FDA, Novartis and Facebook

Whether or not FDA releases formal guidelines on social media anytime soon, it is clear that they are monitoring what their pharma constituents are doing. The good news is that today there is much more to monitor among the CDER crowd. The bad news is that FDA's DDMAC continues to focus on minutiae. Remember those 14 warning letters in March 2009 referring to sponsored links. The latest missive to emanate from the hallowed halls of "The Agency" was sent to Novartis, which is quite a progressive company when it comes to social media. The FDA letter cites Novartis' dissemination of content using a Facebook Share widget on Tasigna's branded site. Tasigna, obviously a Novartis drug,  is indicated for certain leukemia patients (Ph + CML).  The letter states: "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."

Many of my colleagues in the agency business got right on this case and did a thorough job of dissecting the issues.  Among them was Jonathan Richman of Bridge Worldwide and the amazing Dose of Digital blog who released a Digital Alert that covered all the bases and recommended solutions. Jonathan was correct in pointing out that DDMAC was not going after social media at all -  they were still harping on the fair balance issue (the content, not the medium). He wrote, "The FDA argues that the content in these META tags should include fair balance (risks, side effects, warnings, etc.) since they had the drug name and indication. The FDA did not have an issue with Facebook sharing in of itself, but rather the content that the site generates automatically, which cannot be changed by the user."

Another good take on the brouhaha comes from Wendy Blackburn of InTouch Solutions who publishes ePharma Rx. First read FDA WidgetGate: Implications and Recommendations and then Pharma Social Media Live and Learn.