THE FORUM The industry has responded by drafting its own rules of conduct. In July, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a revised version of its 2002 Code on Interactions with Healthcare Professionals, a set of voluntary guidelines designed to ensure the focus of interactions between company representatives and healthcare professionals focus on information about pharma products, providing scientific and educational information, and supporting medical research and education. PhRMA has described the new Code, which takes effect at the beginning of 2009, as reflecting the industry’s continued commitment to pursue policies and practices that comply with the highest ethical standards and best serve the needs of patients and the healthcare community. In PhRMA’s statement announcing the revised Code, PhRMA Chairman Richard Clark, chairman and CEO of Merck, noted that the organization is continually examining ways in which it can enhance the essential interactions between companies and physicians and reinforce the integrity of information about the medicines they sell. “Doctors rely on accurate and appropriate information about new medicines to provide the best possible care to their patients,” said David Norton, company group chairman of Johnson & Johnson’s pharmaceuticals group, in the organization’s July statement. “The changes to the Code demonstrate that the members of PhRMA are committed to continue enhancing how our industry serves physicians and patients.” Mr. Norton chairs the PhRMA Affordability & Access Committee that spearheaded the Code changes. The revised Code is advising pharma and biotech companies to: . Prohibit distribution of noneducational items (i.e., pens, mugs, and other branded “reminder” objects) to health care providers and their staff. Companies may still offer items designed for the education of patients or health care providers if they are not of substantial value. Some such examples include teaching models of organs or arteries, adherence materials, or patient assistance information. . Prohibit company sales representatives from taking healthcare professionals out for a restaurant meal, a practice commonly referred to as “dine and dash.” The provision does note, however, that reps can provide occasional informal meals in healthcare professionals’ offices in conjunction with educational presentations. . Ensure that reps are sufficiently trained about applicable laws, regulations, and industry codes of practice that govern interactions with healthcare professionals. Companies are also asked to assess their reps periodically and to take appropriate action if they fail to comply with relevant standards of conduct. . Have company compliance officers certify annually that they have processes in place to comply with the Code. Companies also are encouraged to get periodic external verification of their compliance processes. The Code also includes more detailed standards regarding the independence of continuing medical education (CME); principles on the responsible use of patient identity Carolyn Gretton Marketing Inside the Lines As traditional pharmaceutical marketing methods experience increased government scrutiny and tightened guidelines, THE INDUSTRY IS STRIVING TO BALANCE COMPLIANCE WITH CREATIVITY IN DELIVERING INFORMATION TO HEALTHCARE PROFESSIONALS. Marketing of pharmaceuticals continues to be a hot button issue for many in the public sector. Some state and federal lawmakers are seeking to enact legislation restricting certain pharma marketing practices, with Gov. Deval Patrick of Massachusetts recently signing one such bill into law. THE FORUM Identified prescriber data; and additional guidance for speaking and consulting arrangements with healthcare professionals, including disclosure requirements for healthcare providers who are members of committees that set formularies or develop clinical practice guidelines, and those who also serve as speakers or consultants for a pharmaceutical company. According to a list PhRMA has made available on a page on its Website (phrma.org/code_on_interactions_with_health care_professionals), almost every major U.S. pharma company has pledged to follow the Code. Many of these companies also have posted to their corporate Websites separate announcements of their specific plans for meeting the Code guidelines by the January deadline. For example, Merck says it is establishing a cap on the total annual compensation that can be paid to individuals for speaking on behalf of the company, and AstraZeneca and Eli Lilly both affirmed their intention to eliminate distribution of branded items such as pads, pens, and clocks that serve no educational purpose. (For excerpts from selected company statements on the new PhRMA Code, turn to page 11.) But even before PhRMA unveiled its tighter rules, many pharma marketing executives say companies already had begun adjusting their marketing efforts in response to the intensified scrutiny by regulators and policymakers, and that this has benefited some of the smaller and midsized players in the industry. “I would say the PhRMACode has definitely changed the way that we are now promoting,” says Amy Romero, acting VP, marketing, at Adolor, a specialty pharma company focused on pain management. “But I also believe in some ways it has helped to create a more even playing field between some of the larger and smaller pharmaceutical companies. Some of the restrictions on things like premium items have really allowed marketers at small pharma companies to not feel that they have to spend quite as much to compete within the same space as larger, more profitable pharma companies.” Ken Ribotsky of CoreCreate concurs, stating that while these “branding” items had a purpose, they had became a crutch that marketers were too quick to lean on. Now the “guidelines” may actually be leveling the playing field a bit. No longer will companies be able to simply blanket a doctor’s office with stuff, and marketers will now have to rely on cre ating memorable brands. (For more information, please turn to page 22.) Dave Mihalik, director, portfolio marketing strategy, at EKR Therapeutics, a specialty company focused on acutecare products for the hospital setting, says the new PhRMA Code is continuing to steer the industry away from volume driven marketing plans. Al Topin of Topin & Associates, says the whole purpose of developing a communications strategy is to help marketers make the decisions they need to accomplish their objectives. A simple and focused strategy forces brand teams to prioritize resources, activities, and budgets from the start. By keeping the strategy simple, decisions can become almost obvious when one asks: “Does this support the strategy or not?” (For more information, please turn to page 42.) “I think the scrutiny has highlighted some areas where some marketers were pushing the limits in the way in which they were trying to get their messages across to customers,” Mr. Mihalik observes. “It became clear that some marketing plans that may have been a bit aggressive going largely after prescription volume increases had to be evaluated. Marketing plans need to be built around the efficient, medically appro Marketing plans need to be developed around the efficient communication to physicians about the benefits of the product to a specific patient population. Dave Mihalik EKR Therapeutics THOUGHT LEADERS PAUL DIMATTIA. Executive Director, Commercial Operations, AstraZeneca, Wilmington, Del.; AstraZeneca is an international healthcare business engaged in research, development, manufacturing, and marketing of prescription pharmaceuticals and a supplier for healthcare services. For more information, visit astrazeneca.com. DAVE MIHALIK. Director, Portfolio Marketing Strategy, EKR Therapeutics, Bedminster, N.J.; EKR Therapeutics is a specialty pharmaceutical company focused on identifying, fostering, and targeting the growth of acutecare hospital products to improve patient outcomes and quality of life. For more information, visit ekrtx.com. AMY ROMERO. Acting VP, Marketing, Adolor Corp., Exton, Pa.; Adolor is a biopharmaceutical company dedicated to the discovery, development, and commercialization of novel prescription pain management products. For more information, visit adolor.com. ROBERT RESTUCCIA. Executive Director, Prescription Project, Boston; Prescription Project promotes evidence based prescribing and works to eliminate conflicts of interest in medicine caused by pharmaceutical marketing to physicians by working with academic medical centers, professional medical societies, public and private payers, and state and federal policymakers. For more information, visit prescriptionproject.org. THE FORUM Appropriate communications to physicians about the benefits of the product to a specific patient population.” Experts at IMS say in addition to specific messages, by segmenting physicians by their prescribing levels for the dynamic market can provide insight on the ideal call frequency for each physician (and hence the required size of Insights From the Insiders PHARMAVOICE ASKED EXPERTS IN THE MARKETING ARENA IF THEY BELIEVE THE RECENTLY ANNOUNCED CHANGES TO THE PHRMA CODE WILL HAVE A SIGNIFICANT IMPACT ON FUTURE MARKETING PLANS. PermissionBased Content The new PhRMA guidelines will assuredly have both short and longterm impact on the way our clients and their strategic communications partners will approach marketing strategies. Quite frankly, clearly articulated guidelines are always better than nebulous gray areas that can foster huge inequities in how large vs. small, or aggressive vs. conservative a stance marketers take in their categories. These new guidelines may feel shockingly restrictive, but after 30 years on the agency side of pharmaceutical marketing, they are only the next episode in the ongoing effort to consistently ratchet down marketers’ ability to freely communicate and suspend certain first amendment rights. Starting in the late 1980s, a series of increasingly punitive codes, from federal or state regulators or from industry selfpolicing, have not stopped us from developing new and innovative ways to deliver important and relevant educational programs or creative branding and awareness initiatives — within the guidelines imposed. We rise to the occasion and solve problems. That’s what marketers do. But eliminating pens, pads, and mugs is a downright silly way to prevent undue influence on prescribing and probably will have more impact on the small businesses that manufacture these items than on delivering quality healthcare. David Chapman Managing Partner CommonHealth For more information, please turn to page 24. Technology Invigoration In response to this challenge we can invigorate the brand by using technologies that engage the physician. One approach would be the development of healthcare portals for the healthcare professional to access password protected content, including mechanisms of action, disease state information, share best practices, as well as participate in content–rich Webcasts with colleagues and associates. Our clients are beginning to establish task forces to review these new guidelines and develop action plans for their companies. We imagine that we will reduced influence on patients, and prescribing decisions heavily affected by the influence of payers. The pharma industry can now focus on offering communication programs that are truly patientcentric and provide unbiased health education, sophisticated adherence support, and tools that will facilitate better dialogues between patients and their doctors. The industry also can support grants and government initiatives that advance the technology and efficiency of practices so that overburdened PCPs have the right tools and unbiased information in front of them and can provide better, more personalized care for their patients. These code changes have the potential to be much more than simply a goodwill campaign; by building new partnerships and rebuilding old ones, it bears the promise of setting new standards for healthcare decision making. Gene Guselli Cofounder, President, CEO InfoMedics Inc. For more information, please turn to page 34. New Service Models In fact, pharma companies, with the implementation of the new service models, have already begun to make many of the changes the new PhRMA guidelines define . Physicians themselves have begun demanding more valuable and medically relevant ser vices and support from pharma — and companies have been responding. For example, recent TNS Healthcare research shows that twothirds of American physicians now consider physicianeducation ser vices highly important in shaping their relationship with pharma — and an equal number put high value on patient education, management, and support pro grams. Doctors clearly see pharma acting to meet these increasingly important service needs. In fact, 80% of U.S. doctors say they have seen an increase in patient education and support services from pharma and 66% have seen increased support around physician education. While the PhRMA guidelines certainly put some important official parameters in place, the interactions between reps and physicians have already been evolving. With the new service model, reps have to transition their role from being just deliverers of sales messages to coordinators of value. The goal of the ultimate model will be for pharma companies and physicians to partner assist our clients to implement these standards within our daily practice as well. Liz Kay VP, Account Services, Healthcare Practice Cramer For more information, please turn to page 32. Educational in Focus There is no question that the establishment of new PhRMA guidelines has accelerated the shift from purely promotional DTC advertising to a more educational focus, which offers patients and providers real “brand value” in the form of effective and supportive patient education. The PhRMA guidelines have pushed pharma marketers to look closely at and assess what their consumers, patients, really need. And a large part of that answer is clear and understandable educational pro grams that help patients to make important decisions about their health — from recognizing their symptoms to talking with their healthcare providers to helping them understand and stick to their treatment plans. Marketers who include strategic patient education as a core element of their brand plan are more likely to maximize lifetime patient value, increasing both acquisition and adherence. Increasing the likelihood that patients will start and then adhere to treatment is a shift that benefits all key stakeholders — patients, healthcare providers, and ultimately the brands them selves. Jill Balderson Senior VP, HealthEd Strategic Marketing/Business Development HealthEd For more information, please turn to page 36. Rebuilding the Relationship The PhRMA code changes are both positive and not unexpected. The time has indeed come to begin to rebuild the critical relationships between the pharmaceutical industry, physicians, and patients. Future marketing plans can take the industry in interesting, new directions — away from the traditional and increasingly murky, sales rep driven promotions toward ones that provide meaningful support to physicians who are clearly struggling under the burdens of paperwork, compressed time and the salesforce) with great precision. In one analysis on an established brand in a chronic care market, IMS learned that prescribing volume peaked in segments with a low volume of prescriptions for the dynamic market following just two or three sales calls. In contrast, physicians who were high prescribers to the dynamic market continued to respond to in achieving their shared objective of providing optimal treatment and support for patients. Wes Michael Executive VP TNS Healthcare For more information, please turn to page 30. Educational in Focus The recent changes in the PhRMA code may generate much noise and reaction in the industry, but in the long run, they really will not have that much impact on our clients’ communications with their customers. The intent of the communications materials we develop is to provide branding and education on efficacy, safety, and appropriate patient selection. Clients look to us for materials to provide to physicians for their patients to further enhance their understanding of a specific medical condition and how a product might help them manage their condition — in other words, to help provide the best possible care to patients, which comes from the code. Though pens, pads and mugs have never been crucial to an effective marketing plan, they have served the purpose of keeping the brand name top of mind. Patient and physician educational materials will simply have to work harder in the future to accomplish this goal. Tanja Noren Account Group Supervisor Topin &Associates For more information, please turn to page 42. Permission Based Content Brilliant news:The mouse pad is dead — long live more meaningful messages that will resonate with our customers. The ubiquitous assortment of tchotchkes emblazoned with the drug’s PI, and in some cases black box information, has long been the “goto” solution for many marketers. Now, we have an opportunity to create permissions based content — permissions of our audience to communicate to them by engaging them with relevant information. Thank you PhRMA, now we can stop flooding the channels with meaningless gibberish and stick to the principle of the code — that a healthcare professional’s care of patients should be based, and should be perceived as being based, solely on each patient’s medical needs. I’m sure an added bonus will be an increased ROI and less waste in the world. Ross Thomson Executive VP, Chief Ideation Officer Vox Medica Inc. For more information, please turn to page 16. Multimedia, One Way Forward Going forward, we will continue to employ the latest interactive video technologies. The way people interact with video on Web pages, mobile devices, and social networks is evolving. Video was once a passive medium. Now, however, people interact with video on the platform of their choice. The iPhone and other smart phones show how far we’ve come with mobile streaming video. New rich Internet applications (RIAs) will enable marketers to create higher quality video and multimedia applications. Marketers will deliver efficient, effective, accurate ROI metrics in real time. Best of all, RIAs will free marketers from the constraints of Web browsers. We’ll see more engaging Micro applications and widgets, all of which will be platform agnostic. The phenomenal growth of Websites such as YouTube demonstrate the keen interest in video among consumers. Video isn’t just watched — it’s shared. Video can anchor a social network, as we’ve seen on several YouTube channels; it is becoming a centerpiece of community. On the professional side, there’s a lot of video, including interactive video, being used to talk to physicians. So we’re staying active with video and RIA technologies to deliver brand messages to target ed audiences. MarcWeiner Managing Partner CommonHealth For more information, please turn to page 25. Direct to Patient Internet Contact With the guidelines limiting depth of contact with physicians nearing implementation, I believe we will start to see a turn toward more direct to patient contact, specifically on the Internet. don’t think that there will be a surge in broad scale media buys for consumer media. I believe there will be more targeted use of the Internet, and marketers who have been afraid to jump into this world will now be forced to do so. We will see more of a focus on prescription retention because acquisition will become more difficult. So to this end there may be more of a focus on consumer (patient) loyalty. Ken Ribotsky President CoreCreate Inc. For more information, please turn to page 22. Measuring Impact We believe that solutions based programs that measure impact and can be easily and quickly implemented are key. Today, clients have to be convinced of the impact we, as service providers, can have on their business. In particular, because the introduction of new and novel compounds has slowed significantly, we are developing solutions to help our clients address the challenges of mature brands — specifically to revitalize these trusted workhorse brands so they can more positively impact our clients’ bottom line. To do this, we always turn to the customer to gain a deeper understanding of how they think and how they define value. Business as usual is not an option in today’s economic environment. Maureen Mangiavas Senior Director, Business Development Red Car Pharma Solutions For more information, please turn to page 18. Technology Investments The new developments require that pharma companies and their partners invest in technologies that are able to collect, aggregate, and reflect a great deal of information against a plethora of guide line factors at the federal, state, local, and client levels. The systems also have to be highly flexible to adapt to the ever changing guideline landscape. While some pharma organizations have chosen to build these inhouse, they often find that the cost and burden are tremendous, and do not really want to use their limited resources to become a software development and maintenance organization. Further, they are unable to leverage the investments and costs across a large enough universe to stay ahead of — or even on — the curve. That’s why so many organizations today are choosing to go outside, to groups that have the technology and know how to hit the ground running, stay within guidelines, and provide an ideal partnership in which everyone wins. Laura Marsh Lynner Executive VP, Managing Director Scientific Voice For more information, please turn to page 26. THE FORUM promotion even after 30 calls. (For more information, please turn to page 20.) All of these different market factors are expected to redefine the marketing models at most pharmaceutical companies. Thought leaders at CommonHealth’s ProCom and Solara business units believe that it is critical for pharmaceutical manufacturers to adapt to the changing market to ensure future success. They propose that a new localized and customercentric marketing model must be used and it must include more than just the current practice of marketing multiple brands through separate pathways to the same audiences. The model must address the evolving practice management, care delivery, patient management, and cost containment issues while ensuring these solutions align to both the pharmaceutical brand and corporate priorities. (For more information, please turn to page 25.) Scrutiny on marketing practices is not the only challenge companies must manage, they also have to address concerns from payers. As such, experts at AmerisourceBergen Specialty Group (ABSG) suggest that companies develop a market value plan, which is a strategic and tactical platform upon which a product’s value proposition is built, validated, and delivered to decision makers. ABSG suggests that a seamlessly executed market value plan enhances patient access to healthcare technology and can have multimillion dollar implications. (For more information, please turn to page 38.) ONE SMALL STEP While response to the PhRMA Code changes has been generally favorable, some organizations say the guidelines don’t go far enough. Jim Dutton, president of the CMR Institute, a nonprofit organization that educates and certifies pharmaceutical sales representatives, says the revised Code is a step toward enhancing the value of the physicianrep interaction. In addition, however, he believes the next step is to adopt uniform national certification standards for sales reps to demonstrate the industry’s commitment to educating health care professionals to benefit patients. “Unbranded education that includes therapeutic knowledge, disease management, pharmacology, and patient quality of life issues will help representatives be a more valuable resource to physicians who need to have the most current and accurate information about medicine and advances in healthcare,” Mr. Dutton says. Prescription Project, a nonprofit group that promotes evidence based prescribing and seeks to eliminate conflicts of interest in medicine caused by pharmaceutical marketing to physicians, also describes the new guidelines as “a step in the right direction,” but notes that in the past, PhRMA’s codes have not been adequately enforced. “Promotional spending by the industry has increased, rather than declined, since the updated 2002 PhRMA code,” Robert Restuccia, executive director, said in a prepared statement. He referred to data from Vermont — one of the few states requiring disclosure of marketing payments — that show in 2006, 676 payments were made for food valued at more than $100, despite the 2002 Code’s stipulation that meals provided to healthcare professionals should be modest by local standards. “A voluntary code does not take the place of legislation,” Mr. Restuccia observed. Many in the pharma industry disagree. Ms. Romero says in her experience, most companies tend to support efforts at selfregulation. “Quite frankly, believe that there’s some fear of what will happen if companies do not voluntarily comply,” she says. “In fact, it’s the pharma companies themselves who sometimes report violations of marketing and promotional regulations to the U.S. Food and Drug Administration. “I think the knowledge that other companies are watching for questionable promotional practices coupled with a concern of gaining a reputation for being an organization that is considered too aggressive compared with other companies, will also also encourage compliance with the guidelines,” Ms. Romero continues. “There is a bit of peer pressure, and I think those outliers are definitely subject to promotional scrutiny, including salesforces, observing some of those behaviors and reporting that information back, because companies want a professional and fair playing field.” Others in the industry, though, believe some concerns do remain. Amy Romero Adolor I think commercial groups will continue to do some realignment, some reassessing of the use of the field time in specific areas, and turn to spending some of those dollars on other nonsalesrep activities, or nonpersonal promotional activities. THE FORUM “It’s a tightrope,” Mr. Mihalik observes. “Voluntary industry policing certainly has weaknesses in how some of these com panies intrepretand therefore adhere to the Code.The first time the PhRMA guidelines were rolled out in 2002, they were a good idea, but I can’t say if industry did a good enough job in the execution of the guidelines in practice.” Nevertheless, Mr. Mihalik does view the changing marketing environment as a great opportunity for smaller companies to separate themselves from the crowd. Large pharma companies will be busy shifting marketing tactics and trying to reposition themselves to be compliant with the new Code, leaving com panies such as EKR to write their own marketing history. The challenge most big pharma companies face, unlike their specialty peers, is that they have more older products that they may need to revitalize in light of the lack of new blockbusters on the horizon.Tasked with having to infuse new life into older brands, Maureen Mangiavas of Red Car Pharma Solutions, a division of The Hal Lewis Group, believes that companies should adopt a “recontextualization” approach. Recontextualization is finding ways to obtain new data from relevant stakeholder cohorts that illuminates their realworld clinical atmosphere and then create intersections between that context and the brand to imbue the brand with a renewed relevance. (For more information, please turn to page 18.) Most would agree that the days of legendary blockbuster launches and their massive budgets are fewer and farther between. George Glatcz of Vox Medica goes so far as to say the party is pretty much over. As trends indicate, the industry is shifting from a blockbuster model of primary care, single indication brands to a broad and multifaceted array of brands that defy conventional categorization. And for more mar keters to survive, their approach has to be radically different. In the past, there was a tendency to invest in huge media buys and enormous sales teams to overcome mediocre branding. But with the market changing so quickly and the world becoming more connected, a new vision is required. (For more information, please turn to page 16.) TURNINGTOTHEWEB Technology is becoming an increasingly critical element of pharma marketing, as companies reduce the size of their salesforces and physicians become increasingly difficult to see. One way in which companies are responding to these challenges is by broadening their use of electronic tactics, such as edetailing. A report released earlier this year by TGaS Advisors states that pharma continued to spend 34 cents of every online marketing dollar on edetailing in 2007. In a case study analysis that explores integrating tradition al media with interactive tactics, thought leaders at Communications Media Inc. outline the opportunities, challenges, solutions, and benefits for pharma companies that can successfully meld the expertise of different agencies to achieve the optimal goal of reaching healthcare professionals. (For more information, please turn to page 28.) Another technology growing in popularity is esampling, with some pharma companies building this convenient tool into a larger marketing effort. One example is the digital Webkey campaign that AstraZeneca recently launched for its migraine medicine Zomig, which employs a novel device to deliver information and esampling channels to physicians. (For more details on the Zomig campaign, please turn to page 12.) The PhRMA Code’s Impact “As a science driven and values based company, Amgen is committed to exchanging information with healthcare providers in an ethical and responsible way, and with the best interests of patients always in mind.We fully support the new PhRMA Code.We will continue to ensure that our practices consistently meet or exceed its guidelines.” — Kevin Sharer, Chairman and CEO,Amgen Inc. “The revised Code complements our philosophy that any interaction with healthcare providers should be about providing information that helps them decide on the right medicines, for the right patients, at the right time.” — Rich Fante,VP of Brand and Portfolio Operations, AstraZeneca. “Acceptance of the revised PhRMA Code is consistent with our ongoing commitment to ensure the integrity of our relationships between representatives and doctors, as well as to protect medical judgment and treatment choices from inappropriate influence.” —Johnson & Johnson statement on Responsible Interaction with Healthcare Professionals “We believe that the meaningful Code revisions that have been adopted will address the concerns of our various stakeholders and strengthen the public trust in our industry.

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