Page 1 of 24
`
`SENJU EXHIBIT 2298
`
`LUPIN V. SENJU
`
`IPR2015-01099
`
`SENJU EXHIBIT 2298
`LUPIN v. SENJU
`IPR2015-01099
`
`Page 1 of 24
`
`

`
`INTRODUCTION
`
`Activities conducted as part of pharmaceutical marketing and promotion
`
`are an important component of educating and informing consumers and
`health care professionals about new treatments. Direct—to—consumer (DTC)
`
`advertisements aim to inform patients of important treatment options,
`while pharmaceutical sales representatives work to get accurate, up-to-
`
`date information on medicines to health care professionals.
`
`These efforts have also been the subject of debate, with some questioning
`
`their value. This booklet offers facts about pharmaceutical marketing and
`promotion. We believe these facts are important to consider as the value
`
`of marketing and promotion are debated.
`
`Since our last publication on marketing and promotion,‘ the pharmaceutical
`industry has worked to improve the dissemination of information about
`
`medical advances and to address concerns. One important change was the
`
`unanimous approval by PhRMA’s Board of Directors of Guiding Principles
`
`on Direct to Consumer Advertisements About Prescription Medicines. These
`
`voluntary Principles express the commitment of PhRMA members to deliver
`
`DTC communications that are a valuable contribution to public health.
`
`In addition, in 2008 PhRMA adopted a newly revised Code on Interactions
`
`with Health Care Professionals. The strengthened code reflects a
`
`commitment to maintaining the highest ethical standards in all
`marketing practices and to promote the best patient care possible.
`
`This publication shows the role of marketing and promotion in speeding the
`
`dissemination of valuable improvements in medical care. It also highlights
`
`the important role that marketing plays in getting patients to discuss a
`
`range of health issues with their physicians, resulting in patients receiving
`needed treatment.
`
`We hope that the information contained in this booklet will enhance
`
`dialogue surrounding pharmaceutical marketing and promotion by
`
`providing a perspective that often is not heard. We look fon/vard to further
`
`exploration of how best to get patients into needed treatment, and how to
`
`more rapidly and appropriately disseminate valuable medical technology.
`
`‘Pharmaceutical Rsearch and Manufacturers of America, “Tough Questions — Straight Answers Pharmaceutical Marketing 8: Promotion,‘ (Washington, DC: PhRMA, Fall 2004)»
`http:.".-".vww.phrma.orglfi |esITough_0uestions.pdf.
`
`Page 2 of 24
`
`Page 2 of 24
`
`

`
`NOILDITCIOHLNI
`
`—I
`
`>c
`
`u
`I-
`I11
`0‘H
`
`nO2-
`
`1
`H1
`
`2-
`
`1
`VI
`
`TABLE or CONTENTS
`
`KEY FACTS 1
`
`MARKETING TO HEALTH CARE
`PROVIDERS & PRESCRIBING PATTERNS 3
`
`Pharmaceutical sales representatives provide
`doctors with important information about
`new treatment options that is factored
`into prescribing, but studies find that many
`other factors, including insurers’ policies,
`affect prescribing decisions, often with
`greater impact. In fact, about 2 out of
`3 medicines prescribed in the US. are
`generic—much higher than in nearly
`all other developed countries.
`
`INFORMATION TO HEALTH CARE PROVIDERS 5
`
`Government regulates the marketing of
`pharmaceuticals, and companies strive
`to provide reliable, valuable information.
`Delivering this information is key to making
`physicians aware of the latest advances.
`
`SAMPLES 6
`
`Samples provide many benefits to patients,
`allowing them to begin treatment sooner and
`helping them find the right medicine.
`
`"GIFTS" TO HEALTH CARE PROVIDERS 7
`
`PhRMA’s member companies are committed
`to following the highest ethical standards
`and all legal requirements in their interactions
`with health care professionals. In 2008, they
`adopted a newly revised code that, among
`other things, redefines the narrow category
`of educational items company representatives
`can give to health care professionals.
`
`DTC & PHYSICIAN I PATIENT RELATIONSHIP 8
`
`Many physicians and patients report that DTC
`advertising enhances their communication.
`
`UNDERDIAGNOSIS & UNDERTREATMENT 9
`
`Studies report significant underdiagnosis
`and undertreatment of serious conditions
`that affect millions of Americans. While
`
`these conditions, such as diabetes and
`cardiovascular disease, can often be treated
`
`effectively, left untreated they generate poor
`health outcomes and high health costs for
`avoidable hospitalizations. Pharmaceutical
`marketing and promotion help address this
`problem by raising awareness of disease
`symptoms and treatments, and prompting
`patients to visit their doctor.
`
`PATIENT EDUCATION & EMPOWERMENT 12
`
`DTC advertising creates awareness of diseases
`and treatment options, helps get patients into
`needed treatment, and empowers patients
`with information.
`
`DTC & PRESCRIBING PATTERNS 13
`
`A majority of physicians report not feeling
`pressure to prescribe requested medications.
`In fact, many physicians recommend lifestyle
`changes and other treatments when patients
`request a specific medicine.
`
`DTC ADVERTISING & DRUG PRICES I SPENDING 15
`
`Government agencies and independent
`experts report no direct relationship between
`drug marketing and drug prices.
`
`SPENDING ON PROMOTION AND R&D 17
`
`Pharmaceutical companies are very research-
`intensive and spend significantly more on
`research and development than on marketing
`and promotion.
`
`GOVERNMENT & INDUSTRY REGULATION 19
`
`Pharmaceutical marketing is closely regulated
`by the U.S. Food and Drug Administration
`(FDA) to help assure that promotional
`materials are accurate, fairly balanced, and
`limited to information that has been approved
`by the FDA. Many pharmaceutical companies
`have also adopted voluntary pharmaceutical
`industry guidelines that lay out standards for
`interactions with health care providers and
`appropriate DTC marketing.
`
`Page 3 of 24
`
`Page 3 of 24
`
`

`
`KEY FACTS
`
`The facts below are a preview of the full content contained within
`
`this brochure. For more information on each Key Fact, go to the
`
`corresponding page number listed.
`
`Marketing to Health Care Providers
`
`either always useful (52%) or often useful
`
`8: Prescribing Patterns
`
`o A 2008 physician survey by KRC Research
`
`(17%). 95% of physicians surveyed agreed
`that samples allow patients to start immediate
`
`found that the vast majority of physicians say
`
`treatment and 84% said that samples provide
`
`their clinical knowledge (92%) and a patient's
`
`them with useful first-hand experience.
`
`unique situation (88%) greatly influence their
`
`o A recent Kaiser Family Foundation survey found
`
`prescribing decisions. 35% point to patients’
`
`that 75% of physicians frequently (58%) or
`
`coverage and fonnulary as an important
`
`sometimes (17%) give patients samples to
`
`factor in prescribing, while just 11% say that
`
`pharmaceutical company representatives greatly
`
`assist them with their out-of-pocket costs.
`(See pg 6)
`
`influence them. Surveys by Boston Consulting
`
`Group and Tufts Center for the Study of Drug
`
`Development echo these findings.
`
`- 1/3 of physicians report that they do not
`
`always discuss treatment options that are
`
`not covered by an insurer.
`
`o Approximately 67% of all prescriptions used
`
`in the United States are generic. This is a sharp
`
`increase in recent years—49% of prescriptions
`
`in 2000 were for generics—and one of the
`
`highest generic use rates in the world.
`(See pgs 3-4)
`
`Information to Health Care Providers
`
`Physician I Patient Relationship
`
`- According to an FDA survey, a vast majority
`
`(over 90%) of patients who asked about a
`
`drug reported that their physician "welcomed
`
`the question.’’
`
`- The FDA survey also polled 500 physicians
`and found that:
`
`- 73% believed that DTC ads helped
`
`patients ask thoughtful questions.
`
`o 53% of physicians considered the
`number one benefit of DTC ads to be
`
`the better discussions they had with
`
`their patients about their health.
`
`- Nearly 90% of physicians are either very satisfied
`(29%) or somewhat satisfied (59%) with
`
`- 91% of physicians said the patient did not
`
`try to influence the course of treatment in
`
`the information they received from company
`
`a way that would have been harmful.
`
`representatives, according to the KRC survey.
`
`(See pg 8)
`
`The BCG survey yielded similar results with over
`
`90% of physicians believing infonnation from
`
`representatives to be either very valuable (38%)
`or somewhat valuable (53%).
`(See pg 5)
`
`Samples
`
`o The 2008 KRC physician survey found 69%
`
`of physicians believe free drug samples are
`
`1
`
`THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
`
`Underdiagnosis & Undertreatment
`
`o American patients receive about 1/2 of
`recommended care, according to a landmark
`
`2003 study by RAND Health.
`
`- The RAND Study also found that for quality
`standards related to medication, patients on
`
`average failed to receive recommended care
`30% of the time.
`
`Page 4 of 24
`
`Page 4 of 24
`
`

`
`Underdiagnosis & Undertreatment Continued
`
`Another RAND study published in the
`Annals of Internal Medicine found that
`
`50% of all quality problems in the use of
`
`medicines was accounted for by underuse,
`
`compared to 3% accounted for by overuse.
`
`A Harvard University/Massachusetts
`
`General Hospital and Harris Interactive
`
`Survey found that:
`- 1/4 of patients who visit their doctor
`
`after seeing a DTC ad receive a new
`
`diagnosis.
`46% of physicians felt that DTC
`
`advertising increased patients’
`
`compliance with prescribed treatment.
`
`By treating patients according to guidelines
`
`and by eliminating the underuse of
`
`high blood pressure medicines, 89,000
`lives could be saved and 420,000
`
`hospitalizations avoided annually.
`(See pgs 91 7)
`
`Patient Education
`
`A 2007 KRC Research survey found that:
`o
`1 in 4 consumers sought more
`
`DTC & Prescribing Patterns
`
`A 2006 Government Accountability Office
`
`(GAO) report found that only 2-7% of
`consumers who saw a DTC advertisement
`
`requested and ultimately received a
`
`prescription for the advertised drug.
`
`A 2002 study on the effect of DTC
`
`advertising on demand for pharmaceuticals
`
`revealed that DTC advertising may increase
`
`demand for a particular brand drug, but
`
`only if it has a "favorable status" on the
`
`insurer's formulary.
`(See pgs 73-14)
`
`DTC Advertising & Drug Prices / Spending
`
`According to the Federal Trade
`
`Commission, ”[DTC advertising] can
`
`empower consumers to manage their own
`
`health care by providing information that
`
`will help them, with the assistance of their
`doctors, to make better informed decisions
`
`about their treatment options...Consumers
`
`receive these benefits from DTC advertising
`
`with little, if any, evidence that such
`
`advertising increases prescription drug
`
`information after seeing a DTC ad.
`
`prices." [Emphasis Added]
`
`4 in 5 consumers agree that
`
`advertising for prescription medicines
`
`can educate people about health
`
`conditions and treatment options.
`
`A Prevention Magazine physician
`
`survey found that 70% of doctors feel
`
`that ads help educate patients about
`available treatments. 67% felt that the
`
`advertisements helped them have better
`
`"The pharmaceutical industry is one of the
`most research—intensive industries in the
`
`United States. Pharmaceutical firms invest
`
`as much as five times more in research and
`
`development, relative to their sales, than
`
`the average U.S. manufacturing firm."
`— Congressional Budget Office, 2006
`
`Total promotional spending 2006 —
`$12.0 billion
`
`discussions with their patients.
`
`- DTC — $4.8 billion
`
`Sl3V:lA3)l
`
`- Office promotion, hospital promotion,
`
`and journal advertising — $7.2 billion
`
`Total R&D spending 2007 — $58.8 billion
`(See pgs 75-16)
`
`The FDA’s 2004 survey showed that in
`88% of cases when patients ask their
`
`physicians about a medicine as a result
`
`of seeing a DTC advertisement, they
`
`have the condition that the drug treats.
`
`A Prevention Magazine patient survey
`
`found that 80% of patients who see
`medicines advertised on television are
`
`aware of the risk information presented,
`
`compared to 66% aware of the benefits.
`(See pg 12)
`
`Page 5 of 24
`
`Page 5 of 24
`
`

`
`MARKETING TO HEALTH CARE
`
`PROVIDERS & PRESCRIBING PATTERNS
`
`Pharmaceutical sales representatives provide doctors with important information
`
`about new treatment options that is factored into prescribing, but studies find
`
`that many other factors, including insurers’ policies, affect prescribing decisions,
`
`often with greater impact. In fact, about 2 out of 3 medicines prescribed in the
`
`US. are generic—much higher than in nearly all other developed countries.
`
`CHART 1: Factors Physicians Consider in Prescribing Medicines
`Percent Saying Great Deal or Some Influence on Prescribing Decisions
`
`Cllnlal knowledg I
`experience
`Paflenfs unique sltuation
`
`Peer-reviewed journals
`Cllnlal practice guidelines
`
`Colleagues & peers
`Paflenfs flnandal status
`
`Information from
`pnannaoeutlcal ca reps
`Pauenfs personal options
`
`
`
`
`Infonnation from Insurance
`co. 5. PBM Reps
`
`i..—
`
`I Great Deal
`I '»
`
`Source: Phamraceutical Research and Manufacturers orAmen'ca, KRC Research: Survey of Physicians’ Opinions About
`Pharmaceutical and Biotech Research Company Acfivities and lnforrnafion, n=501, 2008.
`
`Pharmaceutical marketing to health care
`
`patient's unique situation. Journal articles, clinical
`
`providers is an important part of keeping
`
`guidelines and formularies are all factors that
`
`physicians up-to-date about new treatments and
`
`physicians consider more than pharmaceutical
`
`their risks and benefits. However, it is only one
`
`company representatives’ [See Chart 1].
`
`factor among many in the health care system.
`For instance, health plans may strongly
`
`Two surveys one by The Boston Consulting
`Group (BCG) and the other by the Tufts
`
`influence prescribing through formulary design
`
`Center for the Study of Drug Development,
`
`and utilization management strategies, among
`
`echoed these findings. In the BCG survey,
`
`other factors. A recent KRC Research survey
`
`54% of physicians reported that formularies
`
`sponsored by PhRMA found that by far the most
`
`have a major impact on prescribing decisions,
`
`important factors in prescribing are a physician's
`
`50% identified peers, and 47% identified
`
`clinical knowledge and experience and the
`
`clinical guidelines, compared to 14% who
`
`‘ KRC Research, ‘Physicians’ Opinions About Pharmaceutical and Biotech Research CompanyActivities and Infonnation,' n=501, 2008, sponsored by Pharmaceutical Research
`and Manufacturers ofAmerit'a.
`
`3
`
`THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
`
`Page 6 of 24
`
`Page 6 of 24
`
`

`
`said pharmaceutical representatives have a
`
`a study in Health Affairs noted that physician
`
`major impact? The Tufts Center for the Study
`
`counterdetailing by insurance companies and
`
`of Drug Development found that among
`
`pharmacy benefit managers to encourage the
`
`factors influencing prescribing decisions in 2007,
`
`use of generic is "gaining momentum." In the
`
`physicians considered the following to be "very
`
`public sector, some Medicaid programs have
`
`important": continuing medical education
`
`recently hired physicians and pharmacists to visit
`
`(68%), information from peers (43%), and
`payer's decisions (37%). Only 13% of physicians
`
`doctors’ offices and encourage them to prescribe
`generics.‘-* Counterdetailing by payers and their
`
`considered information from pharmaceutical
`
`agents to influence prescribing decisions is not
`
`companies "very important.“
`
`Research published in Health Affairs reports that
`
`subject to FDA regulation, while detailing by
`pharmaceutical companies is FDA—regu|ated.
`
`one-third of physicians do not always discuss
`
`Counterdetailing is only one of many payer
`
`treatment options when those options would
`
`tactics to influence physician prescribing. The
`
`not be covered by the patient’s insurer.5
`
`It is also important to note that approximately
`
`67% of all prescriptions dispensed in the
`
`U.S. in 2007 were for generic drugs,‘‘ up
`from 49% in 2000.7 Moreover, the U.S. has
`
`one of the highest generic market shares of
`
`any developed country? These facts clearly
`
`demonstrate that the regulated information
`
`conveyed through pharmaceutical company
`
`marketing of brand medicines is only one of
`
`many factors that physicians consider when
`
`making prescribing decisions.
`
`The range of influences on prescribing extends
`
`beyond those identified above. For example,
`
`Health Affairs study also reported that Blue
`Cross Blue Shield of Florida sends letters to
`
`doctors who are low prescribers of generics.
`
`In addition, other health plans plan to
`
`distribute generic drug samples to contracted
`physicians.‘° According to The Wall Street
`
`Journal, during a three—month program in
`
`2007, Blue Cross Blue Shield of Michigan paid
`doctors for switching patients from the brand
`
`statin they had been taking to a different
`
`statin’s generic copy.“ The physician survey by
`
`KRC Research found that 80% of physicians
`
`have been asked by an insurer to switch a
`
`prescription to a different drug—not merely a
`
`generic copy of the drug they prescribed.”
`
`CHART 2: Brand and Generic Shares of Prescriptions Filled: 1996-2007
`
`
`
`HHVDHl'|V3H019N|l3)lZlVW
`
`
`
`SNH3J.lVd9N|El|tDS3Eld’8SHElG|l\0Hd
`
`—I— Branded Products
`
`Source: PhRMA Analysis of National Prescription Audit" data from IMS Health, data through 3"’ Quarter of 2007.
`’Boston Consulting Group, 2002 BCG Proprietary Physician Survey, n=399, 2002.
`‘Tufts Center for the Study of Drug Development, atlloak 2008, (Tufts CSDD: Boston, 2008)‘
`5 M,Wynia et al., "Do Physicians Not Offer Useful Services Because of Coverage Restrictions?," HealIhAl/airsZ2, no.4 (Ju|ylAugust 2003): 190197.
`‘Pharmaceutical Research and Manufacturers of America, Ana/ysisofll/arional Prescrplion Audit“ data /ram IM5 Health, data through 3rd Quarter of 2007.
`7IMS Health, October, 2007.
`' M. Danzon and M.F. Furukawa, ' Price and Availability of Pharmaceuticals: Evidence from Nine Countries,’ HealthA/fails Web Exclusive, 29 October 2003,
`httpzi/content.heaIthaffairsorg/cgiIreprintih|thaff.w3.521vi (accessed 25 March 2008).
`9). Malkin et al., “The Changing Face of Pharmacy Benefit Design,‘ Hea/n‘zAf/airs23, no.1 (2004) 194-199, page 198.
`'0 Ibid
`"V. Fuhrmans, ‘Doctors Paid To Prescribe Generic Pills,’ The Wall Streetloumal, 24 January 2008.
`"KRC Research, ‘Physicians’ Opinions About Pharmaceutical and Biotech Research CompanyActivities and Information,‘ n=501, 2008, sponsored by
`Pharmaceutical Research and Manufacturers ofAmerica.
`
`Page 7 of 24
`
`Page 7 of 24
`
`

`
`INFORMATION TO HEALTH CARE PROVIDERS
`Government regulates the marketing of pharmaceuticals, and companies
`strive to provide reliable, valuable information. Delivering this information
`is key to making physicians aware of the latest advances.
`“There is a clear need for interactions between
`
`physicians and the pharmaceutical industry
`to ensure the free fl ow of valid scientifi c
`information. When the information is accurate
`and complete, physicians have the necessary
`tools to make the right prescribing decisions.”20
` – American Medical Association, Testimony
`
`economist David Cutler and then-Stanford researcher
`Mark McClellan. Through promotional activities for a
`then-new treatment for depression, “Manufacturers
`of SSRIs [depression medications] encouraged
`doctors to watch for depression and the reduced
`stigma afforded by the new medications induced
`patients to seek help.”17 As a result, diagnosis and
`treatment for depression doubled over the 1990s.
`However, underdiagnosis and undertreatment remain
`high: 16.2% of Americans suffer from a depressive
`disorder, of those, only 51.6% receive treatment.18
`
`Physicians evaluate information from a range of sources,
`including continuing medical education, journal articles,
`clinical practice guidelines, and company representatives.
`They consider many aspects of information from
`representatives to be useful: 95% say information about
`drug interactions is useful, 95% value information about
`the latest drugs and treatments, 92% fi nd answers to
`specifi c questions they have useful, and 90% appreciate
`information about patient assistance programs.19
`
`According to the Institute of Medicine, science
`and technology have been advancing at an
`unprecedented pace in recent years.13 Despite this,
`diffusion into practice is slow: One study found that
`medical research takes 17 years to be incorporated
`into clinical practice.14 Pharmaceutical marketing
`plays a valuable role by delivering the newest
`information on medicines to physicians and helping
`to translate new technologies into practice.
`
`This information must be reliable. State and federal
`government regulations govern the marketing of
`products, and serious consequences exist for non-
`compliance. Only a product’s scientifi cally proven
`properties, verifi ed by the FDA, can be discussed
`in its marketing. Furthermore, pharmaceutical
`representatives strive to provide the most accurate
`information in order to build credibility and earn the
`trust of physicians over time.
`
`Published research has looked at whether
`physicians see value in pharmaceutical
`promotional and marketing efforts. A 2008 KRC
`Research survey reported that nearly 90% of
`physicians were either very satisfi ed (29%) or
`somewhat satisfi ed (59%) with the information
`they received from company representatives.15 A
`2002 BCG survey yielded similar results.16
`
`The value of disseminating information to
`physicians is evident in a study by Harvard
`
`13 Institute of Medicine, Crossing the Chasm: A New Health System for the 21st Century, (Washington, DC: National Academy Press, March 2001).
`14 E.A. Balas and S.A. Boren, “Managing Clinical Knowledge for Health Care Improvement,” Yearbook of Medical Informatics 2000: Patient-centered Systems, (Stuttgart, Germany: Schattauer, 2000), 65–70.
`15 KRC Research, “Physicians’ Opinions About Pharmaceutical and Biotech Research Company Activities and Information,” n=501, 2008, sponsored by Pharmaceutical Research
`and Manufacturers of America.
`16 Boston Consulting Group, 2002 BCG Proprietary Physician Survey (400 respondents), 2002, as reported in “Pharmaceutical Marketing and Promotion, Creating Access to
`Innovation,” Economic Realities in Health Care Policy 3, no. 1, (Pfi zer: 2003): 11.
`17 D. Cutler and M. McClellan, “Is Technological Change in Medicine Worth It?” Health Affairs 20, no.5 (September/October 2001): 11-29.
`18 R.C. Kessler, P. Berglund, O. Demler et al., “The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R),” The Journal of the
`American Medical Association 289, no.23 (18 June 2003): 3095-3105.
`19 KRC Research, “Physicians’ Opinions About Pharmaceutical and Biotech Research Company Activities and Information,” n=501, 2008, sponsored by Pharmaceutical Research and Manufacturers of America.
`20 American Medical Association, “Paid to Prescribe?: Exploring the Relationship Between Doctors and the Drug Industry,” Statement to the Special Committee on Aging, United
`States Senate, (Washington, DC: Statement of Robert M. Sade, 27 June 2007) http://aging.senate.gov/events/hr176rs.pdf, (accessed 29 August 2007).
`
`5 THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
`
`Page 8 of 24
`
`

`
`,.,_
`
`>2EU
`ms;
`"U
`mg
`oz
`55U
`,-HZ
`I-4
`‘A0
`
`I|
`
`'|'|
`>I’
`—l
`I
`
`Samples provide many benefits to patients, allowing them to begin
`
`treatment sooner and helping them find the right medicine.
`
`SAMPLES
`
`Another role that pharmaceutical promotion
`
`samples provide them with useful first—hand
`
`often plays is providing samples to physicians.
`Doctors may distribute samples to patients for
`
`experience. According to the chairman of the
`
`Asthma and Allergy Foundation's Medical-
`
`several reasons—for instance, to get patients
`
`Scientific Council, samples are "an important
`
`started on therapy right away, to optimize
`
`way of trying to find out which [medicines]
`
`dosing or choice of drug before committing to
`
`work for patients?”
`
`a particular course of treatment, and sometimes
`
`to help patients who might not be able to afford
`medicines on their own.
`
`A 2008 KRC Research survey found 69% of
`
`Although the main role of samples is to allow
`
`patients to try a medicine before filling a full
`
`prescription and to start treatment right away,
`in some cases physicians provide samples to
`
`physicians believe free drug samples are either
`
`help patients who are financially struggling. A
`
`always useful (52%) or often useful (17%).2‘
`
`recent Kaiser Family Foundation survey found
`
`S31dWVS
`
`Ninety-five percent of physicians surveyed
`
`agreed that samples allow patients to start
`immediate treatment and 84% said that
`
`that 75% of physicians frequently (58%) or
`
`sometimes (17%) give patients samples to assist
`
`them with their out—of—pocket costs.” In the
`
`survey by KRC Research, 93% of physicians
`
`said drug samples helped them assist those
`
`patients who are uninsured or in need of
`financial assistance.“
`
`"[Samp|es provide] a clear and
`
`direct benefit to patients who have
`
`— American Medical Association, Testimony
`
`a medically indicated need for
`
`treatment, but lack the resources
`
`to obtain the necessary care."Z5
`
`" KRC Research, ‘Physicians’ Opinions About Pharmaceutical and Biotech Research CornpanyActivities and Information,’ n=501, 2008, sponsored by Pharmaceutical Research
`and Manufacturers ofAmerica.
`'7 J. Saranow and AD. Marcus ‘lite Higher Cost of Sneezing —As Nonprescription Clarhin Hits Shelves, Insurers Jack up Prices of Other Allergy Drugs,’ The Wdl Street Journal, 10
`December 2(X)2.
`'3 Kaiser Family Foundation, Nafionalsurvey a/Physicians,Top|ines, November 2006, httpd/vimwkftorglkaiserpollslupload/7584.pdf (accessed 10 December 2007).
`“KRC Research, ‘Physicians’ opinions About Pharmaceutical and Biotech Research Coinpartyimctivities and Information,’ n=501, 2008, sponsored by Pharmaceutical Research
`and Manufacturers ofAmerica.
`“American Medical Association, ‘mid to Prescribetz Exploring the Relationship Between Doctors and the Drug Industry,‘ Statement to the Specia/Committee onAging, United
`5115 Senate, (Washington, DC: Statement of Robert M. Sade, 27 June 2007) httpdlagingsenategov/eventsllrl76rs.pdfi (accessed 29 August 2007).
`
`Page 9 of 24
`
`Page 9 of 24
`
`

`
`“GIFTS” TO HEALTH CARE PROVIDERS
`
`PhRMA’s member companies are committed to following the highest
`ethical standards and all legal requirements in their interactions with
`health care professionals. In 2008, they adopted a newly revised code
`that, among other things, redefi nes the narrow category of educational
`items company representatives can give to health care professionals.
`
`In 2008, the PhRMA Board adopted a newly
`revised Code on Interactions with Health Care
`Professionals (the “PhRMA Code”), refl ecting
`a commitment to working with health care
`professionals for the benefi t of patients. The
`PhRMA Code starts with the fundamental
`principle that a health care professional’s care
`of patients should be based—and should be
`perceived as being based—solely on each
`patient’s medical needs and the health care
`professional’s medical knowledge.
`
`The PhRMA Code reaffi rms that interactions
`between company representatives and health
`care professionals should be focused on
`providing information on products, scientifi c and
`educational information, and supporting medical
`education. Thus, the revised Code prohibits
`distribution of non-educational items, such
`as pens, mugs, and other “reminder” objects
`adorned with a company logo to health care
`professionals. The Code acknowledges that such
`items may foster misperceptions that company
`interactions with health care professionals are not
`based on informing them about medicines.
`
`Informational discussions by company
`representatives provide health care professionals
`with valuable information about new medicines
`that can lead to improved patient care. The new
`
`Code states that company representatives are
`permitted to offer an occasional meal as long
`as it is modest, and only offered in the offi ce or
`hospital setting, in conjunction with educational
`presentations. Limiting these meals to the
`offi ce or hospital setting, instead of restaurants,
`ensures that the meal is merely incidental to
`the substantive communication between the
`representative and the health care professionals
`in a professional setting.
`
`The revised PhRMA Code reaffi rms that
`representatives should not give health care
`professionals any items for personal benefi t
`or provide tickets to any recreational or
`entertainment events. It allows a company to
`engage health care professionals for bona fi de
`consulting services, provided that the company
`has a legitimate need for the services, the
`arrangement is not a reward or inducement to
`prescribe a particular medicine, and compensation
`is based on the fair market value of those services.
`
`The revised PhRMA Code contains a compliance
`mechanism, requiring companies that state their
`intentions to follow the Code to certify annually that
`they have policies and procedures in place to foster
`compliance. PhRMA will identify on its website the
`companies that intend to follow the Code and the
`status of their compliance certifi cations.
`
`7 THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
`
`Page 10 of 24
`
`

`
`“GIFTS” TO HEALTH
` CARE PROVIDERS
`
`DTC & PHYSICIAN /
`PATIENT RELATIONSHIP
`
`8
`
`DTC & PHYSICIAN / PATIENT RELATIONSHIP
`
`Many physicians and patients report that DTC advertising enhances
`their communication.
`
`According to an FDA survey
`
`of patients, over 90% of patients
`
`who asked about a drug reported
`
`that their physician “welcomed
`
`the question.”26
`
`– FDA Survey, 2004
`
`to the positive benefi t that advertisements
`for prescription drugs have on patients. The
`survey revealed several clear trends: “African
`American physicians see DTC advertising as
`providing substantial educational benefi ts;
`physicians believe that DTC advertising
`helps rather than hurts the doctor-patient
`relationship; and African American physicians
`see the benefi ts of DTC advertising
`outweighing its drawbacks.”29
`
`Pharmaceutical advertising increases
`communication between the physician and
`patient. According to a 2004 FDA survey of
`patients, over 90% of patients who asked
`about a drug reported that their physician
`“welcomed the question.”26
`
`An FDA survey polled 500 physicians and found
`that 73% believed DTC ads help patients ask
`thoughtful questions, and 53% of physicians
`considered the number one benefi t of DTC ads
`to be the better discussions they had with their
`patients about their health. The overwhelming
`majority of physicians (91%) said the patient
`did not try to infl uence the course of treatment
`in a way that would have been harmful.27
`
`Many doctors fi nd that, overall, DTC
`advertising benefi ts patients and helps
`strengthen the patient/physician relationship.
`Research published in 2004 in Health Affairs
`reported that 70% of surveyed doctors
`reported that ads help educate patients about
`available treatments. Sixty-seven percent felt
`that the advertisements helped them have
`better discussions with their patients.28
`
`Another physician survey published in 2006 in
`the Journal of the National Medical Association
`echoed these fi ndings, reporting that 66% of
`African American physicians surveyed attested
`
`26 K. Aikin, J.L. Swasy, A.C. Braman, “Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs – Summary of FDA Survey
`Research Results, Final Report,” (Washington, DC: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and
`Research, 19 November 2004) http://www.fda.gov/cder/ddmac/Final%20Report/FRfi nal111904.pdf (accessed 30 October 2007).
`27 Ibid.
`28 J. S. Weissman et al., “Physicians Report on Patient Encounters Involving Direct-to-Consumer Advertising,” Health Affairs Web Exclusive, 28 April 2004, http://content.
`healthaffairs.org/cgi/reprint/hlthaff.w4.219v1 (accessed 25 March 2008).
`29 Albert Morris et.al., “For the Good of the Patient, Survey of the Physicians of the National Medical Association Regarding Perceptions of DTC Advertising, Part II, 2006”
`Journal of the National Medicine Association 99, no. 3 (March 2007), http://www.nmanet.org/images/uploads/Publications/OC0287.pdf (accessed 25 March 2008).
`
`Page 11 of 24
`
`

`
`UNDERDIAGNOSIS & UNDERTREATMENT
`
`Studies report signifi cant underdiagnosis and undertreatment of serious
`conditions that affect millions of Americans. While these conditions, such
`as diabetes and cardiovascular disease, can often be treated effectively, left
`untreated they generate poor health outcomes and high health costs for
`avoidable hospitalizations. Pharmaceutical marketing and promotion help
`address this problem by raising awareness of disease symptoms and
`treatments and prompting patients to see their doctor.
`
`Getting patients into needed therapy is one of
`the most important r