[UPDATE, Sept. 29, 2010: Our recommendations and guidance have changed since we made this post. Check out this latest post for the update.]
Last week, the FDA issued a Warning Letter for the website for their drug, Tasigna. The main issue in the violation was content that was shared via social media. The Tasigna site had Facebook sharing buttons that, like other sites, automatically generate content for sharing. The content of this content is what the FDA cited. This content is drawn from META description tags on the website. These tags are invisible to visitors, but are used by search engines.
The FDA argues that the content in these META tags should include fair balance (risks, side effects, warnings, etc.) since they had the drug name and indication. The FDA did not have an issue with Facebook sharing in of itself, but rather the content that the site generates automatically, which cannot be changed by the user.
This is a potentially serious issue for all pharma marketers, but one that isn’t as bad as it seems on the surface. Several team members and I here at Bridge Worldwide prepared a response document that details the issues raised in the FDA Warning Letter and also our recommendations on how to deal with the issues FDA brings up in the letter.
You can download a copy of the document here:
(UPDATED: 9/29: Please download our updated recommendations here: Digital Alert-Bridge Worldwide-Social Sharing in Regulated Industries (954 downloads)
We welcome your comments and please feel free to share with your colleagues. As always, if you find it useful, please send out a tweet or Like this post so that others get a chance to see it too.
Some other good commentaries on this issue can be found here:
Digitas Health Facebook Regulatory Alert — Digitas Health