2008 PhRMA Marketing Code

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CodeonInteractionswithHealthcareProfessionals


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Table of Contents

Preamble

1 Basis of Interactions

2 Informational Presentations by Pharmaceutical Company

Representatives and Accompanying Meals

3 Prohibition on Entertainment and Recreation

4 Pharmaceutical Company Support For Continuing Medical

Education

5 Pharmaceutical Company Support for Third-Party

Educational or Professional Meetings

6 Consultants

7 Speaker Programs and Speaker Training Meetings

8 Healthcare Professionals Who Are Members of Committees

That Set Formularies or Develop Clinical Practice Guidelines

9 Scholarships and Educational Funds

10 Prohibition of Non-Educational and Practice-Related Items

11 Educational Items

12 Prescriber Data

13 Independence and Decision Making

14 Training and Conduct of Company Representatives

15 Adherence to Code

Questions and Answers

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Preamble

The Pharmaceutical Research and Manuacturers o America (PhRMA)represents research-based pharmaceutical and biotechnology companies.

Our members develop and market new medicines to enable patients to livelonger and healthier lives.

Ethical relationships with healthcare proessionals are critical to our missiono helping patients by developing and marketing new medicines. An impor-tant part o achieving this mission is ensuring that healthcare proessionalshave the latest, most accurate inormation available regarding prescriptionmedicines, which play an ever-increasing role in patient healthcare. This

document ocuses on our interactions with healthcare proessionals thatrelate to the marketing o our products.

Appropriate marketing o medicines ensures that patients have access tothe products they need and that the products are used correctly or maxi-mum patient benet. Our relationships with healthcare proessionals arecritical to achieving these goals because they enable us to

informhealthcareprofessionalsaboutthebenetsandrisksofour

products to help advance appropriate patient use,

providescienticandeducationalinformation,

supportmedicalresearchandeducation,and

obtainfeedbackandadviceaboutourproductsthroughconsultation

with medical experts.

In interacting with the medical community, we are committed to ollowingthe highest ethical standards as well as all legal requirements. We are alsoconcerned that our interactions with healthcare proessionals not be per-ceived as inappropriate by patients or the public at large. This Code is toreinorce our intention that our interactions with healthcare proessionals areproessional exchanges designed to benet patients and to enhance thepractice o medicine. The Code is based on the principle that a healthcareproessionals care o patients should be based, and should be perceivedas being based, solely on each patients medical needs and the healthcareproessionals medical knowledge and experience.


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Thereore, PhRMA adopts this updated and enhanced voluntary Codeon relationships with U.S. healthcare proessionals. This Code refects

and builds upon the standards and principles set orth in its predecessor,the PhRMA Code on Interactions with Healthcare Proessionals that tookeect on July 1, 2002. Like the 2002 edition, this Code addresses interac-tions with respect to marketed products and related pre-launch activities.PhRMA member companies relationships with clinical investigators andother individuals and entities as they relate to the clinical research processare addressed in the PhRMA Principles on Conduct o Clinical Trials andCommunication o Clinical Trial Results.

This updated Code will take eect in January 2009.


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1 Basis o InteractionsOur relationships with healthcare proessionals are regulated by multipleentities and are intended to benet patients and to enhance the practice omedicine. Interactions should be ocused on inorming healthcare proes-sionals about products, providing scientic and educational inormation,and supporting medical education.

Promotional materials provided to healthcare proessionals by or on behalo a company should: (a) be accurate and not misleading; (b) make claimsabout a product only when properly substantiated; (c) refect the balancebetween risks and benets; and (d) be consistent with all other Food andDrug Administration (FDA) requirements governing such communications.

2 Inormational Presentationsby Pharmaceutical Company

Representatives and Accompanying MealsInormational presentations and discussions by industry representativesand others speaking on behal o a company provide healthcare providerswith valuable scientic and clinical inormation about medicines that maylead to improved patient care.

In order to provide important scientic inormation and to respect health-care proessionals abilities to manage their schedules and provide patient

care, company representatives may take the opportunity to present inor-mation during healthcare proessionals working day, including mealtimes.In connection with such presentations or discussions, it is appropriate oroccasional meals to be oered as a business courtesy to the healthcareproessionals as well as members o their sta attending presentations, solong as the presentations provide scientic or educational value and themeals (a) are modest as judged by local standards; (b) are not part o anentertainment or recreational event; and (c) are provided in a manner con-ducive to inormational communication.

Any such meals oered in connection with inormational presentationsmade by eld sales representatives or their immediate managers shouldalso be limited to in-oce or in-hospital settings.


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Inclusion o a healthcare proessionals spouse or other guest in a mealaccompanying an inormational presentation made by or on behal o a

company is not appropriate. Oering take-out meals or meals to be eatenwithout a company representative being present (such as dine & dashprograms) is not appropriate.

3 Prohibition on Entertainment

and RecreationCompany interactions with healthcare proessionals are proessional innature and are intended to acilitate the exchange o medical or scienticinormation that will benet patient care. To ensure the appropriate ocus oneducation and inormational exchange and to avoid the appearance o im-propriety, companies should not provide any entertainment or recreationalitems, such as tickets to the theater or sporting events, sporting equip-

ment, or leisure or vacation trips, to any healthcare proessional who is nota salaried employee o the company. Such entertainment or recreationalbenets should not be oered, regardless o (1) the value o the items; (2)whether the company engages the healthcare proessional as a speaker orconsultant, or (3) whether the entertainment or recreation is secondary toan educational purpose.

Modest, occasional meals are permitted as long as they are oered in the appro-priate circumstances and venues as described in relevant sections o this Code.


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4 Pharmaceutical Company Support orContinuing Medical Education

Continuing medical education (CME), also known as independent medical

education (IME), helps physicians and other medical proessionals to obtaininormation and insights that can contribute to the improvement o patientcare, and thereore, nancial support rom companies is appropriate. Suchnancial support or CME is intended to support education on a ull rangeo treatment options and not to promote a particular medicine. Accordingly,a company should separate its CME grant-making unctions rom its salesand marketing departments. In addition, a company should develop objec-tive criteria or making CME grant decisions to ensure that the program

unded by the company is a bona de educational program and that thenancial support is not an inducement to prescribe or recommend a par-ticular medicine or course o treatment.

Since the giving o any subsidy directly to a healthcare proessional bya company may be viewed as an inappropriate cash git, any nancialsupport should be given to the CME provider, which, in turn, can use themoney to reduce the overall CME registration ee or all participants. Thecompany should respect the independent judgment o the CME providerand should ollow standards or commercial support established by the

Accreditation Council or Continuing Medical Education (ACCME) or otherentity that may accredit the CME. When companies underwrite CME,responsibility or and control over the selection o content, aculty, edu-cational methods, materials, and venue belongs to the organizers o theconerences or meetings in accordance with their guidelines. The companyshould not provide any advice or guidance to the CME provider, even iasked by the provider, regarding the content or aculty or a particular CME

program unded by the company.

Financial support should not be oered or the costs o travel, lodging, orother personal expenses o non-aculty healthcare proessionals attendingCME, either directly to the individuals participating in the event or indirectlyto the events sponsor (except as set out in Section 9 below). Similarly,unding should not be oered to compensate or the time spent by health-care proessionals participating in the CME event.

A company should not provide meals directly at CME events, except that aCME provider at its own discretion may apply the nancial support provid-ed by a company or a CME event to provide meals or all participants.


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5 Pharmaceutical Company Support orThird-Party Educational or ProessionalMeetings

Third-party scientic and educational conerences or proessional meetings cancontribute to the improvement o patient care, and thereore, nancial supportrom companies is appropriate. A conerence or meeting is any activity, held atan appropriate location, where (a) the gathering is primarily dedicated, in bothtime and eort, to promoting objective scientic and educational activities anddiscourse (one or more educational presentation(s) should be the highlight othe gathering), and (b) the main incentive or bringing attendees together is tourther their knowledge on the topic(s) being presented.

Since the giving o any subsidy directly to a healthcare proessional by acompany may be viewed as an inappropriate cash git, any nancial sup-port should be given to the conerences sponsor, which, in turn, can usethe money to reduce the overall conerence registration ee or all attend-ees. When companies underwrite medical conerences or meetings otherthan their own, responsibility or and control over the selection o content,aculty, educational methods, materials, and venue belongs to the organiz-

ers o the conerences or meetings in accordance with their guidelines.

Financial support should not be oered or the costs o travel, lodging, orother personal expenses o non-aculty healthcare proessionals attendingthird-party scientic or educational conerences or proessional meetings,either directly to the individuals attending the conerence or indirectly to theconerences sponsor (except as set out in Section 9 below). Similarly, und-ing should not be oered to compensate or the time spent by healthcareproessionals attending the conerence or meeting.

6 ConsultantsConsulting arrangements with healthcare proessionals allow companiesto obtain inormation or advice rom medical experts on such topics as themarketplace, products, therapeutic areas and the needs o patients. Com-panies use this advice to inorm their eorts to ensure that the medicinesthey produce and market are meeting the needs o patients. Decisionsregarding the selection or retention o healthcare proessionals as consul-tants should be made based on dened criteria such as general medical


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expertise and reputation, or knowledge and experience regarding a par-ticular therapeutic area. Companies should continue to ensure that consul-tant arrangements are neither inducements nor rewards or prescribing orrecommending a particular medicine or course o treatment.

It is appropriate or consultants who provide advisory services to be oeredreasonable compensation or those services and reimbursement or reason-able travel, lodging, and meal expenses incurred as part o providing thoseservices. Any compensation or reimbursement made in conjunction with aconsulting arrangement should be reasonable and based on air market value.

Token consulting or advisory arrangements should not be used to justiycompensating healthcare proessionals or their time or their travel, lodging,

and other out-o-pocket expenses. The ollowing actors support the exis-tence o a bona de consulting arrangement (not all actors may be relevantto any particular arrangement):

awrittencontractspeciesthenatureoftheconsultingservicestobe

provided and the basis or payment o those services;

alegitimateneedfortheconsultingserviceshasbeenclearlyidentied

in advance o requesting the services and entering into arrangements

with the prospective consultants;

thecriteriaforselectingconsultantsaredirectlyrelatedtotheidenti-ed purpose and the persons responsible or selecting the consultantshave the expertise necessary to evaluate whether the particular health-care proessionals meet those criteria;

thenumberofhealthcareprofessionalsretainedisnotgreaterthanthe

number reasonably necessary to achieve the identied purpose;

theretainingcompanymaintainsrecordsconcerningandmakesap-propriate use o the services provided by consultants;

thevenueandcircumstancesofanymeetingwithconsultantsarecon-ducive to the consulting services and activities related to the servicesare the primary ocus o the meeting; specically, resorts are not ap-propriate venues.


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While modest meals or receptions may be appropriate during company-sponsored meetings with healthcare proessional commercial consultants,companies should not provide recreational or entertainment events inconjunction with these meetings.

It is not appropriate to pay honoraria or travel or lodging expenses tonon-aculty and non-consultant healthcare proessional attendees atcompany-sponsored meetings, including attendees who participate ininteractive sessions.

7 Speaker Programs and SpeakerTraining Meetings

Healthcare proessionals participate in company-sponsored speakerprograms in order to help educate and inorm other healthcare proession-als about the benets, risks and appropriate uses o company medicines.

Any healthcare proessional engaged by a company to participate in suchexternal promotional programs on behal o the company will be deemed

a speaker or purposes o this Code, and the requirements o Section 7apply to company interactions with that healthcare proessional in his orher capacity as a speaker. Company decisions regarding the selection orretention o healthcare proessionals as speakers should be made basedon dened criteria such as general medical expertise and reputation,knowledge and experience regarding a particular therapeutic area, andcommunications skills. Companies should continue to ensure that speak-ing arrangements are neither inducements nor rewards or prescribing a

particular medicine or course o treatment.

Speaker training is an essential activity because the FDA holds compa-nies accountable or the presentations o their speakers. It is appropriateor healthcare proessionals who participate in programs intended to trainspeakers or company-sponsored speaker programs to be oered reason-able compensation or their time, considering the value o the type o servicesprovided, and to be oered reimbursement or reasonable travel, lodging,

and meal expenses. Such compensation and reimbursement should only beoered when (1) the participants receive extensive training on the companysdrug products or other specic topic to be presented and on compliancewith FDA regulatory requirements or communications; (2) this training willresult in the participants providing a valuable service to the company; and (3)the participants meet the general criteria or bona de consulting arrange-ments (as discussed in Section 6 above). Speaker training sessions should


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be held in venues that are appropriate and conducive to inormational com-munication and training about medical inormation; specically, resorts arenot appropriate venues.

Any compensation or reimbursement made to a healthcare proessional in

conjunction with a speaking arrangement should be reasonable and basedon air market value. Each company should, individually and independently,cap the total amount o annual compensation it will pay to an individualhealthcare proessional in connection with all speaking arrangements. Eachcompany also should develop policies addressing the appropriate use ospeakers, including utilization o speakers ater training and the appropriatenumber o engagements or any particular speaker over time.

Speaker programs may include modest meals oered to attendees and shouldoccur in a venue and manner conducive to inormational communication.

While speaker programs oer important educational opportunities tohealthcare proessionals, they are distinct rom CME programs, and com-panies and speakers should be clear about this distinction. For example,speakers and their materials should clearly identiy the company that issponsoring the presentation, the act that the speaker is presenting onbehal o the company, and that the speaker is presenting inormation that

is consistent with FDA guidelines. Beyond providing all speakers with ap-propriate training, companies should periodically monitor speaker programsor compliance with FDA regulatory requirements or communications onbehal o the company about its medicines.

8 Healthcare Proessionals Who AreMembers o Committees That SetFormularies or Develop ClinicalPractice Guidelines

Healthcare proessionals who are members o committees that set ormu-

laries o covered medicines or develop clinical practice guidelines that mayinfuence the prescribing o medicines oten have signicant experiencein their elds. That experience can be o great benet to companies and


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ultimately to patients i these individuals choose to serve as speakers orcommercial consultants or companies. To avoid even the appearance oimpropriety, companies should require any healthcare proessional who is amember o a committee that sets ormularies or develops clinical guidelinesand also serves as a speaker or commercial consultant or the company

to disclose to the committee the existence and nature o his or her rela-tionship with the company. This disclosure requirement should extend orat least two years beyond the termination o any speaker or consultantarrangement.

Upon disclosure, healthcare proessionals who serve as speakers orconsultants or companies should be required to ollow the procedures setorth by the committee o which they are a member, which may include

recusing themselves rom decisions relating to the medicine or which theyhave provided speaking or consulting services.

9 Scholarships and Educational Funds

Financial assistance or scholarships or other educational unds to permitmedical students, residents, ellows, and other healthcare proessionals intraining to attend careully selected educational conerences may be oeredso long as the selection o individuals who will receive the unds is made bythe academic or training institution. Careully selected educational coner-ences are generally dened as the major educational, scientic, or policy-making meetings o national, regional, or specialty medical associations.

10 Prohibition o Non-Educational andPractice-Related Items

Providing items or healthcare proessionals use that do not advancedisease or treatment education even i they are practice-related items o

minimal value (such as pens, note pads, mugs and similar reminder itemswith company or product logos) may oster misperceptions that companyinteractions with healthcare proessionals are not based on inorming themabout medical and scientic issues. Such non-educational items should notbe oered to healthcare proessionals or members o their sta, even i theyare accompanied by patient or physician educational materials.


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Items intended or the personal benet o healthcare proessionals (suchas foral arrangements, artwork, music CDs or tickets to a sporting event)likewise should not be oered.

Payments in cash or cash equivalents (such as git certicates) should not

be oered to healthcare proessionals either directly or indirectly, except ascompensation or bona de services (as described in Sections 6 and 7).Cash or equivalent payments o any kind create a potential appearance oimpropriety or confict o interest.

It is appropriate to provide product samples or patient use in accordancewith the Prescription Drug Marketing Act.

11 Educational ItemsIt is appropriate or companies, where permitted by law, to oer itemsdesigned primarily or the education o patients or healthcare proessionalsi the items are not o substantial value ($100 or less) and do not have valueto healthcare proessionals outside o his or her proessional responsibili-

ties. For example, an anatomical model or use in an examination roomis intended or the education o the patients and is thereore appropriate,whereas a DVD or CD player may have independent value to a healthcareproessional outside o his or her proessional responsibilities, even i itcould also be used to provide education to patients, and thereore is notappropriate.

Items designed primarily or the education o patients or healthcare proes-

sionals should not be oered on more than an occasional basis, even ieach individual item is appropriate.


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12 Prescriber DataCompanies use non-patient identied prescriber data to acilitate the e-cient fow o inormation to healthcare proessionals. Such prescriber data,which does not identiy individual patients, may serve many purposes,including enabling companies to: (a) impart important saety and risk inor-mation to prescribers o a particular drug; (b) conduct research; (c) complywith FDA mandated risk management plans that require drug companies toidentiy and interact with physicians who prescribe certain drugs; (d) trackadverse events o marketed prescriptions drugs; and (e) ocus marketingactivities on those healthcare proessionals who would most likely benetrom inormation about a particular drug.

Companies that choose to use non-patient identied prescriber data toacilitate communications with healthcare proessionals should use thisdata responsibly. For example, companies should (a) respect the conden-tial nature o prescriber data; (b) develop policies regarding the use o thedata; (c) educate employees and agents about those policies; (d) maintainan internal contact person to handle inquiries regarding the use o the data;and (e) identiy appropriate disciplinary actions or misuse o this data.

In addition, companies should respect and abide by the wishes o anyhealthcare proessional who asks that his or her prescriber data not bemade available to company sales representatives. Companies may demon-strate this respect by ollowing the rules o voluntary programs that acilitateprescribers ability to make this choice.

13 Independence and Decision MakingNo grants, scholarships, subsidies, support, consulting contracts, or edu-cational or practice related items should be provided or oered to a health-care proessional in exchange or prescribing products or or a commitmentto continue prescribing products. Nothing should be oered or provided ina manner or on conditions that would interere with the independence o ahealthcare proessionals prescribing practices.

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14 Training and Conduct o CompanyRepresentatives

Pharmaceutical company representatives play an important role in deliver-

ing accurate, up-to-date inormation to healthcare proessionals about theapproved indications, benets and risks o pharmaceutical therapies. Theserepresentatives oten serve as the primary point o contact between thecompanies who research, develop, manuacture and market lie-saving andlie-enhancing medicines and the healthcare proessionals who prescribethem. As such, the company representatives must act with the highestdegree o proessionalism and integrity.

Companies should ensure that all representatives who are employed by oracting on behal o the companies and who visit healthcare proessionalsreceive training about the applicable laws, regulations and industry codeso practice, including this Code, that govern the representatives interac-tions with healthcare proessionals. In addition, companies should train theirrepresentatives to ensure that they have sucient knowledge o generalscience and product-specic inormation to provide accurate, up-to-dateinormation, consistent with FDA requirements.

Companies should provide updated or additional training in all o theseareas as needed or their representatives who visit healthcare proessionals.

Companies should also assess their representatives periodically to ensure thatthey comply with relevant company policies and standards o conduct. Com-panies should take appropriate action when representatives ail to comply.

15 Adherence to CodeAll companies that interact with healthcare proessionals about pharmaceu-ticals should adopt procedures to assure adherence to this Code.

Companies that publicly announce their commitment to abide by theCode and who complete an annual certication that they have policies and

procedures in place to oster compliance with the Code will be identiedby PhRMA on a public web site. The certication must be signed by thecompanys Chie Executive Ocer and Chie Compliance Ocer. The website will identiy the companies who commit to abide by the Code; provide

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contact inormation or their Chie Compliance Ocers; and, at the appro-priate time, publish the status o each companys annual certication.

Any comments received by PhRMA relating to a companys observanceo the Code or conduct that is addressed by the Code will be reerred by

PhRMA to the relevant companys Chie Compliance Ocer.

In addition, companies are encouraged to seek external verication periodi-cally, meaning at least once every three years, that the company has poli-cies and procedures in place to oster compliance with the Code. PhRMAwill prepare general guidance or such external verication and will identiyon its web site i a company has sought and obtained verication o itscompliance policies and procedures rom an external source.

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Questions&AnswersCODE


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Q.1Under the Code, may items such as stethoscopes be oeredto healthcare proessionals?

A. No. Under the Code only items designed primarily or the educa-tion o patients or healthcare proessionals may occasionally beoered to healthcare proessionals, i the items are not o sub-stantial value and do not have a value to healthcare proessionalsoutside o their proessional responsibilities. While medical equip-ment, such as stethoscopes, obviously plays an important rolein patient care, such equipment is primarily designed or patient

treatment, not or patient or healthcare proessional education,and thereore it would be inappropriate or companies to oersuch equipment to healthcare proessionals.

Q.2

Under the Code, could a company provide healthcare pro-essionals with pens or clipboards designed to be used byhealthcare proessionals or patients in the healthcare proes-sionals ofce along with brochures that provide educationalinormation about the companys product?

A. No. The Code states that providing healthcare proessionals withitems that do not advance disease or treatment education is

not appropriate, even i these items are practice-related items ominimal value, such as clipboards, pens, mugs or similar itemswith or without company logos or product names printed onthem. Providing such non-educational items could oster misper-ceptions that the companys interactions with healthcare proes-sionals are not based on providing inormation about productsor health conditions, and thereore companies should not oernon-educational items to healthcare proessionals or their sta,

even i they are accompanied by educational materials. It would,however, be appropriate or a company to distribute educationalbrochures without pens or clipboards. These same guidelinesapply with regard to the distribution o items to healthcare pro-essionals at third-party scientic and educational conerences orproessional meetings.


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Q.3Under the Code, what are examples o permissible items thatmay be provided to educate healthcare proessionals?

A. The Code states that it is appropriate or companies, where permit-ted by law, to occasionally oer items primarily designed or theeducation o patients or healthcare proessionals, as long as suchitems are not o substantial value ($100 or less) and do not have avalue to the healthcare proessionals outside o their proessionalresponsibilities. For example, companies may provide educationalitems such as a medical text book, a subscription to a relevant sci-

entic journal, or copies o relevant clinical treatment guidelines.

Q.4Under the Code, what types o patient education items maycompanies provide to healthcare proessionals to help them in

educating their patients?

A.Where permitted by law, companies may occasionally oer tohealthcare proessionals items designed to help educate patients,such as anatomical models or examination rooms, inormationalsheets and brochures, patient sel-assessment and tracking tools,or written materials that inorm patients about adherence to medi-cine regimens, healthy liestyle choices or the availability o patientassistance programs. Such items should not be o substantial value,i.e. they should be $100 or less.

Companies may also provide to healthcare proessionals educationalitems designed or use by patients to assist in the administration otheir treatment or management o their conditions. Such items shouldonly be provided to healthcare proessionals or patients where theitems are permitted by law, may be considered essential to propertreatment or compliance and where delivery through a healthcareproessional is an appropriate method o delivery to the patient. Forexample, companies may provide through healthcare proessionalspatient starter kits that help enhance the patients appropriate use othe prescribed medicine. Providing non-educational items to health-care proessionals or patient use is not appropriate, even i theseitems are o minimal value, such as pedometers, stopwatches, orother general tness items.


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Q.5Under the Code, may gol balls and sports bags be provided ithey bear a company or product name?

A. No. As stated in the prior version o the Code, gol balls andsports bags, even i o minimal value, do not advance disease ortreatment education and thereore should not be oered, regard-less o whether they bear a company or product name.

Q.6Under the Code, may healthcare proessionals be providedwith gasoline or their cars i they are provided with productinormation at the same time?

A. No. As stated in the prior version o the Code, items intended orthe personal benet o a healthcare proessional should not be

oered.

Q.7The Code states that company representatives or their imme-diate managers working in company feld sales organizationsmay conduct inormational presentations and discussionsaccompanied by occasional, modest meals in the healthcareproessionals ofce or hospital setting. What types o presen-tations and meals would this include?

A. An inormational presentation or discussion conducted by com-pany representatives or their immediate managers working ineld sales may be accompanied by an occasional modest mealin the oce or hospital setting. Such modest meals may onlybe oered provided that the manner o presentation is condu-cive to a scientic or educational interchange and is not parto an entertainment or recreational event. For example, a sales


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representative who is providing scientic or educational inorma-tion regarding a companys products to one or a ew healthcarepractitioners working in the same oce, could provide a modestmeal (e.g., sandwiches or pizza) to physicians and sta attendingthe representatives inormational presentation in the physicians

oce at lunch time. Providing such modest meals on more thanan occasional basis would not be appropriate.

Q.8Can a feld sales representative o Company B conduct an

inormational presentation accompanied by a meal or ahealthcare proessional in a restaurant down the street rom ahospital?

A. No. An inormational presentation or discussion conducted bya eld sales representative or her immediate manager may onlybe accompanied occasionally by a meal i the presentation isheld in the healthcare proessionals oce or hospital. This is toensure that any meal oered by eld sales representatives or theirmanagers is merely incidental to a substantive interaction with ahealthcare proessional in the oce or hospital setting where thehealthcare proessional typically conducts proessional conversa-tions. In addition, any meal oered must be modest as judged bylocal standards; the presentation must not be part o an entertain-ment or recreational event; and the presentation must be pro-vided in a manner conducive to inormational communication. I a

hospital practitioner does not have an oce conducive to inor-mational communication, then a presentation may be provided ina hospital caeteria or other meeting space within the hospital andmay be accompanied by a modest meal.


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Q.9A feld sales representative o Company X provides pizza orthe sta o a medical ofce during lunch time. Is this consis-tent with the Code?

A. Providing an occasional meal would be consistent with the Codei the sales representative will provide an inormational presenta-tion to the medical sta in conjunction with the meal o modestvalue, so long as the location o the in-oce presentation isconducive to scientic or educational communication. Merelydropping o ood or the oce sta, however, would not be con-

sistent with the Code.

Q.10A feld sales representative o Company X invites physicians tomeet to hear a scientifc and educational presentation about a

new drug at the ca at a nearby bookstore. Lunch is providedby the representative and, ollowing the presentation (which isin small groups), each physician is given a git certifcate orbooks in the amount o $30. Does this conorm to the Code?

A. No. While the presentation may present scientic or educationalinormation, a company eld sales representative should notprovide even a modest meal to healthcare proessionals outside

o the oce or hospital setting (except under the limited circum-stances where the eld sales representative attends a company-sponsored speaker program to provide logistical support andhelp monitor compliance with FDA requirements see Question13 below). In addition, an open-ended git certicate is a cashequivalent. A medical textbook, a book on patient care, or a gitcerticate redeemable solely or a medical textbook or book onpatient care could be provided i it is not o substantial value

($100 or less).


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Q.11A district sales manager at Company C invites 30 physicians toa corporate suite at a proessional baseball game or a 45-minute scientifc and educational presentation ollowed by abuet and the three-hour game. Does this conorm to the Code?

A. No. The provision o entertainment and/or recreational activi-ties, including entertainment at sporting events in connectionwith an educational or scientic presentation or discussion, isinconsistent with the Code, just as in the prior version. In addi-tion, under the Code, inormational presentations by company

representatives or their immediate managers in eld salesorganizations may only be accompanied by a modest meal ithe presentations occur in the healthcare proessionals oce orhospital setting.

Q.12Under the Code, could a senior business executive employedby a company provide a healthcare proessional with an oc-casional meal outside o the healthcare proessionals ofceor hospital?

A. The Code does not prohibit company employees other thaneld sales representatives or their immediate managers rom

providing an occasional meal incidental to a substantive interac-tion with a healthcare proessional outside o his or her oce orhospital, as long as (1) the meal is modest as judged by localstandards; (2) the meal is not part o an entertainment or recre-ational event; and (3) the interaction takes place in a venue andmanner conducive to inormational communication.


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Q.13Company Y would like to engage an expert physician to dis-cuss recent advances in therapy or a group o local health-care proessionals, and would like to meet and provide a mealto attendees in the private room o a local restaurant. Underwhat circumstances can this comply with the Code? Could alocal feld representative in the companys sales organizationattend the event or purposes o assisting the outside speakerand helping to assure that the content o the presentationcomplies with FDA requirements?

A. The Code contemplates that a company may engage a health-care proessional to provide medical or scientic inormation toa group o healthcare proessionals on behal o the company.Such speaker programs may include modest meals oered toattendees and may occur in locations outside o the oce orhospital setting, as long as they occur in a venue and mannerconducive to inormational communication. In this case, Compa-ny Ys chosen location o a private room in a local restaurant maybe conducive to inormational discussion, and the meal providedto attendees should be modest as judged by local standards.In addition, Company Y should ollow the provisions o Section7 o the Code on speaker programs. For example, Company Yshould make sure that the speaker is appropriately trained andthat the speaker and her materials clearly identiy the companysponsoring the presentation and the act that the speaker is pre-senting on behal o the company. In addition, Company Y shouldperiodically monitor its speaker programs or compliance with

FDA regulatory requirements. It would be appropriate or a localeld representative in the companys sales organization to attenda speaker program or purposes o assisting the speaker withlogistics and helping to assure that the content o the presenta-tion complies with FDA requirements.


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Q.14Under what circumstances would the Code permit a com-pany to provide entertainment or recreational activities tohealthcare practitioners?

A. Under the Code, companies may not provide entertainment orrecreational activities to healthcare practitioners who are notemployees o the companies in any context, including situationswhere those practitioners are providing a legitimate service tothe companies, such as when they act as bona de consultantson an advisory board or are trained at a speaker-training meet-

ing. Thus, companies should not invite healthcare proessionalsto sporting events, concerts, or shows, or provide them withrecreational activities such as hunting, shing, boating, ski trips,or gol outings, even i those entertainment events or recreationalactivities are intended to acilitate inormational interchangesbetween the company representative and the healthcare proes-sional. Similarly, it would be inappropriate to provide these typeso entertainment and recreational events in conjunction withpromotional scientic presentations by medical experts.

Q.15Company A retains a small group o 15 nationally known phy-sicians regarding a therapeutic area relevant to company Asproducts to advise on general medical and business issuesand provide guidance on product development and researchprograms or those products. These physicians are paid eesthat are typical o the ees paid to thought leaders in thistherapeutic area. They normally meet once or twice a year atresort locations to discuss the latest product data, researchprograms and Company plans. Does this comply with theCode? I it does, is it appropriate to pay or the spouse o thehealthcare proessional to attend, as well?

A. No, this arrangement or engaging healthcare proessionals toobtain advice on the companys commercial operations doesnot appear to comply with the Code. It is appropriate or com-panies to engage healthcare proessionals to provide bona de


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advisory services as long as the number o healthcare proession-als is reasonably necessary to achieve an identied purpose, andthey are paid compensation that is reasonable and at air marketvalue or the services provided. It would not be appropriate,however, to hold such a consultant meeting at a resort venue. In

this case, the number o advisors seems reasonably small andthe scope o services seems to be reasonably well dened. Theadvisors seem to have been selected based on their expertise inthe areas where advice is needed. The compensation appearsconsistent with the Codes provision that consultant ees shouldbe reasonable and based on air market value. Nevertheless,holding consultant meetings at resort locations is not appropriateunder the Code. The acilities chosen should be conducive to the

services provided as well as reasonable and appropriate to theconduct o the meeting. In addition, only modest meals may beoered to such consultants, and companies should not providerecreational or entertainment events to the healthcare proession-al consultants in conjunction with these meetings. It would not beappropriate to pay or the cost o the spouse o the advisor. I thespouse attends, it should be at the cost o the advisor.

Q.16Company A considers whether to invite 300 physicians/consul-tants to a two-day and one-night speaker-training program ata regional gol resort. All attendees would be compensated ortheir participation, and their expenses would be reimbursed.

Prospective speakers would be selected based on recommen-dations o the Companys district managers and an assess-ment o their qualifcations by the Companys medical or sci-entifc personnel. Each o the attendees would be required tosign an agreement in advance covering the services they willprovide. They would be educated by a aculty on the ull rangeo data surrounding the disease state and the Companys drugproduct, on presentation skills, and on FDA regulatory require-

ments. The Company needs to train 300 speakers in order toensure that enough speakers will actually be available whenneeded. Training sessions take both days, and the Companyprovides or a ew hours o gol and expensive meals, such aslobster and flet mignon. Does this program conorm to theCode? I so, is it appropriate to pay or a spouse o the health-care proessional, as well?


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A. No. This arrangement would not conorm with the Code. Speak-er training is an essential activity because the FDA holds compa-nies accountable or the presentations o their speakers. How-ever, the Code provides that speaker training meetings should

be held at appropriate venues and specically states that resortsare not appropriate venues or training speakers. Moreover,providing entertainment (e.g., gol) and expensive meals to ahealthcare proessional in a speaker training program would notcomply with the Code, although modest meals may be oeredto attendees. The Company does appear to satisy provisions inthe Code that require potential speakers to be selected basedon dened criteria such as medical expertise, knowledge andexperience and to undergo extensive training that would result ina valuable service being provided to the company. The arrange-ment also appears to meet reasonable indicia o a bona deconsulting relationship. The number o speakers being trained isimportant; i signicantly more participants were trained than thecompany plans to use as speakers, this arrangement would notcomply with the Code. The amount o time spent training speak-ers should be reasonable in relation to the material that has tobe covered. The compensation and lodging oered to prospec-

tive speakers should be evaluated to assure that it is reasonablecompensation or their time and based on air market value. Itwould not be appropriate to pay or the cost o the spouse o thehealthcare proessional. I the spouse attends, it should be at thecost o the healthcare proessional.

Q.17A sales representative invites a physician out or a roundo gol and lunch ollowing the gol. The physician is verybusy and is difcult to see in her ofce. The cost o the goland the lunch combined are $65. Does this comply with theCode?

A. No. As stated in the prior version o the Code, it is inconsistentwith the Code to provide entertainment or recreational activitiessuch as gol. In addition, occasional, modest meals providedby a representative or his immediate manager working in a eldsales organization are limited to in-oce or in-hospital settings inconjunction with inormational presentations and discussions.


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Q.18Under the Code, may a healthcare proessionals spouseor other guest be included in a meal with a pharmaceuticalcompany representative that is provided in connection with aninormational presentation by or on behal o the company, ithe healthcare proessional pays or the spouse or guest?

A. No. The Code provides that it is not appropriate to include aspouse or guest at a meal in connection with an inormationalpresentation, regardless o who pays or their meal, unless thespouse or guest would independently qualiy as a healthcare pro-

essional or whom the inormational presentation is appropriate.

Q.19A company is asked to und a CME program as a platinumlevel supporter. This level o support includes the opportunity

or the company to directly sponsor a lunch at the event. Maythe company become a platinum level supporter?

A. It is appropriate under the Code or a company to provide und-ing to a CME provider, which the provider can use at its discretionto provide meals or all participants. However, a company shouldnot control how the provider spends the unding, and a companyshould not sponsor or host a meal directly at a CME program.

A company may und a CME program at a particular level osupport designated by the CME provider and be publicized orproviding that level o support, as long as the company does notseparately promote, publicize or otherwise take advantage o anyoption to be identied as the sponsor o a meal.


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Q.20A national specialty society is holding its three-day annualconerence, which includes business meetings, entertain-ment, and a hal day o educational programs or whichphysicians may receive CME credit. May a company sponsora reception or lunch at the conerence?

A. The Code provides that a company should not provide or spon-sor meals directly at CME events. However, at third party con-erences or proessional meetings at which CME activities com-prise only a part o the conerence or meeting, a company may

sponsor a meal or reception at the conerence i it is permittedby the group holding the conerence or meeting and is clearlyseparate rom the CME portions o the program. In such cases,any meals or receptions sponsored by a company should bemodest and clearly subordinate to the amount o time spent atother aspects o the meeting. In addition, companies should bemindul o standards set orth by ACCME or other accreditingbodies that may apply in these circumstances.

Q.21May a company publicize its interest in a general topic or aCME program or which a grant would be provided?

A. Yes, a company may communicate to multiple CME providers orthe public a general topic or a CME program that might be o in-terest to physicians. For example, a company may publicize thatit will consider unding the topics o new treatments or diseasemanagement techniques in a particular therapy area such asdiabetes or hypertension. However, the company should ollowCME accreditation standards considering the nature and speci-city o the CME topics that the company may propose, keeping

in mind the Codes statement that nancial support or CME isintended to support education on a ull range o treatment op-tions and not to promote a particular medicine. In addition, thecompany may not suggest the speakers or review or make anysuggestions concerning the specic content o a particular CMEprogram, even i asked by the CME provider.


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Q.22Under the Code, may a company make a charitable contribu-tion such as purchasing a table at a undraising dinner or aoursome slot at a undraising gol tournament?

A. Yes, but the company may not invite healthcare proessionals toattend the event at its expense. The company may use some orall o its allotment or its own employees, and return any unusedportion to the sponsoring organization to use as it wishes.

Q.23Under the Code, may a company compensate a consultant orbona fde services by providing an item with a legitimate pa-tient beneft in lieu o paying an honorarium or ee?

A. I the consulting arrangement otherwise complies with the Code,and the air market value o the item represents reasonablecompensation or the services provided, this may be permissible.However, it would be important to comply with all applicablerecordkeeping and reporting requirements, just as with cashcompensation. The written agreement or the consulting servicesshould set orth the compensation and its air market value, anddisclose that this is taxable income.

Q.24Does the Code apply to interactions with physician ofcemanagers, receptionists, and similar personnel who may not behealthcare proessionals?

A. Although the Code does not directly apply to persons who arenot healthcare proessionals, it would be dicult to separate acompanys interactions with any o a physicians employees romthose directly with the physician. Thereore, the Code should beollowed under these circumstances.


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Q.25Does the Code address the issue o disclosure o companyinteractions with healthcare proessionals who are memberso committees that develop ormularies or clinical practiceguidelines?

A. Yes. The Code states that, to avoid even the appearance oimpropriety, companies that have retained a healthcare pro-essional member o a ormulary or clinical practice guidelinescommittee as a commercial consultant or speaker shouldrequire the health care proessional to disclose to the com-

mittee the existence and nature o his or her relationship withthe company. This disclosure requirement should extend orat least two years beyond the termination o any consultantor speaker arrangement. Upon disclosure, healthcare proes-sionals should be required to ollow the procedures set by thecommittee o which they are a member; these procedures mayinclude a requirement that healthcare proessionals recusethemselves rom decisions relating to the medicine about whichthey provided speaking or consulting services. It is reasonableor a company to rely on healthcare proessionals judgmentregarding how to implement these requirements regardingdisclosure and subsequent interactions with the committees onwhich they are members.

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2008 PhRMA Marketing Code

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