Novartis got a snail-mail missive from DDMAC for a product-specific FaceBook widget. According to DDMAC, the widget, that provided a link to content about the Tasigna (a treatment for forms of Philadelphia chromosome-positive CML) omitted risk information and broadened the drug's indication. The widget let users to post links to product information on their FaceBook wall.
DDMAC said the content, in most cases a sentence or two, made claims about Tasigna's efficacy, but did not include any risk information. While the shared content included a link to Tasigna websites, which include risk information, DDMAC said it was not sufficient.
"For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug," the agency said in the letter.
DDMAC also cited the company for not submitting the "FaceBook Share" content for review prior to dissemination, although the company did submit the content contained in the Tasigna website as required.
Sounds a lot like the 14 DDMAC letters sent out in November 2009 on the general topic of sponsored Google links. The key take-away from those letters wasn’t that the agency was condemning the use of social media – but that “sponsored” = “advertising.” Sound logic.
Is a company-sponsored product-specific FaceBook widget advertising? Of course.
The Tasigna letter should not be taken as a signal that the agency is restricting use of social media – it’s a signal that the rules (which, in this case are pretty clear) should be followed. But, no doubt, those rules need to be clarified.
On a more peculiar note (and according to a report in the Pink Sheet), “The agency said DDMAC is not working on draft guidance for issues related to Internet adverse event reporting because it is outside its purview.”
That is surprising and disappointing – and requires further thought from the folks at White Oak.
