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Don’t Wait for Comprehensive Social Media Guidance

On December 31st, the FDA finally released its long awaited guidance on the use of social media, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." (click to download the actual PDF).  As most of us expected, the FDA did not provide comprehensive guidance.

This should not be a surprise, the FDA is never going articulate how any pharmaceutical firm should use Facebook or Twitter.  Given how quickly the social landscape changes (see my post on Google+) by the time the FDA issued its guidance, they would have to post an update.  And as soon as they posted an update, they would need to completely re-write it.  

The social world moves at warp speed, and the FDA is smart enough to know they could never keep up.  So instead of waiting expectantly and most impatiently for Godot, we need to move forward on our own accord and embrace the current FDA guidance, albeit in its limited form and look to the successful examples (here & here) of social pharma engagement that already exist.  By the way, Jonathan Richman has a terrific flow chart on how the FDA guidance breaks down the handling of responses.

In our testimony to the FDA back in 2010, we analyzed recommendations submitted to the FDA by PhRMA, Abbott Labs, AstraZeneca, Bayer, Eli Lilly, Genentech, Johnson & Johnson, Merck, Novartis, Pfizer, Sanofi-Aventis, and Sepracor.  Based on our analysis we proposed a framework for compliant social interactions that many pharmaceutical manufacturers have since embraced to engage both patient and providers in fundamentally new ways.  

Yet, as far as the industry has come, there is still so much opportunity in front of us. Both pharmaceutical and medical device manufacturers should continue to explore innovative ways to interact in social settings and adhere to the core principles we shared in 2010:

• prominently disclose their identities in all communications,
• accept accountability for content produced within the span of their control,
• provide a balanced account in every message with appropriate links to add'l information, and
• monitor the web properties they maintain for off-label comments and adverse event reports.

If manufacturers stay true to this model than they have nothing to fear from the FDA, at least when it comes to digital and social interactions.