The use of social media by regulated industry is faltering because of fear, timidity, and misunderstanding.
I'd like to make five main points that are often overlooked or misconstrued when we discuss social media in the context of regulated speech:
1. There is a difference between online advertising and social media
When the FDA sent out the “famous 14” warning letters about sponsored Google links, many pharmaceutical regulatory review professionals said, “See, told ya – you can't use social media,” and breathed a secret sigh of relief – another sign of an ever-growing regulatory Stockholm Syndrome.
But they were wrong, because when you read the letters it becomes quickly evident that the FDA's Division of Drug Marketing, Advertising, and Communication equates “sponsored links” not with social media – but with paid advertising. In the context of those letters, “sponsored” equals “paid.” And there are rules for that.
Beware, because as Disraeli said, “A precedent embalms a principle.”
2. There is a difference between social media platforms and social media content
The FDA sent out a warning letter regarding a YouTube video in which a paid celebrity spokesperson said that a drug had “cured” her disease (a decidedly off-label claim, shades of Dorothy Hamill and Vioxx). And some internal reviewers industry-wide said, “See, you can't use YouTube.” Not so. If the content is non-compliant, then it is non-compliant regardless of platform. On the positive side, I believe the reverse is also true.
Division of Drug Marketing, Advertising, and Communication Director Tom Abrams has made it clear that when there is guidance from the agency on social media, it will not include agency direction on how to use specific platforms such as YouTube or Facebook or Twitter – and that includes emerging mobile platforms too.
3. The fear of adverse event discovery is dangerous and misguided
As recently as last November, one large pharmaceutical company told me that its official policy was not to monitor social media sites for fear of unearthing adverse events. This would not play well in a newspaper story or in front of a Congressional subcommittee.
Industry's regular and public social media “AE-phobia” only reinforces the public's erroneous notion that industry communications are solely about money and marketing – and the public health be damned. Social media abhors a vacuum. In 2011 we must embrace and rejoice in social media's capability to unearth adverse experiences early and often. Quod erat demonstrandum.
4. The fear of user-generated content and off-label conversations is real … but
There are many solutions, ranging from moderating comments (which are generally accepted by social media communities as long as they understand the necessity for such moderation) to corporate responses directing the user to a given product's PI and pre-vetted company web pages.
But these tactical solutions don't solve or even begin to address the issue of “property owner” vs. “property user,” an issue that was mentioned by the FDA in its Federal Register notice for its November 2009 Part 15 hearing.
That's an issue that the FDA would be wise to address in its forthcoming guidance to industry.
5. Who's responsible for what?
Social media is a big place. Can any single company be held responsible for what's said about itself or its products anywhere online? Consider the current on-the-books guidance, which reads, “Applicants should review any internet site sponsored by them for adverse experience information, but are not responsible for reviewing any internet sites that are not sponsored by them.”
But what does “sponsored” mean?
Consider the oft-heard TV voice-over, “This portion of the Masters is sponsored by (name of erectile dysfunction product). Nobody in the viewing audience thinks the sponsor chose the speed of the greens or the pairing of the golfers, or the height of the rough. But say “sponsored” on interactive social media and watch the sparks fly at internal regulatory review.
Abrams has said that FDA guidance will address corporate responsibility for correcting and monitoring third-party sites for misinformation. It would be very useful for Abrams' division to also clarify, among other things, what “sponsored” means.
Let me be blunt – expecting a regulatory 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 ahead any further or faster. Social media is the new frontier. It is the crucial grade that exists between regulated speech and user generated content. In the 21st century, it is where the public health rubber meets the communications road.
Social media requires interactive engagement in real time. It requires you to play rather than purchase. And that's a wonderful opportunity – because you cannot purchase passion.
Peter J. Pitts is senior partner/director of global regulatory and health policy at Porter Novelli and a former FDA associate commissioner.