Digital Expert Q&A
-
Thinking deeper about Sidewiki and the FDA: Why the obvious advice might be just wrongAnswered November 11th, 2009 by Expert:The following is the introduction to a new whitepaper from Heartbeat Digital:
Five years from now, people may look back the Fall of 2009 as the season that
finally changed the world of healthcare social media. That’s because of two
recent events that may disrupt the social media landscape for pharma, perhaps
permanently.The first was Google’s introduction of Sidewiki as part of its latest toolbar
download. For the three or four people who may have missed the volley of
alarmed emails that followed the announcement, Sidewiki allows anyone using
the Google toolbar to comment on any website, without asking any permission.
The comments appear on the side of the Web page in question (thus the name).
They can be seen by anyone else who has installed the Google toolbar, and they
can’t be removed by the site owner. Call it “Social Media, Like it or Not.”The second event is the FDA’s public hearings on November 12 and 13 on “the continually evolving nature of the internet, including Web 2.0 and social-media tools, as well as their expansion to applications such as mobile technology.” A pretty big digital grab-bag there, but from the nature of FDA’s specific questions, it seems clear that the agency is most interested in the implications of social media (note: the author has been invited to present his point-of-view at the hearings.)
The FDA’s decision to seek guidance is newsworthy for several reasons. First,
because the FDA has never, ever done so before when it comes to the Internet,
opting instead to answer questions as they came up from pharma companies, or
to merely have people guess what the agency’s position might be. Second, it
indicates that the FDA is taking Web 2.0 much more seriously than it had before,
perhaps – just perhaps – realizing that it represents a major advance in patient
communications about medicines and other healthcare topics.This is potentially very good news. For without clear guidelines, pharma has
been wrapped in a social media straitjacket. The industry’s efforts so far have
been extremely constricted because they are not sure whether they will be held
accountable for rogue comments, including possible adverse events or off-label
claims.Taken together, the invention of Sidewiki and the attention of the FDA may
fundamentally alter how drug manufacturers participate in social media
conversations. Sidewiki may force companies to finally participate; the FDA may
enable it. But what should you do about it?(Please download and read the rest of this whitepaper here.)
Leave a reply



