FDA Social Media Hearings Part Deux: TO MONITOR OR NOT TO MONITOR? AND WHAT'S UP WITH GOOGLE?
One of the most strongly, consistently stated tenets about social media is that if a company does nothing else, it should at least actively "listen." But for regulated drug and device companies, what if listening and monitoring yields mountains of hard to vet, potentially adverse event information that must be reported? Or uncontrolled consumer discussion and posting of off-label use of regulated drugs and devices for which a manufacturer could theoretically be held accountable?
If comments from presenters and questions from FDA at today's hearings are any indication, there will be a glacier-like but inevitable move toward policy that codifies the "safety" of active listening and monitoring without a corresponding and untenable burden of accountability for Internet "policing" beyond what a manufacturer has created or sponsored.
There were several suggestions for FDA to define what could be constituted as "best effort" for monitoring and reporting. What will that be? Stay tuned but don't hold your breath.
Similarly, industry presenters repeatedly recommended prominent use of links within manufacturer-controlled content to the FDA web site where product-specific safety and labeling information resides, and also to the MedWatch site where adverse events can be officially reported.
It was abundantly clear that industry -- not FDA -- will lead the regulators to viable solutions.
Meanwhile, wrapping up the day was Google, which in a remarkable display of audacity didn't utter a peep about SideWiki. Go figure. Good thing for Google it was the end of a long day and people were in no mood to linger and interrogate.
Posted by Jim Weinrebe on November 12, 2009 at 9:44 PM
Comments (0) | TrackBack (0)
