FDA Guidance Unveiled!

In a surprise end-of-year move, the Food and Drug Administration (FDA) has issued clear guidance about when it will issue guidelines about giving guidance for the use of social media in the pharmaceutical industry.

While industry pundits were expecting some form of actual guidance for the use of social media before year-end, FDA’s head fake and unexpected punt downfield left commentators scratching their blogs in confusion.

“This is a subject about which we must exercise an abundance of deliberation,” declared N. Tendto Stallmore, commissioner of pre-guidance guidance guidelines. “Before we give definitive tentative and ambiguous guidance, we first have to develop guidelines about that guidance-giving. As 2010 closes, we want to give you guidance now about that guidance-guideline process.”

When asked what precisely this pre-pre-guidance actually was, Mr Stallmore stated, “Well, it’s just going to take a while longer. We’ve had a year to consider the guidance-giving process, but the preliminary guidelines are still under internal review. Then there will be a period of public commentary on the guidelines for giving guidance, before we solidify those and then move on to the guidance itself. Right now we’re thinking 2Q, and you can fill in the year.”

Industry blogger and gadfly John Mack questioned whether social media would still even be around once this entire process was complete. According to Stallmore, “That is one of the scenarios we’re mapping out in the guidance-giving guidelines, which may push the process back even further, since we now have to develop course-correction guidance guidelines in case the marketplace changes at any step in the process. We’re expecting to employ a multi-variate co-extensive re-feedback null-defying loop to help us develop on-the-fly guidelines about guidance for the guidelines that will shape the guidance. Am I making ourselves clear?”

In other FDA news, it was announced that pre-marketing approval has just been granted for sulfa drugs.

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The Yardstick

I was having a conversation last week with one of my contacts in a life sciences company, who was lamenting the fact that not only do unrealistic questions get asked about ROI regarding digital/social media strategies, but that there seems to be a dearth of any holistic way of tracking effectiveness for ALL marketing efforts.

Do we REALLY have a clue about the financial value and return our various marketing initiatives, across all channels? Is there an effective way to benchmark marketing ROI across all channels?

From what I’m seeing, very few companies are taking a holistic view of marketing strategy/effectiveness across multiple channels; most still seem to be stuck in the inertia of looking only at silos, and only at short-term results.

So – if you know of a company that is really making progress in this area (life sciences or not) – can you share in the comments how this is getting done? I’m not looking for answers like, “we backed up a dump truck with all the gold in Fort Knox to the front door of a big global consulting firm and they re-engineered us!” I’m looking for tangible solutions, and/or groundbreaking examples.

What are you seeing? Please stuff the comments with ideas, suggestions, helpful links…thanks!

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Healthcare Agencies and Social Media: Start Here

For years, I’ve advocated that healthcare companies gain a clear picture of the opportunities (and potential problems) presented by social networks. It’s a somewhat complicated and very fast-moving world – how does a pharmaceutical company, or a healthcare agency, get started on the right foot?

Here are three key perspectives. Start here!

1. Start small, but with a strategic, long-term plan. Don’t be “that guy”!

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2. Don’t treat social media as its own topic. It is part of a holistic business strategy.

Social Media is not a Strategy

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3. Realize that you’re not dealing with an isolated trend, or a marketing fad. Digitally-fueled networked communications is The New Normal.

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There are many particulars to learn about how social networks are impacting the healthcare space, but the most important thing you can possibly do is begin with the correct perspectives. When you understand how and why the landscape is being re-shaped by networked communications, then all the details about tools and platforms begin to line up.

One perspective to bear in mind – the usage of social networks is exploding. Check out this real-time updating table to see! And – what percentage of pharma professionals use/plan to use social media in 2011? Answer here.

Of course, everyone is (or should be) interested in current examples of how social media is used in healthcare. The absolute best resource for this is at Jonathan Richman’s Dose of Digital blog – the Pharma and Healthcare Social Media Wiki. Explore!

Roche is a leader in articulating and publishing common sense social media guidelines for its employees.

PLUS – here are some blog posts providing helpful analysis:

Social Media is NOT for Advertising Pharma Brands – Jon Richman

The Beginner’s Guide to Pharma Social Media – Jon Richman

10 Things I’d Like to Start Hearing about Pharma Social Media – Jon Richman

The Rise of the ePatient – Steve Woodruff

But Are We Communicating? – Steve Woodruff

Oh – and about those reportable adverse events…

Want more? OK – Just scroll through my Impactiviti SocialRx page.

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