Thursday, June 21, 2012

"Low Hanging Fruit" Keeps FDA Busy & Out of Pharma's Social Media Hair

Another tidbit I picked up this week at CBI's 3rd Annual Forum on Social Media Regulations and Compliance is the notion that the FDA is too busy going after the "low-hanging fruit" of promotional violations to pay much attention to violations of regulations involving social media and other esoteric Internet "tricks" such as the manipulation of meta tag data.

This came up in a discussion I started about the use of meta tags to create organic search results that are effectively branded ads lacking the FDA-required important safety information (ISI). I discussed this in previous blog posts (Who's in Charge of Your "Invisible" Metadata? WARNING: Don't Invoke the "Invisibility Rule" and Are Organic Search Results Next on FDA's Chopping Block?):
Metadata is usually "invisible" content inserted within the header of the HTML code that creates a Web page. This includes a "description" of the page or Web site and keywords. Some of this information is used by search engines to find the page and include a description of the page in the natural search result.
When you do a Google search on "Viagra," for example, you will find a "sponsored" link (i.e., paid search ad) like this:

You will also find this unpaid natural search result:

BOTH the paid ad and the search result contain content that is written and controlled by Pfizer. The natural search result content that begins with "Learn about..." is exactly the content that Pfizer included in its "description" meta tag within the HTML code for the home page. Google just lifted that content. Users cannot control this content, only Pfizer can -- by editing the meta tag.
A medical/legal/regulatory (MLR) expert in the audience said: "The fact that the FDA may not be pressing that issue right now is because of the low-hanging fruit." He went on to further speculate that even when FDA issues its long-awaited social media guidance this practice would not be addressed because the FDA is looking at "larger organic issues."

I contend, however, that the FDA has already addressed this issue in a notice of violation (NOV) letter to Novartis regarding the use of meta data to create a "Facebook Share" social media widget that generates Novartis-created information for Tasigna that can be shared with Facebook users (see Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget). Organically speaking, this seems to be equivalent to using meta data to create a search result as described above, no?

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