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Regulatory and Marketing Symbiosis from Concept to Commercialization

by Good Promotional Practices on Jul 07, 2011

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For successful commercialization, the relationship between the seemingly opposing forces of Marketing and Regulatory need to be aligned very early on in the process. In this webinar, we will examine how Marketing and Regulatory must collaborate closely to design a product, develop support to substantiate its claims, and promote it for both optimal market adoption and regulatory compliance. These represent the best Good Promotional Practices.

As such, we will explore why it is critical for regulatory and marketing to create a symbiotic relationship in support of the claims strategy from the initial design review, including during development of clinical trials and sales materials.

We will also decode the common personality traits of your marketing and regulatory colleagues and give you concrete examples of how to work together more synergistically. A regulatory-marketing interaction framework to support cross-functional symbiosis will be introduced, and we will discuss balancing needs, wants and tradeoffs. Lastly, we will touch briefly on the need to gain consensus by putting it in writing via an SOP or other signed document.

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RAPS:We will start today with a few housekeeping items followed by speaker introductions and then dive into the core of this webinar. There will be 15 minutes for questions and answers at the end.Next slide.
RAPS:Today’s speakers have extensive experience in creating, implementing and monitoring promotional content review in medical device companies, and they are excited to join us today to share some real-world advice.Elsa Abruzzo is President of the regulatory consulting firm, ARAC LLC, and has 20+ years of successful regulatory, quality, and clinical experience with innovative medical devices and disruptive biotechnologies, including embolic agents, stents, biomaterials, active implantables, and percutaneous heart valves. Elsa has worked at companies such as Baxter, Cordis Johnson and Johnson, CryoLife, Percutaneous Valve Technologies, AtriCure, InnerPulse, and Merlin MD. She designed, developed and executed U.S. and international clinical trials, including Bayesian adaptive designs and break-through first-in-man studies. Elsa’s regulatory strategies have resulted in worldwide commercialization of products. Her clients, primarily startup and emerging growth companies, span the globe and a variety of medical disciplines. Elsa is Regulatory Affairs Certified and a RAPS Fellow for the Class of 2010. She has a BS in Engineering from the University of Miami and is a co-founder and co-host on Think Talk Radio on 55KRC in Cincinnati (55KRC.com or www.ThinkTalk Radio.com). Maureen Shaffer is the VP of Life Sciences for Prolifiq Software and has 20 years of global marketing experience. She has created and driven game-changing strategies, products and teams at VC-backed startup, emerging growth and multibillion dollar medical device companies. Maureen began her career launching Cordis’ first PTCA balloon catheter and more recently built and led the marketing team at AtriCure where they grew from $9M in revenues to $50M. She has also worked at innovative companies such as US Surgical, Heartport and Converge and launched more than 100 innovative products. Maureen recently jumped into the software space with Prolifiq to develop mobile fulfillment solutions for the increasingly complex challenge of sales and marketing in medical device, pharmaceutical and biotech companies. Maureen has a BS in Biomedical Engineering from Duke University.As a point of disclosure, Maureen is the managing editor of goodpromotionalpractices.com for which Prolifiq is one of the sponsors, and Elsa is a regularly contributing blogger on the site.With that I’ll turn it over to ELSAwho will begin our presentation.Next slide.
ELSA: First, I have a quick story. During a recent conversation with a friend in real estate compliance,…she vented about her department’s interactions with Marketing and Sales. I found it interesting that our topic today is applicable in a variety of Regulated industries.As I analyzed my friend’s frustrations, I realized that part of HER dilemma stemmed from an unequal distribution of power. Her Department reports into Marketing & Sales some levels above her position and she found herself defending COMPLIANCE issues in meetings where she was CLEARLY outranked. So properly balanced teams and well-defined roles are key… Additionally, Compliance had NOT been addressed early enough in the development and now my friend who had valid changes was viewed by Marketing as trying to delay and raise the cost of much needed materials. It was just too easy to blame Compliance for an OVERALL failure of the SYSTEM. This example demonstrates how we can drill down into some practical issues during this webinar…so PLEASE don’t be shy and share with the group.Now let’s jump right in. When we say that sales is all about the numbers, we’re usually talking about setting quotas and driving revenue. However, the risk of regulatory and marketing not working in sync is ALSO driven by the numbers. So Let’s look at some of these drivers…
ELSA: Reason #1 why is it critical for regulatory and marketing to work symbiotically: Maintain your stock price. The following example is very familiar to Maureen and I, even though we both had moved on to other companies prior to this inflection point at AtriCure… During our time there, Maureen and I worked together with Quality to establish and integrate robust and thorough procedures and processes from concept to commercialization. Nonetheless, as you can see from the graph of the AtriCure stock over ~ 15 months, the sheer announcement of a DOJ probe around off-label promotion reeked significant havoc on the stock price. At the time …AtriCure, despite good management and products, was an emerging growth company with $50M in sales and limited resources and funds. While our practices withstood DOJ and HHS scrutiny, a small settlement was made. Even though AtriCure’s stock has now fully recovered, the lesson we can learn for this example is that it doesn’t matter if you are innocent or guilty… these situations cast shadows on the company and are distracting and time-consuming. This can also happened at a critical point in the company’s growth cycle, as it did for AtriCure. Marketing and Regulatory have to work together to prevent this.
ELSA: Moving on to Reason #3 of why TODAY is the day to link proverbial arms with your regulatory and marketing comrades: The criminal enforcement branch of the FDA has VOWED to pursue medical device companies and the DOJ and qui tam attorneys are focusing on the “wild west behavior” in medical devices because illegal pharma sales and marketing behavior is becoming more subtle.Additionally, PPACA (pronounced pea-pack-ah) the Patient Protection and Affordable Care Act is providing $350 million for healthcare fraud and abuse activities. The Patient Protection and Affordable Care Act (PPACA)[1][2] as you may know was signed into law by PresidentBarack Obama on March 23, 2010. This act and the Health Care and Education Reconciliation Act of 2010 (signed into law on March 30, 2010) made up the health care reform of 2010. You can read more about this on our Good Promotional Practices Dot Com blog.The FDA, DOJ and qui tam lawyers have upped their ante for medical devices. Have you? (advance slide)
ELSA: Onto Reason #4of why you we should find a way for regulatory and marketing to work more synergistically: It may protect Management and Employees from prosecution. This is an excerpt from the indictment of 3 sales managers and the former CEO of Stryker Biotech by the state of MA stemming from off-label promotion. Note the phrases highlighted here: Promoted or caused to be promoted, advised, recommended, wrote. These are all heavily influenced first by regulatory and marketing.Sales reps are on the front lines promoting and educating HCPs and communicating that first-hand knowledge internally to managers and othersIn many organizations, and particularly emerging growth companies, sales and distributors account for the largest number of folks in the organization. There are simply more of them communicating so the stakes are higher. How are regulatory and marketing in your organization working together to get out in front of this?-Additionally, we know that the DOJ prosecuted 80,000 individuals and 200 companies, the majority for fraud. (per Dabney Friedrich, Commissioner at US Sentencing Commission). And, that 50% of the company prosecutions involved named high-level individuals.Plus, former senator and chair Arlen Specter was recentlyquoted saying that "Fines are not a deterrent to future conduct like jail terms are.” (advance slide)
ELSA: So with the anti-kickback and false claims statues general management, as well as marketing/reimbursement/sales, have more obvious stakes in the pie. It’s clear to see here how not being compliant in these areas causes everyone to lose. However, with off-label use the lines between goals and responsibilities become more blurred …and best practices and consequences are not as well understood, particularly by upper management. So here is Reason #5 to play nicely in the sandbox with your cross-functional colleagues: Off-label Use is not only complicated it is profuse. The audience for this webinar understands the difference between on and off-label... However, even for seasoned professional it is not as simple as it seems, as some of your regulatory folks can attest by the existence of multiple sessions on this topics at last years and this years RAPS Annual Conference and at a plethora of other meetings and educational/society sites. We all know of multitude of scenarios that can be encountered… and rules that apply. We also often rely on the fact the FDA cannot control the practice of medicine…well they don’t have the legal jurisdiction to do so… and that physicians may choose to use the device in a manner that may not coincide with your approved labeling/intended use. However, how you inform that physician and promote your device is your responsibility and under FDA’s review and enforcement purview. So you need to facilitate exchange of scientific information responsibly and in compliance with those dissemination rules. Allowable methodologies for dissemination/safe harbors are complicated and can as easily be legal as be violative. This can become very complicated, very quickly… particularly at the broadband and 4G lightning speeds of internet and social media… and increases the complexity of control for Legal, Regulatory, Marketing and Sales.Ok, now that I’ve done my job highlighting the reasons why it is critical and urgent NOW to work together… I will let Maureen give you some actionable advice on how to decode your colleagues to improve your working relationships and minimize potential hurdles. (advance slide)
MAUREEN: Thanks Elsa. “Can’t we all just get along”: seems like a pretty simple and achievable concept, but is it really?… Both Elsa and I have toddlers and much like toddlers having to share a toy… a simple concept can be complicated by human nature, the set of expectations and preconceptions we all carry, or in this case our differing work personalities and goals.(advance slide)
MAUREEN:Let’s kick this off with some quick stereotypes to take this to an extreme. Superman (or woman) is the proverbial do-gooder, saving humankind from evil. Sounds like regulatory, right: following the rules and saving physicians from evil brochures? Certainly regulatory needs superhuman strength to fend off Marketing, the green-eyed revenue monster intent on strong-arming those approval signatures, right? Well, that is how regulatory may see it. Marketing may see, at times, that regulatory is a blockade to sales and marketing’s job. Let’s review some intersections of misunderstanding and ask a few questions before we move further into this section.(advance slide)
MAUREEN: Since I spent 20 years in marketing, I polled some of my astute regulatory colleagues as to some of their frustrations about marketing. And, I heard things like why I am spending time on a submission for a losing product? Why does marketing always come to me at the last minute for approval on materials? Why do they look confused when I refuse to sign when legal already signed it? Worse of all, have you or your boss(es) ever received a subpoena or a surprise FDA inspection of your promotional materials? I think this would make you question what Marketing had been doing.If you would like to share some of your frustrations with Marketing on IM or later via email, we would love to hear them and address them in a future GPP blog. Again, anonymity is yours if you request it. This is clearly telling of some of the gaps in understanding that Regulatory and Marketing need to discuss.
MAUREEN:So, now a quick poll. Regulatory folks on this call, read through these questions and please answer. Remember, all your answers will be kept completely confidential. Joanne, would you please pull up the poll? We will give everyone a few minutes to answer.It looks like everyone is done voting. Joanne, would you please display the results?As you can see, these three traits seem to resonate with Regulatory. Now let’s switch over to Marketing.
MAUREEN: Back to my Marketing Hat again… Here are some of the challenges that I have heard from marketing folks about regulatory. If any of these resonate or you have an opinion, pls IM us with your comments.If you are in marketing, have you ever struggled to get regulatory to sign off on promotional materials or had to request sales return materials to revise them? I once was asked by a PRC earlier on in my career to substantiate my promotional claim that 4x4 gauze absorbed blood. While that seemed a bit over the top, marketing does need to be able to back up every single claim made. Abiomed was just hit with a warning letter this month for unapproved advertising and labeling claims for their Impella product requiring that they immediately cease these activities. And, sales moves at high speed with quotas to hit every month. The speed with which marketing is asked to adapt is often a point of friction with regulatory needing to be careful and safety-focused.This list is telling of some of the gaps in understanding that Regulatory and Marketing need to discuss and resolve.
MAUREEN:So, now a quick poll. Marketing folks on this call, read through these questions and please answer. Remember, all your answers will be kept completely confidential. Joanne, would you please pull up the poll? We will give everyone a few minutes to answer.It looks like everyone is done voting. Joanne, would you please display the results?As you can see, these three traits, quite different from Regulatory, seems to accurately describe how marketing perceives themselves. Now let’s move on to decoding what all this means.(advance slide)
MAUREEN:Myers-Briggs, one of my favorite personality tests, scores people on four dimensions with two choices for each dimension. Here is a list of the four dimensions and what they mean. I was introduced to Myers-Briggs in college and circled back to it a few times. The most important was the year I spent commuting 2 hours a day with a regulatory colleague and friend (yes, friendship is indeed possible!). One day, we found ourselves discussing our Myers-Briggs personality types. And, we were the exact opposite which I have coded here. Before we dig in, which one do you think is regulatory? Which one marketing? I will help you out by telling you that I find the feeling/thinking dimension to be the most variable amongst regulatory and marketing personnel. So, as most of you have now surmised, she was/is an ISFJ and I am an ENTP…as you see here. More about our commuting later. Over time and in different jobs, I found that there were very similar traits amongst my successful regulatory colleagues. While these specific dimensions may or may not apply to you, the concept is still valid. Let’s discuss that.First, there is no right or wrong on any of these four dimensions. One is not a better or more valuable dimension than another. Society and companies need all types of people. And, we are all capable of all these traits. What is important in Myers-Briggs is to understand which one you naturally prefer and work in more naturally.Second, the labels they apply here should not be interpreted in the dictionary context we understand. Let’s walk through them. Introvert vs. Extrovert, or I vs. E. This dimension is about interaction with the world—do you prefer to bake ideas internally before sharing or do you need/want to share incomplete ideas in order to fully bake them through discussion? Where might this be frustrating for Marketing and Regulatory?Sensing vs. Intuitive, S vs. N. How we gather information. I am a huge N and my friend is a huge S. Each dimension is on a sliding scale of more or less. There are no absolutes but this one is very clear for us. She notices things, like a newly painted mailbox on our route to work. After she mentioned it, since we had been doing Myers-Briggs, she astutely said, “this is the first time you’ve seen that mailbox, isn’t it?” And, she was right. Ns see the big picture. We focus to the future and are less about the here and now. In short, I am focused on the forest and she on the trees. Both are important but very different. The importance here is that you understand, respect and adapt to your differences.Feeling vs. Thinking– the most commonly misunderstood dimension is about decision making. F Feeling does not indicate a lack of logic but a preference to make decisions oriented towards their impact on other people. T, or Thinking indicates that the person makes decisions objectively and may be misinterpreted as cold or uncaring.And, finally, Judging vs. Perceiving, J vs. P– how we prefer to live. Js like order and structure, planning and closure. Ps like to be spontaneous, flexible and open to possibilities. Is it any wonder why Regulatory and Marketing can struggle to get along?What draws us to and makes us great in our respective professions of Marketing and Regulatory is our differences in how we view, perceive and interact with the world. Back to my commuting story, we successfully typed the Myers-Briggs for every employee at this company. What it did was remove any prior bias around whether a specific behavior was positive or negative from our individual POV. And, it opened the door to understanding and respect for a different view of the world—no better or worse than ours. The most important takeaway here is that you need to decode anyone with whom you are struggling to develop a relationship. Then, you will be able to better see their POV. Simple but powerful. Try it!(advance slide)
MAUREEN:I think sometimes that our differing POVs get in the way of the best mutual outcome for the company and for patients. I have also seen, in lieu of understanding and respect, many assumptions are made. Most of which are simply untrue. We need regulatory to get the product cleared or approved and to keep the company and patients safe. Certainly dealing with the FDA would be no picnic for a marketing person. On the other hand, marketing and promotion has long suffered from cross-functional misunderstanding of the difficulty and speed that it takes to be successful strategically and tactically. A key study published on diversity, conflict and performance found that the most effective and efficient workgroups or teams had high informational diversity (effective) and low value diversity (efficient). What does this mean? Basically, lots of POVs and different information in a discussion yields the most effective result but at the sacrifice of efficiency. Regulatory and Marketing have that, so check one off. To negotiate the high information diversity, they viewed relationships as important tasks for a team. They let go of managing someone’s process, how they accomplished a task, and focused instead on what the task was or should be. From our Myers-Briggs lesson, it should be clear that trying to manage someone else’s process would be an exercise in futility.Secondly, in order to maximize efficiency in addition to effectiveness, they had to find a common value. What common values do you have with your colleagues in either Marketing or Regulatory? Identifying this will allow you to move forward through conflict because you all agree on a higher purpose. If you don’t have one, we are here to help. Let’s try some common ground on for size…(advance slide)
MAUREEN:We have learned now why Regulatory and Marketing working together is critical—it can have a severe and long-lasting effect on you as an individual and your business. We learned why we often disagree, how our different styles and personalities require rethinking our previous assumptions about our cross-functional colleagues and how we must challenge ourselves to adapt to foster better working relationships. We landed on the need to find a common ground between Regulatory and Marketing. And, now we are going to introduce a Regulatory-Marketing Framework, The Four Phases of Concept to Commercialization along with 4 quick tips for techniques you can implement to bring Regulatory and Marketing together to advance the company and its products.(advance slide)
MAUREEN:The common ground and common value for regulatory and marketing needs to be the patients you all build products for. Okay, so you may think this is obvious. However, when was the last time you were in a discussion between departments where you stopped a nonproductive discussion by asking, “but what about the patient?” What difference would this have made in your conversation? Would it have shifted the focus? If we keep patients at the front of mind, then compliance and revenues naturally follow. This simple question also lifts conversations above any cross-functional dysfunction and moves everyone towards a common purpose, the PATIENT. Elsa, over to you.ELSA: To step back a few slides, for the record, I am not an ISFJ…Maureen says I am an E…SFJ. Obviously we are generalizing Regulatory and Marketing personnel personalities, but there are some truths and more importantly, concepts for understanding and moving forward more effectively and efficiently. As regulatory personnel we too need to recognize the company’s and customer’s needs and balance these against our regulatory and compliance responsibilities. As you can see by this diagram, our mutual involvement is necessary through-out the product life cycle, and the process filter must be patient centered. Maureen, back to you. (Maureen advances slide)
MAUREEN:So, we start with the first of the four sections that move us from concept to commercialization: Design With the PATIENT in Mind. What I am going to talk about in this design section is not engineering but what regulatory and marketing need to level set at CONCEPT phase. You have heard the phrase, “measure twice; cut once” or “an ounce of prevention is worth a pound of cure”. Well, that is what smart, thoughtful upfront planning at concept phase nets you and your company. More specifically for this talk, these data will serve as an objective discussion ground for Regulatory and Marketing to orient themselves around the patient to achieve the end goal of successful, revenue-generating launch. I know the majority of folks on this call are regulatory. So, in an effort to build understanding, I am going to walk you through a few examples of what data I have generated, as a marketing person, in the past for concept review. All of this information is publicly available, some for a fee, and I would be glad to share sources if you contact me after this meeting. For now, let’s move forward.
MAUREEN:Marketing needs to understand and share with Regulatory the disease for which they intend to market the device. And, they need to drill down into the details. This company was developing an implantable pain pump which delivered approved drugs directly to the intrathecal space next to the spinal cord. We looked at the current usage of implantable pumps in the US and found that the majority were for noncancer pain. Since data was not available down another level of detail, we looked at all noncancer pain diagnoses in the US. We see on the top right that the top 3 reasons for non-cancer pain are arthritis, neck pain and back pain as the top 3. However, based on journal research and review of reimbursement decisions by large payors, we ascertained that neck pain and arthritis are rarely treated with or reimbursed for implantable pumps. However, back pain, neuropathic pain and CRPS were both scientifically supported and reimbursed. For severe cancer pain (the indication reimbursed and scientifically supported), it was a broad group of cancers that caused severe pain. And, for spasticity, the majority of spasticity was caused by stroke. Stroke was too complex a disease to be effectively treated with antispamodic drugs. Additionally, we found that morphine was frequently used to treat both severe cancer pain and non-cancer back pain, neuropathic pain and CRPS.Let’s stop for a minute. Can you see how crucial this data would be to regulatory in making decisions around testing and approvals/clearances? How it might inform indication statements you seek? And, how it might help to bring regulatory and marketing onto the same page around the patient?One note, while this was clearly a follow on product to one already in the market, I have performed similar analyses for new, leading edge products.
MAUREEN:Moving on to look at where the patients who have noncancer back, neuropathic and CRPS pain plus severe cancer pain and use morphine in pain pump, i.e. which practitioners are they going to see? If we look at the top prescribers (thank you supreme court for recently upholding the ability to buy and mine this data after multiple challenges), we see that anesthesiologist, physical medicine, internal and family medicine at the forefront. However, when we layer on when they use pain pumps in the chart in the lower right, we see that they are saved for after less invasive therapies have failed. So, the top prescribers of morphine for pain pumps are not actually internal and family medicine. Physical medicine and rehab along with neurology tends to co-prescribe with antispasmodics and clinical/regulatory advised that we go for one simple drug approval so we ruled these HCPs out. That left us with anesthesiologists as our primary target audience. When I saw this data, my first thought, and perhaps yours, was, “where are the surgeons?”
MAUREEN:So, it turns out that many anesthesiologists were taking advantage of the boon in ASCs, trained with general surgeons or spine surgeons to implant pain pumps and opened their own pain management clinics. Predominately physician owned and growing. What impact could this have on product and study design? These were relatively new surgeons. Product design and training needed to focus on simplicity, ease of use, and crucially, human factors. The same assumptions about a trained spine surgeon using this device vs. a trained anesthesiologist would not hold.How about study implementation? How many ASCs do you think have research nurses? Or reimbursement departments which understand clinical trial device and procedure reimbursement? It had profound implications for how, where and the support services we build around our trials. In fact, making a few assumptions and some calculations, I projected that the majority of US pump implantations were occurring in ASCs. Regulatory might initially say that since 40% of implants are done in hospitals, that hospital sites only should be recruited for clinical trials however, look at the growth charts in ASC procedures. That wouldn’t make long-term sense for the company. These are all important data to discuss and share at CONCEPT review.
MAUREEN:And, of course, back to patients. Which age groups are involved? Do they have other comorbities that will need to be considered? Does the font of your IFU need to be in large type? Spanish? What activities do they like?At one company helping to brainstorm recruiting clinical trial patients, we had a few Harley riders want the procedure. They wanted to get off Coumadin (to be clear, this was not an indication or claim then nor is it now). They told their friends who told their friends. This became a point of discussion with regulatory about this claim because this was a young, highly motivated group because of the higher probability than population of falling and having an intracranial hemorrhage.Heartport was a minimally invasive heart surgery company to stop heart and perform cardiac surgery minimally invasively via small incisions. I came onboard just in front of launching their products. The largest open heart market was CABG. Mitral Valve surgery was 1/3 of the CABG market in the US. But, if you drill deeper in the patient characteristics, CABG patients were typically over 65, had prior surgeries or comorbidities, and the procedure was more difficult for surgeons. They also cared less about cosmesis. On the other hand, mitral valve patients were generally younger and female. They cared about cosmesis. So, a much higher market share could be obtained in mitrals. In retrospect, regulatory trials, clearances and testing would have been differently focused.
Maureen:It is important to also consider at concept review to know where the patients are geographically. This will help you choose clinical trial sites in the testing phase.
MAUREEN:And, both marketing and regulatory need to understand how they intend to outreach to physicians, patients and all the other influencers at the outset so that, “you have to sign this. we have to get this to the printer this afternoon” is dramatically reduced. One of the most important takeaways from all this for Regulatory is that this allows you to become a consultant to Marketing. If you know what they are trying to achieve and how they intend to achieve it, you can stop saying no (that’s not a great feeling anyway) and start offering suggestions on what CAN be done and HOW it can be done within regulations. I can tell you that this made an enormous difference with me and Elsa as well as other regulatory colleagues I have worked with in the past. When I was able to explain the why, my regulatory colleagues and I could brainstorm solutions together that worked well for our patients, customers, sales people and protected everyone involved.
MAUREEN:A quick poll to close out this section.Regulatory folks on this call, read through these questions and please answer. Remember, all your answers will be kept completely confidential. Joanne, would you please pull up the poll? We will give everyone a few minutes to answer.It looks like everyone is done voting. Joanne, would you please display the results?As you can see, Let’s ask one more question before finishing this section…
MAUREEN:[read question]Regulatory folks on this call, read through these questions and please answer. Joanne, would you please pull up the poll? We will give everyone a few minutes to answer.It looks like everyone is done voting. Joanne, would you please display the results?As you can see, Now back toElsa to walk you through the next two steps of regulatory-marketing symbiosis: product testing and approval, or clearance
ELSA: I guess it’s befitting that I tackle the testing portion of the talk since I was a CQE for many years… TEST WITH THE END IN MIND… doing the right thing will always guide you correctly… yes follow the applicable standards, but again, the process filer is patient centered …so all testing will be with this in mind.
Elsa: Not only do you need to work together with your Marketing colleagues early and often, you should have one overriding plan that guides you through the steps of the product development cycle we just covered. You HAVE to have the discussions that can answer the relevant and meaningful questions that drive your project plans… such as … Can bench or animal data help? How should the studies be conducted to provide the best support for both submissions and marketing needs? How can we best structure our clinical trials to support both approval (meeting endpoints and showing clinical utility) and claims? Can we use any of the bench and animal data to support any claims or product feature information? …How do we reference this testing in our marketing materials?… Can we divide websites for different Markets and use it to our advantage (in a compliant manner)? (advance slide)
ELSA:Here is a quick tip for bridging the gap … use general questions such as these to tease out the common ground…
Elsa: More specifically ask yourself these 4 or similar questions when designing the commercial launch plan. You will always have tradeoffs and it will take time to orient regulatory and marketing to each other. Next time you are in a meeting and there is unresolved conflict, in order to get back to common ground with a high-level values, ask your team these questions. Ideally, even get the team on board by presenting these in advance of conflict so you have an easier entrée when conflict arises to introduce and discuss these. Or, make a version of your own that fits your team, company or situation.[read questions]
ELSA: To close out this section, let’s talk science…Habits can be either very helpful or keep us stuck in a rut. Since we all work in medical devices, let’s make talk about brain science and habits.Habits are generally positive. In fact, habits are believed to be a way to conserve cognitive resources and make decisions more efficiently. For example, driving home from work is a routine, so your brain can think about other things, like what to have for dinner, without ever missing a turn. Why should you care about this and what does it have to do with testing anyway? Bottom line, change takes focus and energy. Real mental focus and energy. Confounding change is that data has shown that stressed animals are more likely to continue bad habits even if they produce a negative result because the stress interferes with their ability to change. Do you ever get stressed at work? We all do. If you want to change, improve yourself, your company and your cross-functional relationships, it is going to take effort and focus to change and discard old, out-of-date, useless habits. Challenge yourself to open your eyes and question what behaviors you have that may be inhibiting symbiosis.With that, let’s jump into Phase III: Approve with the end in mind. (advance slide)[backup notes: http://www.psychologytoday.com/blog/the-science-willpower/201003/why-habits-are-hard-change-and-printers-hard-buyHave to be motivated first then ready to make the difficult decision. Basal ganglia striatum is engaged when learning new things even looking at dots in a different order. Read more: Stressed brains rely on habit - The Scientist - Magazine of the Life Scienceshttp://www.the-scientist.com/blog/display/55873/#ixzz0oQJehP79]
ELSA: Approve with the end in mind and as Maureen and I have done… develop a fast, easy, and flowing signature so that you can get through the approval portion of the promotional review meeting that much quicker. So to recap… we have learned how to Design and Test with the end in mind. Now onto Approval with the end in mind. Of course, in some countries, like the US, it might also be clearance. This is where all the previous work comes together to prove to regulatory authorities around the world that your product deserves claims and indications that you, marketing and others are targeting.Let’s jump in.
ELSA: Before I turn the presentation over to Maureen, I want to leave you with an excerpt from “The Inconvenient Truth about Change Management” from McKinsey… the top quote provides the impetus for having a GPP Plan and a system like PACE which we will introduce shortly… the bottom quote provides the support for having a cross-functional PRC team that is truly vested in that process.Now back to Maureen, NEXT SLIDE…
MAUREEN:Great information from Elsa on Testing and Approving with the Patient in Mind. We move onto the final section before discussing documentation and taking your questions. Launch with the end in mind, focused on the customer and most importantly, the patient.
MAUREEN:It is helpful to filter your promotional content review through a high level set of filters that give their assessment some structure and ensure proper coverage of all potential issues. As Elsa discussed, you have all created testing plans that support the agreed upon claims. And, since Marketing knows which claims are valid and what the testing said, they are in a much better position to tee up materials that meet these requirements. Let’s walk through these quickly:Items #1-3 are pretty straight forward, but there are nuances particular to your company and your products…so having a GPP Plan and policy are very important. Certainly, FDA thinks so…Item #4, the Risk Communication Guidance filter, has particular applicability for content that will be used in the trade show environment. FDA’s Guidance for Industry “Presenting Risk Information in Prescription and Drug and Medical Device Promotion” issue May 2009 is a great reference --- become familiar with this guidance – you may wish to incorporate sections of it into your relevant GPP SOPs or at least reference this document.You may also wish to take a look at the study released this month on the FDA risk information consumer labeling study for pharma. Great information for developing risk vs. benefit statements and disclosures.For items 5, while med device is not held legally to the fair and balanced standard, they may be soon. And, wouldn’t you want, per Elsa’s previous slide, to ensure that your grandmother had all the right information to make the best possible decision. Consider it.Lastly, item 6, transparency. One of my favorites. Simply put, transparency is required because you will be found out an judged in the court of public opinion, which can be brutal.(advance slide)[backup: The guidance covers advertisement and promotional labeling for prescription devices with respect to the disclosure of risk information so that risk and benefit information are presented accurately, comparably in a prominent manner, location, and type and a non-misleading way to the target audience (health professionals and consumers – specific patient populations). Although the guidance does not cover OTC drug promotional labeling… FDA makes it clear in the document they do regulated this separately. Although the guidance is still a draft, the laws upon which it is based are in place. And, many warning letters on promotional materials reference exact statements contained within this guidance. The guidance can also help establish a good foundation for your PRC reviews. We all know that promotional materials cannot be false or misleading and must reveal material facts about the product including risks, but FDA goes through great length in the 24 pages of the Risk Communication Guidance to specifically help industry understand their position. In the guidance FDA emphasize the “Net Impression” or message communicated by the piece conveys as a whole and includes many examples for each of the filters they list for review of promotional labeling. With “Net Impression” FDA is following well-developed social principles used by the Federal Trade Commission to determine whether the piece overall is misleading and to do this is uses “reasonable consumer standard” approach – examining the piece from the “perspective of a consumer (what ever the consumer is – such a a particular health professional or patient population) acting reasonably in the circumstances”. This approach does not preclude multiple interpretations of a claim so long as they are reasonable. FDA will take into account expertise of the lay consumer and the trained healthcare professional. FDA is also very aware for the purposes of “Net Impression” that “cognitive science research has demonstrated that all people, regardless or expertise, are only able to think through and process a limited amount of information at one time. This principle guides some of the filters they discuss in detail throughout the document. We don’t have time to go into a detailed review of the guidance and its many wonderful review filters, but here are just a few of the general considerations:Use of consistent language for target audience – to balance how risk and benefit information is conveyed – for example using friendly language for claims and then the word “syncope” instead of “fainting” for the risks.Use of signals – how text is emphasized should be balanced (e.g. use of headings vs. subheadings, bolding, etc.) -- in this case the content is also important – for example using the heading “Important Risk Information about Device X” is preferable to “important Information about Device X”… yes FDA is delving deep into how they will review your promotional pieces so you have to be as detailed in your reviews.Framing Risk Information – or how a particular piece of information is stated or conveyed by emphasizing positive or negative information in vague versus specific terms that may make the presentation of risk/benefit information unbalanced or minimize the risk. For example referring to your brand name for benefits and the generic name of the drug for your risks…Hierarchy of Risk Information – where it appears on a piece… FDA does not want the risk information buried on the bottom of page 8 brochure … Memory research consistently shows that people are better able to recall the beginning and the end of a list than the middle… however, first in line still has more prominence… also ordering the risks in a way that can mislead falls under this filter – for example stating drowsiness as a side effect after you state that patients should not drink alcohol when taking the drug – patients might associate the drowsiness with the alcohol use (adjunctively) rather than just a side effect of the drug itself regardless.The guidance goes on to cover content considerations, format considerations (which include print promotion as well as non-print promotion such as videos, broadcast ads, and similar audio and visual pieces). FDA even discussed the use of text that is superimposed on other images in video or broadcast ads termed (SUPERs)… and gives a whole host of considerations for how SUPERS may be best used to convey the proper “Net Impression”. Finally FDA concludes with the statutory requirements of the Law and makes it clear that although FDA does not review 510 (k) promotional pieces as they do for PMA products, that these must also comply with the law and recommendations in the guidances will be applied to their review.Next slide.
MAUREEN:This slide is busy and hard to read, but the results are quite fascinating… Now, these are also pharma cases and they are retrospective, but there is a lot we can learn from them now that FDA and DOJ are turning their collective attention to medical device companies. It is imperative that both regulatory and marketing understand and partner to prevent these sorts of activities. Here is the short version:•In a published Harvard review of off-label pharma whistleblower complaints over the last 10 years, there were 41 complaints arising from 18 unique cases and 55 whistleblowers, leading to US$7.9 billion in recoveries. •At the time of the alleged fraud, the whistleblowers worked as pharmaceutical sales representatives (39/55, 71%), sales or accounting managers (11/55, 20%), and unaffiliated physicians (5/55, 9%).35 (85%) have employed off-label marketing strategies by expanding the use to a different disease state (in 49% of those cases the disease has had similar symptoms, but it is not the same disease)22/41 (or 54%) have expanded the use to a variation of the approved indication… and 34% expanded to a variation of the approved dosing schedule…Then the table goes into actual off-label marketing practices…including 90% of off-label practices arising internally and permeating to sales. So you need as we discussed earlier to work together on cohesive commercialization plan. I strongly recommend you read the article because I guarantee this is where the FDA DOJ and their fine government friends are going hunting in medical devices.(advance slide)[backup: With Financial incentives getting top billing at 85% despite all of the media and government focus in this area, followed by “distorted presentation of supporting evidence” at 76% -- CME and influence on peer-review literature and ghost writing also remain high. Internally the off-label practices are even higher at 90%, but vary by the type of practice. So internally we are preaching off-label to our sales and marketing staffs.We are also dangerously still involved with the payer-related side… helping our prescribers with reimbursement and in 72% of those cases we are showing them how to circumvent billing restrictions and in an outstanding 61% there is falsification of billing codes…Last but not least we are still employing direct to consumer off-label practices through physicians or pharmacies and even through funding of consumer organizations.]Here is the link: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000431
MAUREEN:So now I get to give you my secondTip (Tip #2)… Get a Cross-Functional PRC that meets regularly. At our last RAPS webinar a year ago, this is what we heard. About 50% of the respondents have this type of PRC, 30% do not and 20% are working on it. We don’t have time to get into a detailed discussion of a PRC or the PACE program, but we have full presentations on these topics available for viewing on the good promotional practices resources page. A cross-functional, regularly convened PRC is a must in this litigious environment. Plus, it is yet another chance to assemble your marketing and regulatory colleagues and sit in a room getting to know each other as real, relatable people. Who knows, you might even improve the materials and protect your company along the way—not a bad expenditure of time.
MAUREEN:Similarly to GMPs we believe that for GPPs, a systematic, regular, and continuous review program with feedback assessment is critical to creating a GPP PLAN that not only keeps you compliant and out of some of the troubles we reviewed earlier, but that is also efficient, effective and timely in providing your internal and external customers with the promotional materials that will convey your relevant and intended communications. So to this end, let me briefly introduce PACE. PACE is a straightforward four-step process for collaborative review and dissemination of tangible and digital content. Prepare, Analyze, Categorize, Execute. After brainstorming over a year ago, Elsa came up with this great acronym—all that trial naming came in very handy! Think of PACE as a vaccine protecting your company against risk. PACE is simple and provides transparency and consistency. Additionally, it provides the opportunity to bring key stakeholders, including regulatory, legal, and marketing, together to collaborate. Lastly, these systematic development and approval processes are the building blocks for a Communication or Content History Record or CHR, which will help you and your company in a worse-case scenario.… We’ve used PACE in a variety of very complicated regulatory situation and it works. Again, we don’t have time to go into detail regarding PACE, but the system goes hand-in-hand with the PRC and primary filters we just discussed. So, you can check out the resources page on goodpromotionalpractices.com for previous webinars.(advance slide)
MAUREEN:As an example of how regulatory and marketing can collaborate, let’s try a tradeshow. A minimum of six months prior to their tradeshowappearance, the Tradeshow Plan review is listed on the PRC’s agenda for their weekly meeting. The Marketing Manager would submit a formal plan for their appearance that outlines the objectives for the show, as well as all activities and content that they will bring to bear to meet their goals. It’s important that the PRC sees a plan of this nature so that they can take a holistic view point that will allow them to manage their overall “net impression” as per the FDA’s risk guidance as well as identify all the granular level detail items that need to be reviewed.For one reason why this is important, lookup Shire’s untitled letter from November 2009. It outlines the issues that DDMAC (Division of Drug Marketing and Communications)had with the net impression of a brochure holder, waiting room brochure and parent’s guide.We will now take you through a few ideas to implement in your concept to commercialization, symbiotic system.
MAUREEN:Here is an example of a great regulatory-marketing construct for a launch video perhaps to be used at that tradeshow. Work together in advance to develop key constructs that apply the structure regulatory craves with the flexibility marketing likes—a table to fill in with predetermined headings. It is especially important that the PRC visit the plans for video and other rich media at the Concept phase. With production costs measured in the tens of thousands, mistakes or risks that perpetuate later in the development cycle can become prohibitively expensive.(advance slide)
MAUREEN:As the concept to commercialization route continues for promotional materials, we can see an example of what can happen when marketing starts and finishes a brochure without consulting regulatory or having a process like a PRC in place to require concept, design freeze and final approval of materials.Three quick issues here. And, I am sure you could find more.First, what is the source of that statement the headline: “Drizzle is preferred for AV thrombolysis by 80% of physicians.”? Is it an internal or independent third-party study or survey? Did the survey include a statistically significant number of patients? What is the appropriate citation to this survey, and where on the brochure should it be included? The answers to these questions underlie the larger question of whether this statement is appropriately substantiated.Second, what types of physicians were surveyed? Are they in specialties that actually treats AV thrombolysis and that use the Drizzle in accordance with its approved label? The answers to these questions underlie the larger question of whether the statement could be appropriately viewed as on-label.Our next concern is the mention of Teflon, here in the body copy. The question here is not necessarily one about promotion. Rather, the question is, has they obtained the appropriate license to use the Teflon trademark and given appropriate attribution? This question demonstrates the need to have a highly coordinated, cross-functional PRC in order to have the requisite subject matter expertise to identify and address legal and regulatory issues of all stripes.The third point are the pictures at the bottom. For example:Where in the vasculature are the photos taken (does this need to be called out)?Is the implied target anatomy in these photos covered in Drizzle’s cleared indication?The citation below the photos (Courtesy of Dr. Jones, St. Joes, Ocean Grove) implies these photos are from clinical use of the product, so why is there a histology photo included in the set?The two photos showing the before and after of the vessel after thrombolysis appear to be shown in different views/planes, is this correct or can this be misleading? Was the same imaging modality used in the before and after photos? Do we need to put more detailed regarding what was infused, infusion parameters, etc.? Do these photos represent the best result or a reasonable, mean result?You get the idea.(advance slide)
MAUREEN:Now that we’ve covered a couple promotional pieces, we move onto the execution phase.The PRC should open room on their agenda if any issues or unexpected risks are encountered at a tradeshow … a timely review will allow for a proper response, and also raise awareness so that the same issue is not repeated in the future. A trade show plan included proper training for all booth staff, and it included instructions on what promotional content could be shared, with whom. The PRC should also ensure that SOPs pertaining to distribution of promotional content are in place and that proper training is conducted for activities beyond trade shows, including physician interactions, especially if new, unapproved or uncleared or investigational products or drugs are shown or discussed. Ideally, the PRC takes it a step further and ensures that compliance is proactively built into sales work flows. Proper content library and delivery solutions can help here. Many companies are also finding that transitioning from print to digital can make it easier to comply with applicable rules.Going digital can also help create communications history records that give the PRC visibility into how content is being used, and make them aware of current compliance patterns and potential new risks.
MAUREEN: Tip #3… when balancing the needs with the wants and thus resorting to dissemination of off-label information, please follow the Good Reprints Guidance. This slide shows that most of the companies that participate in our other webinars on Good Promotional Practices are using this guidance. Now back to Elsa to close us out on SOPs and documentation.
ELSA: Avoid hearsay … memories are conveniently short lived (Next Slide)…
ELSA: As FDA and Legal would expect, PUT IT IN WRITING … if you’ve got a good plan it will be one that both Marketing and Regulatory can live with and will not have major issues signing… and yes this can be done efficiently if …as we have discussed before… we collaborate early and often… So Marketing folks take your regulatory colleagues out to lunch with your lavish budgets and get the process started…(advance slide)
ELSA: GPP. GPP stands for Good Promotional Practices – the best practices for medical device, diagnostic, pharmaceutical and biotech companies to promote and provide information to their customers and patients about their products and the procedures and disease states that surround them. We have all heard the quote, “those who cannot remember the past are condemned to repeat it.” Well, we learned decades ago with GMPs that inspecting out quality at the end of a manufacturing process is less effective than building quality into the process. However, we are currently facing numerous quality control issues with promotional and non-promotional materials, and the DOJ, FDA, SEC and other regulatory bodies are currently using their enforcement efforts to inspect it out. We already know the solution -- we need to build quality into, as part and parcel of, our promotional processes.We already know how important design controls are to apply solid principles of design to medical devices, GMP is to quality output as human factors are to proper and safe usage. Now we need to apply these principles and understanding to the creation and dissemination of promotional and other customer-facing content to protect your company, your sales people and, most critically, to protect physicians and patients.
ELSA: Step one. The first step in GPP for Promotional Content Review is to apply some of the best principles of design controls to systematic content creation. What you see on the left side of the slide are basic tenets of design control – no mystery to anyone in this webinar. And, on the right side are the analogous best practices for systematic content creation. First, start with the end in mind. A project brief. At a minimum, it should include what you are trying to accomplish, for whom, and within what parameters such as time and budget you are trying to accomplish them.Secondly, the content creation cycle starts when the project brief is completed – at the concept stage – not when, as I am sure many of you have encountered, when Marketing has a brochure designed and wants your approval to print it tomorrow.(http://www.slideshare.net/truedigital/how-to-write-a-creative-brief-by-true-digital)Staged project reviews by a cross-functional team are also best practices for content creation. And, a risk analysis equivalent to risk analysis in design controls is crucial to uncover potential issues ahead of time, e.g. what if this material is combined with this other material, such as a disease awareness brochure with a procedural video? What if this collateral was given to a specialty for which there is no indication? You may want to consider different elements of externally-facing risk, such as reputational, human risk and financial risk. Preventative measures are of course part of your risk analysis and correlate to assessed level of reasonable risk.
ELSA:Step 2. Step 2 in GPP for Promotional Content Review is to marry the best of GMP to Systematic Content Control. Procedures for Content control might include…Internal and field procedures – you may think they should be the same but the working environment of a sales rep, for example, is quite different than employees who work in house so while they may be part of the same SOP, the manifestation should be quite different.Akin to a DHR, a content or communications history record captures the life cycle of the content from project brief to customer delivery.There is traceability and change control mechanisms for updating or obsoleting content globally.The training of global field sales personnel requires a different approach than training production workers. More on that in a minute.And, while CAPA is the gold standard, RAMP, or Risk Analysis and Mitigation Plan, is an extension of standard risk analysis with periodic polling and surveying similar to SEC disclosure checklists to uncover areas of potential concern and focus. It is worth taking a few minutes and reading Appendix C of Pfizer’s CIA which talks about their RAMP system. And, while they use it more as an overarching tool for safety/product liability, healthcare law,Compliance as well as advertising and promotion issues including the risk of off-label promotion, it has useful considerations for crafting your promotional RA and mitigation plan.Next slide please.
ELSA:Step three is the consideration of Human Factors to Promotional Content Review. The FDA defines human factors:Easier and safer. Translated to our topic, What can we do to make it easier and safer for sales and marketing to do the right thing?Then they talk about clinical and home settings. Well, what have we done to consider the daily lives of sales and marketing and their environments?Then, “the identification and investigation of use-related errors”. Use-related errors. What if we assumed that sales and marketing were in fact, use-related errors. If we assume that sales and marketing wants to do the right thing, then how would we change our approach to content review, approval, training and dissemination?(advance slide)FDA’s definition of human factorshttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/HumanFactors/default.htm
ELSA: Finally,Tip #4. A frequently discussed topic on our GPP Blog, as well as many other sites and meetings, is how we tackle social media. From a regulatory perspective, this compliance monster is hard to corral, but you start by having a policy and plan to set expectations, rules, and consequences and then SOPs to help execute and maintain decorum. And, both Regulatory and Marketing has to be involved in the creation of this SOP. During one of our other webinars, only a small percentage of the companies participating had actually drafted policies that cover Social Media communications. Granted, this was a year ago…and things may be very different now at the rate social media is growing …with exponentially expanding number of sites and apps. I read earlier this week that Medtronic just unveiled a “mobile application” that enables doctors to monitor patients with implantable heart devices through the firm's CareLink Network and access patient data directly from their iPhones and other Apple products. The company is considering expanding the use of the application to Blackberry and other mobile platforms. The world is moving forward quickly, your company needs a social media SOP, everyone is using it (really) and you need to give people guidelines.In fact, it is a great way to open the door to discussion and learn more about the challenges both departments face in this ever-faster moving space. Plus, it is a great opportunity for you to learn. (advanceslide)
RAPS:Thank you Elsa and Maureen.Now, we move into our Q&A section. We strongly encourage you to ask questions during this section and take advantage of our great speakers experience. To ask a question, [RAPS to explain]Elsa and Maureen:Elsa: Thank you RAPS. Maureen and I will now answer questions. [With 5 minutes to go, RAPS will end question period.]RAPS: Thank you Elsa, Maureen and all the participants on the call for your time today. Last slide please.