need to continue to rely on common sense!

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