• FDA No Facebook "Friend" Of Novartis (Part I)
  • August 23, 2010
  • Law Firm: Holland Hart LLP - Denver Office
  • On July 29, 2010, the FDA issued its first social media traffic ticket to Novartis’ meta data link connected to the “share” button on its Tasigna web site. The feature allows consumers to send Novartis created information about its drug products such as Tasigna to “friends” of the consumers via the news feed. The FDA cited four separate violations  of the Federal Food, Drug and Cosmetic Act in the metadata.  First, the meta data omitted the risk factors with respect to the drug. Second, the meta data effectively broadened the indication for the use of the drug by not including its limitations by the the FDA (i.e. chronic phase and accelerated phase myelogenous leukemia resistant to prior therapy). Third, unsubstantiated superiority references (“ next generation”). Fourth, failure to submit form 2253 regarding the disclosure of promotional content.

        The problem is that some social media has technical limitations as to the length of content that will be provided that may limit the use of pharmaceutical advertising efforts. Search engines ignore anything more than 160 characters in the meta description and Facebook is limited to 50 characters. If a company like Novartis would provide a full and fair balance concerning any of its drugs they would not be included in the text of the social media message.

        There are a number of  digital advertising supporting blogs that have chastised the FDA concerning the relevancy and validity of its concern.

    Let’s be clear here.  The share button allows you to share content on a website with your friends on Facebook. It posts some content from the site as well as link on your Facebook page.  Does any rational person really believe that ANYONE is going to read the brief content and either ask for an Rx or make a healthcare decision ?  But we’re not talking about a rational person we’re talking about the FDA whose job it is is to make credible health information from pharma difficult to share.  Clearly they don’t get it.

    World of DTC Marketing.com, August 5, 2010 post by Rich Meyers.

        Bridge world wide,  http://www.bridgeworldwide.com which describes itself as a “leading digital and relationship marketing agency” has issue its own response to the FDA which suggests the following potential remedies to the FDA concern.

        Keep or add “Like” and sharing functionality to all pages on every site. We believe this an expectation of users and encourages word of mouth sharing of your content. This new Warning Letter does not change our opinion on this topic.

    Specific Facebook tags should be added to every page where a Like button is placed to make the most effective use of this technology and the Social Graph.

        META descriptions and Facebook tag descriptions should be rewritten not include the drug indication or other specific disease-related information, but should still give enough information about the page to entice customers to click on search results.

        META descriptions should be included as part of every legal and regulatory review of any website that may fall under the jurisdiction of the FDA.

        There are significant concerns that have been raised about the use by pharmaceutical companies of social media which shall be explored more in Part II.