During a past episode of Mad Men, the creative team at Sterling/Cooper is hard at work ideating on a “women’s product” campaign when someone asks, “What do women want?”
Strolling by, Roger Sterling quips, “Who cares!”
Well, when it comes to social media, what does pharma want -- and who cares?
Many will say “regulation from the FDA -- in fact, a great many. But is that really what pharma wants?
Yesterday I participated in a small roundtable (sponsored by AstraZeneca) on “Examining the Roles of the FDA and the Pharmaceutical Industry in Social Media.”
(Full disclosure: I ate two small eggplant and tomato tea sandwiches and drank 2.5 cups of organic coffee. I did not offer to reimburse AZ for the “gift.”)What does pharma want? One of the opening comments was that pharma wants the “ability to engage” in social media. My response to that was to ask 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 that came up early – and that generated a lot of conversation – was the need to bifurcate the discussion of digital advertising from that of social media. There are rules for digital advertising, paid digital advertising. 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. It’s where the rubber meets the road.
What pharma wants (or should want) is specific areas of clarification from the FDA on this new and exciting zone of opportunity.
What of the empowered digital healthcare consumer that we hear so much about? Well – there were a few of them in attendance at the AZ confab and they had some interesting things to say.
What struck a chord for me was when one of the civilians in the room (by which I mean a patient) said that she really had no idea why pharmaceutical companies chose to absent themselves from disease-related social media conversations. She assumed it was because Big Pharma is afraid of mixing it up with real people in real time dialogue.
And she’s right, of course – but for reasons she didn’t suspect. The ensuing explanations of adverse event reporting and other compliance-related issues didn’t cause her to nod her head, but rather to say (indeed, almost insist) that “pharma should explain to people why they’re not there.”
Blame the FDA! was the knee-jerk reaction. 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 the pharmaceutical 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. It is, to directly quote CDER Director Dr. Janet Woodcock, “where the people are." Healthcare begins at search.
But, someone pushed back, that’s why we need more directive regulation from the FDA. I fundamentally disagree (1) that’s what’s needed and (2) that’s what’s coming. Let me explain.
(1) IMHO, “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 DTC advertisements. That was a precise request for a tangible deliverable that resulted in direct and 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 Part 15 hearing and (alas) equally so in the lengthier (but equally non-specific) docket submissions.
(2) 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 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.
Where there’s a will there’s a way.
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 out there 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.
Of course, there’s the subtle but crucial differentiation between “permissible” and “appropriate.” 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? Where there’s a will, there’s a way.
And AZ – thanks for the sandwiches and kudos for a job well done.
