Like It or Not, FDA, Social Media is Here to Stay
While the latest draft guidance from the FDA on responding to off-label requests sheds some light on the agency’s social media stance, the document has only left folks scratching their heads about what it means for pharmaceutical marketers. What reads like a giant asterisk, the 15-page document provides only minimal insight.
There is a key takeaway here. Public, unsolicited requests for off-label information can only be addressed in private, one-on-one communications, but should be generated by medical or scientific personnel only. Ok. By following this guidance, a firm does not have to comply with the disclosure requirements related to promotional labeling and advertising. Failure to comply could be used as evidence of a firm’s intent that a product be used for unapproved or uncleared use.
Well, that certainly clears things up, right? Nope.
What about guidance on responding to solicited requests, such as a request to a firm’s tweet on off-label study results ? Nope.
How about guidance on unsolicited requests for approved and cleared products? Zilch.
Anything regarding guidance on solicited requests for approved and cleared products? Nada.
Some of the top PR blunders in 2011 occurred as a result of inappropriate uses of Twitter and Facebook. The latest draft guidance sets the tone for any further recommendations that may or may not follow. However, the gray line between what’s good social media practice and what will get you a slap on the wrist or worse still exists leaving firms just as confused as ever.
So, where does this leave those wanting to know where the line is in social media communication in a regulated environment? Until the FDA drafts an all-encompassing set of guidelines of appropriate use, it’s in the best interest of firms to proceed with caution. It doesn’t mean you should pull the plug on your Facebook site or stop Tweeting, but it does mean that you should consistently monitor engagement and really think through the manner in which you respond. This first set of draft guidance lacks the recommendations that firms were hoping for, but it does offer some insight into how the FDA is beginning to finally wrap their heads around this whole social media “fad”.
Check out some other interesting perspectives on this topic:
Fierce Pharma – FDA: No off-label sharing in social media
Slate – FDA Releases Draft Guidelines on Social Media and the Pharmaceutical Industry
Adage – FDA’s Social-Media ‘Guidelines’ Befuddle Big Pharma