Lack Of Social Media Guidance From The FDA: Push Forward Or Put Programs On Pause?

Here I was thinking that this article would be a piece of cake. The FDA intended to issue its guidance on how pharmaceutical companies could use social media by the end of 2010. I thought for sure this column would be prime real estate.

I was sitting on beach-front property and I could already see the article taking shape. I would discuss the implications of the new regulations, how pharmaceutical companies could plan for social media engagements in 2011 and the limitations of the new guidelines.

Change of plans.

The FDA has indicated that guidance won't come until Q1 of 2011. My advice to you: don't hold your breath. Many healthcare marketers have been toeing the sideline in hopes that a statement from the FDA would be enough to nudge them onto the social media playing field. While that didn't happen as planned, I'm not sure it matters much.

FDA guidance is not the biggest hurdle holding back pharmaceutical social media programs nor is there any guarantee that whatever comes out of the FDA will provide more clarity. In fact, it's entirely possible that once the FDA does state its position, engaging in social media for pharmaceutical companies could be more restrictive, not less.



Rather than focus solely on the pending social media guidance from the FDA, healthcare marketers should be using this time to re-evaluate and identify the primary reason social media programs are stuck in neutral.

Put simply: is the lack of clarity from the FDA just a convenient excuse for staying out of social media?

Don't get me wrong, the uncertain regulatory environment is a significant and valid reason to proceed with caution. But it's a hurdle that can be overcome now and in the future. What I'm suggesting is that marketers dig a bit deeper and evaluate the readiness of their company for a social media engagement. Chances are, if you think the only thing holding you back is the FDA there are probably other underlying issues.

For example, there could be a cultural misalignment at your company that is hindering social media progress. Companies need to have a cultural willingness to not only try, but mess a few things up along the way. This is a new mode of communication, particularly for healthcare companies, and there will be missteps.

A company that is completely risk averse is a poor fit for social media. Have you educated internal stakeholders about the value and purpose of a social media engagement? There could be internal roadblocks you have yet to consider because you are operating under a false assumption that FDA guidance is the only obstacle. Do the internal resources exist to make a social media engagement work?

It's not enough to only engage the marketing team. Individuals from legal, compliance and IT among others should be a part of the process from the outset. Have you determined your reason for engaging in social media and your strategy for achieving those objectives?

Ultimately, the draft guidance from the FDA is only one minor piece of the puzzle. True, it is currently holding many marketers back. But should it? The truth is: effective social media engagements can occur with or without guidance from the FDA. However, success is infinitely more difficult without addressing some of the questions outlined above.

So while you thought you might ring in the New Year with a gift from the FDA -- all is not lost. And if you still are looking for a reason to celebrate I hear the Balinese have their New Year in March -- right around the time we should be hearing from the FDA.

1 comment about "Lack Of Social Media Guidance From The FDA: Push Forward Or Put Programs On Pause? ".
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  1. Jeffrey M from 3v07, January 3, 2011 at 1:36 p.m.

    Why are you waiting for the FDA/ Even if you choose to be the most conservative comapny on earth, there is so much to do in Social Media that requires nothing from the FDA. Taking sound brand principals and adapting them to the nature of the social media environment is a requirement today. Like all communication environments, the key is to being very creative with what you know you CAN do. Every company should be building their base now, and we are doing it successfully for one of the most ethical major pharmaceutical and medical device companies in the world with incredible results. Any company with the plan to drive consumers into the doctor's office, create an affinity for their brand, or be instantaneous with awareness of new brands at brand launch (and more) with their target audience already has many strategies and tactics we have proven work effectively.
    I did the 50th dot-com. It was for a biotech company. Then ran around the country telling my pharma and meddev clients you HAVE to do this and was told all the reasons why it was a silly redundance of paper, no doctor has a URL, etc. etc.
    None of these reasons apply here. Think past thinking about it and act now and you will see immediate results. 3v07 has the proven, acceptable tactics to show for it.
    Social media is a here. It has its own search engine and advertising that Facebook people prefer to Google, etc. It has loyalty. it has targeting. It has word of mouth. It has video. It has the complete ability to be effective and compliant now.
    We have mountains of data to show the cost effectiveness, unique opportunity and the ability to own your space. It has INCREDIBLE effectiveness.

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