10 things you should know about FDA’s new social media guidance

Yesterday the Food and Drug Administration (FDA) released draft guidance for digital media. The document was short and to the point, and focused more on content created by the general public than content created by the pharmaceutical industry.

Reading the document, I was struck by 10 factors that I think will influence how we handle digital media moving forward:

1. If you weren’t looking for it, you might have missed it. The title for FDA’s new proposed guidance is: Fulfilling Regulatory Requirements for Post-Marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. The draft guidance is only 7 pages long and 3 of those pages are typical government formatting.
2. It’s not what you think. The overall message focuses less on “overall digital media guidance” and more on when pharma companies, or their respected communications firms, must report information to the FDA. The guidance provides information on what must be submitted to FDA in regard to adverse events, off-label usage and other items.
3. FDA recognizes you can’t control the public. Previously pharma companies avoided digital media for fear of User Generated Content (UGC) and resulting adverse events or off-label usage. Now FDA states that isn’t the manufacture’s responsibility to monitor and report on the whole of UGC on the internet.
4. There is a catch. You are responsible for UGC if you start an online conversation by purchasing website ads, placing editorial content on a website, hosting tweet chats and so on. Since you are an active starter of online conversation, you are ultimately responsible to report things that happen in that conversation.
5. FDA will not actively monitor everyone’s tweets…. just yours. FDA will not monitor channels unaffiliated with users (pharma companies and their agents.) FDA will only review and monitor assets owned and operated by pharma companies and their agents. So if a woman in Kansas posts on Facebook that she uses your product as a sleep aid when it’s clearly an anti-flu medicine, you will not be held responsible as long as she doesn’t post that comment on any of your controlled digital assets.
6. Submit your digital properties to FDA every month. FDA suggests that companies submit all digital media assets that are in a public arena (blogs, Twitter, Facebook, company forums and so on) via Form FDA 2253 or Form FDA 2301.
7. If your employee or agency partner creates it, the entire company is held accountable. No matter where a company or its agents post content, they are ultimately responsible for that content.
8. This isn’t all that new. In the creation of this document, FDA borrowed heavily from a 2009 document, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.
9. Formatting matters. When you submit 2253 and 2301 forms, FDA suggests that you use a format that “takes formatting factors into consideration.”  This will allow FDA to quickly verify whether you control a digital property where a UGC has appeared.
10. It’s just a draft. Remember, this is draft for the official guidance; it is not written in stone and is subject to change.

My take:

All in all, I am happy with what FDA is proposing. The guidance is not restrictive and provides us with a framework to move forward. It’s good to hear that FDA understands we can’t control what the general public says online.

I do have a few reservations and most of them focus on point 4. Say, for instance, you are running ads in an ad network and one of them appear on a website you have never seen. On that site someone makes a comment that you have never seen. In FDA’s eyes, you are responsible for that conversation since an ad of yours appeared on that site.  Scary.

What reservations do you have about this new draft guidance? Let me know.