Novartis Gets Warning Letter For Facebook Widgit

Novartis has been told off by the FDA in a

about a social media Facebook widgit that appears on the company’s Tasigna website. The problem? “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,” said the FDA letter. As such, the FDA has said the company is in violation of the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations.

When clicked on, the Facebook Share widget (which has now been removed from the Tasigna website) generated Novartis-created information for its oncology drug Tasigna that could be shared by being displayed on a Facebook user’s profile and, potentially, on the homepage stream of all of their friends. According to the FDA, each time a link is shared by one user, potentially hundreds of new people may see and click through.

Although users can add comments about the shared information, the information itself as provided by the original source (Novartis) cannot be modified. In the case of Tasigna, the shared information was too promotional and did not communicate the risks of using the drug, which has been associated with a number of serious risks including sudden death and liver function abnormalities. The FDA also added that the information “inadequately communicated the drug’s FDA approved indication” and implied “superiority over other products”.

Novartis was asked to submit a written response to the letter by 12 August 2010.

According to a blog from Pharmaceutical Executive, this is the first known enforcement by FDA regarding Facebook.

www.fda.gov