FDA’s First Facebook Enforcement Action

In what may signal regulators’ growing focus on advertisers’ use of social media, particularly in regulated industries, on July 29, 2010, the FDA issued its first Facebook-related citation in connection with Novartis’ use of Facebook’s share function on its Tasigna® website. By clicking on the “share” button on the website, consumers could post Novartis-created information about Tasigna® (“Shared Content”) on their Facebook profile walls, which would then be sent to the consumers’ “friends” via the newsfeed.  It also allowed a consumer to send a separate message containing the Shared Content to their “friends” on Facebook.  The FDA cited four (4) ways in which the website and the Facebook “share” widget violated the Federal Food, Drug and Cosmetic Act and the FDA implementing regulations: (i) omission of risk information, (ii) broadening of drug indication, (iii) unsubstantiated superiority claims/overstatement of efficacy, and (iv) failure to submit.
 
According to the FDA, the Shared Content included representations and/or suggestions about the efficacy of Tasigna® but failed to disclose any risk information, making the Shared Content misleading by suggesting that Tasigna® was “safer than has been demonstrated by substantial evidence or substantial clinical experience.”  Even though the Shared Content included a hyperlink that directed consumers to a page that contained the required risk information, the FDA stated that this was not sufficient disclosure.  Promotional materials “must contain risk information in each part as necessary to qualify any claims made about the drug” in order for those promotional materials to be “truthful and non-misleading.”  The Shared Content also included brief statements about the medical conditions that Tasigna® can treat, and FDA concluded this “misleadingly broaden[ed] the indication for Tasigna® by suggesting that it was useful in a broader range of conditions or patients than had been demonstrated by substantial evidence or substantial clinical experience.” 
 
The FDA’s dismissal of the hyperlink provided as part of the Shared Content as an adequate means of disclosure coupled with its declaration that the Shared Content must be submitted for approval (in the manner consistent with all other promotional materials for pharmaceutical products) clearly indicates that the FDA considers the information generated by the drug company and disseminated via social media to be advertising and, as such, subject to applicable regulations.  Although the FDA has yet to issue guidelines in response to the social media hearings it conducted in June, this action provides an important indication of the FDA’s thinking.   — Terri Seligman