By DJ Edgerton
I believe the FDA assumes inherent common sense – and I believe that’s exactly their problem.
Hear me out. I know you’re thinking, “Are you kidding? The FDA? The ones who mandate mile-long warnings nobody listens to and stipulates enormous patient inserts nobody will ever read? That’s your definition of common sense? And you think that they think enough of us to think that we have common sense?”
That’s not what I’m talking about. What I’m talking about is the actions they assume people will take, and the basis they assume for those actions.
The FDA says that all of this information needs to be seen up front because they’re assuming that patients will first, take all of it in, and second, behave in a manner that conforms to an understanding of that information and its consequences.
They base their rules on the assumption that you will read all of the provided information. (Or, if you don’t, it’s not their fault, because at least they gave it all to you.) And then, they assume that the action you take is a direct result of that information.
That’s the problem. The FDA is assuming that people always behave logically.
Let’s not be cliched and quote Mr. Spock from Star Trek before we agree that this is not always the case.
You could argue that it’s not necessarily that they assume intake, comprehension and logical action – but rather, that it’s just a massive CYA policy so that if you don’t, again, it’s not their fault. But, then, why all the rules about how immediately available it all has to be?
Can’t we just put the information out there somewhere, tell people where to find it, and trust that if they’re smart, they’ll go get it?
However, as my esteemed colleague Sven put it… “Darwinism is not a particularly attractive way to run a regulatory body.”
I guess he’s probably right.
But my main point is that I think we need to be aware both of how the FDA functions, but also, that it will be useful for us to look at how digital media function, too.
In another one of those great TED talks, http://www.ted.com/talks/jonathan_zittrain_the_web_is_a_random_act_of_kindness.html, internet law expert Jonathan Zittrain makes a convincing argument – I’d even call it just an explanation – of how digital media exist only because of the inherent goodness of humanity.
We pass information along. We help each other. There are always bad apples, but the majority of humanity does work for our collective good, mostly in tiny ways. He uses the example of passing a beer along a row at a baseball game. That’s how the Internet works.
I believe that it’s possible to take the legal and political need to CYA, the medical need to provide patients the best care possible, the technological need to trust each other and figure it out as we go – and come up with revelatory work in the digital pharma space. But I think that the key is to take all of those into account.
If all you focus on every day is the first, you’ll be long-winded and boring. If the second, you’ll miss opportunities to do things differently, and leave out peripheral details that can be important. If the third, you’ll probably fall flat at least a couple of times.
Checks and balances. They were a good idea in 1776. They still are today.