Posted by Michael Spitz

By @SpitzStrategy

The power and potential of social media excites and intimidates every industry, as brand stewards the world over continuously experiment, indulge, sometimes get their hands slapped, but resolutely embrace communications channels billions of people already consider the norm. Pharmaceutical and medical device companies are equally tantalized, yet do little more than fake it for fear of regulatory repercussion. Seems we talk incessantly about social media, but never really indulge.

Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest and a former associate commissioner at the FDA is convinced we’re long overdue. Hesitant about participation until formal guidance is released? An excuse! Concerned about adverse event reporting, reputation management, and off-label conversations? No worries! Recently presenting his “Social Media Manifesto” during Social Media Week, the effect was like one touch screen hand tapping.

According to Pitts, pharma has nothing but its own fear and ignorance in the way of embracing genuine two-way communication—a welcome if still highly controversial perspective. Seems if we really understood the law, pharma could and should dive right in. Really? Really really: Does that make Pitts the Edgar Allen Poe of healthcare communications, luring pharma to its doom, or a sweeping force of reason and social good, facilitating and encouraging the inevitable?

Let’s further abuse the metaphor and examine his unique prescription for engagement, and consider how reshaping corporate infrastructure may be as important as fully understanding the regulatory landscape. Perhaps by combining Pitts’ fresh perspective with a revitalized approached to healthcare social media monitoring, management, and moderation, a muzzled industry can finally begin to converse with its constituents, providing ongoing benefit to millions of patients in need.

FDA Phobia and Faux Social Media
As Pitts points out, and all of us working within digital health have understood for years, “FDA-phobia” virtually paralyzes every move pharma makes in social media. Although arecent analysis by Fleishman and Hillard of the 173 warning letters issued from 2008 to 2012 revealed only a single one directly tied to a pharma social media venture, the industry continues to do little but dabble in the medium, with proprietary, branded networks never genuinely crossing the line into real-time user-generated content sharing.

The upshot is missed opportunities, including connecting with healthcare professionals, patients, and caregivers in ways they already do themselves, reputation management, social listening, consumer-driven innovation, emergency response, and eventually realizing the full industry potential for advancing public health. If the mission of pharma industry is to improve health and wellness for patients worldwide, then what better way to facilitate and encourage that than through such a Renaissance of open communication?

Central to the dilemma is how pharma tends to view itself. The relationship between marketing, medical, and regulatory insiders is often fragmented and sometimes contentious. That shouldn’t come as a surprise, since their respective goals, metrics of success, and challenges differ and are often mutually contradictory: MLR defensively worries about compliance, while marketers seek engagement and ROI boosts in scripts. And how is any risky venture possible in an atmosphere devoid of trust and open cooperation?

Tom Abrams, head of the FDA Office of Prescription Drug Promotion (OPDP) recently stated the agency’s intention to meet the legally mandated July 2014 deadline for social media guidance. Reticent as to what it will exactly encompass and how it will address such pivotal issues as the one-click rule, Abrams is nonetheless insistent that issuance of guidance is among the highest of FDA’s priorities, because social media helps provide good and useful information for public health concerning prescription drugs and medical conditions.

But in lieu of that guidance, and assuming even after its issuance that challenges will remain regarding handling social media within ever-fluctuating digital platforms such as Twitter, Facebook, blogs, and ones not even developed yet, what can the industry do to make it possible? And how can an ancient and sluggish “Pharmasaurous” evolve into a modern digital health organism, one that John Nosta describes as integrating new technology, apps and ideas that deliver on the promise of improved medical care, health, and wellness?

Pitt Crew to the Pharma Social Media Rescue
Peter Pitts asserts pharma already has what it needs to succeed. The first tool is internal, the sheer willingness for “blazing new territory through real-time learning” by overcoming the paralysis so common to regulated industries. The second is the FDA’s already-issueddraft guidance for responding to unsolicited, off-label requests; despite the document not addressing adverse events, identifying asset owners vs users, or even defining what “sponsored” means, Pitts insists it packs enough punch to enable diving right into social.

By clearly interpreting the off-label guidance, extrapolating proven principles, and “reading between the lines,” pharma can, according to Pitts, explore the mine field strewn territory of social media with minimal risk. Throughout his thought-provoking and entertaining “Social Media Manifesto” he tells a compelling story punctuated by key lessons for marketers, medical and legal regulators, and their agency/PR partners, all of which can be pulled into practical recommendations and best practices. A few key insights:

Advancing Public Health Is the Gold Standard for Compliance
Why should pharma do social media at all? The banal answer is to help market their drugs. But what benefit, ideally, do these drugs provide the public? Improved health. As such, the use of social media should ultimately be directed toward advancing the public health, as realized through communicating factual and timely information about these treatments. After all, who knows their own Rx better, and has the ability to address erroneous info and adverse events?

To accomplish this broader goal of social good, pharma not only has the capacity but the responsibility to fix misinformation and report problems. Since millions of people are already using social channels to discuss their health and the drugs they use to treat illness, pharma must consider these “emerging electronic media” channels in the same way they do other forms of communication. And since systems are already in place to handle this process, the draft guidance on off-label requests is relevant, actionable, and surprisingly prescriptive.

Do Social Good through Responding to Requests and Fixing Errors
The first such clarification provided by the guidance is differentiating “solicited” from “unsolicited” requests. The former are those prompted in any way by the drug company or any of its representatives or employees. The latter are those requests for information initiated by anyone not in any manner associated with the firm, including healthcare professionals, third-party organizations, academics, patients, and their caregivers.

FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to information about the firm’s products.

Historically, pharma companies have remained compliant by responding to unsolicited, off-label requests through a private communication to the individual making the query. Should that request be made via a social media network or similar channel the same rules should apply in terms of the one-on-one nature of that response. Specifically, the request might be made in a public forum, but the official response must be offline. That precedent gives pharma a turnkey and proven methodology for handling them.

Loosely defined, such “off-label requests” also include overt adverse events. Analogous to the legacy protocols already described, adverse events as reported or even monitored through social media channels should be processed through the existing, tried-and-trueregulations and methodologies previously in place. Yet again, the key is treating off-label requests and erroneous information through online sources in exactly the same, risk-averse manner they are already being handled offline, a process ultimately designed to protect patients.

The Internet has also spawned a variety of social media tools that host online content primarily created and published by users other than the intellectual property owner or product manufacturer.  In some cases, this online content may not be accurate.

Off-label conversations don’t always come in the form of questions, and may include factually inaccurate statements potentially endangering patients. Again, pharma can and should step in to provide clarity and accuracy regarding the treatment options they know so well, and the guidance addresses how to do that even within a public forum. In practice, the pharma company should respond with an embedded link to FDA-approved prescribing information only, and not any promotional material, including the brand.com.

Same Rules Apply
A similar “channel agnostic” approach to off-label communication applies to healthcare professionals and formulary committees. The current “Good Reprint Practices on Unapproved New Uses” already establishes regulatory precedent for point-of-care conversations between pharma sales reps and physicians, and can similarly be extrapolated to rules for off-label conversations occurring online and in a public forum through social media platforms. The key insight here is that content is content and must be evaluated as such, whether “live” and in person, or digital and via social media.

An important corollary to all this is the need for social media monitoring, especially of those public platforms where these posts and their responses are occurring. Much has been made of the perceived danger and potential hassle of doing this kind of surveillance, but alandmark study revealed that the incidence of actual adverse events is extremely low—while big pharma has already stepped up to the need. Imagine the potential of being able to listen and analyze millions of health conversations, in real-time…

Pharma Lessons and Continued Challenges
Drafting guidance for social media is inherently difficult, so don’t just blame the FDA. A key problem is the variability and malleability of each platform, the user-interface and business rules for Facebook, Twitter, and YouTube constantly in flux. Since the form of where and how content is shared can’t effectively be regulated, the content has and certainly will be. And since pharma already has systems in place for effectively handling off-label and other requests, the same methodology should be used and applied regardless of the platform.

As we’ve seen, this simple idea has broad practical ramifications. On the one hand, unsolicited off-label requests and erroneous information must be treated the same regardless of the channel used to communicate them. On the other, pharma has the ability, responsibility, and proven methodology to correct misinformation and react to adverse event reporting wherever these conversations are taking place. Medical and regulatory review is therefore still central and vital, regardless and inclusive of all channels being used.

With all these proven processes already in place, why so serious, pharma? A remaining challenge is gaining a simple understanding of what “social media” is, where its boundaries can be drawn, and how the channel is different than conventional advertising in terms of content, functionality, and intent. The 14 warning letters issued by the FDA in 2009 sent a seismic shock through healthcare marketing still felt today, but a basic analysis reveals all of these citations were related to “sponsored” links (paid advertising), and not social media.

Online healthcare marketing mysteries do remain, however, issues that the promised FDA guidance slated for 2014 will hopefully address. Central to them is figuring out the digital dividing line between content a pharma company controls and is therefore responsible for, as opposed to content a pharma company has no control over and presumably shouldn’t be responsible for, but is nonetheless associated with. Since digital is by nature a universe of dynamic, contextual, interconnected content, pharma needs to know.

For example, if a pharma launches a web page or builds an app, then any and all content within that digital asset must be compliant. But digital doesn’t adhere to fragmented boundaries, it destroys them by seamlessly integrating diverse content and user experiences. Besides, why must pharma be responsible for associated content online, when in contrast a broadcast TV ad has no regulated association with the content of the TV show it “sponsors”—even if that show happens to discuss off-label use of the advertised drug?

Another nagging challenge is safety information, the Pandora’s Box of “fair balance”: No one denies that audiences should be exposed to an equal proportion of warnings about drug side effects as information concerning effectiveness, but little data exists as to the best way this vital info can and should be conveyed. Insisting that safety information should always be visible is hardly an assurance that it will be read let alone understood; worse still, the limited online and now mobile real estate often makes that impossible.

The Pendulum Swings
So what’s holding the industry back? If Pitts is right and the industry already has what it needs to proceed and succeed, then why are few if any pharma and device companies embracing the paradigm shift, and leaping right in? From my experience, most pharma eMarketing reps, franchise and brand managers, clinical and regulatory people generally understand the conceptual importance and opportunity of engaging with constituents through social media—and many even have exposure to and understand Pitt’s ideas about their feasibility.

IMHO, the core problem of healthcare social media engagement for pharmaceutical and device manufacturers isn’t conceptual, but logistical. Rather than tearing down the old school model of broadcast media marketing, legacy inertia and entrenched systems preclude these big companies from reorganizing themselves and reallocating the resources necessary to properly embrace and derive the most benefit from “emerging electronic media” in a manner their HCP and DTC audiences already expect and participate within.

Such a fundamental problem plagues all verticals, not only healthcare. “Subcompact Publishing” offers up a brilliant summary and analysis of how digital transforms the very essence of what and how we communicate, as seen through the eyes of publishing; the notion of “skeuomorphic models” is central to the dilemma here, namely the habitual practice of applying business practices from one medium directly to another, simply because they seem easier or feel more comfortable. What we gain in familiarity, we lose in efficacy.

What’s instead needed is a completely new way to structure and resource the marketing and regulatory departments of pharma and device companies. We can talk all day long about the need and benefit of healthcare social media, attend conferences, hold breakout sessions, tweetchat, and consult, but none of it will—and none of it has—made any difference, because the companies ostensibly tasked to execute these initiatives do not have the bandwidth and infrastructure required to make it so. Brave new world indeed.

Traditional broadcast media is unidirectional and static. That meant you create some content, put it into a channel, and blast it out there; six months or a year later, you rev the marketing engine back up and do it all over again. In stark contrast social media is a daily, hourly, minute-to-minute real time experience that completely redefines the form, content, and mechanism of messaging. What was once an annual or biannual initiative demands a day-to-day schedule—and the resources to staff it, manage it, and continuously optimize it.

So even if pharma marketing and regulatory departments completely understand and agree with everything Pitts recommends, they currently don’t have the organizational structure and raw logistics in place to actually make things happen. They might have the Pitts, but they need the Pendulum—the ability to cut a new swath in a new medium that demands an entirely new way to communicate with constituents. Everyone in the industry awaits FDA guidance, when what we really need is a roadmap to reorganization and partnering.

The Vital Role of Agency Partners
Ironically enough, “reorganization” is just another day on the farm for the pharma agency. From the very top of enormous holding companies to the bottom of small digital boutiques, the mantra “Agency is Dead!” haunts the communications landscape like a Nietzschean lullaby. The reason is simple: As full service “AOR” type agencies have acquired digital capabilities and smaller digital shops have struggled to evolve to full service, pharma and device companies meanwhile started to wonder why they are needed at all.

The problem: What, exactly, does an “agency” do? Does an agency provide brand strategy? Tactical execution? Does an agency actually build a website, CRM program, or app, or instead just farm it out for pharma? Who does what, where, when, why, and for whom? Competition is fierce in the industry, has never been this intense. The paradox is that the line is long to represent and service the big pharma brands, but nobody seems to know the best way to get the job done, especially when the job is continuously being redefined.

But now that we have the Pitts, it’s time for the Pendulum—the sharp blade that both destroys and creates as it swings. The old school marketing and communications broadcast news model has got to go. In its place the new school social media and mobile model must become entrenched, and evolve right along with the ever-changing, transformative digital health playing field it supports. But how can pharma embrace this approach? Exactly what does it need to succeed when the role of the agency has become so ambiguous?

A Noble Mission with Transparent Intent
The solution to this problem, like most challenges, is one of getting back to the basics. The answer does not lie in launching a revolutionary new “multi-channel” campaign or building a social media Taj Mahal. Instead, agencies and PR firms have the unprecedented opportunity to partner across all verticals in a manner that addresses the core mission of digital health: Advance public health by using the tools the public already uses to communicate with each other and bring about behavioral change.

To accomplish such a lofty goal we need to start with a few key elements. These include not only educating brand teams about what’s possible and risk averse, but also demonstrating what is strategically and tactically required to actually make things happen. Since monitoring, management, and maintenance are so vital to any social media initiative, agencies and PR firms can go beyond the build to supplement finite pharma resources and staff with additional capabilities that “emerging electronic media” increasingly demand.

Few deny that social media and mobile have introduced arduous complexities to communications. But digital health can become a solution instead of a problem if seen for what it actually is: An amamzing tool for connecting patients, caregivers, healthcare professionals, treatment providers, and institutions with the information necessary to advance public health. Sure user-generated content is hot, unpredictable, and potentially explosive—but so is all of healthcare. Can you think of any goal more important or worthy?


No comments

Be the first one to leave a comment.

Post a Comment