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:
- Abbott
- Amgen
- AstraZeneca
- Bayer
- Baxter
- Bristol-Myers Squibb
- GSK
- Johnson & Johnson
- Lilly
- Novartis
- Novo Nordisk
- Pfizer
- Roche
- Sanofi-Aventis
- Takeda
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.
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I see Sidewiki as a completely separate site from the corporate site.
Let’s go back a few years and imagine you are using a free dialup service. When you visit the Merck website, a popup ad from the dialup service comes on and advertises widgets. Is Merck responsible for those widgets being FDA approved? Should Merck legal review the copy?
Sidewiki is an annotation service provided by a third party (Google) that is not controlled by Merck. Why should pharma take responsibility for annotations by third parties?
The PI describes the means for individuals (patients, HCPs) to report AEs. If a tagger writes “cialis made jimmy jones weener fall off on tuesday” on a subway car, do we need to call the dogs out to report this?
Chris P hits the nail on the head. This article goes substantially in the wrong direction implying that sidewiki information is “on the page” as if its published by the site.
The point the author of the original post makes is that it is not apparent whether and when information posted to a Sidewiki will or will not be imputed to the pharmaceutical or medical device company that sponsors the underlying web site for purposes either of “off-label” promotion or of adverse event reporting responsibility. After all, FDA’s regulations appear to require reporting of adverse events whenever a company becomes “aware” of information that has the requisite degree of detail to permit meaningful reporting. The “Jimmy Jones wiener fell off example” cited above may well require reporting by the company under current FDA rules once the company becomes “aware of” it from the Sidewiki posting. This kind of wholesale and haphazard adverse event reporting seems like an odd way to monitor drug safety in the United States in the 21st Century. Indeed, recent amendments to the law, such as the new REMS provisions, new post-market study authority, and the new active surveillance system that FDA is required to develop and implement suggest that it may be time to modify the “become” “aware of” standard for adverse event reporting that is now codified in FDA’s regulations on the subject.
Likewise, it is not clear whether and when merely creating a facility (e.g. the underlying company web site) that permits “off-label” communication through the use of new tools such as Sidewiki makes the sponsor of the site liable for the all the information available there. There are analogies in other areas of media law, such as the circumstances where publishers are and are not liable for information that appears in their publications, that might serve as analogies for when “off-label” information should or should not be imputed to the sponsor. There is signficiant potential liability associated with “off-label” promotion, as evidenced most recently by the Pfizer $2.3 billion settlement in the Bextra case. It seems only fair and appropriate for FDA, in consultation with the Department of Justice and the Office of Inspector General, to articulate clear standards for when a company is legally responsible for “off-label” communications. Put differently, does the company implicitly endorse and adopt an “off-label” posting on a Sidewiki if it fails to add an immediate and conspicuous disclaimer of that label use? If so, what would be an effective disclaimer? If it does add such a disclaimer, will this nevertheless be cited as itself evidence of the company’s implicit endorsement of the “off-label” promotion? People are free to say what they want in the unaffiliated blogosphere. Why should merely placing this information in a Sidewiki on a company web site, over which the company utterly lacks control, impose any duties on the sponsor?
These are all important questions that FDA should absolutely address.
ARNIE FRIEDE
ARNOLD I. FRIEDE & ASSOCIATES
Arnie@FriedeFDALaw.com
Just for you – I have put a sidewiki on the FDA’s homepage!
Pip pip!
I agree with Chris. Frankly, there is little difference between Sidewiki and every other online existing (or future) annotation service. Manufacturers should not be expected to patrol the entire web for transgressions that they cannot realistically be expected to prevent.
I agree that Sidewiki is a separate entity. So is Wikipedia. However, the fact that it appears on one’s home page makes it a slightly different animal. Should pharma be responsible? Probably not. Does that mean that the agency that regulates pharma will necessarily see it that way? We don’t know. After all, an agency that understood how patients use the Internet to get healthcare information would not have sent out the 14 untitled letters about paid search. My point is, we can’t take it for granted that the FDA will interpret Sidewikis reasonably.
It does NOT appear on one’s home page. It appears as a side bar in the browser. The home page is moved to the right in the browser window.
Yep, technically you are right and I need to be careful about choosing my words – but it is not visible unless one goes to the home page and sees the icon. You don’t see it from any other spot. And while it is housed separately, it is nevertheless there at your home page for others to see.
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