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Renee Webb RAC
Regulatory Leader
GE HealthCare
Elgin IL
United States
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Hi Tara,
Yes we just went through this process. Our marketing people want to do two types of social media 1st, a blog that allows comments and 2nd, an open chat forum for customers only. We had several meetings to discuss the types of information they want to post and the purpose of the sites. For example, in one case they want to have "thought leadership" (no product information). We also proactively tried to think of every bad situation and how we would handle it (ie. what if someone posts a complaint, off label discussions etc). We had a fundamental disagreement over the need to have everything reviewed prior to posting. Marketing was adamately against it as it "ruins the experience" and RA/Legal was for it for compliance purposes. We are expecting the comments to be on the mild side, however we planned for the worst case.
In the end, here is what we decided - everything gets reviewed. We put together a training plan and a decision tree checklist to help determine if something needs to be escalated. The moderator (a marketing person) will have the training on things such as complaint handling, ad/prom process, etc. We also had discussion that the moderator should be savvy in the product in order to identify off label discussions. There are two ways to set our site - moderator gets all the comments and does a pre-screen or all the reviewers get the comments emailed directly to them and everyone can see them simultaneously. There are pros and cons to each approach. We went with the moderator doing a first screen in my business and another area went with the email approach. The site itself will be properly labeled and has disclaimers to check before users get access.
I think we made a very diligent effort to meet marketing needs while staying compliant. It would be nice if we could get some direction from FDA. They are so behind the 8 ball on this topic! Since this is new for our company, it was understood all around that the policy may need to be revisited and updated as we see what kinds of traffic and comments are actually being posted.
Thanks,
Renee
Original Message:
Sent: 06-06-2011 10:51
From: Tara Turney
Subject: Social Media
In light of the FDA's delay of guidance regarding social media for promotional usages, has anyone proactively defined a policy for the usage of social media by your marketing and sales organizations?
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Tara Turney RAC
Senior Regulatory Affairs Specialist
Salient Surgical Technologies
Portsmouth NH
United States
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