FDA, Fair Balance, Novartis, and the Myth of “one click”

It is easy to get drawn into the minutiae of regulators actions with respect to social media, and miss the big, over-arching concern – namely “fair and balanced”.

The medium is irrelevant – it is the message that counts. Consumers are supposed to be able to get all the relevant facts in a fair and balanced way.

Novartis tried to use social media to spread the word about one of their drugs “Tasigna”,and got it wrong enough that the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) issued a notice of violation letter on July 29th 2010 to them. This is a big deal because it was the first time the FDA has ever mentioned social media in one of their violation letters, and because lawyers use these letters to determine what the FDA will allow.

So what did they do wrong? Simply by embedding a third party sharing button (just like the one on this website) on the Tasigna page. If you pressed the Facebook button within the ShareThis toolbar then it created an entry on your Facebook wall, which I’ve included in this post as it has been removed from the site.

It does not really matter whether it is Facebook or LinkedIn, or any of the other social media sites – they all work in the same way. There is a section where the content is dictated by the site hosting the button (the Novartis Tasigna website), and there is a section where the owner of that page can add their comment (in reply to “What’s on your mind”). The fixed content is passed as “meta-data” to the social media site. There has been alot written about meta-data by commentators on this FDA warning, but all you need to know is that you can’t see the content until it is written on your social media page, you can’t edit it, AND the social media site limits its size (in the case of Facebook to 420 characters).

The problem for Novartis was two fold – they did not realize that they owned the space on the user’s page because they wrote it (via meta-data) and the user could not alter it. So it was no different from an advertisement in an paper magazine that they should have submitted to the FDA, and did not. Secondly they chopped down the displayed message so it fitted within 420 characters and hence missed out alot of vital information that made the advertisement “fair and balanced”.

It is easy to get wrapped up in all the medical related language – but the basic issue would be the same if this was a British financial services advertisement that used Facebook in the same way – there is insufficient information (or too much, if you look at it another way) to be fair and balanced, and the fact that there is a “one-click” link to the website with all the information needed to make it fair and balanced does not matter.

So if “one-click” does not save you, is social media beyond medical salvation?

In a word “no”.

I think that the best way to see these advertisements is like political yard signs (small signs stuck in people’s front gardens). All they say is the name of the candidate and their slogan – plus some contact details. But they are more powerful than a simple advertisement because they are endorsed by the owner of the yard. When you see your neighbour endorsing a candidate it says something about the candidate, and also something about your neighbour.

So simply building a community that points people to your website is powerful in itself.

Now if the rules change and “one-click” is enough to satisfy the “fair and balanced” criteria then I think we will see social media take off as an advertising medium for healthcare in just the same way that Direct To Consumer (DTC) advertising did in the 1990s.

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