Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 1
`
`

`

`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,1 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 refl ects 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 forward to further
`exploration of how best to get patients into needed treatment, and how to
`more rapidly and appropriately disseminate valuable medical technology.
`
`1 Pharmaceutical Research and Manufacturers of America, “Tough Questions - Straight Answers Pharmaceutical Marketing & Promotion,” (Washington, DC: PhRMA, Fall 2004)
`http://www.phrma.org/fi les/Tough_Questions.pdf.
`
`Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 2
`
`

`

`INTRODUCTION
`
`TABLE OF CONTENTS
`
`TABLE OF 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 fi nd 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 U.S. 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 benefi ts to patients,
`allowing them to begin treatment sooner and
`helping them fi nd 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, redefi nes the narrow category
`of educational items company representatives
`can give to health care professionals.
`
`DTC & PHYSICIAN / PATIENT RELATIONSHIP 8
`Many physicians and patients report that DTC
`advertising enhances their communication.
`
`UNDERDIAGNOSIS & UNDERTREATMENT 9
`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 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 specifi c medicine.
`
`DTC ADVERTISING & DRUG PRICES / 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 signifi cantly 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.
`
`Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 3
`
`

`

`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
`& Prescribing Patterns
`• A 2008 physician survey by KRC Research
`found that the vast majority of physicians say
`their clinical knowledge (92%) and a patient’s
`unique situation (88%) greatly infl uence their
`prescribing decisions. 35% point to patients’
`coverage and formulary as an important
`factor in prescribing, while just 11% say that
`pharmaceutical company representatives greatly
`infl uence them. Surveys by Boston Consulting
`Group and Tufts Center for the Study of Drug
`Development echo these fi ndings.
`• 1/3 of physicians report that they do not
`always discuss treatment options that are
`not covered by an insurer.
`• 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
`• Nearly 90% of physicians are either very satisfi ed
`(29%) or somewhat satisfi ed (59%) with
`the information they received from company
`representatives, according to the KRC survey.
`The BCG survey yielded similar results with over
`90% of physicians believing information from
`representatives to be either very valuable (38%)
`or somewhat valuable (53%).
`(See pg 5)
`
`Samples
`• The 2008 KRC physician survey found 69%
`of physicians believe free drug samples are
`
`either always useful (52%) or often useful
`(17%). 95% of physicians surveyed agreed
`that samples allow patients to start immediate
`treatment and 84% said that samples provide
`them with useful fi rst-hand experience.
`• A recent Kaiser Family Foundation survey found
`that 75% of physicians frequently (58%) or
`sometimes (17%) give patients samples to
`assist them with their out-of-pocket costs.
`(See pg 6)
`
`Physician / 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.
`• 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.
`• 91% of physicians said the patient did not
`try to infl uence the course of treatment in
`a way that would have been harmful.
`
`(See pg 8)
`
`Underdiagnosis & Undertreatment
`• 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.
`
`1 THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
`
`Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 4
`
`

`

`K E Y F A C T S
`
`2
`2
`
`DTC & Prescribing Patterns
`• A 2006 Government Accountability Offi ce
`(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 13-14)
`
`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 benefi ts from DTC advertising
`with little, if any, evidence that such
`advertising increases prescription drug
`prices.” [Emphasis Added]
`• “The pharmaceutical industry is one of the
`most research-intensive industries in the
`United States. Pharmaceutical fi rms invest
`as much as fi ve times more in research and
`development, relative to their sales, than
`the average U.S. manufacturing fi rm.”
`
`– Congressional Budget Offi ce, 2006
`• Total promotional spending 2006 –
`$12.0 billion
`• DTC – $4.8 billion
`• Offi ce promotion, hospital promotion,
`and journal advertising – $7.2 billion
`• Total R&D spending 2007 – $58.8 billion
`(See pgs 15-16)
`
`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 9-11)
`
`Patient Education
`• A 2007 KRC Research survey found that:
`• 1 in 4 consumers sought more
`information after seeing a DTC ad.
`• 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
`discussions with their patients.
`• 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 benefi ts.
`(See pg 12)
`
`Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 5
`
`

`

`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 fi nd
`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
`U.S. 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 Infl uence on Prescribing Decisions
`
`Clinical knowledge &
`experience
`
`Patient’s unique situation
`
`Peer-reviewed journals
`
`Clinical practice guidelines
`
`Colleagues & peers
`
`Patient’s financial status
`
`Patient’s coverage & formulary
`
`Information from
`pharmaceutical co. reps
`
`11%
`
`Patient’s personal options
`
`17%
`
`53%
`
`43%
`
`37%
`
`40%
`
`35%
`
`Prior authorization restrictions
`
`29%
`
`Amount of the co-pay
`
`25%
`
`Information from Insurance
`co. & PBM Reps
`
`6%
`
`38%
`
`92%
`
`88%
`
`7% 99%
`
`11%
`
`99%
`
`41%
`
`94%
`
`47%
`
`52%
`
`46%
`
`41%
`
`90%
`
`89%
`
`86%
`
`76%
`
`74%
`
`72%
`
`71%
`
`68%
`
`Great Deal
`Some
`
`63%
`
`55%
`
`42%
`
`43%
`
`44%
`
`Source: Pharmaceutical Research and Manufacturers or America, KRC Research: Survey of Physicians’ Opinions About
`Pharmaceutical and Biotech Research Company Activities and Information, n=501, 2008.
`
`Pharmaceutical marketing to health care
`providers is an important part of keeping
`physicians up-to-date about new treatments and
`their risks and benefi ts. However, it is only one
`factor among many in the health care system.
`
`For instance, health plans may strongly
`infl uence prescribing through formulary design
`and utilization management strategies, among
`other factors. A recent KRC Research survey
`sponsored by PhRMA found that by far the most
`important factors in prescribing are a physician’s
`clinical knowledge and experience and the
`
`patient’s unique situation. Journal articles, clinical
`guidelines and formularies are all factors that
`physicians consider more than pharmaceutical
`company representatives2 [See Chart 1].
`
`Two surveys, one by The Boston Consulting
`Group (BCG) and the other by the Tufts
`Center for the Study of Drug Development,
`echoed these fi ndings. In the BCG survey,
`54% of physicians reported that formularies
`have a major impact on prescribing decisions,
`50% identifi ed peers, and 47% identifi ed
`clinical guidelines, compared to 14% who
`
`2 KRC Research, “Physicians’ Opinions About Pharmaceutical and Biotech Research Company Activities and Information,” n=501, 2008, sponsored by Pharmaceutical Research
`and Manufacturers of America.
`
`3 THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
`
`Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 6
`
`

`

`said pharmaceutical representatives have a
`major impact.3 The Tufts Center for the Study
`of Drug Development found that among
`factors infl uencing prescribing decisions in 2007,
`physicians considered the following to be “very
`important”: continuing medical education
`(68%), information from peers (43%), and
`payer’s decisions (37%). Only 13% of physicians
`considered information from pharmaceutical
`companies “very important.”4
`
`Research published in Health Affairs reports that
`one-third of physicians do not always discuss
`treatment options when those options would
`not be covered by the patient’s insurer.5
`
`a study in Health Affairs noted that physician
`counterdetailing by insurance companies and
`pharmacy benefi t managers to encourage the
`use of generics is “gaining momentum.” In the
`public sector, some Medicaid programs have
`recently hired physicians and pharmacists to visit
`doctors’ offi ces and encourage them to prescribe
`generics.9 Counterdetailing by payers and their
`agents to infl uence prescribing decisions is not
`subject to FDA regulation, while detailing by
`pharmaceutical companies is FDA-regulated.
`
`It is also important to note that approximately
`67% of all prescriptions dispensed in the
`U.S. in 2007 were for generic drugs,6 up
`from 49% in 2000.7 Moreover, the U.S. has
`one of the highest generic market shares of
`any developed country.8 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.
`
`Counterdetailing is only one of many payer
`tactics to infl uence physician prescribing. The
`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.10 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.11 The physician survey by
`KRC Research found that 80% of physicians
`have been asked by an insurer to switch a
`The range of infl uences on prescribing extends
`prescription to a different drug—not merely a
`beyond those identifi ed above. For example,
`generic copy of the drug they prescribed.12
`CHART 2: Brand and Generic Shares of Prescriptions Filled: 1996-2007
`
`MARKETING TO HEALTH CARE
`PROVIDERS & PRESCRIBING PATTERNS
`
`4
`4
`
`80%
`
`70%
`
`60%
`
`50%
`
`40%
`
`30%
`
`20%
`
`10%
`
`0%
`
`54
`
`46
`
`57
`
`43
`
`60
`
`40
`
`64
`
`67
`
`37
`
`33
`
`51
`
`49
`
`50
`
`50
`
`52
`
`48
`
`Branded Products
`
`Generic Products
`
`2000
`2001
`2002
`2003
`2004
`2005
`2006
`2007*
`Source: PhRMA Analysis of National Prescription Audit™ data from IMS Health, data through 3rd Quarter of 2007.
`3 Boston Consulting Group, 2002 BCG Proprietary Physician Survey, n=399, 2002.
`4 Tufts Center for the Study of Drug Development, Outlook 2008, (Tufts CSDD: Boston, 2008).
`5 M. Wynia et al., “Do Physicians Not Offer Useful Services Because of Coverage Restrictions?,” Health Affairs 22, no.4 (July/August 2003): 190-197.
`6 Pharmaceutical Research and Manufacturers of America, Analysis of National Prescription Audit™ data from IMS Health, data through 3rd Quarter of 2007.
`7 IMS Health, October, 2007.
`8 M. Danzon and M.F. Furukawa, “Price and Availability of Pharmaceuticals: Evidence from Nine Countries,” Health Affairs Web Exclusive, 29 October 2003,
`http://content.healthaffairs.org/cgi/reprint/hlthaff.w3.521v1 (accessed 25 March 2008).
`9 J. Malkin et al., “The Changing Face of Pharmacy Benefi t Design,” Health Affairs 23, no.1 (2004) 194-199, page 198.
`10 Ibid.
`11 V. Fuhrmans, “Doctors Paid To Prescribe Generic Pills,” The Wall Street Journal, 24 January 2008.
`12 KRC Research, “Physicians’ Opinions About Pharmaceutical and Biotech Research Company Activities and Information,” n=501, 2008, sponsored by
` Pharmaceutical Research and Manufacturers of America.
`
`Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 7
`
`

`

`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
`
`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
`
`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
`
`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
`
`Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 8
`
`

`

`INFORMATION TO HEALTH
`CARE PROVIDERS
`
`S A M P L E S
`
`SAMPLES
`Samples provide many benefi ts to patients, allowing them to begin
`treatment sooner and helping them fi nd the right medicine.
`
`samples provide them with useful fi rst-hand
`experience. According to the chairman of the
`Asthma and Allergy Foundation’s Medical-
`Scientifi c Council, samples are “an important
`way of trying to fi nd out which [medicines]
`work for patients.”22
`
`Although the main role of samples is to allow
`patients to try a medicine before fi lling a full
`prescription and to start treatment right away,
`in some cases physicians provide samples to
`help patients who are fi nancially struggling. A
`recent Kaiser Family Foundation survey found
`that 75% of physicians frequently (58%) or
`sometimes (17%) give patients samples to assist
`them with their out-of-pocket costs.23 In the
`survey by KRC Research, 93% of physicians
`said drug samples helped them assist those
`patients who are uninsured or in need of
`fi nancial assistance.24
`
`Another role that pharmaceutical promotion
`often plays is providing samples to physicians.
`Doctors may distribute samples to patients for
`several reasons—for instance, to get patients
`started on therapy right away, to optimize
`dosing or choice of drug before committing to
`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
`physicians believe free drug samples are either
`always useful (52%) or often useful (17%).21
`Ninety-fi ve percent of physicians surveyed
`agreed that samples allow patients to start
`immediate treatment and 84% said that
`
`key fact
`
`“[Samples provide] a clear and
`direct benefi t to patients who have
`a medically indicated need for
`treatment, but lack the resources
`to obtain the necessary care.”25
`– American Medical Association, Testimony
`
`21 KRC Research, “Physicians’ Opinions About Pharmaceutical and Biotech Research Company Activities and Information,” n=501, 2008, sponsored by Pharmaceutical Research
`and Manufacturers of America.
`22 J. Saranow and A.D. Marcus “The Higher Cost of Sneezing – As Nonprescription Claritin Hits Shelves, Insurers Jack up Prices of Other Allergy Drugs,” The Wall Street Journal, 10
`December 2002.
`23 Kaiser Family Foundation, National Survey of Physicians, Toplines, November 2006, http://www.kff.org/kaiserpolls/upload/7584.pdf (accessed 10 December 2007).
`24 KRC Research, “Physicians’ Opinions About Pharmaceutical and Biotech Research Company Activities and Information,” n=501, 2008, sponsored by Pharmaceutical Research
`and Manufacturers of America.
`25 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).
`
`6
`
`Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 9
`
`

`

`“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
`
`Opiant Exhibit 2169
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 10
`
`

`

`“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/