FDA Guidance on Responding to Unsolicited Requests for Off-Label Information

The Social Media Guidelines Nobody Expected!

Two days after Christmas, on December 27, 2011, while most of us were still on vacation, the FDA quietly issued "Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." Section VI. of this guidance addresses responding to unsolicited requests on public forums such as the Internet.

While this may not be the "social media" guidance many people were expecting, it does include guidelines for responding to unsolicited requests for off-label information encoun-tered through "emerging electronic media."

This article takes a closer look at how the off-label guidelines apply to social media such as Youtube, Blogs, and Twitter.

Topics include:

A Bit of History
Defining "Off-label"
What We Expected Was This
In Best Interest of Public Health
Public vs. Private, Solicited vs. Unsolicited
Youtube and Solicited Requests
Blogger Example of "Solicited Request"
Proving Solicitation is Difficult
Twitter Example of "Solicited Request"
Private Responses and Serving the Public Interest
Sales and Marketing May be Seen, but Should NOT Be Heard From!
The Burden of Responding
Docket Open for Comments
Legal Challenges

Chart: FDA Guidance Translator

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