Among the more unusual regulations that we might see in 2011, FDA is slated to publish draft guidance on the use of social media. Yes, you read that correctly. A recent message from the Division of Drug Marketing, Advertising, and Communications (DDMAC) says that the division has “been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:
• Responding to unsolicited requests
• Fulfilling regulatory requirements when using tools associated with space limitations
• Fulfilling post-marketing submission requirements
• Online communications for which manufacturers, packers, or distributors are accountable
• Use of links on the Internet
• Correcting misinformation” (via EyeOnFDA.com)
The agency is targeting a publish date of 1st Quarter 2011, so we should see this very soon. One bullet points specifically to the online communications of distributors, so this will impact those GAWDA members who manufacture or distribute medical gases.
I was surprised to learn that the FDA was stepping into the realms of Twitter, Facebook, LinkedIn, et al, but it does make sense to a certain extent—social media are largely unregulated. We’re in a new age with social media, and with it come unique challenges. Bullet #2 raises an intriguing point: how do you meet regulations when Twitter limits your characters?
I’m still undecided on this, but I want to hear what you think: Has the FDA overstepped its bounds, or do you welcome the idea of social media guidelines? What social media issues would you like guidance on?