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May 19, 2016 admin0

Social Media, Risk, Cross-Functional and Strategy


Renowned author and literary critic Lawrence Clark Powell said, “Write to be understood, speak to be heard, read to grow.” The idealism inherent in this statement is inspirational for the pharmaceutical industry when overcoming communication challenges. Barriers are eliminated through insightful interpretation of the written word, verbalization of details that ensure full comprehension and total absorption of etched material to expand knowledge base. A smooth and seamless exchange of information results from the creative ways enlisted to handle social media, risk, cross-functional and brand strategy dialogue.

Social Media

LindaDiPersio-MayArtwork1In the digital age, it is imperative that pharmaceutical companies have an online discourse with patients to continue moving forward and not fall behind. Facebook is a tremendous opportunity to engage and connect with patients worldwide. The challenge with social media is that the continuous redesign of rules and regulations require strict adherence. Worldwide regulatory bodies, including the World Health Organization and the United National Health Care Organization, mandate the type of drug information companies can disseminate. In the United Kingdom, referring to the name of a prescription drug or an internet address is considered advertising which is prohibited for prescription medications. In the United States, the Food and Drug Administration stipulates that brands must add the associated risk information to their social media campaigns and allow accessibility to effective risk discussions.

Prevailing over this challenge by posting generic – rather than specific – information about drugs creates a community that explores widespread topics and promotes a mission with patients as Facebook “fans.” The potential to advance the corporate image of pharma companies is reinforced when patients read and comment on engaging medical information. Although pharma is not permitted to direct patients about the benefits of medications or which to purchase, they are at liberty to respond in broader terms and promote online drug awareness campaigns. Pharma should delineate the terms of engagement on Facebook pages and state plainly the types of comments that receive a response.

Cross-Functional Communication

LindaDiPersio-MayArtwork2In a 2014 study “Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges,” 48% of drug companies reported a lower level of comprehension with interdisciplinary regulatory requirements. Some internal teams are not aware of the timing of changes in the regulatory environment. These individuals believe that an agency approves a drug merely because it is clinically beneficial but they fail to notice its cost-effectiveness and trial design. Internal groups do not understand fully the impact of regulatory strategy on developing drugs, authorizing medications to be put on the market, and marketing after the approval process has ended.

The remedy is for regulatory affairs to lead discussions with cross-functional teams about processes that provide clarity on current guidelines. Regulators should promote the benefits of guidelines and set forth perspectives and priorities that impact the way prescription medication is developed. Focusing on the rules that increase the chances of medications entering and remaining in the market not only results in improved internal team communications but also stronger relationships with regulatory agencies.

Risk Communication

LindaDiPersio-MayArtwork3Communicating risk is a critical component in the reputation of pharma companies. Summary of product characteristics, package inserts, patient information leaflets and cartons are all tools currently regulated based on templates. The call to action arises when the use of templates limits the flexibility of companies to adapt risk messages to certain targets. These templates do not afford companies the opportunity to understand the message perception by different audiences and the fundamental drivers of change in patient and prescriber behavior to increase safety and minimize danger.

The comeback is for pharma companies to assimilate a separate group of communication professionals who focus solely on coordinating conversations aligned with objectives that are accepted by key stakeholders unaffiliated with regulatory agencies. Pharma companies need to emphasize promotional material with supporting factual sources. A team of professionals must determine communication effectiveness, gauge audience reaction and modify the level of risk accordingly. It is essential that trained individuals who know how to manage risk, which may become public later and damage the company reputation, be assigned exclusively to handle the internal dialogue about impactful issues. The relationship between risk communication, perceptions and management is of major concern and it is important that it be addressed.

Drug vs. Brand Strategy

Pharma companies focus their communication efforts on illnesses with the best or “one and only” treatment. In the future, if the severity of diseases diminishes with just one treatment or with only one medicine that is different from others on the market, communication strategies will have less value.  Newly introduced medicines are only unique for a short period of time because constant innovations enable more effective drugs to enter the market. Innovative drugs with reduced prices enter the market and profits decrease.

The technique to settle this is to shift communication strategies from centering on drugs to building brand policies. Connecting brands to concepts makes the pharma industry stronger. Pharma needs to promote what differentiates them from their competitors with a distinguishable brand identity. An umbrella brand protects and empowers medications and also makes it easier to launch drugs that have curative capabilities while a new communication strategy uses brand journalism and consumer engagements to spread the word about the brand. Articulating messages with clarity and being aware of brevity is of utmost consequence. When brand leadership is revealed to the general public, prestige and stature enhance the reputation of the drugs.

In conclusion, communication is a two-way street, but the conveyance does not always occur fluently. Messages from the sender are not necessarily understood in their entirety by the receiver in the intended sense which results in a communication breakdown. Pharma needs to gain the confidence and courage to develop creative solutions that master dialogue challenges with social media, expressing risk, communicating information cross-functionally and brand strategy.




“Cross-Functional Communication of Pharmaceutical Regulatory Strategy Boosts Organizational Impact.” Business Wire. (2014)

Cura, M. and Costa, M. “Communication in the Pharmaceutical Industry from Product to Brand.” Developing Ideas. (2015)

Elgie, D. “Pharma Brands on Social Media:  Overcoming the Challenges.” Emoderation. (2015)

O’Riordan, B. “6 Challenges Facing Pharma Communications.” Pharmafile. (2015)

“Risk Communication and the Pharmaceutical Industry.” SpringerLink. (2015)


May 19, 2016 Linda Ruschau0

It’s probably safe to say that you’ve been to the doctor at least once in your adult life. So you can probably relate to this:

You’re sitting on the exam room table in your physician’s office.  In your head, there’s a lengthy list of questions related to the reason for your visit – an aching back, perhaps, or persistent heartburn, maybe a minor sprain – and you’re hoping you don’t forget any of them. Your doctor walks into the exam room after what feels like an eternity, even though it’s probably only been 10 minutes, and asks, “How are you today?”

“I’m fine,” you answer.

You’re not alone! Doctors say this is a common scenario … and one that makes effectively treating patients all the more challenging.  “I’m fine” has become a default response.

One of the most important interactions individuals can have is about their health. But empowering patients, educating them to take control of their health – avoiding the default “I’m fine” answer – is one of the greatest challenges DTC marketers face. In fact, it’s one of the greatest communication challenges in healthcare, period.

It’s also one of the greatest opportunities. So how can you overcome that challenge? Where do you start?

In my opinion, the most effective way to overcome communication challenges starts in the exam room. And it’s so critical to the patient, the physician and the pharmaceutical marketer to get that interaction right.

I call it the “magic moment.” It’s that moment in the scenario I described above, right before the doctor comes in. You’re sitting on the crinkly-paper exam room table (with your phone put away!). You look up and see a display of approachable, aspirational brochures. Or maybe it’s a mounted digital device that invites you to learn more about your symptoms with a few taps of your fingertips. The privacy of the exam room is a safety net where you can learn more about the reason for your visit, arm yourself with questions for your doctor and feel empowered to discuss your diagnosis after engaging with meaningful, condition-specific education.

What constitutes meaningful education? Easy-to-understand, for starters. Eighty-seven percent of U.S. adults read at an intermediate level or lower, so materials are most effective when written in what health literacy experts call “plain language” – a fifth-grade reading level, at most.[1] It’s easy for us as marketers to lose sight of this and go for the more complex messaging, but if patients can’t understand what we are saying, they won’t be empowered to ask the right questions.

PIXR_HomeTopicScreen_InUnit_21April2016Then there’s the medium itself, which can also make patient education more meaningful: interactive touchscreen technology, engaging videos and, yes, even print – each medium is particularly effective for certain patient demographics.  All serve as an opportunity to appeal to a patient’s learning preference and to provide a guide to a patient’s condition.

But content is also key. The most meaningful exam room education addresses not just the condition, but the underlying causes, lifestyle management and treatments as well. Treatment options will obviously vary depending on the condition and the progression of the disease state – so education must help patients learn how to communicate with their doctors throughout their diagnosis and journey.

This approach works. According to PatientPoint results, 9 out of 10 patients learned a tip they could take action on from our exam room education, while 96% of patients agreed we make health information easy to understand.[2] This translates into 5 to 1 ROI and 11% NRx average lift.[3]

So the next time you’re in your doctor’s office, sitting on that crinkly-paper exam room table, take a look around. Look for information that’s meaningful and draws you in. If you’re seeing one of the healthcare providers that such provides such resources, it’ll be there, ready to empower you to take control of YOUR health.



[1] Static Brain, “Illiteracy Statistics.” 2014.

[2] PatientPoint national survey. 2015.

[3] Symphony Health Solutions. 2015.

May 19, 2016 Graeme Jamieson0

Managing social media in the healthcare space can be challenging and must be approached with a unique strategy by brands.  In my experience, a brand’s objectives for organic social media can run the gamut from listening and research, to marketing and engagement, to sales and CRM.  (Not all at once, thankfully.) I’m focused on achieving success in the organic space, and leveraging insights to optimize a brand’s paid social spend. However, in my research on the health industry, it often seems that companies eschew interaction on social platforms, with their best case scenario avoiding any kind of pique or penalty. As such, too many paid social efforts appear unfitted based on the audience they are serving.

Chat bubbles

Somewhat inevitably, this approach leads to a disregard for several social media fundamentals – authenticity, balance, connectivity – a scheme not ideal for controlling the message. To be fair, it’s a not a universal failing, for I did come across some modestly successful provider-as-lifestyle-partner posts, and message boards with brand-as-facilitating-host.  My first impulse was to diagnose a vicious cycle where lack of resources or talent led to a subsequent deficit in results, which in turn ensured a steadfast lack of commitment, and caused the under-investment in resources.

Learning the primary root of social media anxiety in pharma

I read industry blog after industry blog, which led me to the FDA’s Guidance for Industry documents. It is clear those drafts are daunting. During a recent poll conducted at an industry event, 95% of respondents cited compliance as the root of their reluctance to participate in social media.  It was not a lack of resources, nor talent, and not a difficulty in measuring ROI.

Understanding the FDA and compliance

Knowing the reason why most companies are reluctant to add paid social as a channel, I decided to read every line and footnote in each draft guidance from May 2009 to June 2014. I read every warning letter or notice of violation stemming from digital media over the past six years. I studied the FD&C Act and the Electronic Code of Federal Regulations.  I evaluated the advertising policies for each major social platform, even though I’m not a media buyer. I absorbed Mark Senak’s white paper, FDA Communications Oversight in a Digital Era, too.  Finally, I called the FDA.

My own point of view is that exposure to warning letters, notices of violation, or adverse events occasioned by social marketing, is evidently overstated. By my calculation, since 2009, the Office of Prescription Drug Promotion at the FDA have issued only three WLs/NOVs specific to social media.  As for the reporting of adverse events, I won’t make the mistake of downplaying their function. But I will say that of the sample studies I’m aware of, on average only 3% of posts include each of the four elements required for their reporting.  That’s a low number, whichever way it’s spun. I did not discuss my views with the FDA, and the FDA was not able to answer all of my questions. However, I emerged from that conversation with clarity.

We talked about social media platforms with character space limitations (Facebook ads are character-limited).  I also asked about reminder advertisements and reminder-like ads (which you should read more about, from the Food & Drug Law Institute’s Advertising & Promotion Conference, in October 2014).

What’s the risk?

The central tenet of my theory after the research, is that there is risk associated with any communication, but the notion that social media is some kind of unnavigable domain doesn’t stand up to scrutiny.  The legal and regulatory culture is different at every organization and remaining in compliance is no easy task.  Yet when a majority of violations are for omitting (or minimizing) risk, or because of unsubstantiated claims, one wonders how the content found its way out the door?  It is possible that small firms will take more chances, but when bigger players are using self-denial as a form of discipline, neither strategy provides the means to achieve meaningful ROI from social.

The solution with social media has to be audience-first. 

There are powerful listening and analytics tools that reveal a target audience: who the audience is, what the audience wants, when they want that, and how often to deliver it.  This information forms the bones of a basic social strategy which is allied to an objective. Regardless of whether it’s Pharma/Rx, OTC, or HCP, the underlying objective is conversion. Successful conversion is best achieved by understanding the organic audience, which in turn improves paid-social creative, targeting, and performance.

For this to work at scale, I’d recommend becoming familiar with the June 2014 Guidance for Industry , the forthcoming use of links to third party sites, and understanding how a reminder or a reminder-like ad can be customized and tested, be creative but not careless.

In terms of the big picture conversation; if other industries are deploying custom contact strategies, why isn’t health?  The most enduring social relationships originate from empowering exchange.

May 13, 2016 Bob Ehrlich2

I was a strong supporter of the Novartis heart failure disease awareness ad. This was the one with the man in the room with water pouring in and filling up the room. It was criticized by some doctors for being alarmist. I never thought so myself, as heart failure is about as serious cause for alarm as there can be.

Bob Ehrlich
“Entresto is a solid ad that is memorable and positive.”
-Bob Ehrlich

The disease ad was a precursor to a branded ad for Entresto, which I can’t stop thinking of as Ernesto. This ad is the polar opposite in tone to the disease education campaign. While the message of preventing heart failure is the same, the branded ad takes an uplifting approach.

The ad uses the song from Annie, “Tomorrow” which I guarantee you will sing for at least 24 hours after seeing it. It is a series of patient vignettes where the actors sing parts of the song. The message is that Entresto will help make more tomorrows possible. The commercial is beautifully simple and engaging.

I have to give Novartis and their agency, McCann, a lot of credit for a combination of disease and branded ads so different yet entirely complementary. The disease ad really stopped you in your tracks alerting viewers that heart failure is something to watch out for and act on. While deadly serious in tone, I think it was entirely appropriate. They could have used the same idea for the branded ad but they smartly chose to play up the positives. It is better to promise in the branded campaign hope about living longer than warning about early death.

What was necessary in the disease ad to get your attention was not the best approach in the branded ad. Instead showing a world of family and friends that you can enjoy longer if you treat with Entresto was a good approach. I am sure the doctors critical of the disease ad had the opposite reaction to the “Tomorrow” campaign.

I am not sure whether the criticisms from the medical community affected the branded strategy. Maybe that led to the decision to go more upbeat. In any event, whatever the reason, Entresto is a solid ad that is memorable and positive

May 6, 2016 Bob Ehrlich0

I wanted to explain why after 16 years of developing conferences we decided to run one solely on tv and print this fall. It seems odd that the media with the most spending seems to get the least discussion on the agenda. Our DTC National offers a wide array of topics but most are in new media. I always ask people to submit speaking proposals on television and print but few are received. While drug marketers are anxious to learn the latest on new media, there is a lot that can be improved in the meat and potatoes category.

Bob Ehrlich
“Strive to do it better.”
-Bob Ehrlich

Most of our speakers are on digital, big data, patient relationships, point of care, and technology. While this may be the DTC future, the overwhelming media allocation remains in television and print. After 20 years maybe there is not much left to learn in mass media. I kind of doubt that.

We are seeing great new creative in mass media so clearly agencies and clients are learning how to constantly improve their ads. We are also learning so much more about patient receptivity to ads depending on day part, show type, and where the ad is in the show. We are seeing FDA doing many studies on elements of advertising from supers, cartoon images, how risk is narrated. We are getting new research that dissects effectiveness to new levels of detail.

We are also experiencing growth in mass media for drug categories that never would have used it a few years before. Cancer and rare diseases have decided that the ROI is positive using mass techniques. So there seems to be a renaissance in expanding use of mass media.

We also see print titles doing quite well. DTC ads dominate some magazines. I have always believed there is tremendous opportunity to improve the creative impact in print. Too many ads are still missing a dominant headline or visual, choosing dense copy and too many sub headlines. While FDA mandates make print more difficult, there is no reason any ad should not be visually arresting.

My guess is every media plan can be 10-20% more effective with some simple tweaks. Better creative, more pre-testing, more targeted media planning, and more robust evaluation are all possible and affordable. In 20 years of being involved in DTC I have seen many campaigns that I know are weak, yet somehow they made it on air. Mediocre ads get through for many reasons. It can be bad copy strategy, testing the wrong objectives, rushed creative, forgetting the competitive set, group think, overloading information, or many other factors. Sometimes there is so much testing that the marketers are overwhelmed and miss the need to simplify for consumers.

So in October we will do an entire conference that never mentions social media, mobile, relationship marketing, or personal fitness devices. Instead we will focus on making our tv and print ads better, spending more effectively, and doing better analysis. I am not pushing mass media over new media, just recognizing that if more than 80% of our budget is spent there, we might as well strive to do it better.

May 5, 2016 Phil Baumann0

By developing and implementing solutions for handling adverse events in social media, your company has the opportunity to leverage key information from the largest focus group in the world.

In my previous column, I discussed how social media can be viewed as a “perpetual focus group.” The sheer and ever-expanding volume of these conversations represent a virtually infinite set of data that can be transformed into valuable information. All of this information — even Adverse Events (AEs) and Product Quality Complaints (PQCs) — can provide insights that power decisions and support action.

The role of adverse events on social media

Social media, like any other media, is a source of AEs and PQCs. Given the immense volume of tweets, Facebook status updates, Instagram photos, blog posts, and conversations on forums, it is to be expected that while people are sharing their health experiences, AEs and PQCs are bound to be mentioned. These can occur either intentionally (for example, “I took Drug Rx and I woke up to a rash on my leg”) or incidentally (“I’m so grateful for the nurses who took such good care of me when I was in the hospital after my car accident. Also, Drug Rx has been working well for me.”).

Since the early days of social media, there have been two opposing schools of thought on the best ways to handle AEs on social media. One school of thought views AEs as an absolute obstacle to any pharmaceutical company getting involved in social media. The other school does not view AEs as a problem, but rather, in my opinion, projects a nonchalant attitude about the nuances of social conversations and the identification of AEs.

I am not a student of either school of thought. Based on my professional experience within clinical settings and my knowledge of drug safety, I believe the best stance is to acknowledge the challenges that AEs present while, at the same time, to develop and implement practical day-to-day solutions — systems that ensure proper identification and triaging of AEs, as well as the ability to leverage AEs for analytics and insights.

How to monitor and categorize adverse events

PhilBaumann_April2016artworkFundamentally, AEs can yield useful information when monitored closely, safely, and properly. Over a period of several months, for instance, thousands of AE posts can be classified according to an objective-based process. Then, identified and triaged appropriately, these AEs can be classified into categories.

Let’s explore one example: “Drug Rx has been a life-changer for me. So far, it’s been doing what my doctor says it’s supposed to do. Occasionally, I get a little rash on my right arm, but other than that, I’m truly grateful.”

In this scenario, we have an AE (assuming we can identify the person reporting it). We also have references that can be classified. “It’s doing what my doctor says it’s supposed to do” could be classified as Effectiveness, and “a little rash” could be classified as, say, Immunity. Over time, these AEs can help companies better understand conversations. At the end of the set time period, a company may find that 50% of AEs were Immunity-related, 25% were Cardiovascular, 15% were Respiratory, and so on — providing valuable information for understanding the adverse side effects of a particular agent.

Furthermore, if these posts were also categorized by other data, such as the social media outlet, the topics discussed and the behaviors expressed, the aggregate data offers information beyond purely clinical, perhaps even helping to inform a company’s messaging or marketing strategy.

Establishing well-defined protocols for success

The above example illustrates the basic concept of leveraging social media AE data. In essence, the close monitoring and careful categorization of social media AE data can transform a seemingly complex and vast landscape into a navigable road. But that’s not to ignore the challenge of scalability. The best approach is to start small, evaluate results and evolve incrementally.

Companies need to plan for how they will monitor social media for AEs, because the greatest pitfall is missing AEs altogether and risking patient safety. Training staff in the identification of AEs and the enterprise’s triaging protocol is crucial. In my company’s training program, our agents receive training in the nuances of social media, in addition to traditional AE and PQC training, to ensure they do not miss AEs. After identification, the documentation and communication protocols need to be established and clearly understood by all team members.

The first step of merely identifying AEs can be challenging within itself, as information related to AEs or potential AEs are often ambiguous or sparse, especially due to the word or character limitations on certain social media platforms, such as Twitter. Furthermore, a company cannot publicly respond to a tweet that simply says, “My inhaler isn’t working” by asking, “What do you mean by working”? So the company is left wondering, is this an AE (lack of efficacy), a PQC (a malfunction), both an AE and a PQC, and/or an opportunity for patient education? In the inhaler example, the company could respond with, “We’re interested in learning more. Please contact us at 800-555-5555.” This is where the pharmaceutical company’s ability to interact publicly in social reaches its limit, but still presents an opportunity to demonstrate a caring, human voice, while adhering to regulations. Training must include steps for evaluating an AE and how to extract the key data.

Exploring ethical implications

Because the general principles of monitoring for AEs also apply to social media, compliance with FDA regulations is, for the most part, straightforward. Yet beyond the regulatory responsibilities of AEs, ethical issues arise. For example, it is inevitable that companies may stumble upon mentions of a competitor’s agent with a potential AE, either on their own branded properties or within the broad social media space. Companies are not required to report another company’s AEs to the FDA, but should they? Well-established processes, understood by all within a company, can help guide these and other ethical decisions.

Pharmaceutical companies are committed to patient safety, product safety, and effectiveness. By investing in and developing resources to ethically and efficiently manage AEs on social media, companies can transform the fear of these AEs into mutually beneficial results. In the long run, better understanding of all AEs — social media or otherwise — can help expand the knowledge of drug researchers, providers, and marketers; advance the industry; and improve the well-being of the patients we serve.