Ready, Willing, and Legal: Marketing Without FDA Guidelines

finger trap

[Photo from somegeekintn]

If you’re in pharma or healthcare marketing I’m sure that by now you’ve heard that the seemingly mythical FDA guidelines on social media have been delayed. They will likely be delayed until sometime in the first quarter of this year according to their statement. Of course, it is the first quarter right now, so when this might happen is anyone’s guess.

Here’s the notice they sent via email:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:

  • Responding to unsolicited requests
  • Fulfilling regulatory requirements when using tools associated with space limitations
  • Fulfilling post-marketing submission requirements
  • On-line communications for which manufacturers, packers, or distributors are accountable
  • Use of links on the Internet
  • Correcting misinformation

Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.

(thanks to Eye on FDA for sharing the email)

Personally, I’m more than a bit tired of hearing about “the guidelines.” They’ve been built up to the point that they are now positioned as the holy grail of marketing for pharma. Once they come, the world will change for the better and everyone will be free to do whatever they want all with the blessing of the FDA.

If you’re one of the people that think this, then you’re likely to be extremely disappointed. In my opinion, the guidelines (if and) when they come will be a let down for nearly everyone. Anyone with low expectations won’t fall into this group. You should be in the low expectations group. Think about it. The FDA isn’t going to say, “go forth and use social media however you want.” They probably aren’t going to suddenly allow the legendary (if fake) “one-click rule.” They aren’t going to fix or clarify adverse event reporting rules since DDMAC, the division issuing the guidelines, has no real remit over adverse events (that’s CDER if you really want another acronym). Notice that their message about the delay includes nothing about adverse events. They also aren’t going to tell you what you can and can’t do on Twitter or Facebook. Issuing guidelines about a specific platform isn’t exactly planning for the future.

So, let’s relax. There’s quite a bit you can do right now without any guidelines. Like what, you ask? For starters, how about any of the hundreds of examples on the Pharma and Healthcare Social Media Wiki? Of note, not a single industry program on this list has ever received a Warning Letter or Notice of Violation from the FDA. Someone is doing something and not getting into any trouble. Just saying…

What else can you do? Well, I did a talk at the 2010 E-Patient Connections Conference last fall (note: save the date for this year’s). The topic of my talk was all about what you can do now in digital marketing without any new guidelines. I aptly titled it: Ready, Willing, and Legal. It seems fitting that I should share that presentation with you now since you’re all waiting once again.

You can view the presentation along with the audio on SlideShare. I’ll embed it here as well. Sorry for the less than professional audio quality. It’s my own recording and my iPhone isn’t a sophisticated recording studio.

If you want to download a copy of the presentation in PowerPoint format, you can, but there’s a catch. For now, it’s only available to those who Like Dose of Digital on Facebook. If you do already, then great. It’s yours to download. If you haven’t connected yet on Facebook, well, here’s your chance. Head directly to the “New Stuff” tab to pick it up. If you don’t want to do this, then check back in a couple of weeks when I release it to everyone on the Pubs and Presos section of the blog. If you don’t feel like checking back or (like me) won’t remember to do that, then you can sign up for our New White Papers and Presentations email list. We’ll send you an email when a new presentation or paper is available. Sign up here.

I hope this presentation gives you some sense that there’s still quite a bit you can do right now without any guidelines, most of which is very low risk with a big potential impact. Feel free to leave your comments about what else companies should be doing right now.

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2 thoughts on “Ready, Willing, and Legal: Marketing Without FDA Guidelines

  1. Excellent blog Jonathan. I agree, we should “relax.” Even if the FDA does publish it’s policy, enforcing it is another animal.

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