A while back, pharma companies/marketers operated under an assumed framework that if more complete disclosure about named drugs was one-click away (the “one click” rule) on the web, that should be sufficient. A series of FDA warning letters eventually put the freeze on that notion.
However, in a hyperlinked world, I think that compliance and disclosure via hyperlinks is the only logical method to both enter into the fragmented world of web communications, AND provide full information for patients and physicians. Anyone who has seen printed product information (the “PI”) littering pages of magazines (following a drug ad) immediately understands that providing all of that disclosure in web formats – esp. social media – is totally unrealistic.
Today, a new service was announced which really got me thinking. Check out http://cmp.ly/ – in fact, first read this overview. Having standardized shortened URLs to deal with new FTC requirements for blogger disclosure is a brilliant idea. But I think this has the potential to go much further, by providing a standardized method for hyperlinked disclosures for pharma (and other regulated industries).
Let’s say that a pharma company has 5 corporate disclosure documents that are universally used, and that the company has 4 products, each with a PI. Every one of those documents can have a fixed and predictable link, so that in tweets on Twitter, in blog posts, or in Google ad links, those disclosure documents are “1-click” accessible.
This can be a paid service for a company like those who launched cmp.ly. Let’s say your the first pharma company to pay for this linking/forwarding service. You get http://p1.cmp.ly. A corporate disclosure statement can then be at You get http://p1.cmp.ly/1. A specific product PI could be at http://p1.cmp.ly/5. And onward – the 30th company to sign up would be at http://p30.cmp.ly, etc.
Device companies? d(x).cmp.ly, etc. Banks? b(x).comp.ly, etc.
Frankly, I don’t see any alternative to something like a “one-click rule” – it was never official before, and never standardized, but an approach like this might make it easier for the FDA to get comfortable with the notion.
What do you think?
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John Murray says
You’re right on. I personnaly think we should ditch the term “one click rule”. The internet is too dynamic for that kind of restriction. “One Click” is an arbitrary convention that will open one door and slam shut all others for the next twenty years while technology leaves the “regulated” in the dust. I prefer a standard of “Conspicuous and Systematic Access” There should be an initiative of universal conventions for disclosures (a wide variety of them). Getting to a good system will be artificially suppressed by “one” click, when technology may be able to be more useful with a few more clicks and use of icons and easy to use information systems. “One click” may be easy for people to get their head around and get regulators to agree with something (that’s one form of progress), but it might also stifle alternative and better forms of progress in the coming years.
FDA itself uses lots of its own behavioural science and pseudo-science and theories of net impressions to support its enforcement. The Department of Justice goes farther to piece together lots of “facts” into theories of intended uses to support record-breaking misbranding cases. Enforcement relies on fact patterns-why can’t compliance and solutions rely on fact patterns? (actually they can, but I find it’s too unfamiliar for people to work on). Compliance programs typically work in the negative -stop something bad by putting a restriction in place. Compliance programs could work better by using an overlapping strategy and put twice the effort into making a good fact pattern…encourage something good and useful and realistic versus simply discouraging something bad.
Your thinking is right on target. Regulatory compliance solutions tend to be very two dimensional slap-on sticks and glue–invented in the time constraints of copy approval meetings to fix a proposal that needs to be approved “this week.” Often times its a backward look at something someone else did and simply copying it. Quick solutions become conventions that last forever (some good, some terrible and everything in between).
What you’re thinking, and what I’ve been thinking too. Is much more promising, and ultimately logical and useful. We need the technology and information systems to be the friend of regulation rather than the problem.