On July 29, 2010, the FDA issued a warning letter to Novartis stating that content shared through Facebook and ShareThis functionality "... 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. In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products."
At issue was a single sentence embedded in the site's "meta-data," that small snippet of text historically intended only for the automated eyes of search engines, and not the actual eyes of visitors. In this instance, that snippet of "meta data" contained incomplete labeling information for the Tasigna product. In turn, that embedded snippet of text—no more than a single sentence—was picked up by a widget to display on an individual’s Facebook page.
While the resulting headlines generated in response to the warning letter seem to focus on the medium being used, Facebook and ShareThis, the real issue may lie in the fact that in pharma marketing, the people who know what to say and the people who understand the medium through which it is said are frequently not the same people.
Novartis did not set out to mislead consumers, nor did they intend to subvert regulations by communicating with the 500 million users of Facebook. In this case, they provided regulatory oversight only on the content that could be read on the printed page (or in their web browsers) and ignored that which lives beneath the surface. But understand this, the inner workings of your website is not the Matrix. It's not some shape shifting ghost in the machine, nor is it a minefield of legal toe poppers.
It's text. The same kind of text as any other, which can be shaped, managed and designed to safely and legally deliver your message.
In the absence of purposefully written, legally reviewed and properly implemented content, that small army of automated thingamajigs crawling the internet will decide on their own what gets displayed on Facebook, or Google, or the news aggregator potential investors access on their cell phones.
So, with that in mind, do this:
Make sure your legal affairs team reviews all content and claims. But first, be sure you know where all your content and claims are located and present the meta data in the copy deck for review
Consider implementing a safe boilerplate meta-data statement that gets picked up by the widgets of the world in the event a more tailored or specific statement isn't already in place
Remember that it may not be enough to work with a marketing agency that understands pharma, or a technology vendor that understands marketing. These days you have to work with an agency that understands technology AND marketing AND pharma
In recognition of meta-data's practical importance and legal significance, HDMZ provides specific tools within our CMS and steps within our process to manage this type of content - drop us a line to learn more (firstname.lastname@example.org).