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Friday, June 26, 2009

Acromegaly Answers Blog Raises Interesting Regulatory Question

My friend @skypen just Tweeted me this request: "John, interesting social media initiative by Tercica for niche patient community. Would love your thoughts." See his summary post "Compass launches blog and webinars for niche community."

I'll focus on the Acromegaly Answers Blog, which "posts blogs from patients, caregivers, patient service specialists, nurses, doctors and others who live with and manage acromegaly every day." Ipsen, a global pharmaceutical "Group" based in France, sponsors this blog.


According to MedAdNews, "Comments are approved by the med legal team and is moderated in collaboration between Compass and Ipsen regularly and checked at least once every 24 hours, usually every 12 hours, so that if there is any adverse events they can be reported in the appropriate timeframe."

I applaud that commitment to handling AEs that may be discovered via this blog. However, I believe that the blog's disclaimers about who is responsible for the content will raise some issues with the FDA.

At the bottom of the blog page is included these disclaimers:
"Comments that appear on this blog are the opinion of the poster, not Ipsen, and may or may not be accurate."

and

"This blog is moderated. Your inputs may therefore not be posted. Still, you remain responsible for the content of your inputs."
These disclaimers -- especially the first one -- contradict what I heard Preeti Pinto, Executive Director, Promotional Regulatory Affairs at AstraZeneca, tell the audience yesterday at CBI’s 2nd Annual Bio/Pharmaceutical Emerging Media Optimization for Consumer-Focused Marketing conference.

Pinto essentially said "If you sponsor it, you are responsible for the content" as far as the FDA is concerned. She also said, I believe, that when you moderate comments submitted and post those comments, you are also responsible for the content.

What do you think?

Is Ipsen responsible for content on its sponsored Acromegaly Answers Blog?
Yes
No
Maybe
I have no idea!

4 comments:

  1. Anonymous1:31 PM

    What is the reference for "If you sponsor it you are responsible for it"? Where has the FDA said this? Thanks

    ReplyDelete
  2. You'll have to ask Pinto that.

    ReplyDelete
  3. Anonymous3:14 PM

    In your view, how is this different than JNJ BTW, which has been around since 2007, also moderates comments and has a nearly identical comment disclaimer? (It reads "The comments contained on this site come from members of the public, and do not necessarily reflect the views of Johnson & Johnson Services Inc. or of JNJ BTW. Johnson & Johnson Services Inc. and JNJ BTW do not endorse or approve of their content.")

    ReplyDelete
  4. Hi there,

    You have published a good post here. But I just wanted to ask that I really had a feeling that some phrases on the post reflects somebody processes. I want to know exactly the meaning of some phrases on the post like on " If you sponsor it, you are responsible for the content ".

    Thanks.

    ReplyDelete

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