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The FDA Off-Label Guidance vis-a-vis Social Media

Senior Director, Social Media

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On Dec 27 the FDA released guidance to help pharmaceutical firms handle unsolicited requests for off-label information. This document caused quite a stir in the digital pharma marketing world because it deals directly with social media (called “emerging electronic media”) as it relates to the main topic.

Here is a summary of what you will find in the document:

As for social media, coined “emerging electronic media” by the FDA, there is the following specific guidance:

What Does this Mean for Pharma?

Generally, these guidelines reinforce the unwritten rules that pharma companies are already following. Specifically, companies need to be careful of promoting the idea of discussing off-label topics or spurring questions by having that information inferred from patient testimonials, social share tools, or other supplied information.

One Important Question Remains

What will happen if an e-Patient collects off-label information on a drug from the manufacturer and then turns around and posts that information on the same social media site where the initial request was made?

Our opinion is that, as long as this posting was not prompted or suggested by the drug manufacturer, then the FDA will not hold them responsible for that activity.

More About the Author

Brad Einarsen

Brad is Klick's Senior Director leading the social practice. His group ensures that clients get the best bang for their buck on the social platforms.

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