Strolling by, Roger Sterling quips, “Who cares!”
Well, when it comes to social media, what does pharma want – and who cares?
What pharma wants (or should want) is specific areas of clarification from the FDA on this new and exciting zone of opportunity.
Industry's general response to its tenuous toe-dips into social media is, “Blame the FDA!” But that's not fair.
How can the agency be blamed for industry's reluctance to push the boundaries – even a little? Fear of warning letters? Fear of unearthing adverse events? I say, where there's a will, there's a way. If you won't blaze the path – even a little – then don't expect anyone to know where you want to go.
Unfortunately, blazing new territory through real-time learning is not, shall we say, historically a tradition of regulated industry. Everyone wants to do new and exciting things – second.
More regulation? Be careful, that may be precisely what you get.
What are the odds, lacking direction, expertise and experience, that DDMAC will deliver some kind of deus ex machina solution? Expecting the Holy Grail will only lead to disappointment and frustration. And blaming the FDA when that happens won't make anything better or move the social media agenda any further ahead. If industry is expecting to climb the steps of the agency's headquarters at White Oak on its knees, kiss an FDA relic, and miraculously throw away the crutches hobbling its ability to participate in social media, well, there had better be a Plan B.
Where there's a will there's a way.
Then there's the question of what “sponsored” mean?
Let's do a brief thought experiment. Consider a televised PGA tour event.
When a product logo for an erectile dysfunction medicine appears on the screen and the announcer intones, “This portion of the Masters is sponsored by DRUG NAME HERE,” nobody in the viewing audience takes that to mean the “sponsor” has chosen the speed of the greens, the height of the rough, or the pairing of golfers in the tournament. But say “sponsored” on a social media site and watch the sparks fly at internal regulatory review.
At the end of the day, the issue of social media and FDA regulations was summed up nicely by another senior member of the FDA brain-trust who told me privately that, “We need to learn to talk to people the way they talk to each other – and that's going to create a culture shift at the FDA.”
Sound advice that reinforces the truth that social media cannot be used in the same way as advertising. Social media is interactive – and it is interactively egalitarian.
Rather than rubbing the magic lamp and wishing for FDA guidance, we need to burn the midnight oil and work harder to make healthcare communications via social media a reality – because an educated consumer really is industry's best customer.
Peter Pitts, a former associate commissioner of the FDA, is a partner and director of global regulatory and health policy at Porter Novelli. He is also president of the Center for Medicine in the Public Interest.