How do you solve a problem like Sidewiki? (our apologies to the Sound of Music)

By Jeffrey N. Wasserstein

Your faithful bloggers at FDA Law Blog are, as you might expect, big fans of social media tools.  After all, we blog, we tweet, and we are on LinkedIn, and Facebook (but no, we’re not friending all of our readers).  (We also have a neat Web 1.0 website.)  But one new social media tool leaves us, along with much of the pharmaceutical and medical device world, slightly befuddled, and we hope that FDA, in deciding how to regulate Web 2.0 offers up some guidance on how to deal with Google’s Sidewiki.

For all you 20th Century types who aren’t familiar with Sidewiki, it is a new app from the Google toolbar that essentially allows users to comment or discuss any website on that website.  The comments are available to any user of Google toolbar and appear in association with a particular website, although the comments are actually hosted by Google, not the owner of the website.  What Sidewiki does is convert a standard Web 1.0 static one-way website (website to reader) into a Web 2.0 two way fluid website, since users can add their own commentary and criticisms to the website.

Well that’s wonderful, you are thinking, greater information sharing is wonderful in our Web 2.0 world!  Information wants to be free!  The only problem, for you pharma or medical device types, is how is this going to be regulated?  What happens if someone posts an adverse event on the sidewiki associated with your website?  What if a user (hopefully not one of your sales reps) posts a comment about the wonderful off label uses of your products?  What happens if a competitor trash-talks your products?  Not so wonderful now, is it?

Marketing will want to control the wiki, drug safety will want to ban company personnel from it lest they find more adverse events, and the lawyers out there (self included) will grumble that it would be nice if FDA gave more clarification about these things.  (And no, warning letters are not clarification!) 

One solution is complete involvement.  Have someone monitor the discussion, and, where appropriate, correct off label comments and other inappropriate discussions.  They would refer any potentially identifiable adverse events to the drug safety or postmarket surveillance departments.  Another solution is to be completely hands off.  Don’t allow anyone from the company to get involved, and perhaps not even to read the comments (but oh so tempting to know what people are saying, isn’t it?)

One company has taken somewhat of an intermediate tact.  Astra Zeneca (AZ) put a comment in the sidewiki for the AZ website (and since it always appears on top of all the comments, it’s a sticky wiki.  Sorry, couldn’t resist).  The comment notes that AZ doesn’t monitor the sidewiki comments, and that readers shouldn’t expect any type of response.  They gave alternative website and email contact information for users to use if they needed a response.  Assuming they’ve also instructed employees not to post on the sidewiki, they’ve protected themselves to some degree.  We’re not sure whether this provides adequate protection if an identifiable individual discloses an adverse event and it turns out that AZ personnel do monitor the sidewiki, but lawyerly small print can’t protect against all risks.

Many FDA-regulated companies have avoided setting up an online forum for consumers or patients  for fear of not knowing how far to regulate the discussions.  Perhaps sidewikis will force their hands, since Google does not seem to allow the companies to opt out at this time.  Once a company is forced to deal with someone else’s forum, perhaps other social media tools will come easier.  Perhaps not.  (How do you fit fair balance in 140 characters on Twitter?)

This is a brave new world we’re in, and it seems that www is increasingly standing for “wild, wild, West.”  And while we can hope (or grumble) for FDA to give some guidance as to how to handle the increasing morass that is the world wide web, perhaps in time for Web 3.0, playing the ostrich and hoping the internet goes away is simply not an option.