In April of 2004, I wrote an article for Health Affairs about the FDA’s draft guidance on direct-to-consumer advertising. The title was “Turning Point or Tipping Point: How to harness the power of direct-to-consumer advertising to create better-informed consumers and better potential customers.” The gist of my argument was that direct-to-consumer advertising shouldn’t be viewed as only a potent marketing tactic, but also a robust tool to advance public health. Alas, my argument largely fell largely on deaf ears.
More than six years later we’re talking about social media. And it’s exciting. People searching for healthcare information online are like animals on the hunt. They go where the scent of information is strongest.
The potential is enormous. Today, healthcare begins at search. But then, alas, there are all those pesky regulatory questions. Angst about adverse events and off-label conversations, about correcting misinformation and responsibility for this new and thrilling and chilling and uncontrollable thing called “user-generated content.”
When it comes to 21st century communications, consumer empowerment is both a blessing and a curse—because you can’t control it like advertising. And that causes regulatory headaches where rules are gospel and precedents preach.
Advertising, in its most traditional sense, is a one-way medium designed to influence behavior through the thoughtful and creative use of words and images. If the medium is the message, then “advertising” is the antonym of “social media.”
Social media must be considered within the broader context of social marketing. The anti-Barry Goldwater “Daisy” ad was an early example of social marketing. The ad, shown only once, started a national conversation. And the interactivity played out in voting booths across the nation. Harry and Louise are the direct descendants of Miss Daisy.
Social media is, by definition, social. Its driving force is interactivity between multitudinous constituencies–the most important being peer-to-peer. Social media requires you to play, not purchase.
Remember–the medium is the message. Just how comfortable and capable is regulated industry when the new operating system is a world where the only constant is change? Finally, we have a brave new world where marketing communications is as much about selling as it is about educating.
Last year the U.S. Food and Drug Administration held a hearing to discuss the issues surrounding social media and regulated industry. It was the Super Bowl of FDA hearings.
Two days and 70 presentations later, many questions had been raised, none were answered, frustrations vented, and there was a general feeling that maybe something would come of it all. But what does that mean?
It means don’t hold your breath. FDA operates in FDA time (which it defines as “the time it takes to get it right”) – almost the opposite of social media time (which is generally “instant gratification”).
As a senior FDA official said to me in the wake of the hearing, “We understand the issues of speed and timeliness–we just don’t know how to deal with it.”
Immediately after the hearing (almost exactly a year ago), I predicted an FDA guidance sometime in late 2010 or early 2011 that focuses on three issues:
(1) The range of adverse event reporting responsibility (not a redefinition of what an adverse event is – but what regulated industry is responsible for online).
(2) Ways to make the FDA’s reporting system for adverse events, MedWatch, more visible (even to the degree of mandating prominent display of a MedWatch icon on print and broadcast advertising, promotional materials and, obviously, online).
(3) The creation of safe harbor parameters to allow (and, hopefully, encourage) regulated industry to correct misinformation on the Internet.
Three weeks ago, Tom Abrams, the director of the FDA’s Division of Drug Marketing, Advertising, and Communications made me sound very prescient when he said some social media guidance might be released by the end the year and will address issues related to Internet drug promotion–not how to use specific social media tools like Facebook, YouTube and Twitter.
“What we’re going to do,” said the FDA’s promotional panjandrum, “is address questions like how to respond to unsolicited requests for information, what’s the corporate responsibility for correcting and monitoring third party sites for misinformation, what’s the corporate accountability for having people post promotional videos and things like that.”
“And things like that.” How precise.
The current FDA guidance on internet-related responsibility says, “Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”
I predict we’ll see something that looks and sounds a lot like that. In other words, a long wait for more of the same. Another victory of ambiguity (which regulators love since it gives them unlimited authority) over predictability.
Surprisingly then, when asked what they’re waiting for to take a deeper dive into social media, industry marketers respond, “guidance from the FDA.”
Really? What does Pharma expect? What does Pharma want?
Many will say “regulation from the FDA”— in fact, a great many. But is that really what Pharma wants? Is it really what Pharma needs?
What does Pharma want? Many say that Pharma wants the “ability to engage” in social media. My response to that is whether Pharma has the “will” to engage – because they certainly have the ability, if they choose, to use it. And where there’s a will, there’s a way.
Another issue is the need to bifurcate the discussion of digital advertising from that of social media. There are rules for digital advertising, paid digital advertising – like sponsored Google links. Social media, on the other hand, is the New Frontier. It’s the crucial gray zone that exists between regulated speech and user-generated content.
What pharma wants (or should want) is specific areas of clarification from the FDA on this new zone of opportunity.
And what of the empowered digital healthcare consumer? What do they think about the absence of regulated industry from the social media space? Civilians (by which I mean patients) have no idea why regulated industry opts to absent themselves from disease-related social media conversations. They assume it’s because industry is afraid of mixing it up with real people in real-time dialogue.
And they’re right–but for reasons they don’t suspect. Explanations of adverse event reporting and other compliance-related issues don’t resonate–and it’s not because consumers are ignorant.
It’s precisely the reverse. Consumers are smart. That regulated industry actively runs away from proactively unearthing adverse experiences in social media just reinforces the general public’s notion that industry communications are just about the money – and not about them. As the saying goes in our nation’s capital, “if you’re not at the table, you’re on the menu.”
Industry’s general response is, “Blame the FDA!” But that’s not fair and it’s not true.
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.
Here’s an even more basic question–what’s the right thing to do? I submit that it’s irresponsible to actively avoid participating in the social media healthcare conversation. Social media, to directly quote the FDA’s Director of the Center for Drug Evaluation and Research Janet Woodcock, “is where the people are."
To which industry generally responds, “That’s why we need more directive regulation from the FDA.”
I fundamentally disagree that’s what’s needed or that that’s what’s coming. “We need more regulation” just doesn’t cut it. Since there is no direct “ask” from industry, it’s impossible to expect the FDA to offer direct guidance. It’s not like requesting guidance for direct-to-consumer advertisements. That was a precise request for a tangible deliverable that resulted in specific rules and regulation.
More regulation? Be careful, that may be precisely what you get. Also, more guidance means nothing without a more precise reference. “More” relative to what aspects of social media? These details were lacking at last November’s hearing and (alas) equally so in the lengthier (but equally non-specific) docket submissions that followed.
What are the odds, lacking direction, expertise and experience, that the FDA 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 their ability to participate in social media, well, there had better be a Plan B.
Then there’s the question of language and syntax. For example, what does “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.
Fore!
This also leads to the still vague regulatory distinction between property owner and property user – an issue in dire need of FDA clarification. Discussion of this important social media issue in FDA docket submissions? Try and find it.
And, of course, there’s the subtle but crucial differentiation between “permissible” and “appropriate.” Social media’s “community norms” do not match up at all with FDA “regulated norms.”
And this returns us to where we started. What does pharma want? Do they want social media, primarily, as a new channel for marketing or do they see it as a new and exciting and robust and dynamic mechanism for advancing the public health through real-time interactive communications? Indeed–why not both?
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.”
Just so. And just as it should in marketing departments across regulated industry.
Jean-Ah King, special assistant to FDA’s DDMAC Director Abrams, made an interesting comment the other day. She said, “If you choose to do promotion in social media, just make sure that at the end of the day what we’re looking at is in the best interest of the public health.”
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 interactivity 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.
