More Thoughts on the Strategic and Regulatory Implications of Sidewiki

On Monday, the posting on Eye on FDA talked about 3 new tools either introduced or in beta testing by Google – Google Squared, Google Fast Flip and Google Sidewicki.  Of the three, Sidewiki has the most strategic and regulatory implications, and merits some follow up comments and aspects that should be stressed.

To recall, Sidewicki is a new application in the Google Toolbar that allows a person to go to a Web site, insert a sidebar and write commentary that will then be attached to the Web site.  When other people who have Sidewicki visit that same site, they can see the commentary and add their own.  This can be done on any site.  I began one on this blog, for example.  

That seems simple enough, but actually the implications are huge.  Consider the communications paradigm as it existed before the launch of Sidewiki.  There are bascially four types of media:

• Earned Media – the printed word.  Earned media is the media you get when reporters cover your story.  While you don't have total control over content, your messages do get included.
• Paid Media – the media you buy.  Advertising.  Where you have near total control over message and as such, it is not as credible as earned media.
• Owned Media – the stuff you churn out.  This is brochures, pamphlets, white papers and of course, your Web site.  Again you have maximized control over content which diminishes the credibility in the eyes of the consumer.
• Shared Media – all social media.  In other words, places where you can put out a message, but others will be free to comment, change and pass along.  This is low control over content.  

What Sidewiki single-handedly accomplishes is to take your piece of owned media – your Web 1.0 Web site – and converts it instantly to a Web 2.0 function of shared media.  That is huge.  And as mentioned on Monday, it raises some regulatory questions, such as:

1. Are companies held responsible for the content in a Sidewiki?
2. If an adverse event is reported on a Sidewiki, does a company have an obligation to have Sidewiki installed and be monitoring the content?
3. Should a company correct misinformation that is published in a Sidewiki or once a company begins participating in the Sidewiki does it become responsible for the rest of the site?
4. What if a person not connected with the company states an off-label use on the Sidewiki – is the company under an obligation to correct that, and if not, is the company perceived as promoting the off-label use by not correcting it?  There is a potential Warning Letter if you do, potential Warning Letter if you don't situation here.  
5. Is there any reason competitors can't go onto a Sidewiki and state claims about their own product?
6. If a company does go onto Sidewiki and mention a brand, do they have to communicate full risk information?

As you can see, there are not only profound regulatory questions associated with this new tool for pharma, but there are competitive and strategic communications questions as well.  MedReg is going to be pulling their hair out over this one.  And frankly, answers to these questions cannot wait for the lengthy FDA process for deciding what it is going to do about regulating social media.  But the considerations go way beyond mere regulation.  Your Web site is no longer your own.  You need to think about what that means for you and your goals and your communications strategy.  Sidewiki slipped in, but it is seismic.