In comments submitted to the FDA regarding recent social media guidance (read “FDA Publishes First Piece of Long-Awaited Social Media Guidance” for background), the Digital Health Coalition (DHC) — comprised mostly of pharma companies and digital agencies — suggested that the FDA establish a “lab” to “help ensure the guidance progresses in a manner and at a rate to be informative and protective for all parties involved.”
“One critical point of any guidance is applicability in the real world,” said DHC. “It will be helpful for the DHC and its members, for the FDA to take as many practical and real examples of current social media tools and environments and run simulations on what this guidance could mean in each case [my emphasis].”
“To complicate things, there are innovations and new platforms coming out all the time and one could never be exhaustive about it without being dated months later, but such a detailed and joint exercise with industry and agency experts would be highly informative and would reveal the practical realities of this evolving guidance.”
“Realizing we do not live in a world of black and white,” noted DHC, “we do need additional and more concrete real-world examples of what ‘limited scope’ with regard to ‘influence’ means in practical terms to further foster innovation of interactive patient communication.”
The DHC said it is willing to “partner with the FDA to identify such concrete examples and perhaps create mock-ups in a laboratory environment for further analysis and discussion.” I guess this is a pitch for an RFP from DHC.
What would such a “laboratory” look like?
All seriousness aside, DHC has taken up an idea I hinted at a long time ago.
Back in 2011, when many pundits first sensed the FDA was dragging its feet developing the promised social media guidance, I suggested that FDA was financially strapped and understaffed and clearly needed help. I asked “To get this help, does the FDA plan to pull in any outside consultants, hire additional experts internally, or approach the drug industry itself to help craft the guidelines?” (see “FDA Intern & the Quest for Social Media Guidelines“).
While DHC thinks FDA needs help, FDA may feel pharma needs some schooling itself. See “FDA Launches Social Media Educational Initiative for Pharma“.