Pharmalot: Why form this coalition? Bard: I spent the better part of the past decade at Manhattan Research looking at technology and innovations and how people are interacting with the internet to get information. Even before we heard terms like social media, we saw patents were trying to get access to specific information and physicians would as well. Over time, we wanted to see what was possible. And as you know, from 2000 to 2010, the experience became very different - from looking at the Internet like it was an encyclopedia to something where you’re talking to people.
Pharmalot: Was there a specific impetus, though? Bard: Well, over time, we would talk about how the pharmacuetical industry would become part of the conversation and every year it was the same thing - what was the barrier? Regulatory, legal. Then, in November 2009, the FDA had their public hearing on social media and everyone came and did the dog and pony show. I was one of many speakers. But we still had to answer the questions about what the physician wants and what do consumers want? There was a good overview, but no solution. And I think what we learned from the process was that there was a good conversation, but there’s been a lot of frustration. We need to set guardrails and parameters. The reality check for a lot of folks is that DDMAC (the FDA’s Division of Drug Marketing, Advertising and Communications) probably won’t come out and say the 10 things you need to do. Even if they come out with guidance, most folks in the pharmaceutical and health industries still wouldn’t know what to do, because they haven’t thought through the whole thing…
Pharmalot: What exactly do you hope to accomplish, though? Bard: One thing that came to mind is whether we can pull together a network, like a meet up or a tweet up. The thought was if you do that in a somewhat loose manner, you can have conversations, but not a hard-defined approach or mission. So is there a way to do this as a structured group and have people feel like it’s an entity with participation and working toward goals? So we hit on a non profit, a quasi think tank. But it’s not just talking and waxing philosophical. We hope there’ll be a way to come to agreement on certain things, such as responsible digital marketing, and look at how we can attack some of these problems. But not using legalese. We hope to have practical solutions, to use tools to solve problems.
Pharmalot: You have a fair number of pharma people on the board. Do you plan to widen the representation? And if so, how? With more patient groups? Bard: We looked at buckets of pharmaceuticals and technology, and the other is kind of regulatory. We do plan to build out patient advocacy. Obviously, there’s a lot of industry interest. We don’t want it too top heavy. We don’t want it be a majority. We do need to beef up other parts. Ideally, it would be one-third pharmaceuticals, one-third tech and one-third a combination of patient advocate and regulatory, too. Maybe the kind of former FDA people you typically see in law firms or they’re independent consultants, but they understand process where marketing folks may not.
Pharmalot: We recently asked some drugmakers about their reactions to the upcoming changes at Facebook (in which pharma will no longer be able to disable comments on main pages). How tough of a spot are they in and what should they do? Bard: What to do is uncertain. But we don’t have an option. It’s really an unfortunate situation where folks look at something and say they don’t have a solution. Look, these weren’t amazing Facebook strategies to begin with. Their presence on what is, by nature, an interactive platform is not interactive. We’re calling out the fact that they want a brand experience with interactive platform, but they’re not interactive. The reaction from industry is a perfect example of some of the things we’re trying to attack. So how can this be used? They need to have a process in place. If someone reports an adverse event, let’s come to some agreement there’s value and utility in Facebook the same way you see YouTube, but not a static one-way channel.
Pharmalot: What do you make of the fact that some may walk away, even as a last resort? (back story) Bard: It’s unfortunate. Looking at the very nature of it, you don’t need market research to prove it. When someone wants to interact on a social platform, some kind of experience is an expectation. Leaving a billboard is not in sync with what Facebook is or social media is. I don’t think it’s in anyone’s best interest to let things go stale in a rapidly evolving world. And don’t’ look at the world today, but try to look at it in 2015. It’s going to be a lot more interactive and transparent.
5 Comments
I wish Mark the best of luck but in talking with some people who work for Biopharma I think he is has a hell of a challenge. There are two things that I believe are limiting what pharma can do on social media. First, there is the lack of resources and infrastructure within pharma. Digital marketing has become a speciality and there are a lot of branch expertise to do it right at a time when pharma seems to be cutting people. The second issue is talent. I have seen a hell of a lot of talented people leave the industry and a lot of people that are left don't seem willing to be patient advocates as it's often too personally dangerous to their careers to do so.
Ed: Interesting interview. I don't want to comment on the content specifically, but on you. My favorite part of the interview? “What exactly do you hope to accomplish, though?” I love your direct approach. Sadly most journalists and bloggers never ask the question you asked. They just accept whatever the speaker/interviewee says. Thanks for trying to get specific answers we can all use.
Having worked in brand management, including e-initiatives for years I can tell you that the very existence of the ISI (safety disclosure) which is a complex legal and medical statement to be read and repeated verbatim and not abbridged is the source of all social media difficulties. FDA rules require that any time a claim is made (and with pharma ANYTHING and EVERYTHING is viewed as a claim) the ISI has to be immediately visible. Given that most ISIs are lengthy paragraphs there simply is not enough screen real estate to display even under the best intentions. Realize also that the definition of off-label is so precise that even the slightest deviation from the PI can be construed as off-label. Hence that legalistic language is the only way to remain compliant. Media and e-communications folks need to realize that even the most tenured and experienced of us have tried and failed due to rules we have obey to remain compliant.
I think this is a great move and if nothing else forcing a coordinated dialog. While I love it, I do think the group is lacking ancillary service industry representation like ad agency and PR folks.
While this may not be the focus or desire, even some minor representation will help as people in these groups, in many cases, are the overall industry experts.
This is really a lobbying effort to press the FDA (and Congress) to weaken required safeguards for pharma/health digital and social marketing. This group may have some clout, given heavyweights like Google and big pharma on its advisory board. But until they acknowledge that the way digital and social media marketing operates, serious health safeguards for consumers and professionals are required--they will lack credibility. Among the issues they should address can be found here: http://www.centerfordigitaldemocracy.org/cdd-asks-fda-revise-its-proposed-research-digital-marketing-drugs-and-health-products