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	<title>Pharma Exec Blog &#187; E-Media</title>
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		<copyright>&#xA9;Advanstar Communications </copyright>
		<managingEditor>gkoroneos@advanstar.com (Advanstar Communications)</managingEditor>
		<webMaster>gkoroneos@advanstar.com(Advanstar Communications)</webMaster>
		<category>Pharmceuticals</category>
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		<itunes:summary>The Business of Pharmaceuticals</itunes:summary>
		<itunes:author>Advanstar Communications</itunes:author>
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		<title>Forget Digital Differentiation&#58; Focus on Cross-Channel &#039;Fusion&#039;</title>
		<link>http://blog.pharmexec.com/2013/04/17/forget-digitial-differentiation-focus-on-cross-channel-fusion/</link>
		<comments>http://blog.pharmexec.com/2013/04/17/forget-digitial-differentiation-focus-on-cross-channel-fusion/#comments</comments>
		<pubDate>Wed, 17 Apr 2013 16:14:24 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[E-Media]]></category>
		<category><![CDATA[Guest Blog]]></category>
		<category><![CDATA[Technology]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[cross-channel fusion]]></category>
		<category><![CDATA[digital marketing]]></category>
		<category><![CDATA[digital pharma]]></category>
		<category><![CDATA[Marketing]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=5386</guid>
		<description><![CDATA[Forget digital differentiation and innovation. You need to be focusing on cross-channel &#8216;fusion&#8217;, writes Peter Houston.
Like you, I get invites to attend educational webinars on an almost daily basis; I probably actually attend one every couple of weeks.
Most invites get passed over because it’s not my field, I’ve heard it all before or I don’t [...]]]></description>
			<content:encoded><![CDATA[<p><em>Forget digital differentiation and innovation. You need to be focusing on cross-channel &#8216;fusion&#8217;, writes Peter Houston.</em></p>
<p>Like you, I get invites to attend educational webinars on an almost daily basis; I probably actually attend one every couple of weeks.</p>
<p>Most invites get passed over because it’s not my field, I’ve heard it all before or I don’t have the time to attend. One caught my eye recently though, mainly because a phrase in the title chimed with a lot of the work I am doing in the magazine market: “Cross-channel”.<span id="more-5386"></span></p>
<p>Magazines, <em>Pharm Exec</em> included, are working really hard to distribute their content through the channels their audiences use most. Print is still a big one no matter what went on at Newsweek, but also so is digital in the shape of the web, email, social media and mobile apps.</p>
<p>Of course, the quest to fill your target audience’s information channels is every bit as relevant to pharma leaders as it is to magazine editors: Focus on one place and you’ll get passed over. With this imperative in mind, I got in touch with Fonny Schenck at digital marketing firm Across Health, the organiser of the “Cross-Channel” webinar that caught my eye, to ask him his views on cross-channel marketing in pharma.</p>
<p>He explained that companies are coming to realize that digital is not just about “differentiation” and “innovation” — the next stage is “fusion”, the integration of digital into the overall marketing mix.</p>
<p>Isn’t digital going to take over the whole world though? Not according to Schenck, who says, “It may replace certain channels, but it would be naïve to say that it will be the main channel.”</p>
<p>As you might have guessed, that doesn’t mean business as usual. “The meaning of some &#8216;old&#8217; channels will be redefined thanks to the arrival of digital”, Schenck says. He cites Wolfgang Riepl, a German Newspaper editor who said way back in 1913, “New, further developed types of media never replace the existing modes of media and their usage patterns. Instead, a convergence takes place, leading to a different way and field of use for these older forms.”</p>
<p>Until now, most companies, whatever market they are in, have been experimenting with digital in isolation. Disconnected marketing and in many cases limited budgets, have resulted in mixed business outcomes. Schenck believes that by integrating digital channels in the overall mix, and executing coordinated cross-channel campaigns, significantly better business impacts will be seen.</p>
<p>There has never been a greater number of channels for pharma companies to communicate with patients and HCPs, but marketers are struggling to consolidate the opportunity. “The saying &#8216;tactics in search of strategy&#8217; still holds true in pharma” says Schenck. He thinks the problem is that proven tactics are not sexy enough, the focus falls on “innovative” new channels and while it’s fine to run pilots, the problem comes when the tested tactic is not rolled out across the organization.</p>
<p>“Impact measurement is very often poorly done. Ideally, there is an upfront business-case assessment, followed by leading and lagging qualitative and quantitative metrics, but in most cases this data is missing. In addition, learnings are not shared rapidly across the organization, leading to reinvention of the wheel all the time,” Schenck says.</p>
<p>Too many digital projects are reactionary, almost about filling perceived competitive gaps in the marketing mix rather than dealing with any real information need. According to Schenck, digital is still being resorted to if the higher-cost traditional mix cannot be maintained. This can work, but it strongly depends on the market, lifecycle stage and competitive pressure.</p>
<p>“Digital is not a silver bullet. Increasingly, we are seeing more sophisticated uses of digital, integrated with offline channels, and initial steps towards customization, ” Schenck explains. He offers tablet detailing as an example of a clear cross-channel opportunity that is being missed.</p>
<p>“In our experience, this critical feature is not being used a lot. That’s probably also why most marketers are unhappy with their tablet detailing programme — ‘making tablet detailing a success’ it is the top priority of over 300 marketers who participated in our Digital Barometer 2013.”</p>
<p>So what does Schenck thing pharma marketers should be doing to implement effective cross-channel campaigns?<br />
First up define the target audience and develop your key messages and action triggers. Plan for a sustained campaign across key channels with clearly defined reach, sequencing and estimated impact. Then work up a creative execution that will maximize customer engagement. It’s also important to centralize campaign management. Oh and you’ll need a cross-channel customer database.</p>
<p>“Increasingly, we will direct channels to customers based on their channel acceptance rather than ‘carpet bombing’. Also the messages will be customized based on the individual/segment needs. To make that ‘right message, right channel’ happen through multichannel, you need to have actionable customer information in your database — which very often is missing.”</p>
<p>To make it easier to figure out if all this is working, A-Cross has developed a framework to measure the impact of new channels relative to the rep impact with the intention of developing a proxy for rep activities. Schenck says a key benefit of this approach is that companies understand the metrics very well, because it links the new (digital) to an established gold standard.</p>
<p>“Of course, there is more to cross-channel than just creating the same share of voice through multichannel – we need to move more towards pull, personalization and online/offline integration… but it is a great start.”</p>
<p>The Across Health webinar, ‘<a href="http://www.a-cross.com/health/events/cross-channel-marketing">Transforming fusion strategy into cross-channel execution</a>&#8216; takes place April 18th at 5pm CET. It will be available on demand after that date.</p>
<p style="text-align: left;"><span style="font-family: Calibri,Verdana,Helvetica,Arial;"><span style="font-size: 11pt;"><em>Peter Houston is former Group Content Director for Advanstar Pharma Science. He is now an independent media consultant and founder of </em></span></span><em><a href="http://flippingpagesblog.com/">Flipping Pages</a>.</em></p>
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		<title>Changing the DNA of Pharma Patient Adherence Programs</title>
		<link>http://blog.pharmexec.com/2013/03/12/changing-the-dna-of-pharma-patient-adherence-programs/</link>
		<comments>http://blog.pharmexec.com/2013/03/12/changing-the-dna-of-pharma-patient-adherence-programs/#comments</comments>
		<pubDate>Tue, 12 Mar 2013 14:48:47 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[E-Media]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Patient Communication]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[healthcare]]></category>
		<category><![CDATA[patient compliance]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[adherence]]></category>
		<category><![CDATA[CBI]]></category>
		<category><![CDATA[health literacy]]></category>
		<category><![CDATA[patient adherence]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=5176</guid>
		<description><![CDATA[by Grant Corbett
Epigenetics is the study of changes in human gene expression, in particular from environmental factors.  Pharma is also experiencing epigenetic change.  Human genes are formed from DNA, which are instructions much like a blueprint.  Similarly, the environment is changing pharmaceutical DNA and how brand marketing is instructed.
For example, pharma’s genetic dependence on traditional blueprints (and [...]]]></description>
			<content:encoded><![CDATA[<p>by Grant Corbett</p>
<p>Epigenetics is the study of changes in human gene expression, in particular from environmental factors.  Pharma is also experiencing epigenetic change.  Human genes are formed from DNA, which are instructions much like a blueprint.  Similarly, the environment is changing pharmaceutical DNA and how brand marketing is instructed.</p>
<p><span id="more-5176"></span>For example, pharma’s genetic dependence on traditional blueprints (and standard agency recipes), targeting revenue from new molecules in the pipeline, is no longer sufficient for survival.  The environment has limited the availability of new blockbuster brands.</p>
<p>Similarly, the environment is changing the DNA of our belief systems. Here I am speaking of the evidence for effectiveness of patient medication adherence interventions.  How is this changing the DNA of brand marketing?</p>
<p>For more than a decade, we have believed that medication non-adherence was the result of patient knowledge and capabilities.  This has driven marketing focused on “patient education”, “segmentation” to identify profiles of patients based on their “barriers” (or “deficits”) and “tailoring” to help customize needed changes in the foregoing.</p>
<p>We have assumed that patient knowledge, of their disease and treatment, and their health literacy capabilities, for example, are critical to patient adherence.</p>
<p>However, the evidence now tells us that our assumptions were wrong.  More than 100 published studies show no correlation between a patient’s level of knowledge of their disease and treatment, and medication adherence.  How many valid studies show a correlation?  None of which I am aware.  Studies have shown that patient knowledge can be increased, but no increase in medication adherence has resulted.</p>
<p>Similarly, recent systematic reviews show no evidence that health literacy is associated with medication adherence in adult or pediatric populations.  As one of these review papers summarizes:</p>
<blockquote><p>&#8220;A critical element of successful self-management is medication adherence. On this front, the evidence has been mixed. Although patients with limited literacy have more trouble understanding primary and precautionary medication label instructions and are less likely to be able to report the name of their medication, there is no consistent finding of worse medication adherence among patients with limited literacy.&#8221;</p></blockquote>
<p>In fact, there is evidence that patients with &#8220;adequate health literacy are more inclined to purposefully not adhere to their discharge instructions.&#8221;</p>
<p>Do health literacy interventions improve adherence?  A 2011 systematic review found no evidence.</p>
<p>What about the promotion of health literacy programs?  Again, a 2011 review reports:</p>
<blockquote><p>&#8220;&#8230;current research on health promotion for participants with low health literacy provides insufficient information to conclude whether interventions for health literacy can attract the target population, achieve an effect that is sustainable, or be generalized outside of clinical settings.&#8221;</p></blockquote>
<p>“Tailoring” messaging based on patient characteristics has been a proposed as a solution to patient barriers.  However, a 2012 review paper, on the efficacy of tailored interventions for self-management outcomes of type 2 diabetes, hypertension or heart disease, concluded:</p>
<blockquote><p>“Tailored interventions had no impact on self-management activities such as medication adherence, self-monitoring, exercise, smoking, or diet control.”</p></blockquote>
<p>So, there is no peer-reviewed evidence to support developing pharma marketing strategy or tactics based on these assumptions of patient deficits.  Money spent in interventions based on these beliefs will produce limited or no ROI, as industry cost-effectiveness evaluations show.</p>
<p>What does the evidence, both academic and industry, show improves medication adherence?  This will be part of what you will hear at the Keynote Panel Discussion at CBI’s Patient Adherence and Support Summit (PASS) on Monday, April 29<sup>th</sup> in Philadelphia.  I look forward to seeing you there.</p>
<p><em>Grant Corbett is principal at Behavior Change Solutions, Inc. He can be reached at grant.corbett@behavior-change-solutions.com</em>.</p>
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		<title>Following Industry, OPDP Hopes to Eliminate Silos in Ad Review</title>
		<link>http://blog.pharmexec.com/2013/03/08/following-industry-opdp-hopes-to-eliminate-silos-in-ad-review/</link>
		<comments>http://blog.pharmexec.com/2013/03/08/following-industry-opdp-hopes-to-eliminate-silos-in-ad-review/#comments</comments>
		<pubDate>Fri, 08 Mar 2013 16:34:45 +0000</pubDate>
		<dc:creator>Ben Comer</dc:creator>
				<category><![CDATA[Advertising]]></category>
		<category><![CDATA[E-Media]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Legal]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Patient Communication]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Sales]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[CDER]]></category>
		<category><![CDATA[DDMAC]]></category>
		<category><![CDATA[Janet Woodcock]]></category>
		<category><![CDATA[OPDP]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=5161</guid>
		<description><![CDATA[The Office of Prescription Drug Promotion (OPDP) is reorganizing its two primary advertising review divisions – professional and consumer – in an attempt to stay in line with the silo-breaking, multi-channel promotional output pouring in from pharma.
The line between physician marketing and consumer marketing has blurred as the facets of a brand campaign – from [...]]]></description>
			<content:encoded><![CDATA[<p>The Office of Prescription Drug Promotion (OPDP) is reorganizing its two primary advertising review divisions – professional and consumer – in an attempt to stay in line with the silo-breaking, multi-channel promotional output pouring in from pharma.</p>
<p>The line between physician marketing and consumer marketing has blurred as the facets of a brand campaign – from disease and drug-mechanism education to efficacy, safety and lifestyle claims – dovetail across the traditional physician-patient separation.<span id="more-5161"></span></p>
<p>“We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions,” wrote Janet Woodcock, director of the Center for Drug Evaluation and Research, in an email on the changes. “The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising.”</p>
<p>Before it got upgraded to a “Super Office” in 2011, OPDP was fondly (or sometimes not so fondly) called DDMAC (dee dee mac), which stood for the Division of Drug Marketing, Advertising and Communications. When DDMAC turned into OPDP, the office was split into two divisions: the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion. As OPDP, the steady stream of warning and untitled letters continued unabated, mostly chastising pharma marketers for misbranding, off-label, overstating the efficacy or minimizing the risks of a product, or the <a href="http://www.mmm-online.com/ddmac-warns-novartis-on-educational-websites/article/169518/">misuse of a color scheme</a>, in one famous educational piece created for Novartis.</p>
<p>With today’s announcement, ODPD, pending final review, will rename its two primary divisions. They will now be called the Division of Advertising and Promotion Review I, and the Division of Advertising and Promotion Review II. Review of promotional materials will be separated and organized by therapeutic class, not by professional or consumer. “ODPP concluded that a structure that integrates the review of health care professional-directed and consumer directed promotion across the two divisions” would meet the stated goals of increasing efficiency, improving work distribution, and eliminating redundancy, wrote Woodcock.</p>
<p>“Our ODPD reviewers will continue to use a comprehensive surveillance, enforcement, and education program to foster superior communication of labeling and promotional information to both health care professionals and consumers,” she wrote.</p>
<p>Tom Abrams remains head of ODPD. For a list of the new review groups categorized by therapeutic area, <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm154886.htm?source=govdelivery">click here</a>.</p>
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		<title>ePharma Summit&#58; Turning Big Data into Better Content</title>
		<link>http://blog.pharmexec.com/2013/03/06/epharma-summit-turning-big-data-into-better-content/</link>
		<comments>http://blog.pharmexec.com/2013/03/06/epharma-summit-turning-big-data-into-better-content/#comments</comments>
		<pubDate>Wed, 06 Mar 2013 18:14:38 +0000</pubDate>
		<dc:creator>Ben Comer</dc:creator>
				<category><![CDATA[Advertising]]></category>
		<category><![CDATA[E-Media]]></category>
		<category><![CDATA[Events]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Patient Communication]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Sales]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[Technology]]></category>
		<category><![CDATA[healthcare]]></category>
		<category><![CDATA[multimedia]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[digital marketing]]></category>
		<category><![CDATA[ePharma Summit]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[patient engagement]]></category>
		<category><![CDATA[Professional Marketing]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=5139</guid>
		<description><![CDATA[Physicians and patients are more intimately engaged with their digital devices than ever before, but the content pharma delivers is either rigidly scientific or numbingly bland. Can stronger analytical processes and more data produce a scalable human voice for individual customers?
If a patient or physician encounters pharma-created content that doesn’t pop with relevance or utility, [...]]]></description>
			<content:encoded><![CDATA[<p><em>Physicians and patients are more intimately engaged with their digital devices than ever before, but the content pharma delivers is either rigidly scientific or numbingly bland. Can stronger analytical processes and more data produce a scalable human voice for individual customers?</em></p>
<p><em><span id="more-5139"></span></em>If a patient or physician encounters pharma-created content that doesn’t pop with relevance or utility, it doesn’t matter how multitudinous the channels are that carry it. There is no patience online for bad content.</p>
<p>Pharma has the resources to create, or hire someone to create, great content. But the problem is that great content lies in the eye of the content beholder. Complicating matters further, that single set of eyes may find certain content relevant or useful in one channel on one day, but may have different needs or expectations in another channel, next week. Digital marketers hope the answer to the problem of effective mass personalization – a term that reads like an oxymoron – is big data and better analytical tools for parsing it. If enough data is compiled about a given patient, for example, it follows that sophisticated, real-time analytics will be able to predictably advise brand managers on precisely what information a patient needs at any stage of her journey, in whichever channel she prefers.</p>
<p>Needless to say, that level of sophistication hasn’t yet occurred in the healthcare industry. Speakers at the ePharma Summit in New York this week appear hopeful that it will happen soon, but many acknowledged the organizational changes that need to happen first.</p>
<p>Continuous questing for new data streams can be a quixotic endeavor, leading to “analysis paralysis,” said Nancy Phelan, VP, customer strategy and operations at Bristol-Myers Squibb. Internally, pharma needs to “think differently about the talent and skill set” needed on the commercial side, and organizations must liberate digital marketing from fixed events like budget cycles and calendar-based points of action (POAs). Companies should institute “real-time processes and decision-making” for digital marketing execution, said Phelan.</p>
<p>On a mobile health panel, Sharon DeBacco, senior director, customer communications and operations at Ironwood Pharmaceuticals (and formerly an AstraZeneca consumer marketing leader and brand director on Nexium and Crestor), said “mobile is a marketer’s dream,” but it’s stuck on the fringes of healthcare, in wellness and fitness apps on the one hand, and in sensors and devices for critical care on the other. Missing is the middle ground patient and his chronic condition. From a content management standpoint, mobile can be “challenging and confusing,” acknowledged Scott Wolf, EVP, sales, at Everyday Health. DeBacco said the challenge for mobile is how to combine the many transactional activities phones and tablets are typically used for, to develop first a greater understanding and then a unified program for consumers.</p>
<p>With regard to the future of professional promotion, “pharma needs to find its way back into doctors’ lives,” said Jordan Safirstein, an interventional cardiologist. “Taking a doctor out to eat and giving them journal articles is antiquated…it doesn’t work.” Sales reps are less effective today because “physicians have no say anymore in what drugs are on the formulary,” said Kecia Gaither, vice chairman, department of Ob/Gyn, director of maternal fetal medicine, at Brooklyn’s Brookdale University Hospital and Medical Center. “That decision comes from the chief financial officer,” and to a lesser extent, the head of pharmacy, she said.</p>
<p>Asked about what pharma can provide to physicians, Safirstein said embedding reference texts within EMRs is one opportunity. “The most common thing I see [in the hospital] is a resident walking down the hall, staring at a screen. Pharma must take advantage of this.” What about copay cards? “I’ve never heard a patient say, ‘Thank God you gave me that coupon card,’” said Safirstein, adding that the biggest innovation to the healthcare system in recent years was the launch of generic versions of Lipitor and Plavix.</p>
<p>Despite ongoing challenges in digital promotion on the consumer and professional side, 72% of the healthcare companies surveyed for a recent Best Practices report said they planned to increase their digital marketing budgets by more than 10% in the next two years. Even with additional resources, will pharma be able to craft relevant and useful messages for individual patients and physicians, and deliver them successfully? The best way to find out what questions a specific customer wants answered, right now, is to ask. The best way to meet that need is to provide an answer, fast. Whether big data, new technology and analytics can help pharma provide that kind of mass personalization – at an acceptable scale and in the context of strict regulatory controls – remains to be seen.</p>
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		<title>Tom Abrams&#58; Caronia Won&#039;t Stop Off-Label Enforcement</title>
		<link>http://blog.pharmexec.com/2013/01/30/tom-abrams-caronia-won%e2%80%99t-stop-off-label-enforcement/</link>
		<comments>http://blog.pharmexec.com/2013/01/30/tom-abrams-caronia-won%e2%80%99t-stop-off-label-enforcement/#comments</comments>
		<pubDate>Thu, 31 Jan 2013 04:31:40 +0000</pubDate>
		<dc:creator>Jill Wechsler</dc:creator>
				<category><![CDATA[Advertising]]></category>
		<category><![CDATA[Agency Insight]]></category>
		<category><![CDATA[E-Media]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Legal]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[leadership]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[CBI]]></category>
		<category><![CDATA[First Amendment]]></category>
		<category><![CDATA[misbranding]]></category>
		<category><![CDATA[off-label]]></category>
		<category><![CDATA[OPDP]]></category>
		<category><![CDATA[Tom Abrams]]></category>
		<category><![CDATA[US v. Caronia]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=4942</guid>
		<description><![CDATA[The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
Speaking at the CBI Pharmaceutical Compliance Congress in Washington DC this week, Tom Abrams, director of the Office of Prescription [...]]]></description>
			<content:encoded><![CDATA[<p>The <a href="http://blog.pharmexec.com/2012/12/12/temple-horrified-by-caronia-decision/">much</a>-<a href="http://blog.pharmexec.com/2012/12/05/us-v-caronia-what-constitutes-truthful-speech/">discussed</a> <em>US v. Caronia</em> case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.</p>
<p><span id="more-4942"></span>Speaking at the CBI Pharmaceutical Compliance Congress in Washington DC this week, Tom Abrams, director of the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER), said that the government is not seeking further review of the Caronia decision, largely because the decision “does not find a conflict between the Act’s misbranding provisions and the First Amendment.”</p>
<p>In fact, the Court of Appeals decision didn’t challenge FDA’s contention that promoting a drug for unapproved uses may be evidence of misbranding. Thus, the Second Circuit ruling – which involved a divided panel, Abrams emphasized – “does not bar the government from continuing to enforce the misbranding provisions of the FD&amp;C Act.” After delivering his remarks on the <em>Caronia</em> case, Abrams told the audience that he would not take any questions on the subject. Maame Ewusi-Mensah Frimpong, deputy assistant attorney general,  consumer protection branch, civil division, at the US Department of  Justice, noted during a separate CBI panel that shortly after <em>Caronia</em>, an off-label <a href="http://www.justice.gov/opa/pr/2012/December/12-civ-1523.html">Amgen settlement</a> went through the Second Circuit, the same court that found in favor of Caronia, without all of the First Amendment fanfare.</p>
<p>Here’s Abrams’ full statement:</p>
<blockquote><p>The government has determined not to seek further review of the Second Circuit’s decision in <em>United States </em>v. <em>Caronia</em>, No. 09-5006-cr (2d Cir.).  FDA does not believe that the <em>Caronia</em> decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FD&amp;C Act).</p>
<p>In 2009, Alfred Caronia was convicted of conspiring to distribute a misbranded drug in violation of the FD&amp;C Act.  A divided panel of the Second Circuit held that the jury instructions erroneously permitted, and that the government’s argument encouraged, the jury to treat speech promoting unapproved (off-label) uses of an FDA-approved drug as a criminal offense in and of itself.  The court of appeals did not address the constitutionality of the theory of liability on which the government had defended the conviction:  namely, that the promotion of a drug for an unapproved use may be relied on as evidence that the unapproved use is an intended one, and a drug that lacks adequate directions for its intended uses is misbranded.</p>
<p>Because the court did not address the constitutionality of a prosecution resting on that theory, and because the court also acknowledged that the First Amendment does not preclude an enforcement action based on speech regarding unapproved uses that is false or misleading, the Second Circuit’s decision does not bar the government from continuing to enforce the misbranding provisions of the FD&amp;C Act, including through criminal prosecution where appropriate, in cases involving off-label promotion.  More generally, the decision does not strike down any provision of the FD&amp;C Act or its implementing regulations, nor does it find a conflict between the Act’s misbranding provisions and the First Amendment or call into question the validity of the Act’s drug approval framework.</p></blockquote>
<p>Abrams said that pharmaceutical promotional materials are “improving,” and that strong voluntary compliance by industry is critical for OPDP to be able to oversee some 80,000 promotional pieces a year. In general, pharma ads appear to be less violative, and of a higher quality, though some materials still present cause for concern, said Abrams. OPDP has &#8220;zero tolerance for misleading promotion,&#8221; he said. In response to a question from the audience on whether OPDP would tread lightly on a company if it voluntarily reported a promotional misstep or mistake, Abrams reiterated the need for voluntary compliance, and said OPDP would hardly ever take an action if a mistake is self-reported, and also corrected. Given the number of promotional materials OPDP is tasked with reviewing each year, the agency must set priorities, said Abrams. Those priorities include ads for newly approved products, drugs with significant risks and products subject to past violations and complaints.</p>
<p>With respect to policy and guidance documents for industry, Abrams once again stated that social media guidelines are among the agency&#8217;s &#8220;top priorities,&#8221; in addition to other areas of interest, including the use of health economic information in making formulary decisions, and the addition of comparative effectiveness claims in a drug&#8217;s label.</p>
<p><em>Additional reporting contributed by Ben Comer.</em></p>
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		<title>Why Don&#039;t Those Damn Marketers &#039;Do&#039; Digital&#63;</title>
		<link>http://blog.pharmexec.com/2013/01/18/why-dont-those-damn-marketers-do-digital-2/</link>
		<comments>http://blog.pharmexec.com/2013/01/18/why-dont-those-damn-marketers-do-digital-2/#comments</comments>
		<pubDate>Fri, 18 Jan 2013 15:45:25 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[E-Media]]></category>
		<category><![CDATA[Guest Blog]]></category>
		<category><![CDATA[Sales]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[digital marketing]]></category>
		<category><![CDATA[Pharma]]></category>
		<category><![CDATA[ROI]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=4889</guid>
		<description><![CDATA[By Sven Awege.
Over the last few years I&#8217;ve worked with pharma marketers trying to preach and teach the virtues of digital channels. It has been a thankless task, with bucket loads of blood, sweat, and tears of frustration. I have used a number of different techniques, from talking about the revolution in big forums to [...]]]></description>
			<content:encoded><![CDATA[<p><em>By Sven Awege.</em></p>
<p>Over the last few years I&#8217;ve worked with pharma marketers trying to preach and teach the virtues of digital channels. It has been a thankless task, with bucket loads of blood, sweat, and tears of frustration. I have used a number of different techniques, from talking about the revolution in big forums to small softly, softly‚ &#8220;express yourself&#8221; type workshops (without incense sticks or trickling water).</p>
<p>Once the adrenalin rush dies down I try to analyze what impact this may have had.</p>
<p>To be fair, some glacially slow progress has been made as the median knowledge of the industry inches forward, but it has not been the tidal wave that some had predicted, or hoped for.<img title="More..." src="http://blog.pharmexec.com/wp-includes/js/tinymce/plugins/wordpress/img/trans.gif" alt="" /><span id="more-4889"></span></p>
<p>Should we be surprised? Probably not.</p>
<p>Looking back to my earlier days as an eBusiness evangelist in the late 90s, where a solid part of our strategic recommendations included &#8220;give your employees access to email&#8221;, we spent many a night conjuring projections with terms such as &#8220;dis-intermediation&#8221; and the like.</p>
<p>I recently took a fresh look at some of those crazy visionary presentations, and guess what: many of them were right, but nearly all the timelines were wrong.</p>
<p>So what went wrong then, and is the same thing happening now?</p>
<p>Nothing actually went wrong, it&#8217;s just that we all got a bit carried away with the media buzz out there, and forget that the majority of world is shackled with resistance to change. Some of that change is personal, some of it is organizational, some legal etc. It simply takes a long time for these to all be aligned for things to happen.</p>
<p>But if you peer through the mist today you can see that there is progress, and that there is no going back. To believe that the current models will not change is simply not accepting the evidence that confronts the observer, taken the avalanche of factors currently impacting our industry.</p>
<p>So if we all agree that the current model is broken, and that we need to be moving somewhere else why is progress still so slow?</p>
<p>There are many market research papers out there identifying the blocking factors to the adoption of digital tools as part of a multi-channel approach. Here are the usual culprits:</p>
<ul>
<li>Lack of senior management commitment</li>
<li>Inadequate or incomplete strategy</li>
<li>Lack of internal (and external) capabilities</li>
<li>MLR resistance to risk or change</li>
<li>Reluctance to reassign budget</li>
<li>Elusive evidence of ROI</li>
</ul>
<p>It is all of the above, but perhaps we&#8217;ve not looked at this through the right prism.</p>
<p>Senior management is there to make educated decisions based on the evidence at hand. They are tasked to steer the ship safely, based on limited information and gut feeling built on decades of experience.</p>
<p>If we are honest with our selves, we have been pretty weak at building the case for doing some of the stuff that we&#8217;re asking our stakeholders to adopt. Yes, in individual impact studies we can demonstrate that an eDetail, or a self-directed video, has a greater impact than none, but we&#8217;re only looking at part of the equation in an artificial configuration, and not even attempting to truly understand the influence and behavioral change attributed to the information coming from different channels.</p>
<p>To build traction and credibility we need to develop and demonstrate deep understanding of channel impact and attribution (including the sales force).</p>
<p>We need to harness this as a lifestyle, living and breathing multiple channels. Knowing what each channel can bring to the table, within the specific environment of each &#8216;business case&#8217; and how to mix effectively a selected number of them in a congruent manner.</p>
<p>The title of this post is &#8220;Why won&#8217;t those damn marketers &#8216;do&#8217; digital?&#8221;</p>
<p>Now that you&#8217;ve read this far I would postulate a different, and more appropriate cut on this:</p>
<p><em>Stop pushing the virtues of digital. If you can demonstrate that channel X and Y , used together, will drive the best business and customer outcomes, your marketers will sit up, listen, then beg to know more! Push will become pull, and the marketers will finally skill themselves up with the tools of tomorrow.</em></p>
<p>In conclusion, we need to become <strong>masters of channel selection</strong>,<em> capable of building quantified scenarios based on desired outcomes and limited resources</em>. And yes, that will take real investment, but senior management should acknowledge and invest accordingly.</p>
<p><em>Sven Awege runs the <a href="http://pharmastrategic.com/">Pharma Strategic</a> blog.</em></p>
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		<title>Hepatitis C&#58; Engaging Patients Online</title>
		<link>http://blog.pharmexec.com/2012/11/16/hepatitis-c-engaging-patients-online/</link>
		<comments>http://blog.pharmexec.com/2012/11/16/hepatitis-c-engaging-patients-online/#comments</comments>
		<pubDate>Fri, 16 Nov 2012 21:26:58 +0000</pubDate>
		<dc:creator>Ben Comer</dc:creator>
				<category><![CDATA[Advertising]]></category>
		<category><![CDATA[E-Media]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[multimedia]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[Genentech]]></category>
		<category><![CDATA[Hepatitis C]]></category>
		<category><![CDATA[online marketing]]></category>
		<category><![CDATA[online strategy]]></category>
		<category><![CDATA[Roche]]></category>
		<category><![CDATA[Search]]></category>
		<category><![CDATA[Vertex]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=4641</guid>
		<description><![CDATA[ 
Given the amount of activity in the hepatitis C drug development space – as evidenced in PharmExec’s 2013 Pipeline report – patients are scouring the internet for information on the disease, available treatments, and soon to be available treatments. A new Industry Standard Research report examines the digital cracks consumers encounter when looking for [...]]]></description>
			<content:encoded><![CDATA[<p><strong> </strong></p>
<p><em>Given the amount of activity in the hepatitis C drug development space – as evidenced in </em>PharmExec’s<em> 2013 Pipeline report – patients are scouring the internet for information on the disease, available treatments, and soon to be available treatments. A new Industry Standard Research report examines the digital cracks consumers encounter when looking for information and treatments, and how to potentially fill them.</em></p>
<div id="attachment_4644" class="wp-caption alignright" style="width: 214px"><img class="size-full wp-image-4644" title="Screen shot 2012-11-16 at 4.23.35 PM" src="http://blog.pharmexec.com/wp-content/uploads/2012/11/Screen-shot-2012-11-16-at-4.23.35-PM.png" alt="Screen shot 2012-11-16 at 4.23.35 PM" width="204" height="207" /><p class="wp-caption-text">Andrew Schafer, president, ISR</p></div>
<p><span id="more-4641"></span>Unlike other therapeutic areas, like diabetes, for example, there aren’t currently a lot of brands for HCV on the market – yet – and most patients searching online for therapies tend to land on branded sites for products made by either Vertex or Genentech, according to Andrew Shafer, president of Industry Standards Research (ISR) and author of a new report on the HCV category.</p>
<p>However, different search terms returned different brands in the category. For example, consumers looking to find more information about the disease tended to land on branded content for Vertex’s Incivek. Consumers in the pre-diagnosis stage, who used search terms like “Do I have Hep C?” were more likely to land on branded content supporting Genentech/Roche’s Pegasys. In both cases, however, brand.com websites were further down the list of search results. Specific search requests for information about medicines and side effects tended to return similar results, but more general search inquires about the disease, it’s a mixed bag for consumers.</p>
<p>“What’s happening is that there’s not a go-to source for information on hep C,” says Schafer. “Online searchers are getting piecemeal information, so they’re going to another site as their search continues.” Schafer says there are two ways to counteract the problem of fickle web searchers and poor organic results for brands: paid search, or the creation of a destination site for hepatitis C information. “Pharma is getting better at providing independent information to patients,” notes Schafer.</p>
<p>Another consideration for digital marketers in the HCV space is where to focus resources in the social realm. According to the ISR report, consumers are willing to discuss and ask for information about HCV on Facebook at a higher rate – four to one – than they are on Twitter. Shafer speculates that Twitter is used less frequently in this case because discussions are more public on Twitter, whereas Facebook is more of a closed, private social network.</p>
<p>Another opportunity for companies with an established presence in HCV, and newcomers to the space, is to build an “influencer network,” to keep new information and announcements front and center online. Last May, the CDC made an announcement urging baby boomers to get screened for HCV. Although there was a spike in online conversation around this announcement, it only lasted for a couple of days, according to the ISR report. “If someone wants to own [the HCV] space, whether it’s Vertex or Genentech or whomever…I think it’s in everyone’s interest – pharma, patients, providers – to grow the influencer network, so that these kinds of stories have longer legs, and more people get tested,” says Shafer.</p>
<p>This is particularly true in HCV, since “the vast majority of people that have it don’t know they have it,&#8221; says Shafer. &#8220;From a pharma perspective, increasing your addressable market by going out and testing everybody is probably a pretty good investment.”</p>
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		<title>Pharmacists&#58; The Other White Coats</title>
		<link>http://blog.pharmexec.com/2012/11/07/pharmacists-the-other-white-coats/</link>
		<comments>http://blog.pharmexec.com/2012/11/07/pharmacists-the-other-white-coats/#comments</comments>
		<pubDate>Wed, 07 Nov 2012 17:21:57 +0000</pubDate>
		<dc:creator>Ben Comer</dc:creator>
				<category><![CDATA[E-Media]]></category>
		<category><![CDATA[Patient Communication]]></category>
		<category><![CDATA[Technology]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[healthcare]]></category>
		<category><![CDATA[patient compliance]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[Manhattan Research]]></category>
		<category><![CDATA[McKesson]]></category>
		<category><![CDATA[patient adherence]]></category>
		<category><![CDATA[Pharmacy]]></category>
		<category><![CDATA[pharmacy benefit managers]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=4587</guid>
		<description><![CDATA[Patients in search of face time with a healthcare provider are stopping into their local drugstores, where consultations are free and the wait time is shorter. Pharmacists are in a unique position, too, to move the needle on drug adherence. 
 
Despite an ever-expanding digital medium, with new channels for conversation and new collections of [...]]]></description>
			<content:encoded><![CDATA[<p><em>Patients in search of face time with a healthcare provider are stopping into their local drugstores, where consultations are free and the wait time is shorter. Pharmacists are in a unique position, too, to move the needle on drug adherence. </em></p>
<p><em> </em></p>
<p><em><span id="more-4587"></span></em>Despite an ever-expanding digital medium, with new channels for conversation and new collections of disease-related information popping up all the time, patients still prize face-to-face interaction with experts. According to recent research conducted by McKesson, 72% of patients cite doctors as the top source for information related to their conditions. The internet comes in second, at 54%, followed by pharmacists at 44%.</p>
<p>Physicians may have time to give patients a rough overview of their disease, but discussions around the importance of drug adherence are lacking. Patients who don’t adhere to their medication regimen – an ongoing and multifactorial problem that not only drives up healthcare costs due to unnecessary hospitalizations, but also punches holes in drug sales – are often not getting the kind of instruction from their physicians that could help move the needle on adherence.</p>
<p>“We know from talking to physicians that they aren’t really armed and able to have those conversations around adherence,” says Derek Rago, VP marketing and strategy at McKesson. “Physicians get detailed on a product, but they don’t get detailed on the specific barriers that patients may face when taking the medication.”</p>
<p>Enter the pharmacist, whom Rago calls “the most trusted advisor in the healthcare continuum.” The role of the pharmacist is changing as patients, shooed out of their doctor’s offices, require more instruction on managing chronic conditions, and dealing with the associated challenges of staying on a medication. To address this need, McKesson, on behalf of its pharma clients, has recruited pharmacists working in retail pharmacies to become behavioral coaches, and to discuss adherence issues with patients on their first and second prescription fill. Participating pharmacists are trained to provide “behavioral coaching sessions” which, in the case of a diabetes program for one client, led to an additional four prescriptions dispensed over 12 months, says Rago. By speaking directly with individual patients, pharmacists can ascertain the barriers to adherence, and accentuate the positives of a medication regimen. “We’ll say, ‘what did your doctor tell you about the medication and what you can expect?’ Then we know what they’ve already been told, so we can properly inform them in a very positive way, and see if they have the conviction and belief that they can stay on medication,” says Rago. Patients can then be segmented and engaged differently based on different needs.</p>
<p>Whether or not they’re a part of McKesson’s network of behavioral coaches, pharmacists in general are playing a more active role in patient care, according to recent Manhattan Research survey data. Of the 752 US pharmacists surveyed, roughly two-fifths said they spend more time providing care and support for patients than they did two years ago. Seventy-five percent of the pharmacists surveyed said they wanted access to online patient education materials from pharma.</p>
<p>Just a few years ago, retail pharmacies fretted over the emergence of mail-order pharmacy, and the large pharmacy benefits managers (PBMs) that hoped (and still hope) to <a href="http://blog.pharmexec.com/2011/10/11/medco-ceo-champions-robots-over-pharmacists/">convert their patients to mail order</a>, a cost-saver for PBMs. But for the second year in a row, consumer satisfaction with mail-order pharmacy has declined, according to J.D. Power report released in late September. “Customer service is becoming an increasingly important advantage of the brick and mortar pharmacy experience,” said Rick Miller, senior director of the healthcare practice at J.D. Power and Associates, in a release on the survey data. The study also found that 37% of customers using in-store pharmacies are asked if they’d like to speak with a pharmacist, up from 35% in 2011.</p>
<p>Technology shouldn’t be discounted of course; with a rise in ePrescribing, and the ongoing adoption of electronic health records, pharmaceutical companies will be able to deliver co-pay assistance to patients through their prescribing physicians &#8211; docs can pin digital co-pay coupons to an ePrescription, for example &#8211; with less of a hassle. And all of this tech-enabled automation is freeing up pharmacists to spend even more time working the floor.</p>
<p>“Newer pharmacists coming through the system are more clinically educated, and they have the highest frequency of patient interaction” among HCPs, says Rago. Those bricks and mortar pharmacies eying the future are “moving the pharmacist from the back of the store to the front, because they think that’s what will differentiate them in terms of the pharmacy business as a whole,” he says.</p>
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		<title>Locating the Human Ghost in the Digital Machine</title>
		<link>http://blog.pharmexec.com/2012/10/18/locating-the-human-ghost-in-the-digital-machine/</link>
		<comments>http://blog.pharmexec.com/2012/10/18/locating-the-human-ghost-in-the-digital-machine/#comments</comments>
		<pubDate>Thu, 18 Oct 2012 19:22:32 +0000</pubDate>
		<dc:creator>Clark Herman</dc:creator>
				<category><![CDATA[E-Media]]></category>
		<category><![CDATA[Events]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Patient Communication]]></category>
		<category><![CDATA[People]]></category>
		<category><![CDATA[Sales]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[Technology]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[digital marketing]]></category>
		<category><![CDATA[Digital Pharma East]]></category>
		<category><![CDATA[ePatient]]></category>
		<category><![CDATA[Quantified Self]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=4523</guid>
		<description><![CDATA[Featured panelists at ExL’s annual Digital Pharma East conference this week included practicing physicians, vocal ePatients, social media gurus and digital marketing consultants with plenty of hours logged in big pharma boardrooms.
Amidst jokes about the red tape constraining pharmaceutical marketing efforts in online social platforms were insights into where the industry should move to better [...]]]></description>
			<content:encoded><![CDATA[<p><em>Featured panelists at ExL’s annual Digital Pharma East conference this week included practicing physicians, vocal ePatients, social media gurus and digital marketing consultants with plenty of hours logged in big pharma boardrooms.<span id="more-4523"></span></em></p>
<p>Amidst jokes about the red tape constraining pharmaceutical marketing efforts in online social platforms were insights into where the industry should move to better incorporate social media, mobile, and digital content into marketing plans.<!--more--></p>
<p>Kerri Sparling, a type I diabetes patient and avid blogger stressed the importance of using tactful, personable communication to influential ePatients when canvassing them to write and advocate new therapies, as well as to address issues pertinent to a company’s agenda. Her ePatient manifesto also drew upon the insight that pharma companies should focus less on creating online communities themselves, but instead should join existing, neutral platforms that promote honest, healthy discussion, as opposed to excessive, disjointed efforts that usually result in lax participation,  tepid dialogue, and an eventual decline into one more digital desert.</p>
<p>An informed panel of physicians gave their often convergent points of view on how they use mobile and other technologies in making decisions in prescribing medicine. One of the common opinions expressed was that although it is good to have access to drug information on a mobile platform (not only for the physician’s reference but for the patient’s as well), the physicians preferred face-to-face interaction with pharmaceutical reps so that they could engage and ask questions directly, and to simply enjoy the human element. This preference jibes with a <a href="http://blog.pharmexec.com/2012/10/12/diabetes-drug-launch-2012-tip-tops-and-promo-flops/">recent report</a> suggesting similar physician preferences.</p>
<p>One of the conference’s keynote speakers, Sinan Aral, a Professor of Informatics, Operations &amp; Management Sciences at NYU’s Stern Business School, spoke on what makes online content viral; using social media to change behavior; and what to make of the huge quantity of data that social media platforms are generating. He stressed the importance of the development and use of apps such as pregnancy tracking and pill reminders as a way to effectively cull data for marketing and research purposes. In this context, Aral also referenced the Quantified Self movement and the <a href="http://www.pharmexec.com/pharmexec/Back+Page/The-Big-Data-Drawback/ArticleStandard/Article/detail/764161">enormous amount of data</a> this movement represents, as a growing number of people begin to measure different aspects of themselves, using trackers and mobile devices in an effort to gain further understanding of the world within the body, and what such self-studies suggest about the world outside.</p>
<p>These are just a few examples of some of the pockets of wisdom embedded at Digital Pharma East. Let us know if you attended the conference and if so, what were your takeaways?</p>
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		<title>Diabetes Drug Launch 2012&#58; Tip-tops and Promo-flops</title>
		<link>http://blog.pharmexec.com/2012/10/12/diabetes-drug-launch-2012-tip-tops-and-promo-flops/</link>
		<comments>http://blog.pharmexec.com/2012/10/12/diabetes-drug-launch-2012-tip-tops-and-promo-flops/#comments</comments>
		<pubDate>Fri, 12 Oct 2012 13:59:42 +0000</pubDate>
		<dc:creator>Clark Herman</dc:creator>
				<category><![CDATA[Advertising]]></category>
		<category><![CDATA[E-Media]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Meetings]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[Amylin]]></category>
		<category><![CDATA[Boehringer Ingelheim]]></category>
		<category><![CDATA[Eli Lilly]]></category>
		<category><![CDATA[Launch]]></category>
		<category><![CDATA[Merck]]></category>
		<category><![CDATA[Professional Marketing]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=4486</guid>
		<description><![CDATA[With Halloween candy flooding the shelves in pharmacies across the nation, it’s only appropriate that we turn the conversation toward an ever-growing drug market and therapeutic area: diabetes.
Promotional spending in the category has steadily risen since 2Q 2011, and was approaching half a billion dollars ($466 million) in the first quarter of this year – [...]]]></description>
			<content:encoded><![CDATA[<p>With Halloween candy flooding the shelves in pharmacies across the nation, it’s only appropriate that we turn the conversation toward an ever-growing drug market and therapeutic area: diabetes.</p>
<p><span id="more-4486"></span>Promotional spending in the category has steadily risen since 2Q 2011, and was approaching half a billion dollars ($466 million) in the first quarter of this year – up from $360.3 million in 2Q 2011 – assuming first quarter DTC spend in 2012 was similar to 4Q 2011 DTC expenditures, according to a recent report from Encuity Research.</p>
<p>During the first quarter of 2012, three of the four biggest-budget US product launches were diabetes drugs: Amylin’s Bydureon, Merck’s Janumet XR, and Boehringer Ingelheim/Lilly’s Jentadueto, respectively. Combined with Boehgringer Ingelheim/Lilly’s Tradjenta, which received FDA approval in May 2011, and Merck’s Juvisync, which launched last October, these five diabetes drugs represent 23% of the total promotional spend for the diabetes market overall. However, brand teams working on these five drugs came to different conclusions about which media channels to prioritize with physicians, and sales figures differed – at least in part – as a result.</p>
<p>Twenty-four percent of first quarter spending in support of Bydureon, which received FDA approval at the end of January, went to meetings and events, and sales grew from $5.3 million to $27.7 million by the end of 2Q, according to IMS Health data. Juvisync – a Januvia/Zocor combo product – launched during 4Q 2011 with a $24.5 million professional spend during that period, but lagged behind the others in sales. Juvisync earned just $557 thousand during 1Q 2012, and $683 thousand in 2Q, according to the IMS data. It’s worth noting that Juvisync spent more on e-promotion than any of the other five launch brands, according to the Encuity report.</p>
<p>Professional spending in support of Tradjenta, the high roller of the bunch, topped $40 million during May to July, over 70% of which went to sales details, and very little of which went to e-promotion, the report found. Tradjenta’s sales in the US jumped 23%, from $25.8 million in Q1, to $33.7 million in Q2, according to IMS data.</p>
<p>Do these figures suggest that budgets focused more on face-to-face interactions, at meetings and in physicians’ offices, provide a stronger ROI? There are many factors involved in a drug’s performance, not least of which are efficacy, safety, price and reimbursement. The patient perspective is particularly important in diabetes as well, since dietary management is a crucial aspect of any treatment regiment. With respect to engaging physicians at launch, most companies are introducing their new drugs in person, and are posting solid returns on the balance sheet, despite a crowded market.</p>
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