The Sidewiki seed is spreading amongst the pharmaceutical industry.
Sidewiki, you will recall, is a new tool brought to you by Google that allows any computer user on the Internet to go to any home page and insert a side bar wiki. They can write what they like on the side bar and those who themselves have installed Sidewiki on their Mozilla Firefox can view it. In essence, as I mentioned in a prior posting, the Web 1.0 site that a company used to have, now becomes a Web 2.0 tool of social media.
That, of course, raises several regulatory questions. If someone writes of an adverse event on a Sidewiki, or promotes an off-label use, it is now on the company's home page. Is the company under a duty to monitor and correct such misinformation or if they do, do they incur liability for doing so? It is a conundrum – and there is no insight apparent from the FDA on the matter.
You would think that in the wake of the launch of Sidewiki, that the legal departments of pharmaceutical companies would have outlined for employees what the company policy is going to be to address the conundrum. At least one company I have heard has forbidden employees to look at Sidewikis, while another I spoke with has had no policy forthcoming.
So far, the companies where Sidewikis are now on their home page are:
- Bristol-Myers Squibb
- Johnson & Johnson
- Novo Nordisk
I'm sure there are others. Ironically, the FDA does not yet have a Sidewiki posted to their home page. But Sidewiki is spreading quickly and just in time for Halloween, to horrify many MedReg departments. Best to start thinking about this.
The utility of Sidewiki so far? Some of the entries are helpful background, some are interesting news items, and while others are self promotional in nature. It is quite a mix.
If you want a primer on Sidewiki – here it is.