FDA Isn't Ready For Us...Stop All E-Marketing!
I've been preaching a bit on my blog (Dose of Digital) about how we have to try to use new digital technologies in healthcare marketing (particularly pharma) . I've also tried to show that it is possible to do use these technologies in a regulatory compliant way...at least for some things.
But I've realized one thing lately. Yes, there are a lot of companies whose internal processes or culture make it extremely difficult to try out some of these new ideas. I've considered this situation and the lack of willingness to break this trend to be the fault of healthcare marketers. However, I realize that I may have been too harsh. In fact, they share the blame.
The reality is that you really cannot do anything promotional in the US without the blessing of the FDA (specifically DDMAC). You even have to pre-clear some materials with them before you use it including DTC TV. You are required to submit a "2253" and you have to do this "at the time of initial publication or dissemination." You really have to see a "2253" to appreciate it. Get yours here and follow along.
As far as government forms go, this one isn't that bad. But you need to do this for every promotional item you create. It's simple when it's a printed core visual aid or a print ad, but what about when it's a blog? John Mack had a good comment about this on a recent post that sort of wonders aloud if each post of blog post (and/or each comment) would have to be submitted with a new 2253. That would be a pretty colossal waste of time and obviously doesn't quite fit with the immediacy that we have come to expect from blogs. It's also a nice deterrent to starting a company blog.
Here's where I'm going with this. Take a quick look at the 3rd page of the 2253. It includes a list of all the codes of the different promotional channels and materials that can be submitted. This is supposed to be an all encompassing list to ensure you use the right code (it's the government...gotta have a code). Some of the things on the list are pretty standard including print ads, direct mail, samples, and exhibit panels. But the list also includes such ancient items as "Professional Price Catalogues," "Professional File Card," and "Professional Computer Disks/Programs/CD-ROM." Hi. Welcome to 1996. Disks and CD-ROMs. Really? I remember these things from my first days in the field as a sales rep 13 years ago. Is anyone still using these? The list also includes extinct items like "Professional Giveaways." Of course, my favorite listing, with FDA showing off its 1950s sensibilities, is "Professional House Organ." Who among us, born after 1970, knows what this is without using Google? Please let me know. Certainly it leaves an active imagination to come up with some explanations.
All of these taken together amount to 40 different categories. Only one of these is related to "The Internets." "WWW" is reserved for "Internet Promotion." That's right, everything related to any activity online goes into this bucket. Now, considering all of the different categories, which one do you think gets the most number of submissions? Without any actual data, I'm going to guess that "WWW" is the most popular when you consider, for example, online display ads, email, and websites. Yet, even these three aren't seperated or warrant their own category. I often wonder if there is one person at FDA who knows how to use "The Computer" who reviews all of this stuff. If it's got a "WWW" on the 2253, it just goes over to Ted in IT for a quick look.
I joke a bit, but this tells me that the FDA isn't ready for us. Consider what it would take to review a single banner ad versus a social networking site or a 100 page website. Yet, they are lumped together. There are much different rules for each and different levels of scrutiny applied. The question is: does FDA even know this is an issue? Who is the expert there on digital marketing who can help set the next generation of rules and regulations so that healthcare marketing can catch up to the rest of the world? I've talked about this lack of expertise being an issue in some of the healthcare companies themselves, but hadn't considered that it might even be worse at FDA. Who's teaching them? They don't have a digital agency that can keep them up to date on trends and who has a vested interest in ensuring that they are.
So, here's what I propose and what you'll seen in the coming weeks: We need nothing short of a new set of rules and guidelines for digital marketing in healthcare. FDA needs to adopt these new rules right away. Why? It's a plus for everyone. It ensures the following:
- Patients and physicians can get better, more up to date information, in the forms they want.
- Healthcare companies can use the channels their customers are demanding and move away from interuptive promotional channels like DTC TV. Costs go down, effectiveness goes up.
- FDA gets everyone on the same page with the rules. It eliminates gray areas about what's allowed and what's not with a channel like social networking, for example. It also helps to ensure that the hundreds of thousands of pages of content created online each year (month?) are properly indexed and reviewed. They'll also have to review fewer DTC TV ads, something they must loathe.
Everyone wins. It'll mean that FDA will have to take some people off the "Professional House Organ" review team and move them over to the new "Social Networking" review team (there are no such teams, of course, but it's fun to picture). FDA is also going to have to admit that it doesn't know everything about digital promotion and that it needs help. It needs help crafting the rules and getting their people educated. Who's going to do that? The answer...Us.
You and me. I'll start by crafting some guidelines on regulations for using digital technologies in promotion. It'll be an open letter to the incoming FDA commissioner (whoever that is). You'll help me make it sharp and add in what I've missed and we'll take it to Washington. It's just crazy enough that it might even work.
We've got to start somewhere. Be on the lookout in the coming weeks for my proposed regulations.
Jonathan is Director of Business Development for Bridge Worldwide, a leading digital and relationship marketing agency, and regularly writes about pharma marketing on his blog Dose of Digital.