Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget

You know you are getting old when the FDA knows more about Facebook than you do! In a July 29, 2010 letter to Novartis, FDA cited violations with regard to a "Facebook Share" social media widget that generates Novartis-created information for Tasigna that can be shared with Facebook users (i.e., “shared content”). FDA said: "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."

To help the recipient of the letter -- Lisa Drucker, Director, Regulatory Affairs -- understand what a Facebook Share social media widget is, the letter includes several footnotes that supplied technical details and explanations:

"Facebook Share is a way for users of Facebook to share articles, pages, video, or flash content of a site with other Facebook users. Over two billion pieces of content are shared each week through Facebook. 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 a brief description (i.e., 'shared content') that will appear on the users’ profiles and, depending on privacy settings, in the home page stream of all of the users’ friends. Each time a link is shared by one user, potentially hundreds of new people may see and/or click through on the link."

and

"As described below, the shared content for Tasigna generated by the Facebook Share social media widget was developed by Novartis and, although Facebook users can add additional comments that are displayed separately from the Tasigna information, the shared content cannot be modified by Facebook users who use this Facebook Share social media widget."

and

"We also note multiple Tasigna web pages contain widgets that allow users to share content via other social media applications offered via the “Share This” tool (http://sharethis.com). Some of the content available to share through these other social media applications raise similar issues to those discussed in this letter."

In a separate document, FDA included a screen shot showing what one of the widgets looked like before Novartis edited its Facebook page:

This looks very much like one of those infamous Google bAdwords (see Lunesta, Google, and "bAdWords")!

Luckily, Digitas Health published a "Facebook Regulatory Alert" that clarified a few issues and sheds some light on how this widget was created.

"The descriptive content displayed by Facebook on the user's page via the Share feature pulled from the [Tasigna] website metadata [my emphasis], which is invisible to most users but relied on by search engines, such as Google, Yahoo!®,and Bing™, to provide a description of the page's content," notes the Digital Health document.

I Warned This May Happen!
In a previous post, I warned that the FDA may cite certain content generated from metadata (see "Are Organic Search Results Next on FDA's Chopping Block?"). While the Novartis example is not exactly what I was talking about, it's pretty close because the FDA is now citing content that is usually hidden but made visible by widgets. If it can do that, why not cite natural search content that is also picked up from metadata tags?

Possibly thinking along the same lines as I am, Digitas Health ended its Alert with this recommendation:

"Because website metadata is used both by search engines in generating organic search listings and by social media channels, such as the Facebook Share functionality, Digitas Health advocates that all site metadata should be included in internal medical/legal/regulatory review and as part of mandatory FDA submissions."

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P.S. Novartis has updated its meta tag on the Tasigna Web site. It now reads: "Tasigna (nilotinib) 150-mg and 200-mg capsules from Novartis is a treatment for Ph+ Chronic Myeloid Leukemia in newly diagnosed adult patients in chronic phase or patients in chronic or accelerated phase who are resistant to Gleevec."

FDA had complained about the previous wording: "These statements of Tasigna’s indication are incomplete, and misleadingly imply that the drug is approved to treat all individuals with Ph+ CML, when this is not the case. At the time this shared content was originally disseminated, Tasigna was only approved as a second-line option after failure or intolerance to prior therapy that included imatinib. Furthermore, Tasigna is only approved for use in patients with Ph+ CML in the chronic or accelerated phases."