What If FDA Mandated Pharma to Use Social Media?

FDA announced that it would delay guidelines on digital marketing until end of Q1 2011. You can read up on it over on Advertising Age here.

Now, much of the attention to this matter – the concerns about Adverse Event reporting, Fair Balance, HIPAA, etc. – has focused on getting FDA to offer guidance on how the regulated life sciences industries can participate in 21st Century media.

It’s a huge issue, fraught with all sorts of nuances (do we need FDA-compliant tweets for goodness sake?) and under-the-hood considerations (data in sharing widgets, etc.).

FDA could go anywhere with this matter. There’s been debate if FDA even fully understands the properties of emerging media and how they all inter-relate. FDA could set a very tight leash on marketing – which would also limit the industry’s ability to interact with patients in ways that could be beneficial.

But one scenario which I’m not sure has been pointed out. What if FDA went in an almost opposite direction. What if FDA actually said to the industry:

We want you to have social media presences so that you can monitor for Adverse Events, track conversations about your products and be immediately available on social networks in cases of public health emergencies.

Furthermore, what if FDA mandated that companies collect, document and store all tweets, blog posts, Facebook status updates and all other public communications?

And not only company-generated communications, but any communications to the companies (e.g. mentions on Twitter). And that the databases be readily subject to audit.

It’s just a thought.

I can’t imagine FDA going this way without at the same time putting a leash on what companies can do.

So what if the following happens? Pharma gets the craziest of both worlds: a mandate to establish digital presences while being limited in what it can actually do. o_O

I don’t know. My sense is that the whole project will be a mess.

The more you think about these peculiar regulatory problems – the deeper you think about all the nuances – you realize how twisted the Web is making things.

Maybe what’s needed isn’t so much social media guidance.

Maybe what’s needed is an entirely different model of regulation: a different regulatory agency, a different Pharma marketing mindset and a better way to deliver molecular and mechanical solutions to human health problems.

Yeah, looks like the Web done gonna ruin a long drug party. đŸ˜‰


0 Replies to “What If FDA Mandated Pharma to Use Social Media?”

  1. Hi Paul,
    I love your blog, but I have to say I’d have to (partially) disagree with this post. I see absolutely what you mean about how monitoring – on one hand – could be a “mess” because it’s not as easy for pharmaceutical companies to tweet back to someone or answer a blog post in the comments because of the heavy legal implications. However, some of our clients (I work with a social media monitoring company, Synthesio, that monitors for several pharma companies) have discovered invaluable information via web listening. It is a shame that they can’t always respond, but there are insights in forums and on blogs that you can’t find in focus groups, either because the question wasn’t asked, or people aren’t comfortable talking about a certain subject, or perhaps because they didn’t think of it at the time ; there are numerous reasons.
    I’ll be in touch though, I’d love to chat đŸ™‚
    Thanks for the great post.

    Michelle @Synthesio

    1. Phil ! Oh cripes, sorry I can’t even blame that on my dyslexicness. Sorry – PHIL đŸ˜€

      social media reason why you should reread before hitting submit

    2. Hi Michelle

      Oh, I agree with you completely – in fact I think companies *should* be using resources to monitor AEs.

      This is actually one of the reasons I started blogging about Pharma & social media.

      My occasional sarcasm over here can be a bit deceiving – I know that, but the hope is to lend a different voice, some humor into what can be a droll topic and attention.

      By “mess”, I’m referring to bureaucratic confusion and inconsistency.

      “Yeah, looks like the Web done gonna ruin a long drug party.” refers to the eclipsing of the Golden Age of Pharma – where mass unilateral communication made it much easier to get messages out and even control them.

      And yes, I would love to chat!


  2. Hi Phil,

    Great article. There is a real challenge with pharma & social media, but of course, where there is a challenge, there is a solution. All early indicators suggest the FDA will be following the FTC guidelines of compliance and disclosure.

    CMP.LY was started as a simple solution for regulatory compliance with the recent FTC requirements for marketers engaging in social media programs. CMP.LY is built around a short coded framework that enables trackable and identifiable disclosures to be included in Tweets, Facebook status updates and short form applications like Foursquare as well as in blogs and web pages. We have expanded to include measurement (for ROI) and reporting capabilities and we are developing additional solutions for more regulated industries including pharma and financial in accordance with pending FDA and SEC regulations.

    And of course, my disclosure:

    Ruth Wagner
    VP Corp Sales

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