I really probably shouldn’t write, or publish, this post.
You’re not supposed to write stuff up when you’re really infuriated.
I’m going to publish it anyway.
Today, at the ePharma Summit conference, we had the much-anticipated talk by Thomas Abrams, Director of DDMAC/FDA. Tom seems like a nice enough guy and this rant isn’t about him personally. We’d probably enjoy a nice talk over a Samuel Adams Winter Ale. It’s about the monstrosity we were subjected to – an overview of the no-decision-making process of this watchdog of American health, the FDA.
DDMAC has ostensibly been on the verge, after many months of deep ponderings, of giving some BASIC guidance to the pharma industry about the use of social media in public communications. Turns out nothing of the sort is imminent. In fact, after today’s overview, I’ve sketched out what I believe must be the (simplified) version of the FDA no-decision-making process:
I am now convinced that the industry cannot count on helpful, pro-active, useful, timely guidance from DDMAC. If I’m not mistaken, FDA never even came out with guidance about the web 1.0 Internet. And now our digitally-networked world is evolving even faster (ironically, FDA is making pretty good use of social media tools – for themselves). Social media does not move at a glacial pace – it’s a sprint. Whatever comes out of this mill in 10 years or so will be about as helpful as guidance about the proper use of a FAX machine.
I’m sure there are some very fine people in the FDA, and when abstracted from the bureaucratic tangle that now engulfs what they do in relation to pharma, there are some noble goals about protecting patient health, etc., etc. But when the only deliverable is a process of considering a process to arrive at a decision-making process about reviewing possible preliminary guidance that may or may not be relevant by the time it sees the light of day, well, I’m sorry, but that has nothing to do with human health. It does, however, have everything to do with opportunity cost – the years and man-hours wasted only hold back the ability of industry and patients to get at useful ways to communicate. That’s what makes me so frustrated. The very folks charged with making sure that the right folks get the right message about the right medicines are prescribing beta-blockers when we need eyeglasses.
More research is not a result. It’s an excuse.
Now, let me temper my rant with this fact: short-sighted dolts in the pharma industry who continue to violate pretty straightforward practices about on-label and accurate marketing are bringing all this on themselves. When will we get more courageous leadership in the pharma industry that sees beyond next quarter’s numbers; that values ethics and integrity above maximized profit? When will we see the Golden Rule instead of the Gold-in Rule? I’m all for fair competition, sales, and profit – this is a business marketplace. And a good number of the folks within pharma are seeking to do things right (I know and work with many of them). But the regulatory tangle we are subjected to today is, at least in part, because of jerks who incentivize jerks to cheat the system.
People inside pharma companies cannot speak this bluntly in a public setting, but I’m an outside voice. I have a mind and a conscience and (hopefully) a few remaining shreds of common sense, and it’s time to just tell it like it is. This industry is in serious need of culture change. And so, evidently, is its watchdog. But maybe that’s a premature conclusion. It needs further study. I’d better hold a public hearing and bring in some experts for more advice…and please, just FAX in your comments.
I’ll post them on my Zamboni for public comment.
UPDATE: forgot about this year-end spoof I did – now it looks downright prophetic!