Why The FDA Will Give Rx/Dx Digital Marketers Enough Rope To Hang Themselves

UPDATE: 4/27/12
Can any reasonable Rx/Dx digital marketing person still use the FDA as an excuse?


The word on the street is that the FDASM guidelines will be released within the next ten days - at least according to Fabio Gratton of Ignite Health a.k.a. @skypen on Twitter.  


I wouldn't doubt it at this point as it is in line with their previous guidance that the release would be pushed to early 2011. 


However, I want to remind readers to not put too much on the release of the guidelines. I wouldn't expect anything revolutionary in terms of thinking, but the FDA will more likely to stay focused in on the message and not the medium, as I noted previously. That I don't think will change. What will be more interesting to watch will be whether this provides the necessary "green light" for companies who have been waiting for guidelines to press onward or whether the anticipated lack of clarity will keep pushing social media further down on the agenda because of lack of guidance provided by the FDA, perhaps lack of a champion in the organization and the effort required to push guidelines through legal and regulatory? 


I suspect that the companies that have a strong champion are already trying to push forward in this area so those that have not ventured very far are likely to be left behind. Engagement is built over time and with repeated and consistent actions. I think it will be very tough for someone to enter the space and think they can instantly turn on their social media efforts. Particularly for Rx/Dx organizations where there is a natural and frankly healthy skepticism anyway. 


Anyway, see what I had to say on the topic previously, I haven't changed my stance.


UPDATE: 10/25/10

So the rumor mill has it that the FDA will release their guidance in December, which I am looking forward to reviewing. There was one paragraph at the end of the post that jumped out at me. 


However, the guidance documents issued by DDMAC will not be platform-specific. Abrams said that guidances for promotion of products on specific Web sites, such as YouTube, Facebook, or Twitter will not be issued. The FDA views these as fleeting, changing technologies and the guidance documents on social media are intended to be general, broad-reaching, and applicable to multiple areas, regardless of platform.
I think what this really says is what I wrote in my original post below about the guidance. Nothing has changed in the past few months to make me change my mind and in fact this reinforces my point a bit. In the end, I think what I said then applies just as much now. 

>>>>
As an Rx/DX industry insider and an observer, I have been watching the continued shift to digital and social marketing. I’ve seen it up close and personal for nearly 10 years (egad, I’ve been at for almost a decade) and I have been blogging around digital and the healthcare industry since late 2007. So I feel like I am relatively qualified to speak about the regulatory requirements of digital marketing in the Rx/Dx industry.


I have seen first hand the process, documentation and rigor that is required to develop marketing in a regulated environment that seeks to ensure safety, quality and legal marketing. It is certainly not trivial.

I also watched the FDA hearings last November and saw expert after expert and presentation after presentation bring forward cogent and nearly consistent thoughts on how the FDA should best develop guidelines for managing digital and Social Media in the future. Most importantly, the discussion revolved around how to keep patient safety at the forefront of digital marketing yet allow effective outreach to patient communities of all types.

Since that time, we have learned that the FDA will likely present their findings in Q4 2010—one full calendar year after the hearings. Based on what I've seen over the last year, it seems that many people are counting heavily on the FDA to provide strict guidelines on what can and cannot be done going forward. Some companies, I am sure, are using the lack of guidance as a crutch to not move forward.

The recent Novartis situation and the FDA warning letter has certainly put a scare in some marketers for using the Facebook share functionality on their Tasigna website. There are some perspectives on this that you can view here and here.

We also know that the FDA plans to beef up their monitoring of this space with the first step in hiring a Director of Communications, I briefly touched on this here.

All-in-all, this has created the opportunity for some conversation, navel gazing and for some hand wringing while everyone waits with bated breath to hear from the FDA--I think there are going to be some people sorely disappointed with the findings and it will certainly not provide conclusive guidance that is black or white for how to proceed.

What I think it will provide is a summation that digital is important, interesting and permanent (if you’re reading this, you know that) and it will focus on keeping patient safety information within easy reach of the patient. This means balanced information, risk information within 1-click and ensuring that products claims can be substantiated. Beyond that, I think people will be left disappointed with what is not defined such as Adverse Event reporting guidelines or procedures specific to digital and social media. There will be alot of gray area and if you are a digital marketer certainly enough rope to hang yourself if you're not careful.  

We know from other sources that the FDA is most concerned with the message and not necessarily the medium, so my question is why does there seem to be an over-reliance upon the FDA and the guidelines? 
In any other circumstance, they do not tell you exactly what to do so I am fairly confident that they won't when it comes to social media either. 

In my view, it comes back to crafting strategies that are patient-centric and are from the outside-in versus the inside-out. Every disease and therapy is different so it’s hard for me to talk patient insights for everything under the sun, but I do know that when it comes to social media that if you focus on what’s important to the customer (engage, start a conversation, be an arrow pointing to resources) versus what’s important to you (broadcast) then you can circumvent many of the risks and fulfill the patient need. 




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1 comments:

  1. Eileen O'Brien said...

    Nice post Jim. I agree, the Novartis letter was very much about the message not the medium. I also agree that the FDA guidance in Q4 will be minimal. No matter what the forum we have to keep fair balance in mind -- which, in my mind, is what makes this industry so interesting!