Monday, October 3, 2011

Pharma, Regulate Thyself!

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By Casey Ferrell

Research Analyst, Cutting Edge Information

Perhaps those who clamor for guidance are misguided. The well-documented lamentations by pharma, in which the regulatory vacuum surrounding social media is blamed for the industry’s inertia and inaction, indicate a pervading wait-and-see attitude that stunts the industry’s ability to keep up with the digital revolution. There is a sense among ePharma thought leaders that the FDA’s long-awaited guidance on the Internet and social media will define the digital marketing landscape and clear up what can and cannot be done. And then we’ll get on with it. None other than Pfizer’s Ray Kerins, VP of external affairs and worldwide communications and VIP in pharma social media circles, said at a recent conference, “We all want guidance. We’re looking for it.”

But is that really the answer? Because according to fresh research by my firm, Cutting Edge Information, competing pluralities of respondents to a digital marketing survey think either FDA guidance is the key or that self-regulation is the way forward. When asked what they would rather see, industry insiders chose self-regulation almost as much as they chose an FDA informal guidance as the most desirable way forward for digital marketing in pharma.

A glance at the board of directors for the newly formed non-profit Digital Health Coalition and one finds the names of some heavy hitters from a broad spectrum of industry sectors, from pharma to agency, from search firms to physician and patient advocacy groups. The level of interest in the coalition’s mission — to develop a code of practice for digital marketing which all industry stakeholders can agree to and abide by — reveals an increasingly popular notion that waiting on regulatory guidance might not optimal. Not only has the FDA twice missed self-imposed deadlines for the guidance, creating a pervasive uncertainty about if and when it will follow through, but concerns abound about the breadth of the potential guidance. Will it tell us how to use individual platforms like Twitter and Facebook? Almost certainly not. Will it definitively determine who is liable when promotional content is shared (or altered) on third-party sites? Probably not. Will it actually provide the working model for acceptable digital marketing that is hoped for? Again, in doubt.

As the realization sinks in that an FDA intervention may not be the panacea that marketers are looking for, it’s clear the alternatives are limited. Individual companies can continue the status quo of feeling their way in the dark, only finding out they crossed a line they didn’t know was there after getting a Notice of Violation. Or, the industry as a whole can begin divesting in digital marketing as a channel, although its ubiquity and potential make this pretty implausible. Or, the industry can collaborate, as has been done in the U.K., and collectively define acceptable parameters for digital marketing based on existing regulations. No small task, admittedly, but better than the wait-and-see approach. In other words, perhaps the time to get on with it is now.
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