Tuesday, December 08, 2009

Coalition for Healthcare Communication Meeting on the FDA Public Hearings, Reflections on Ideas Proposed, and a Call to Keep the FDASM Movement Alive

Dear Readers,

On Thursday December 10th John Kamp, Executive Director, Coalition for Healthcare Communication, has organized a meeting to discuss the recently-held FDA public hearing on the use of the Internet and Social Media; specifically, to reflect on what was said and discuss next steps. A document that was put together by Mr. Kamp reflects the coalitions perspectives regarding several topics presented at the meeting. Below is an outline of that document. Click here if you wish to download the full document in PDF format.

Most promising ideas
  • Create a system to flag and click to risk data
  • Develop a system to elevate all FDA regulated content
  • Reverse course on the "one click away" warning letters
  • Clearly state that without control, companies have no responsibility
  • Make the AER process much more patient and company friendly
  • Coordinate enforcement against internet health scams
Most Difficult to Implement
  • Reverse the FDA position that "one click is insufficient"
Most Unrealistic or Otherwise Bad Ideas
  • Enshrine existing AER reporting and pay for expansion with user fees
  • Send AERs directly to FDA
  • Create a new FDA advisory committee
Next Steps
  • Think this over and make suggestions at the December 10 meeting
  • Reach out to the wider network
  • Develop a short "consensus comment" from a broad array of industry players, a
  • "consensus of the willing"
  • Start developing the AAAA/Coalition FDA Comment now
Along with this document Mr. Kamp also included the following message message which directs those who were sent the invitation to the Dec. 10 meeting to take the following action items:

# # # Excerpt from Mr. Kamp's Message # # #

"Please come prepared to offer writing support for sections of the comment.

Reach out to the wider network. I suggest we try to involve the pharma companies that participated, PhRMA, AdvaMed, IAB, the media companies, including Google, Health Central, WebMD, Waterfront, Sermo, Patients Like Me, etc. If you have contacts or ideas or other resources for this outreach process, we want to hear about it.

Develop a short "consensus comment" from a broad array of industry players, a "consensus of the willing." If there are enough "willing," this could be very powerful comment to FDA, particularly if we could get a consumer group or patient group to join. If you have suggestions, make a list for us.

Start developing the AAAA/Coalition FDA Comment now. Outline what we might best say, starting with our points for the FDA presentation, adding data and other compelling content. We will have a draft outline by the December 10 meeting and will be asking you to contribute to sections."

# # # End of Excerpt # # #

The reason I am sharing this with all of you is that you ARE my wider network -- and, in my opinion, you ARE the coalition of the willing.

What you choose to do from here is up to you. However, I strongly urge (regardless of whether you choose or care to attend this particular meeting) that we all continue to share information with each other -- as this is the only way we are going to be the kind of coalition that can effect change. Whatever you share with me (unless you explicitly request otherwise) will be posted on www.fdasm.com and make it visible to as many people as possible. So please, keep sharing, keep discussing, keep debating, and help keep the movement alive.


Fabio Gratton

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