We’ve waited for what seems like forever to discover more about the FDA’s thinking on social media.  In December 2011, the FDA formally framed how they will interpret regulation surrounding emerging media with a draft guidance (http://1.usa.gov/tY70tG).  The draft guidance can be summed up in the flowchart below and as follows: Answer both public and non-public, unsolicited requests for off-label information in a non-public way using truthful, balanced, non-misleading, non-promotional scientific or medical information.

Honestly, I like the simplicity and consistency of this guidance.  However, the guidance does not address industry limitations in responding to off-label inquiries from non-healthcare professionals.  It’s nearly impossible to differentiate healthcare and non-healthcare inquirers on public forums.  Directing non-healthcare inquirers to contact the company when an off-label inquiry is identified in a public forum will lead to greater consumer frustration given that the door to the off-label information vaults at pharma companies must remain closed to consumers.

In responses to the FDA’s request for input on the draft guidance, let’s ask them to specifically address this gap in guidance. Either allow pharma and medical device companies to respond to consumers with all available information or specifically state otherwise.  Certainly more discussion is warranted in this area and this topic will be followed closely on this blog.

Please call me at 317-797-2244, write at pete@center-first.com, or follow @centerfirst