Holland & Hart Healthcare Law Blog

FDA NO FACEBOOK “FRIEND” OF NOVARTIS (PART II)

    The FDA’s citation to Novartis last week for violations of Federal Law in its use of Facebook “Share” button on its Tasigna website without proper disclosures in the meta tagging, underscore recent concerns about big pharma use of social media and Internet technology to market product. On March 1, 2010, the Center for Digital Democracy an on-line consumer watchdog sent a letter to the FDA requesting that it join the FTC in developing rules for the use of behavioral targeting in on-line marketing and the undertaking of a comprehensive investigation into the use and impact of digital marketing techniques and technologies.

FDA NO FACEBOOK “FRIEND” OF NOVARTIS (PART I)

    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.