DDMAC re Facebook Share – Be Careful of What You Are Sharing

August 6, 2010

By Dara Katcher Levy -

In what we believe is DDMAC’s first foray into tackling one of the “gray-areas” created by social media, on July 29, DDMAC issued an Untitled Letter to Novartis Pharmaceuticals for Rx drug content “grabbed” by a Facebook Share widget. 

For those that aren’t familiar with Facebook Share (yes, we know you’re out there), it is a widget placed on a webpage by the webpage operator that allows users to share a link and brief description of that page on Facebook.  The brief description and link are often fed through a “news feed” and shared with Facebook friends.  Although users can add comments to the brief description, they cannot modify the brief description – which is “grabbed” by the widget from the page itself, and may be a “directed grab” of content through the website’s use of html tags. 

The website for Tasigna (nilotinib) capsules contained a Facebook Share widget, located on the right hand side, under efficacy claims, but above the Important Safety Information for the drug.  The brief description grabbed by the widget came from the upper portion of the page, and included the headline and a graphic.  DDMAC’s objection was that the grab contained no safety information, and in some cases, broadened the drug’s indication and made unsubstantiated superiority claims.  DDMAC did not cite the full website itself for any violations, only the grabs created by the Facebook Share widget.

Further, DDMAC cited Novartis for not submitting the Facebook Share grabs on Form 2253.

As industry anxiously awaits DDMAC’s Guidance on the use of the internet and social media (promised by the end of this year), in the interim, we can likely expect some “previews” of the Guidance through further Warning and Untitled Letters on the topic. 

Fortunately, FDLI is publishing in September a book on social media for FDA-regulated companies.  Order now, they make a great Labor Day gift!  (Full disclosure:  HPM co-blogger in chief, Jeff Wasserstein, wrote one of the chapters.)

Categories: Enforcement