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FDA Letter to Novartis on Facebook Explained

Posted by | 11:25am on Friday, August 6, 2010

This letter does not provide FDA guidance on Facebook 

The FDA sent a letter to Novartis dated July 29, 2010, regarding a Facebook widget on their brand website, Tasigna.com. The key part of the letter notes that: “The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products.”

In addition to Facebook, the site offered a way to share the content on Twitter, Delicious and Digg. This type of “Share This” functionality is increasingly common on websites. Novartis took the widgets down quickly, because when I looked yesterday they were no longer there. The screen shot below, showing the Facebook icon on the top right, is from a Google cached version of the site.

Tasigna.com Showing Facebook Widget

The FDA must have clicked on the widget for every page and reviewed each resulting Facebook message or reviewed the page source and meta description that is pulled. Below is an example, although not one of the ones cited in the letter.

Tasigna.com Facebook Message

It’s the Message NOT the Medium
This letter does not provide FDA guidance on Facebook. The important thing to remember is that this content did not follow existing FDA guidelines. So if you are using Share This on your site, carefully review the resulting text that will be shared. The FDA is paying attention.

This post was contributed by Eileen O’Brien, Director of Search & Innovation for Siren Interactive. You can connect with her on Twitter at @eileenobrien.

About Eileen O'Brien

Eileen has more than 16 years of digital healthcare marketing experience. She is an opinion leader on social media and biopharma, and has been invited to speak at industry conferences and quoted in publications.

View other posts from Eileen

4 Pingbacks/Trackbacks

  • http://www.eveharris.net Eve Harris

    Thanks! I was despairing yesterday as I continued to read hype about the “draconian” FDA and its failure to understand social media. Yours is a voice of reason. @harriseve

  • http://twitter.com/eileenobrien Eileen

    Just found some other great posts on this topic. Chris Truelove talked to Bruce Grant: http://bit.ly/d6v6j9. John Mack wrote about it first and ties in the issue of organic search results: http://bit.ly/bbMc8r.

    Let me know if anyone sees any other ones. We’ll definitely be talking about this on Wednesday during the next #SocPharm tweetchat at 8 pm EST/7 pm CST/5 pm PST.

  • http://maureenhall.wordpress.com Maureen Hall

    This is a great clarification, Eileen, and makes sense of the FDA’s position. Thanks for taking the time and trouble to get behind the story. @hall_mediamaven

  • Karl Schmieder

    Thanks Eileen. I appreciate your take on this story. I think we should all be saying Thanks Novartis because the FDA finally issued a letter to a marketer about their use of social media. All the rest of us, take note.

    • http://twitter.com/eileenobrien Eileen

      Thanks for taking the time to comment Karl. I agree that we should be thanking Novartis and the rest of us take note. This is the first direction from the FDA on meta tags and provides us guidance on organic search.

  • http://HealthIsSocial.com Phil Baumann


    It’s an interesting case, especially since the crux of the matter doesn’t really seem to be about Social Media, but meta elements.

    I think this actually raises a lot of points about *everybody’s* involvement and level of web sophistication, from the FDA to marketers to web experts.

    Funny thing is: Google doesn’t really count meta keywords in its search rankings.

    There’s more about that here – http://bit.ly/9EyLWl

    Look forward to tomorrow night!


  • http://www.linkedin.com/in/robrenjilian Rob Renjilian

    Nice summary, Eileen. The situation does seem closely aligned to the paid search comments a year or so ago. The intent of FDA is the same, IMHO. As I am sure you’ll agree, the due diligence is on our part as digital marketers. Our clients deserve this level of understanding and guidance.

  • http://twitter.com/eileenobrien Eileen

    I was pleased to be quoted in ClickZ’s article on this topic, Pharma on Facebook: FDA Cites Novartis Violations: http://bit.ly/c89SK1.

  • Roger Shubert

    This seems to be another example of recent FDA enforcement of “fair balance” guidance in marketing rather than an attack on social media as an option in the marketers’ toolkit. For several years, the FDA has been pretty clear about presenting FAIR balance (equal coverage and visual representation of benefit and risk profiles) to let the audience decide their course of action (physicians, patients, payors, etc). It’s just in the last few years that the FDA has been enforcing their directives, and now many life sciences companies are on the receiving end of warning letters.

    Warning letters typically do not result in specific fines or penalties but often result in negative publicity and the immediate need to cease the illegal practice. Letters help define boundaries for companies and lines they cannot cross. A current challenge in the industry is that companies keep pushing the envelope and crossing these lines – hence more FDA letters across more types of media.

    I would hope that the negative press here does not discourage life sciences companies from continuing to innovate with social media, as long as you play by the rules it could be a big step forward for the industry that could lead to positive developments in marketing practices.

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