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Novartis Hits Regulatory Snag with Facebook Widget

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Novartis got hit with an untitled letter from FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) on July 30 (posted August 4) for including a “Share on Facebook” widget on its branded website for Tasigna. This the first known enforcement by FDA in regards to Facebook—the massively popular social network.

The agency argued that the trackback link that the button generates is in violation of its marketing code because the link represents the benefits of the drug and not the adverse reactions.

To clarify, “Facebook Share” widgets are plug-ins added to blogs or websites that allow visitors to a site to repost a link to that site onto their Facebook profiles. What appears on the user’s Facebook page (or Wall) is a short excerpt from the site, a link to that page, and usually a thumbnail photo generated automatically. 

According to Digitas Health, the letter concerned the content provided by Novartis to the user, not about comments or messages left by random Facebook users. A major concern by industry and regulators has been how to control user-generated content on social media sites. For example, should a pharma company be held responsible if a banner ad for a drug appears on a public online forum where adverse reactions to the drug are being discussed—even if it’s a third-party site not associated with the drug firm?

“FDA seems more explicitly to be endorsing the view that it will hold pharmaceutical companies accountable solely for the material they provide for use in social media venues, not for any comments made about that material,” Digitas stated in a release. “DDMAC applied the principle of holding pharmaceutical companies accountable for filing only those materials generated by the pharmaceutical company.”

Digitas suggests that pharma companies eschew using the brand name on sites with a Facebook Share widget enabled or simply avoid making claims about the drug’s effectiveness.

FDA stated that the information in the Facebook link was pulled from the website’s metadata description, which Novartis has full control over. Users cannot modify the message; only add additional comments below the link. Digitas recommends that pharma companies planning on including a Facebook Share button should submit the proposed shared content as well as the site’s metadata for FDA review prior to a site’s launch.

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  1. Posted September 2, 2010 at 5:36 am | Permalink

    This is a very interested article that enforces our concerns about how far to take social media. It is clearly a great marketing arm to explore but it is also clear there are a number of changes that need to be made in both legal and business culture before this can be fully utlised within the Pharma sector.

  2. Posted November 6, 2010 at 11:05 pm | Permalink

    Awesome content, well written I must say.

  3. Posted December 30, 2010 at 7:21 pm | Permalink

    Great post. There’s a lot of good data. I did want to let you know something though – I am running Ubuntu with the latest of Firefox and the look and feel of your blog is kind of weird in some places for me. I can understand the articles, but the navigation doesn’t work so great.

  4. Posted November 25, 2014 at 9:33 pm | Permalink

    Yes,social media will be a great power apart from search engine like google, bing,and yahoo,it is now at its baby period, need to grow, need to be mature enough to handle sophoisticated data and content,as well as there should be leagal arms to supervise and balance the power between search engine and social media, otherwise there make comes bad competing.

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