[Get your copy of the FDA Guidance Translator Flow Chart later in this post]
It’s been a long wait, but the FDA finally delivered. They’ve come through with at least some direction for how pharma companies can properly use social media. It’s not a complete answer to every issue, but it is a good start. I’ve reviewed the full contents of the guidance that the FDA released on December 30, 2011 and found it, not surprisingly, a bit hard to follow at times. The full title of the guidance they released is: “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” Catchy.
I’d encourage everyone to read the full guidance. You can get a copy of the PDF right here: FDA Unsolicited Requests Guidance (1732 downloads).
As my gift to all of you, I’ve tore apart this document and created a simple to follow flow chart that you can use to figure out if you can respond to something and how to do it. More on that in a moment.
What the FDA released is NOT a comprehensive set of “Social Media Guidelines” that some companies and people seem to believe are the holy grail/final barrier to the promised land of social media usage for pharma. Rest assured, as I’ll say it again, you won’t see this anytime soon. You’ll continue to get bits and pieces of guidance like what we just got that points you in the right direction. The FDA is never going to tell you the right way to use Facebook or Twitter. It wouldn’t make sense for them to do this. By the time they created the guidance, the platforms might be obsolete. They could have created guidelines for MySpace if we had our druthers about five years ago.
So, be happy for what we’ve got. I’ve read a lot of commentary from different people on this new guidance and most seem to think that it’s completely useless. These are likely the people who were expecting to give a massive document explaining precisely what pharma could do with every aspect of social media. They’re likely to be disappointed with everything the FDA puts out since this massive document isn’t coming. I think this set of guidance, while limited to one issue, is actually very valuable.