CODE ON
INTERACTIONS
with Health Care Professionals

TABLE OF CONTENTS
Preamble								41. Basis of Interactions							62. Informational
Presentations by Pharmaceutical Company
Representatives and Accompanying Meals				6

3. Prohibition on Entertainment and Recreation				7

4. Pharmaceutical Company Support For Continuing
8
Medical Education							
5. P harmaceutical Company Support for Third-Party Educational
9
or Professional Meetings						6. Consultants								107. Speaker Programs and Speaker Training Meetings			

11

8. H
 ealth Care Professionals Who Are Members of Committees
That Set Formularies or Develop Clinical Practice Guidelines		

14

9. Scholarships and Educational Funds					

1510. Prohibition of Non-Educational and Practice-Related Items		

15

11. Educational Items							1612. Prescriber Data							1613. Independence and Decision Making					

1714. Training and Conduct of Company Representatives			17

15. Adherence to Code							18Questions and Answers							19

Preamble
The Pharmaceutical Research and Manufacturers of America (PhRMA)
represents research-based pharmaceutical and biotechnology companies. Our
members develop and market new medicines to enable patients to live longer
and healthier lives.
Ethical relationships with health care professionals are critical to our mission ofhelping patients by developing and marketing new medicines. An importantpart of achieving this mission is ensuring that health care professionals have thelatest, most accurate information available regarding prescription medicines,
which play an ever-increasing role in patient health care. This document focuseson our interactions with health care professionals that relate to the marketing ofour products.
Appropriate marketing of medicines ensures that patients have access to the
products they need and that the products are used correctly for maximum
patient benefit. Our relationships with health care professionals are critical toachieving these goals because they enable us to—• inform health care professionals about the benefits and risks of our
products to help advance appropriate patient use,
• provide scientific and educational information,• support medical research and education, and•o btain feedback and advice about our products through consultation withmedical experts.
In interacting with the medical community, we are committed to following
the highest ethical standards as well as all legal requirements. We are also
concerned that our interactions with health care professionals not be perceived
as inappropriate by patients or the public at large. This Code is to reinforce ourintention that our interactions with health care professionals are professional
exchanges designed to benefit patients and to enhance the practice of
medicine. The Code is based on the principle that a health care professional’scare 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 and experience.

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Therefore, PhRMA adopts this updated and enhanced voluntary Code on
relationships with U.S. health care professionals. This Code reflects andbuilds upon the standards and principles set forth in previous versions of the
PhRMA Code on Interactions with Health Care Professionals. PhRMA member
companies’ relationships with clinical investigators and other individuals andentities as they relate to the clinical research process are addressed in the
PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical
Trial Results.
This updated Code takes effect on January 1, 2022.

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1. Basis of Interactions
Our relationships with health care professionals are regulated by multiple
entities and are intended to benefit patients and to enhance the practice of
medicine. Interactions should be focused on informing health care professionals
about products, providing scientific and educational information, andsupporting medical education.
Promotional materials provided to health care professionals by or on behalf of acompany should: (a) be accurate and not misleading; (b) make claims about aproduct only when properly substantiated; (c) reflect the balance between risks
and benefits; and (d) be consistent with all other Food and Drug Administration(FDA) requirements governing such communications.

2. Informational Presentations by
Pharmaceutical Company Representatives
and Accompanying Meals
Informational presentations and discussions by industry representatives andothers speaking on behalf of a company (collectively, company representatives)
provide health care providers with valuable scientific and clinical information
about medicines that may lead to improved patient care.
In order to provide important scientific information and to respect health care
professionals’ abilities to manage their schedules and provide patient care,company representatives may take the opportunity to present information
during health care professionals’ working day, including mealtimes. In
connection with such presentations or discussions, it is appropriate foroccasional, incidental meals to be offered as a business courtesy to the healthcare professionals, as well as members of their staff attending presentations,so long as the presentation provides scientific or educational value, and themeal provided is: (a) modest as judged by local standards; (b) not part of anentertainment or recreational event; and (c) provided in a manner conducive to
informational communication.
Any such incidental meals offered in connection with informationalpresentations made by field sales representatives or their immediate managers
should also be limited to in-office or in-hospital settings.

6Inclusion of an attendee’s significant other or guest in a meal accompanying
an informational presentation made by or on behalf of a company is not
appropriate. Incidental meals can be provided only where there is a reasonable
expectation, and reasonable steps are taken to confirm, that each attendee has asubstantive interaction or discussion with the company representative. Offering“grab-and-go” meals is not appropriate.
This Section 2 does not address informational presentations that do not include
a meal provided by a company representative.

3. Prohibition on Entertainment and Recreation
Company interactions with health care professionals are professional in nature
and are intended to facilitate the exchange of medical or scientific informationthat will benefit patient care. To ensure the appropriate focus on education andinformational exchange and to avoid the appearance of impropriety, companies
should not provide any entertainment or recreational items, such as tickets tothe theater or sporting events, sporting equipment, or leisure or vacation trips,
to any health care professional who is not a salaried employee of the company.
Such entertainment or recreational benefits should not be offered, regardlessof (1) the value of the items; (2) whether the company engages the health care
professional as a speaker or consultant; or (3) whether the entertainment orrecreation is secondary to an educational purpose. Occasional meals that aremodest as judged by local standards are permitted as long as they are offered in
the appropriate circumstances and venues as described in relevant sections of
this Code.

74. Pharmaceutical Company Support forContinuing Medical Education
Continuing medical education (CME), also known as independent medical
education (IME), helps physicians and other medical professionals to obtain
information and insights that can contribute to the improvement of patient care,and therefore, financial support from companies is appropriate. Such financial
support for CME is intended to support education on a full range of treatment
options and not to promote a particular medicine. Accordingly, a company
should separate its CME grant-making functions from its sales and marketing
departments. In addition, a company should develop objective criteria formaking CME grant decisions to ensure that the program funded by thecompany is a bona fide educational program and that the financial support is
not an inducement to prescribe or recommend a particular medicine or courseof treatment. Since the giving of any subsidy directly to a health care professional
by a company may be viewed as an inappropriate cash gift, any financial supportshould be given to the CME provider, which, in turn, can use the money toreduce the overall CME registration fee for all participants. The company should
respect the independent judgment of the CME provider and should follow
standards for commercial support established by the Accreditation Council for
Continuing Medical Education (ACCME) or other entity that may accredit the
CME. When companies underwrite CME, responsibility for and control over theselection of content, faculty, educational methods, materials, and venue or digitalplatform belongs to the organizers of the conferences or meetings in accordancewith their guidelines. The company should not provide any advice or guidance to
the CME provider, even if asked by the provider, regarding the content or faculty
for a particular CME program funded by the company.
Financial support should not be offered for the costs of travel, lodging, or otherpersonal expenses of non-faculty health care professionals attending CME,
either directly to the individuals participating in the event or indirectly to theevent’s sponsor (except as set out in Section 9 below). Similarly, funding should
not be offered to compensate for the time spent by health care professionals
participating in the CME event.
A company should not provide meals directly at CME events, except that a CME
provider at its own discretion may apply the financial support provided by acompany for a CME event to provide meals for all participants.
This Section 4 applies to in-person CME events and virtual CME events
conducted via a digital platform (with audio and/or video conferencing
capabilities) with or without an associated in-person event.

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5. P
 harmaceutical Company Support for ThirdParty Educational or Professional Meetings
Third-party scientific and educational conferences or professional meetings
can contribute to the improvement of patient care, and therefore, financial
support from companies is appropriate. A conference or meeting is any activity,
held virtually or at an appropriate physical location (typically physical locations
are limited to the health care professional’s country of practice unless there
are security or logistical concerns, which would include international scientificcongresses and symposia), where: (a) the event is primarily dedicated, in bothtime and effort, to promoting objective scientific and educational activities anddiscourse (one or more educational presentation(s) should be the highlightof the event), and (b) the main incentive for bringing attendees together is tofurther their knowledge on the topic(s) being presented.
Since the giving of any subsidy directly to a health care professional by acompany may be viewed as an inappropriate cash gift, any financial supportshould be given to the conference’s sponsor, which, in turn, can use the money
to reduce the overall conference registration fee for all attendees. When
companies underwrite medical conferences or meetings other than their own,
responsibility for and control over the selection of content, faculty, educational
methods, materials, and venue or digital platform belongs to the organizers of
the conferences or meetings in accordance with their guidelines.
Financial support should not be offered for the costs of travel, lodging, or otherpersonal expenses of non-faculty health care professionals attending third-party
scientific or educational conferences or professional meetings, either directly
to the individuals attending the conference or indirectly to the conference’s
sponsor (except as set out in Section 9 below). Similarly, funding should not be
offered to compensate for the time spent by health care professionals attending
the conference or meeting.
This Section 5 applies to in-person third-party scientific and educational
conferences or professional meetings and virtual meetings conducted via a
digital platform (with audio and/or video conferencing capabilities) with orwithout an associated in-person event.

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6. Consultants
Consulting arrangements with health care professionals allow companies
to obtain information or advice from medical experts on such topics as themarketplace, products, therapeutic areas, and the needs of patients. Companies
use this advice to inform their efforts to ensure that the medicines they produce
and market are meeting the needs of patients. Decisions regarding the selection
or retention of health care professionals as consultants should be made based on
defined criteria such as general medical expertise and reputation, or knowledge
and experience regarding a particular therapeutic area. Companies should
continue to ensure that consultant arrangements are neither inducements nor
rewards for prescribing or recommending a particular medicine or course oftreatment.
It is appropriate for consultants who provide advisory services to be offeredreasonable compensation for those services and reimbursement for reasonable
travel, lodging, and meal expenses incurred as part of providing those services.
Any compensation or reimbursement made in conjunction with a consulting
arrangement should be reasonable and based on fair market value and should
not take into account the volume or value of past business that may have beenor potential future business that could be generated for the company by thehealth care professional consultant.
Token consulting or advisory arrangements should not be used to justify
compensating health care professionals for their time or their travel, lodging,and other out-of-pocket expenses. The following factors support the existenceof a bona fide consulting arrangement (not all factors may be relevant to any
particular arrangement):•a written contract specifies the nature of the consulting services to beprovided and the basis for payment of those services;•a legitimate need for the consulting services has been clearly identified inadvance of requesting the services and entering into arrangements withthe prospective consultants;• t he criteria for selecting consultants are directly related to the identified
purpose and the persons responsible for selecting the consultants havethe expertise necessary to evaluate whether the particular health care
professionals meet those criteria;• t he number of health care professionals retained is not greater than thenumber reasonably necessary to achieve the identified purpose;10• t he retaining company maintains records concerning and makes
appropriate use of the services provided by consultants;• t he venue and circumstances of any meeting with consultants are
conducive to the consulting services, and activities related to the services
are the primary focus of the meeting; luxury resorts, high-end restaurants,
and entertainment, sporting, or other recreational venues or events are notappropriate.
While receptions or meals that are modest as judged by local standards may beappropriate during company-sponsored meetings with health care professionalcommercial consultants, companies should not provide recreational orentertainment events in conjunction with these meetings.
It is not appropriate to pay honoraria or travel or lodging expenses to non-faculty
and non-consultant health care professional attendees at company-sponsoredmeetings, including attendees who participate in interactive sessions.

7. Speaker Programs and Speaker Training
Meetings
Company-sponsored speaker programs provide substantive educational
information about the benefits, risks, and appropriate uses of company
medicines and related disease states.
While speaker programs offer important educational opportunities to healthcare professionals, they are distinct from CME programs, and companies andspeakers should be clear about this distinction. For example, speakers andtheir materials should clearly identify the company that is sponsoring thepresentation, the fact that the speaker is presenting on behalf of the company,
and that the speaker is presenting information that is consistent with FDA
guidelines. Beyond providing all speakers with appropriate training, as discussed
further below, companies should periodically monitor speaker programs forcompliance with FDA regulatory requirements for communications on behalf ofthe company about its medicines.

11Incidental meals of modest value may be offered to attendees of companysponsored speaker programs, subject to the following principles:•T he purpose of the speaker program should be to present substantive
educational information designed to help address a bona fide educational
need among attendees, taking into account recent substantive changes
in relevant information (e.g., new medical or scientific information or a
new FDA-approved indication for the product) or the importance of theavailability of such educational programming.
• Only those with a bona fide educational need for the information should be
invited.
• I ncidental meals furnished to attendees must be modest as judged by local
standards, as well as subordinate in focus to the educational presentation.
•C ompanies should not pay for or provide alcohol in connection with the
speaker program.
•T he speaker program should occur in a venue and manner conducive to
informational communication, and a company representative should bephysically present. For speaker programs at third-party venues, the thirdparty venue selected by the company should not be extravagant or themain attraction of the event or perceived as such. Luxury resorts, high-end
restaurants, and entertainment, sporting, or other recreational venues or
events are not appropriate.
•R epeat attendance at a speaker program on the same or substantially thesame topic is generally not appropriate unless the attendee has a bonafide educational need to receive the information presented. Attendanceby speakers as participants at programs after speaking on the same or
substantially the same topic is generally not appropriate.
•F riends, significant others, family members, and other guests of a speakeror an invited attendee are not appropriate speaker program attendees
unless such individuals have an independent, bona fide educational needto receive the information presented.
The PhRMA Code does not address attendance at a speaker program that does
not include an incidental meal to the attendee.
In addition, the following principles apply to companies’ retention of health care
professionals as speakers at company-sponsored speaker programs. First, healthcare professionals may be engaged by companies as speakers for companysponsored speaker programs to help educate and inform other health care12

professionals who have an independent, bona fide educational need toreceive information about the benefits, risks, and appropriate uses of company
medicines and related disease states. Any health care professional engaged
by a company to speak at such external promotional programs on behalf ofthe company will be deemed a speaker for purposes of this Code, and therequirements of Section 7 apply to company interactions with that health care
professional in their capacity as a speaker. It is appropriate for companies to offer
health care professionals speaking on behalf of a company compensation for
their time and reimbursement of certain reasonable travel, lodging, and meal
expenses incurred in connection with company-sponsored speaker programs.
Second, company decisions regarding the selection or retention of health care
professionals as speakers should be made based on defined criteria such as
general medical expertise and reputation, knowledge and experience regarding
a particular therapeutic area, and communications skills. Companies should
continue to ensure that speaking arrangements are neither inducements nor
rewards for prescribing a particular medicine or course of treatment. Companies
should not select a health care professional to serve as a speaker based on pastrevenue that the speaker has generated or potential future revenue that the
speaker could generate by prescribing or ordering a company’s products.
Third, health care professionals engaged by the company as speakers also
participate in company-sponsored speaker training programs. Speaker training
is an essential activity because the FDA holds companies accountable for thepresentations of their speakers. It is appropriate for health care professionals
who participate in programs intended to train speakers for company-sponsoredspeaker programs to be offered reasonable compensation for their time and to
be offered reimbursement for reasonable travel, lodging, and meal expenses.
Such compensation and reimbursement should only be offered when (1) the
participants receive extensive training on the company’s drug products orother specific topic to be presented and in compliance with FDA regulatory
requirements for communications; (2) this training will result in the participants
providing a bona fide service to the company; and (3) the participants meet thegeneral criteria for bona fide consulting arrangements (as discussed in Section
6 above). Speaker training programs should be held in venues and locations(typically limited to the speaker’s country of practice unless there are security
or logistical concerns) that are appropriate and conducive to informational
communication and training about medical information. Venues should not
be renowned, extravagant, or the main attraction of the event or perceived assuch. Luxury resorts, high-end restaurants, and entertainment, sporting, or otherrecreational venues or events are not appropriate.

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Finally, any compensation or reimbursement made to a health care professionalin conjunction with a speaking arrangement (including company-sponsoredspeaker training) should be reasonable and based on fair market value andshould not take into account the volume or value of past business that may
have been or potential future business that could be generated for the company
by the health care professional. Each company should, individually andindependently, cap the total amount of annual compensation it will pay to anindividual health care professional in connection with all speaking arrangements.
Each company also should develop policies addressing the appropriate use of
speakers, including utilization of speakers after training and the appropriate
number of engagements for any particular speaker over time.

8. Health Care Professionals Who are Membersof Committees That Set Formularies orDevelop Clinical Practice Guidelines
Health care professionals who are members of committees that set formularies
of covered medicines or develop clinical practice guidelines that may influence
the prescribing of medicines often have significant experience in their fields.
That experience can be of great benefit to companies and ultimately to patients
if these individuals choose to serve as speakers or commercial consultants forcompanies. To avoid even the appearance of impropriety, companies should
require any health care professional who is a member of a committee thatsets formularies or develops clinical guidelines and also serves as a speakeror commercial consultant for the company to disclose to the committee theexistence and nature of their relationship with the company. This disclosure
requirement should extend for at least two years beyond the termination of any
speaker or consultant arrangement.
Upon disclosure, health care professionals who serve as speakers or consultantsfor companies should be required to follow the procedures set forth by thecommittee of which they are a member, which may include recusing themselvesfrom decisions relating to the medicine for which they have provided speaking
or consulting services.

149. Scholarships and Educational Funds
Financial assistance for scholarships or other educational funds to permit
medical students, residents, fellows, and other health care professionals intraining to attend carefully selected educational conferences may be offered,
so long as the selection of individuals who will receive the funds is made by theacademic or training institution. “Carefully selected educational conferences” aregenerally defined as the major educational, scientific, or policymaking meetingsof national, regional, or specialty medical associations.

10. P rohibition of Non-Educational and PracticeRelated Items
Providing items for health care professionals’ use that do not advance disease ortreatment education — even if they are practice-related items of minimal value(such as pens, note pads, mugs, and similar “reminder” items with company or
product logos) — may foster misperceptions that company interactions withhealth care professionals are not based on informing them about medical andscientific issues. Such non-educational items should not be offered to healthcare professionals or members of their staff, even if they are accompanied bypatient or physician educational materials.
Items intended for the personal benefit of health care professionals (such as
floral arrangements, artwork, or tickets to a sporting event) likewise should not
be offered.
Payments in cash or cash equivalents (such as gift certificates) should not
be offered to health care professionals either directly or indirectly, except ascompensation for bona fide services (as described in Sections 6 and 7). Cash or
equivalent payments of any kind create a potential appearance of impropriety or
conflict of interest.
It is appropriate to provide product samples for patient use in accordance with
the Prescription Drug Marketing Act.

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11. Educational Items
It is appropriate for companies, where permitted by law, to offer items designed
primarily for the education of patients or health care professionals if the items
are not of substantial value ($100 or less) and do not have value to health care
professionals outside of their professional responsibilities. For example, ananatomical model for use in an examination room is intended for the educationof patients and is therefore appropriate, whereas a laptop may have independent
value to a health care professional outside of their professional responsibilities,
even if it could also be used to provide education to patients, and therefore is not
appropriate.
Items designed primarily for the education of patients or health care
professionals should not be offered on more than an occasional basis, even if
each individual item is appropriate.

12. Prescriber Data
Companies use non-patient identified prescriber data to facilitate the efficient
flow of information to health care professionals. Such prescriber data, which does
not identify individual patients, may serve many purposes, including enablingcompanies to: (a) impart important safety and risk information to prescribersof a particular drug; (b) conduct research; (c) comply with FDA-mandated risk
management plans that require drug companies to identify and interact withphysicians who prescribe certain drugs; (d) track adverse events of marketedprescription drugs; and (e) focus marketing activities on those health care
professionals who would most likely benefit from information about a particulardrug.
Companies that choose to use non-patient identified prescriber data to facilitatecommunications with health care professionals should use this data responsibly.
For example, companies should: (a) respect the confidential nature of prescriber
data; (b) develop policies regarding the use of the data; (c) educate employees
and agents about those policies; (d) maintain an internal contact person to handle
inquiries regarding the use of the data; and (e) identify appropriate disciplinary
actions for misuse of this data.
In addition, companies should respect and abide by the wishes of any health care
professional who asks that their prescriber data not be made available to company
sales representatives. Companies may demonstrate this respect by following therules of voluntary programs that facilitate prescribers’ ability to make this choice.

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13. Independence and Decision Making
No grants, scholarships, subsidies, support, consulting contracts, or educationalor practice-related items should be provided or offered to a health care
professional in exchange for prescribing products or for a commitment tocontinue prescribing products. Nothing should be offered or provided in amanner or on conditions that would interfere with the independence of a healthcare professional’s prescribing practices.

14. Training and Conduct of Company
Representatives
Pharmaceutical company representatives play an important role in delivering
accurate, up-to-date information to health care professionals about theapproved indications, benefits, and risks of pharmaceutical therapies. These
representatives often serve as the primary point of contact between thecompanies that research, develop, manufacture, and market life-saving andlife-enhancing medicines and the health care professionals who prescribe them.
As such, the company representatives must act with the highest degree ofprofessionalism and integrity.
Companies should ensure that all representatives who are employed by or
acting on behalf of the companies and who visit health care professionals receive
training about the applicable laws, regulations, and industry codes of practice,including this Code, that govern the representatives’ interactions with healthcare professionals. In addition, companies should train their representatives toensure that they have sufficient knowledge of general science and productspecific information to provide accurate, up-to-date information, consistent with
FDA requirements.
Companies should provide updated or additional training in all of these areas asneeded for their representatives who visit health care professionals.
Companies should also assess their representatives periodically to ensurethat they comply with relevant company policies and standards of conduct.
Companies should take appropriate action when representatives fail to comply.

1715. Adherence to CodeAll companies that interact with health care professionals about pharmaceuticals
should adopt procedures that foster compliance with this Code.
Companies that publicly announce their commitment to abide by the Code andthat complete an annual certification that they have policies and procedures inplace to foster compliance with the Code will be identified by PhRMA on a public
web site. The certification must be signed by the company’s Chief Executive
Officer and Chief Compliance Officer. The web site will identify the companies
that commit to abide by the Code; provide contact information for their Chief
Compliance Officers; and, at the appropriate time, publish the status of eachcompany’s annual certification.
Any comments received by PhRMA relating to a company’s observance of theCode or conduct that is addressed by the Code will be referred by PhRMA to therelevant company’s Chief Compliance Officer.
In addition, companies are encouraged to seek external verification periodically,
meaning at least once every three years, that the company has policies andprocedures in place to foster compliance with the Code. PhRMA has prepared
general guidance for such external verification and will identify on its web site if
a company has sought and obtained verification of its compliance policies andprocedures from an external source.

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PhRMA CodeQUESTIONS & ANSWERS
Q1. Under the Code, may items such as stethoscopes be offered to healthcare professionals?
A. No. Under the Code, only items designed primarily for the education ofpatients or health care professionals may occasionally be offered to healthcare professionals, if the items are not of substantial value and do not have avalue to health care professionals outside of their professional responsibilities.
While medical equipment, such as stethoscopes, obviously plays an importantrole in patient care, such equipment is primarily designed for patient
treatment, not for patient or health care professional education, and therefore
it would be inappropriate for companies to offer such equipment to healthcare professionals.
Q2. Under the Code, could a company provide health care professionals
with pens or clipboards designed to be used by health care
professionals or patients in the health care professional’s officealong with brochures that provide educational information about thecompany’s product?
A. No. The Code states that providing health care professionals with items that
do not advance disease or treatment education is not appropriate, even if
these items are practice-related items of minimal value, such as clipboards,
pens, mugs, or similar items with or without company logos or productnames printed on them. Providing such non-educational items could foster
misperceptions that the company’s interactions with health care professionals
are not based on providing information about products or health conditions,and therefore companies should not offer non-educational items to healthcare professionals or their staff, even if they are accompanied by educational
materials. It would, however, be appropriate for a company to distributeeducational brochures without pens or clipboards. These same guidelines
apply with regard to the distribution of items to health care professionals at
third-party scientific and educational conferences or professional meetings.

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Q3. Under the Code, what are examples of permissible items that may beprovided to educate health care professionals?
A. T
 he Code states that it is appropriate for companies, where permitted by law,
to occasionally offer items primarily designed for the education of patients orhealth care professionals, as long as such items are not of substantial value($100 or less) and do not have a value to the health care professionals outsideof their professional responsibilities. For example, companies may provide
educational items such as a medical text book, a subscription to a relevantscientific journal, or copies of relevant clinical treatment guidelines.
Q4. Under the Code, what types of patient education items may companies
provide to health care professionals to help them in educating theirpatients?
A. Where permitted by law, companies may occasionally offer to health care
professionals items designed to help educate patients, such as anatomical
models for examination rooms, informational sheets and brochures, patient
self-assessment and tracking tools, or written materials that inform patients
about adherence to medicine regimens, healthy lifestyle choices, or theavailability of patient assistance programs. Such items should not be of
substantial value, i.e., they should be $100 or less. Companies may also provide
to health care professionals educational items designed for use by patientsto assist in the administration of their treatment or management of theirconditions. Such items should only be provided to health care professionals forpatients where the items are permitted by law, where they may be consideredessential to proper treatment or compliance, and where delivery through ahealth care professional is an appropriate method of delivery to the patient. For
example, companies may provide through health care professionals patient
starter kits that help enhance patients’ appropriate use of the prescribed
medicine. Providing non-educational items to health care professionals forpatient use is not appropriate, even if these items are of minimal value, such as
pedometers, stopwatches, or other general fitness items.
Q5. Under the Code, may golf balls and sports bags be provided if they beara company or product name?

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A. N
 o. Golf balls and sports bags, even if of minimal value, do not advance disease ortreatment education and therefore should not be offered, regardless of whether
they bear a company or product name.
Q6. Under the Code, may health care professionals be provided with gasoline
for their cars if they are provided with product information at the same
time?
A. N
 o. Items intended for the personal benefit of a health care professional should
not be offered.
Q7. The Code states that company representatives or their immediate
managers working in company field sales organizations may conduct
informational presentations and discussions accompanied by occasional,
modest meals in the health care professional’s office or hospital setting.
What types of presentations and meals would this include?
A. An informational presentation or discussion conducted by company
representatives or their immediate managers working in field sales may be
accompanied by an occasional modest meal in the office or hospital setting.
An incidental meal can be offered in connection with such presentation or
discussion only if the meal is modest as judged by local standards, provided
in a manner conducive to an informational exchange, and not part of anentertainment or recreational event. In addition, an incidental meal can beprovided only where there is a reasonable expectation, and reasonable steps
are taken to confirm, that each attendee receiving a meal has a substantive
interaction or discussion with the company representative. Offering “graband-go” meals is not appropriate. For example, a sales representative providing
scientific or educational information regarding a company’s products to one or a
few health care professionals working in the same office could provide a modest
meal (e.g., sandwiches or pizza) to those who have a substantive interaction or
discussion with the representative. Providing such modest meals on more thanan occasional basis would not be appropriate.
Q8. Can a field sales representative of Company B conduct an informationalpresentation accompanied by a meal for a health care professional in a
restaurant down the street from a hospital?
A. N
 o. An informational presentation or discussion conducted by a field sales
representative or their immediate manager may only be accompanied
occasionally by a meal if the presentation is held in the health care professional’s
office or hospital. This is to ensure that any meal offered by field sales
representatives or their managers is merely incidental to a substantive21

 interaction with a health care professional in the office or hospital setting where
the health care professional typically conducts professional conversations. In
addition, any meal offered must be modest as judged by local standards; thepresentation must not be part of an entertainment or recreational event; andthe presentation must be provided in a manner conducive to informational
communication. If a health care professional does not have an office conducive to
informational communication, then a presentation may be provided in a hospitalcafeteria or other meeting space within the hospital and may be accompanied bya modest meal.
Q9. A field sales representative of Company X provides pizza for a medical
office during lunch time. Is this consistent with the Code?
A. Providing an occasional meal would be consistent with the Code if the sales
representative provides an informational presentation to the medical staff
in conjunction with the meal of modest value, the meal is not part of anentertainment or recreational event, and there is a reasonable expectation, andreasonable steps are taken to confirm, that each attendee receiving a meal
has a substantive interaction or discussion with the company representative.
Merely dropping off food or offering “grab-and-go” meals, however, would not be
consistent with the Code.
Q10. A field sales representative of Company X invites physicians to meet tohear a scientific and educational presentation about a new drug at thecafé at a nearby bookstore. Lunch is provided by the representative and,following the presentation (which is in small groups), each physician isgiven a gift certificate for books in the amount of $30. Does this conformto the Code?
A. N
 o. While the presentation may present scientific or educational information, acompany field sales representative should not provide even a modest meal tohealth care professionals outside of the office or hospital setting (except where
the field sales representative attends a company-sponsored speaker program toprovide logistical support and help monitor compliance with FDA requirements– see Question 13 below). In addition, an open-ended gift certificate is a cash
equivalent. A medical textbook, a book on patient care, or a gift certificate
redeemable solely for a medical textbook or book on patient care could be
provided if it is not of substantial value ($100 or less).
Q11. A district sales manager at Company C invites 30 physicians to a corporate
suite at a professional baseball game for a 45-minute scientific andeducational presentation followed by a buffet and the three-hour game.
Does this conform to the Code?

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A. N
 o. The provision of entertainment and/or recreational activities, including
entertainment at sporting events in connection with an educational or scientificpresentation or discussion, is inconsistent with the Code. In addition, under
the Code, informational presentations by company representatives or their
immediate managers in field sales organizations may only be accompanied
by an incidental, modest meal if the presentations occur in the health care
professional’s office or hospital setting.
Q12. Under the Code, could a senior business executive employed by acompany provide a health care professional with an occasional mealoutside of the health care professional’s office or hospital?
A. The Code does not prohibit company employees other than field sales
representatives or their immediate managers from providing an occasional meal
incidental to a substantive interaction with a health care professional outsideof their office or hospital, as long as (1) the meal is modest as judged by local
standards; (2) the meal is not part of an entertainment or recreational event; and(3) the interaction takes place in a venue and manner conducive to informational
communication.
Q13. Company Y would like to engage an expert physician to discuss recent
advances in therapy for a group of local health care professionals andwould like to meet and provide a meal to attendees in the private roomof a local restaurant. Under what circumstances can this comply with
the Code? Could a local field representative in the company’s salesorganization attend the event for purposes of assisting the outside
speaker and helping to ensure that the content of the presentation
complies with FDA requirements?
A. T
 he Code contemplates that a company may engage a health care professional
to provide medical or scientific information to a group of health care professionals
on behalf of the company. Such speaker programs may include meals that aremodest as judged by local standards offered to attendees and may occur inlocations outside of the office or hospital setting, as long as they occur in a venue
and manner conducive to informational communication. The venue should not
be extravagant or the main attraction of the event or perceived as such. Luxury
resorts, high-end restaurants, and entertainment, sporting, or other recreational
venues or events are not appropriate. In this case, Company Y’s chosen location ofa private room in a local restaurant may be conducive to informational discussion.
The chosen restaurant should not be high-end, the meal provided to attendees
should be modest as judged by local standards and subordinate in focus andincidental to the educational presentation, and the company should not pay for23or provide alcohol in connection with the speaker program. In addition, Company
Y should adhere to the other provisions of Section 7 of the Code on speakerprograms.
Q14. Under what circumstances would the Code permit a company to provide
entertainment or recreational activities to health care professionals?
A. U
 nder the Code, companies may not provide entertainment or recreational
activities to health care professionals who are not employees of the companies
in any context, including situations where those professionals are providing
a legitimate service to the companies, such as when they act as bona fideconsultants on an advisory board or are trained at a speaker training meeting.
Thus, companies should not invite health care professionals to sporting events,
concerts, or shows, or provide them with recreational activities, such as hunting,fishing, boating, or ski trips, or golf outings, even if those entertainment eventsor recreational activities are intended to facilitate informational interchanges
between the company representative and the health care professional.
Similarly, it would be inappropriate to provide these types of entertainment andrecreational events in conjunction with promotional scientific presentations by
medical experts.
Q15. Company A retains a small group of 15 nationally known physicians
regarding a therapeutic area relevant to Company A’s products to advise
on general medical and business issues and provide guidance on productdevelopment and research programs for those products. These physicians
are paid fees that are typical of the fees paid to thought leaders in thistherapeutic area. They normally meet once or twice a year at luxury
resort locations to discuss the latest product data, research programs,
and company plans. Does this comply with the Code? If it does, is it
appropriate to pay for the significant other of the health care professional
to attend as well?
A. N
 o. This arrangement for engaging health care professionals to obtain advice on
the company’s commercial operations does not appear to comply with the Code.
It is appropriate for companies to engage health care professionals to provide
bona fide advisory services as long as the number of health care professionals
is reasonably necessary to achieve an identified purpose, and the health care
professionals are paid compensation that is reasonable and based on fair market
value for the services provided and that does not take into account the volume
or value of past or potential future business generated for the company by thehealth care professional. It would not be appropriate, however, to hold such a
consultant meeting at a luxury resort venue. In this case, the number of advisors
seems reasonably small and the scope of services seems to be reasonably well24defined. The advisors seem to have been selected based on their expertise in
the areas where advice is needed. The compensation appears consistent with
the Code’s provision that consultant fees should be reasonable and based onfair market value and not take into account the volume or value of past businessthat may have been or potential future business that could be generated forthe company by the health care professional. Nevertheless, holding consultant
meetings at luxury resort locations is not appropriate under the Code. The facilities
chosen should be conducive to the services provided as well as reasonable andappropriate to the conduct of the meeting. In addition, only meals that aremodest as judged by local standards may be offered to such consultants, andcompanies should not provide recreational or entertainment events to the healthcare professional consultants in conjunction with these meetings. It would not beappropriate to pay for the cost of the advisor’s significant other. If the significant
other attends, it should be at the cost of the advisor.
Q16. Company A considers whether to invite 300 physicians/consultants toa two-day and one-night speaker-training program at a regional golf
resort. All attendees would be compensated for their participation, andtheir expenses would be reimbursed. Prospective speakers would beselected based on recommendations of the company’s district managers
and an assessment of their qualifications by the company’s medical orscientific personnel. Each of the attendees would be required to sign anagreement in advance covering the services they will provide. They would
be educated by a faculty on the full range of data surrounding the diseasestate and the company’s drug product, on presentation skills, and on
FDA regulatory requirements. The company needs to train 300 speakers
in order to ensure that enough speakers will actually be available whenneeded. Training sessions take both days, and the company provides fora few hours of golf and expensive meals, such as lobster and filet mignon.
Does this program conform to the Code? If so, is it appropriate to pay for ahealth care professional’s significant other as well?
A. No. This arrangement would not conform with the Code. Speaker training isan essential activity because the FDA holds companies accountable for thepresentations of their speakers. However, the Code provides that speakertraining meetings should be held at appropriate venues that are conducive
to informational communication and training about medical information andspecifically states that luxury resorts are not appropriate venues for training
speakers. Moreover, providing entertainment (e.g., golf) and expensive meals toa health care professional in a speaker training program would not comply with
the Code, although meals that are modest as judged by local standards may beoffered to attendees. The company does appear to satisfy provisions in the Codethat require potential speakers to be selected based on defined criteria such as

25

medical expertise, knowledge, and experience and to undergo extensive trainingthat would result in a valuable service being provided to the company. The
arrangement also appears to meet reasonable indicia of a bona fide consulting
relationship. The number of speakers being trained is important; if significantly
more participants were trained than the company plans to use as speakers,
this arrangement would not comply with the Code. The amount of time spent
training speakers should be reasonable in relation to the material that has to becovered. The compensation and lodging offered to prospective speakers should be
evaluated to ensure that it is reasonable compensation for their time and basedon fair market value and not determined in a manner that takes into account thevolume or value of past business that may have been or potential future businessthat could be generated for the company by the health care professional. It would
not be appropriate to pay for the cost of the health care professional’s significant
other. If the significant other attends, it should be at the cost of the health care
professional.
Q17. A sales representative invites a physician out for a round of golf and lunch
following the golf. The physician is very busy and is difficult to see in theiroffice. The cost of the golf and the lunch combined are $65. Does thiscomply with the Code?
A. N
 o. It is inconsistent with the Code to provide entertainment or recreational
activities, such as golf, to any health care professional who is not an employee ofthe company. In addition, occasional, modest meals provided by a representativeor their immediate manager working in a field sales organization are limited toin-office or in-hospital settings in conjunction with informational presentations
and discussions.
Q18. Under the Code, may a health care professional’s significant otheror guest be included in a meal with a pharmaceutical company
representative that is provided in connection with an informationalpresentation by or on behalf of the company, if the health care
professional pays for the significant other or guest?
A. No. The Code provides that it is not appropriate to include a significant other orguest at a meal in connection with an informational presentation, regardlessof who pays for their meal, unless the significant other or guest would
independently qualify as a health care professional for whom the informationalpresentation is appropriate.
Q19. A company is asked to fund a CME program as a “platinum” levelsupporter. This level of support includes the opportunity for the company
to directly sponsor a lunch at the event. May the company become a“platinum” level supporter?

26

A. It is appropriate under the Code for a company to provide funding to a CME
provider, which the provider can use at its discretion to provide meals for allparticipants. However, a company should not control how the provider uses thefunding, and a company should not sponsor or host a meal directly at a CME
program. A company may fund a CME program at a particular level of support
designated by the CME provider and be publicized for providing that level of
support, as long as the company does not separately promote, publicize, orotherwise take advantage of any option to be identified as the sponsor of a meal.
Q20. A national specialty society is holding its three-day annual conference,
which includes business meetings, entertainment, and a half day ofeducational programs for which physicians may receive CME credit. May acompany sponsor a reception or lunch at the conference?
A. The Code provides that a company should not provide or sponsor meals directly
at CME events. However, at third-party conferences or professional meetings
at which CME activities comprise only a part of the conference or meeting, acompany may sponsor a meal or reception at the conference if it is permitted by
the group holding the conference or meeting and is clearly separate from the
CME portions of the program. In such cases, any meals or receptions sponsoredby a company should be modest and clearly subordinate to the amount of timespent at other aspects of the meeting. In addition, companies should be mindfulof standards set forth by ACCME or other accrediting bodies that may apply inthese circumstances.
Q21. May a company publicize its interest in a general topic for a CME program
for which a grant would be provided?
A. Yes. A company may communicate to multiple CME providers or the publica general topic for a CME program that might be of interest to physicians. For
example, a company may publicize that it will consider funding the topics of
new treatments or disease management techniques in a particular therapy
area such as diabetes or hypertension. However, the company should follow
CME accreditation standards considering the nature and specificity of the CME
topics that the company may propose, keeping in mind the Code’s statementthat financial support for CME is intended to support education on a full rangeof treatment options and not to promote a particular medicine. In addition, thecompany may not suggest the speakers or review or make any suggestions
concerning the specific content of a particular CME program, even if asked by the
CME provider.

27

Q22. Under the Code, may a company make a charitable contribution suchas purchasing a table at a fundraising dinner or a foursome slot at afundraising golf tournament?
A. Y
 es, but the company may not invite health care professionals to attend theevent at its expense. The company may use some or all of its allotment for its own
employees and return any unused portion to the sponsoring organization to use
as it wishes.
Q23. Under the Code, may a company compensate a consultant for bona fideservices by providing an item with a legitimate patient benefit in lieu of
paying an honorarium or fee?
A. If the consulting arrangement otherwise complies with the Code, the fairmarket value of the item represents reasonable compensation for the services
provided, and the item does not otherwise take into account the volume orvalue of past business that may have been or potential future business that
could be generated for the company by the health care professional, this may
be permissible. However, it would be important to comply with all applicable
recordkeeping and reporting requirements, just as with cash compensation. The
written agreement for the consulting services should set forth the compensationand its fair market value, and disclose that this is taxable income.
Q24. Does the Code apply to interactions with physician office managers,
receptionists, and similar personnel who may not be health care
professionals?
A. A
 lthough the Code does not directly apply to persons who are not health care
professionals, it would be difficult to separate a company’s interactions with anyof a physician’s employees from those directly with the physician. Therefore, theCode should be followed under these circumstances.
Q25. Does the Code address the issue of disclosure of company interactions
with health care professionals who are members of committees thatdevelop formularies or clinical practice guidelines?
A. Y es. The Code states that, to avoid even the appearance of impropriety,companies that have retained a health care professional member of a formulary
or clinical practice guidelines committee as a commercial consultant or speakershould require the health care professional to disclose to the committee theexistence and nature of their relationship with the company. This disclosure
requirement should extend for at least two years beyond the termination of any

28

consultant or speaker arrangement. Upon disclosure, health care professionals
should be required to follow the procedures set by the committee of which
they are a member; these procedures may include a requirement that healthcare professionals recuse themselves from decisions relating to the medicine
about which they provided speaking or consulting services. It is reasonable
for a company to rely on health care professionals’ judgment regarding how
to implement these requirements regarding disclosure and subsequentinteractions with the committees on which they are members.

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