A Facebook Share widget found on Novartis' Tasigna (nilotinib) website provoked a DDMAC untitled letter, the fourth DDMAC communiqué Novartis has received this year.
In a rare bit of footnoted exposition, letter writer Karen Rulli, DDMAC's acting group leader, demonstrated her knowledge of Facebook Share—a tool used by Facebook members to share content across profiles—noting that with “two clicks, visitors to a website can share any page of that website through Facebook by generating a link to the page, along with a thumbnail image and brief description…that will appear on the users' profiles and, depending on privacy settings, in the home page stream of all of the users' [Facebook] friends.”
The problem with Novartis' Tasigna share widget, according to the letter, was that it presents efficacy claims for Tasigna, but “fails to communicate any risk information.” The widget also “inadequately communicates Tasgina's indication and implies superiority over other products,” the letter said.
Several pages from the physician and consumer portions of the Tasigna website generate unlawful risk omission and a broadening of indication via Facebook Share (and a Share This tool), according to the letter. Additionally, shared content from one of the consumer-directed web pages calls Tasigna a “next generation” treatment, which “misleadingly suggests superiority over other tyrosine kinase inhibitors approved for use in the treatment of Ph+ CML,” a claim not supported by clinical data, the letter said. “DDMAC has previously provided written advisory comments to Novartis about the misleading implications of the phrase ‘next generation' when referring to Tasigna,” the letter admonished, citing advisory letters dated August 14, 2008, and January 25, 2010.
Novartis also failed to submit the shared content to FDA for review, although it did submit the Tasigna website itself, according to the letter.