The FDA’s responsibility is first and foremost to public health and the promotion of safe and effective products. That’s actually a massive undertaking for an agency that seems underpowered—especially technologically—as I’ve witnessed during numerous visits.
So, when the agency made the announcement in December that it would delay draft guidance on social media until the first quarter of 2011 (it had been scheduled to release the guidance by the end of 2010), the fact that these guidelines are not a high priority for the FDA shouldn’t surprise anyone.
In its November 2010 strategic priorities document, FDA named advancing science, security and integrity of the supply chain, compliance and enforcement, special needs populations, and operational excellence as its top priorities. As a consumer of medical products, I want the agency to be focused in these areas.
So, where does that leave social media?  The word “marketing” appears in the document only a few times, only to reiterate the main role of enforcement of compliance and ensuring that marketing is not misleading or untruthful. It seems social media guidelines are not a priority.   
FDA has been consistent in its expectations and guidelines for marketing. Just because there is less space in social media doesn’t mean anyone should expect less need for fair balance.
There may be small new guidelines for specific vehicles, but FDA may only provide sweeping guidelines, and what could be restrictive ones at that, when and if someone steps way over the line. We also all know how legislation works in the US; one big misstep will cause an avalanche of restrictions. No one should want guidelines produced this way.
My experience with FDA is that it does value collaboration. And as a former Discovery scientist, I know that the medical industry is innovative and more than capable of determining how to use social media while keeping within current guidelines. Instead of waiting, innovation could come from those who push innovation every day.
I have heard the argument that if industry comes up with a solution, then it might be more restrictive than FDA would have. I find it more likely that we can create a better solution.
Michele Bennett is chief operating officer, Wool Labs

From the February 01, 2011 Issue of MM+M - Medical Marketing and Media