Over the holidays, and without fanfare, the FDA issued Draft Guidance for Responding to Unsolicited Requests for Off-Label Information. The title of the guidance is a little deceptive in that within the document lies some draft guidance on dealing with social media in the form of ‘public’ platforms where some of this conversation may take place. The guidance doesn’t give us a road map for working with social media platforms such as Facebook and Twitter, but it is progress. The most noteworthy element is that unsolicited public inquiries for off-label information, as an example in YouTube comments for a pharma YouTube channel, should only get medical affairs contact information as a response.
The guidance came out while everyone was still digesting their Christmas dinner and it flew right under the radar of all the pharma Twitterati during the lull between Christmas and New Years. People returning to their offices in January found it in their inbox and panicked that the FDA has said something, anything, about social media. Digital agency leads scrambled to produce a POV on the guidance and the blogs began (email me if you want my POV).
There are now many, many interpretations and analyses out there, and Fabio Gratton did a great job of collecting them into a Storify stream listing all of the articles from media, agencies, pharma companies, and law firms. Another great tool was created by Jon Richman of Dose of Digital fame – this one is a flowchart for deciphering the sometimes tangled logic in the guideline. I love the sense of humor.
The FDA has some sharp people on their staff that clearly understand social media. The original request for response on social media (over two years ago, now) demonstrated a strong grasp of the issues. Therefore, it’s surprising that the FDA does not address moderation in the draft guidance. Moderation may be used to pre-review comments prior to public posting on platforms managed by companies. It is possible using moderation tools to prohibit posting of off-label comments entirely and to respond to an inquiry privately without it ever being seen by the public.
We’ll see if 2012 is the year to finally see some guidelines.
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