CODE ON INTERACTIONS

CODE ON

INTERACTIONS

with Health Care Professionals

TABLE OF CONTENTS

Preamble 2

1. Basis of Interactions 4

2. Informational Presentations by Pharmaceutical Company

Representatives and Accompanying Meals 4

3. Prohibition on Entertainment and Recreation 5

4. Pharmaceutical Company Support For Continuing

Medical Education 5

5. Pharmaceutical Company Support for Third-Party Educational

or Professional Meetings 6

6. Consultants 7

7. Speaker Programs and Speaker Training Meetings 9

8. Health Care Professionals Who Are Members of Committees

That Set Formularies or Develop Clinical Practice Guidelines 10

9. Scholarships and Educational Funds 11

10. Prohibition of Non-Educational and Practice-Related Items 11

11. Educational Items 12

12. Prescriber Data 12

13. Independence and Decision Making 13

14. Training and Conduct of Company Representatives 13

15. Adherence to Code 14

Questions and Answers 15

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

of helping patients by developing and marketing new medicines. An important

part of achieving this mission is ensuring that healthcare professionals

have the latest, most accurate information available regarding prescription

medicines, which play an ever-increasing role in patient healthcare. This

document focuses on our interactions with health care professionals that

relate to the marketing of our 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 to achieving these goals because they enable us to—

• inform 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

• obtain feedback and advice about our products through consultation

with medical 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 our

intention that our interactions with healthcare 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’s

care of patients should be based, and should be perceived as being based, solely

on each patient’s medical needs and the health care professional’s medical

knowledge and experience.

Therefore, PhRMA adopts this updated and enhanced voluntary Code

on relationships with U.S. health care professionals. This Code reﬂects

and builds upon the standards and principles set forth in its predecessor,

the PhRMA Code on Interactions with Health Care Professionals that took

effect on July 1, 2002. Like the 2002 edition, this Code addresses interactions

with respect to marketed products and related pre-launch activities.

PhRMA member companies’ relationships with clinical investigators and

other individuals and entities 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 took effect January 2009 and was last revised September

2019.

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 and supporting

medical education.

Promotional materials provided to health care professionals by or on behalf

of a company should: (a) be accurate and not misleading; (b) make claims

about a product 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

and others speaking on behalf of a company 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 for

occasional meals to be offered as a business courtesy to the health care

professionals as well as members of their staff attending presentations, so

long as the presentations provide scientiﬁc or educational value and the

meals (a) are modest as judged by local standards; (b) are not part of an

entertainment or recreational event; and (c) are provided in a manner conducive

to informational communication.

Any such meals offered in connection with informational presentations

made by ﬁeld sales representatives or their immediate managers should

also be limited to in-ofﬁce or in-hospital settings.

Inclusion of a health care professional’s spouse or other guest in a meal

accompanying an informational presentation made by or on behalf of a

company is not appropriate. Offering “take-out” meals or meals to be eaten

without a company representative being present (such as “dine & dash”

programs) is not appropriate.

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

information that will beneﬁt patient care. To ensure the appropriate focus on

education and informational exchange and to avoid the appearance of

impropriety, companies should not provide any entertainment or recreational

items, such as tickets to the theater or sporting events, sporting equipment,

or leisure or vacation trips, to any healthcare professional who is not a salaried

employee of the company. Such entertainment or recreational beneﬁts should

not be offered, regardless of (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 or recreation is secondary to an educational purpose.

Modest, occasional meals are permitted as long as they are offered in the

appropriate circumstances and venues as described in relevant sections of this

Code.

4. Pharmaceutical Company Support for

Continuing 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 for making CME grant decisions to ensure that the program funded by

the company is a bona ﬁde educational program and that the ﬁnancial support

is not an inducement to prescribe or recommend a particular medicine or

course of 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 support

should be given to the CME provider, which, in turn, can use the money to

reduce 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

the selection of content, faculty, educational methods, materials and venue

belongs to the organizers of the conferences or meetings in accordance with

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

other personal expenses of non-faculty health care professionals attending

CME, either directly to the individuals participating in the event or indirectly

to the event’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 a company for a CME event to provide meals for all participants.

5. Pharmaceutical Company Support for Third-

Party 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 at

an appropriate location (typically limited to the health care professional’s

country of practice unless there are security or logistical concerns, which

would include international scientiﬁc congresses and symposia), where (a) the

gathering is primarily dedicated, in both time and effort, to promoting objective

scientiﬁc and educational activities and discourse (one or more educational

presentation(s) should be the highlight of the gathering), and (b) the main

incentive for bringing attendees together is to further their knowledge on

the topic(s) being presented.

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 support

should be given to the conference’s sponsor, which, in turn, can use the

money to reduce the overall conference registration fee for all attend-ees.

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 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

other personal 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.

6. Consultants

Consulting arrangements with health care professionals allow companies to

obtain information or advice from medical experts on such topics as the

marketplace, 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 of

treatment.

It is appropriate for consultants who provide advisory services to be offered

reasonable 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.

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 existence

of 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 be

provided and the basis for payment of those services;

• a legitimate need for the consulting services has been clearly identiﬁed

in advance of requesting the services and entering into arrangements

with the prospective consultants;

• the criteria for selecting consultants are directly related to the identiﬁed

purpose and the persons responsible for selecting the consultants

have the expertise necessary to evaluate whether the particular healthcare

professionals meet those criteria;

• the number of health care professionals retained is not greater than the

number reasonably necessary to achieve the identiﬁed purpose;

• the retaining company maintains records concerning and makes

appropriate use of the services provided by consultants;

• the 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; speciﬁcally, resorts are not

appropriate venues.

While modest meals or receptions may be appropriate during company

sponsored meetings with health care professional commercial consultants,

companies should not provide recreational or entertainment 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-sponsored

meetings, including attendees who participate in interactive sessions.

7. Speaker Programs and Speaker Training

Meetings

Health care professionals participate in company-sponsored speaker programs

in order to help educate and inform other health care professionals about the

beneﬁts, risks and appropriate uses of company medicines. Any health care

professional engaged by a company to participate in such external promotional

programs on behalf of the company will be deemed a speaker for purposes of

this Code, and the requirements of Section 7 apply to company interactions

with that health care professional in his or her capacity as a speaker. 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.

Speaker training is an essential activity because the FDA holds companies

accountable for the presentations of their speakers. It is appropriate for health

care professionals who participate in programs intended to train speakers for

company-sponsored speaker programs to be offered reasonable compensation

for their time, considering the value of the type of services provided, 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 or

other speciﬁc topic to be presented and on compliance with FDA regulatory

requirements for communications; (2) this training will result in the participants

providing a valuable service to the company; and (3) the participants meet the

general criteria for bona ﬁde consulting arrangements (as discussed in Section

6 above). Speaker training sessions 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 com-

munication and training about medical information; speciﬁcally, resorts are not

appropriate venues.

Any compensation or reimbursement made to a health care professional in

conjunction with a speaking arrangement should be reasonable and based

on fair market value. Each company should, individually and independently,

cap the total amount of annual compensation it will pay to an individual

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. Speaker programs

may include modest meals offered to attendees and should occur in a venue and

manner conducive to informational communication.

While speaker programs offer important educational opportunities to health care

professionals, they are distinct from CME programs, and companies and speakers

should be clear about this distinction. For example, speakers and their materials

should clearly identify the company that is sponsoring the presentation, 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, companies should periodically monitor speaker

programs for compliance with FDA regulatory requirements for communications

on behalf of the company about its medicines.

8. Health care Professionals Who are Members of

Committees That Set Formularies or Develop

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 for companies. To

avoid even the appearance of impropriety, companies should require any healthcare

professional who is a member of a committee that sets formularies or develops

clinical guidelines and also serves as a speaker or commercial consultant for the

company to disclose to the committee the existence and nature of his or her rela-

tionship 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 consultants

for companies should be required to follow the procedures set forth by the

committee of which they are a member, which may include recusing themselves

from decisions relating to the medicine for which they have provided speaking or

consulting services.

9. Scholarships and Educational Funds

Financial assistance for scholarships or other educational funds to permit

medical students, residents, fellows and other health care professionals in

training to attend carefully selected educational conferences may be offered

so long as the selection of individuals who will receive the funds is made by

the academic or training institution. “Carefully selected educational conferences”

are generally deﬁned as the major educational, scientiﬁc or policymaking

meetings of national, regional or specialty medical associations.

10. Prohibition of Non-Educational and Practice-

Related Items

Providing items for health care professionals’ use that do not advance

disease or treatment 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 with health care professionals are not based on informing them

about medical and scientiﬁc issues. Such non-educational items should not

be offered to health care professionals or members of their staff, even if they

are accompanied by patient or physician educational materials.

Items intended for the personal beneﬁt of health care professionals (such

as ﬂoral arrangements, artwork, music CDs 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 as

compensation 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.

11. Educational Items

It is appropriate for companies, where permitted by law, to offer items designed

primarily for the education of patients or healthcare professionals if the items

are not of substantial value ($100 or less) and do not have value to health care

professionals outside of his or her professional responsibilities. For example, an

anatomical model for use in an examination room is intended for the education

of the patients and is therefore appropriate, whereas a DVD or CD player may

have independent value to a health care professional outside of his or her

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 enabling

companies to: (a) impart important safety and risk information to prescribers

of a particular drug; (b) conduct research; (c) comply with FDA mandated risk

management plans that require drug companies to identify and interact with

physicians who prescribe certain drugs; (d) track adverse events of marketed

prescriptions drugs; and (e) focus marketing activities on those health care

professionals who would most likely beneﬁt from information about a particular

drug.

Companies that choose to use non-patient identiﬁed prescriber data to facilitate

communications 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 his or her prescriber data not be made available

to company sales representatives. Companies may demonstrate this respect

by following the rules of voluntary programs that facilitate prescribers’ ability to

make this choice.

13. Independence and Decision Making

No grants, scholarships, subsidies, support, consulting contracts or educational

or practice related items should be provided or offered to a health care

professional in exchange for prescribing products or for a commitment to

continue prescribing products. Nothing should be offered or provided in a

manner or on conditions that would interfere with the independence of a health

care 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 the

approved indications, beneﬁts and risks of pharmaceutical therapies. These

representatives often serve as the primary point of contact between the

companies who research, develop, manufacture and market life-saving and

life-enhancing medicines and the health care professionals who prescribe

them. As such, the company representatives must act with the highest

degree of professionalism 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 health care professionals. In addition, companies should train their

representatives to ensure that they have sufﬁcient knowledge of general science

and product-speciﬁc information to provide accurate, up-to-date information,

consistent with FDA requirements.

Companies should provide updated or additional training in all of these

areas as needed for their representatives who visit health care professionals.

Companies should also assess their representatives periodically to ensure that

they comply with relevant company policies and standards of conduct.

Companies should take appropriate action when representatives fail to comply.

15. Adherence to Code

All companies that interact with health care professionals about pharmaceuticals

should adopt procedures to assure adherence to this Code.

Companies that publicly announce their commitment to abide by the Code and

who complete an annual certiﬁcation that they have policies and procedures in

place 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

who commit to abide by the Code; provide contact information for their Chief

Compliance Ofﬁcers; and, at the appropriate time, publish the status of each

company’s annual certiﬁcation.

Any comments received by PhRMA relating to a company’s observance of the

Code or conduct that is addressed by the Code will be referred by PhRMA to the

relevant 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 and

procedures in place to foster compliance with the Code. PhRMA will prepare

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 and

procedures from an external source.

PhRMA Code

QUESTIONS & ANSWERS

Q1. Under the Code, may items such as stethoscopes be offered

to health care professionals?

A. No. Under the Code only items designed primarily for the education of

patients or health care professionals may occasionally be offered to health

care professionals, if the items are not of substantial value and do not have a

value to health care professionals outside of their professional responsibilities.

While medical equipment, such as stethoscopes, obviously plays an important

role 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 health

care 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 ofﬁce

along with brochures that provide educational information about the

company’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

product names 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 distribute educational 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.

Q3. Under the Code, what are examples of permissible items that

may be provided to educate health care professionals?

A. The Code states that it is appropriate for companies, where permitted by law,

to occasionally offer items primarily designed for the education of patients

or healthcare professionals, as long as such items are not of substantial value

($100 or less) and do not have avalue to the health care professionals outside

of their professional responsibilities. For example, companies may provide

educational items such as a medical text book, a subscription to a relevant

scientiﬁc 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 their

patients?

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 the

availability 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 patients to assist in the administration of their treatment

or management of their conditions. Such items should only be provided

to health care professionals for patients where the items are permitted by

law, may be considered essential to proper treatment or compliance and

where delivery through a health 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 the patients’

appropriate use of the prescribed medicine. Providing non-educational items

to health care professionals for patient 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 bear

a company or product name?

A. No. As stated in the prior version of the Code, golf balls and sports bags, even if

of minimal value, do not advance disease or treatment 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. No. As stated in the prior version of the Code, 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. Such

modest meals may only be offered provided that the manner of presentation

is conducive to a scientiﬁc or educational interchange and is not part of an

entertainment or recreational event. For example, a sales representative who is

providing scientiﬁc or educational information regarding a company’s products

to one or a few health care practitioners working in the same ofﬁce, could provide

a modest meal (e.g., sandwiches or pizza) to physicians and staff attending the

representative’s informational presentation in the physician’s ofﬁce at lunch time.

Providing such modest meals on more than an occasional basis would not be

appropriate.

Q8. Can a ﬁeld sales representative of Company B conduct an informational

presentation accompanied by a meal for a health care professional in a

restaurant down the street from a hospital?

A. No. An informational presentation or discussion conducted by a ﬁeld sales

representative or her 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 substantive 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; the presentation

must not be part of an entertainment or recreational event; and the presentation

must be provided in a manner conducive to informational communication. If a

hospital practitioner does not have an ofﬁce conducive to informational

communication, then a presentation may be provided in a hospital cafeteria or

other meeting space within the hospital and may be accompanied by a modest

meal.

Q9. A ﬁeld sales representative of Company X provides pizza for the staff of 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 will provide an informational presentation to the medical staff in

conjunction with the meal of modest value, so long as the location of the in-ofﬁce

presentation is conducive to scientiﬁc or educational communication. Merely

dropping off food for the ofﬁce staff, however, would not be consistent with the

Code.

Q10. A ﬁeld sales representative of Company X invites physicians to meet to

hear a scientiﬁc and educational presentation about a new drug at the

café at a nearby bookstore. Lunch is provided by the representative and,

following the presentation (which is in small groups), each physician is

given a gift certiﬁcate for books in the amount of $30. Does this conform

to the Code?

A. No. While the presentation may present scientiﬁc or educational information,

a company ﬁeld sales representative should not provide even a modest meal

to health care professionals outside of the ofﬁce or hospital setting (except

under the limited circumstances where the ﬁeld sales representative attends

a company sponsored speaker program to provide 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 and

educational presentation followed by a buffet and the three-hour game.

Does this conform to the Code?

A. No. The provision of entertainment and/or recreational activities, including

entertainment at sporting events in connection with an educational or scientiﬁc

presentation or discussion, is inconsistent with the Code, just as in the prior

version. In addition, under the Code, informational presentations by company

representatives or their immediate managers in ﬁeld sales organizations may

only be accompanied by a 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 a

company provide a health care professional with an occasional meal

outside 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 outside of

his or her 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, and

would like to meet and provide a meal to attendees in the private room

of a local restaurant. Under what circumstances can this comply with

the Code? Could a local ﬁeld representative in the company’s sales

organization attend the event for purposes of assisting the outside

speaker and helping to assure that the content of the presentation

complies with FDA requirements?

A. The 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 modest meals

offered to attendees and may occur in locations outside of the ofﬁce or hospital

setting, as long as they occur in a venue and manner conducive to informational

communication. In this case, Company Y’s chosen location of a private room

in a local restaurant may be conducive to informational discussion, and the

meal provided to attendees should be modest as judged by local standards. In

addition, Company Y should follow the provisions of Section 7 of the Code on

speaker programs. For example, Company Y should make sure that the speaker

is appropriately trained and that the speaker and her materials clearly identify the

company sponsoring the presentation and the fact that the speaker is presenting

on behalf of the company. In addition, Company Y should periodically monitor

its speaker programs for compliance with FDA regulatory requirements. It would

be appropriate for a local ﬁeld representative in the company’s sales organization

to attend a speaker program for purposes of assisting the speaker with logistics

and helping to assure that the content of the presentation complies with FDA

requirements.

Q14. Under what circumstances would the Code permit a company to provide

entertainment or recreational activities to health care practitioners?

A. Under the Code, companies may not provide entertainment or recreational

activities to health care practitioners who are not employees of the companies

in any context, including situations where those practitioners are providing

a legitimate service to the companies, such as when they act as bona ﬁde

consultants 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, ski trips, or golf outings, even if those entertainment events

or 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 and

recreational 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 product development and research programs for those products.

These physicians are paid fees that are typical of the fees paid to thought

leaders in this therapeutic area. They normally meet once or twice a year

at 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 spouse of the health care professional to attend,

as well?

A. No, 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 healthcare

professionals is reasonably necessary to achieve an identiﬁed purpose, and

they are paid compensation that is reasonable and at fair market value for the

services provided. It would not be appropriate, however, to hold such a consultant

meeting at a resort venue. In this case, the number of advisors seems reasonably

small and the scope of services seems to be reasonably well 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 on fair market value.

Nevertheless, holding consultant meetings at resort locations is not appropriate

under the Code. The facilities chosen should be conducive to the services provided

as well as reasonable and appropriate to the conduct of the meeting. In addition,

only modest meals may be offered to such consultants, and companies should

not provide recreational or entertainment events to the health care professional

consultants in conjunction with these meetings. It would not be appropriate to

pay for the cost of the spouse of the advisor. If the spouse attends, it should be at

the cost of the advisor.

Q16. Company A considers whether to invite 300 physicians/consultants to

a two-day and one-night speaker-training program at a regional golf

resort. All attendees would be compensated for their participation, and

their expenses would be reimbursed. Prospective speakers would be

selected based on recommendations of the Company’s district managers

and an assessment of their qualiﬁcations by the Company’s medical or

scientiﬁc personnel. Each of the attendees would be required to sign an

agreement in advance covering the services they will provide. They would

be educated by a faculty on the full range of data surrounding the disease

state 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 when

needed. Training sessions take both days, and the Company provides for

a 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 a

spouse of the healthcare professional, as well?

A. No. This arrangement would not conform with the Code. Speaker training is

an essential activity because the FDA holds companies accountable for the

presentations of their speakers. However, the Code provides that speaker training

meetings should be held at appropriate venues and speciﬁcally states that

resorts are not appropriate venues for training speakers. Moreover, providing

entertainment (e.g., golf) and expensive meals to a healthcare professional in a

speaker training program would not comply with the Code, although modest

meals may be offered to attendees. The Company does appear to satisfy

provisions in the Code that require potential speakers to be selected based on

deﬁned criteria such as medical expertise, knowledge and experience and to

undergo extensive training that 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 be covered. The compensation and lodging offered

to prospective speakers should be evaluated to assure that it is reasonable

compensation for their time and based on fair market value. It would not be

appropriate to pay for the cost of the spouse of the health care professional. If the

spouse 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 her

ofﬁce. The cost of the golf and the lunch combined are $65. Does this

comply with the Code?

A. No. As stated in the prior version of the Code, it is inconsistent with the Code

to provide entertainment or recreational activities such as golf. In addition,

occasional, modest meals provided by a representative or his immediate

manager working in a ﬁeld sales organization are limited to in-ofﬁce or in-

hospital settings in conjunction with informational presentations and discussions.

Q18. Under the Code, may a health care professional’s spouse or other guest

be included in a meal with a pharmaceutical company representative that

is provided in connection with an informational presentation by or on

behalf of the company, if the health care professional pays for the spouse

or guest?

A. No. The Code provides that it is not appropriate to include a spouse or guest

at a meal in connection with an informational presentation, regardless of who

pays for their meal, unless the spouse or guest would independently qualify as a

healthcare professional for whom the informational presentation is appropriate.

Q19. A company is asked to fund a CME program as a “platinum” level

supporter. 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?

A. It 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 all

participants. However, a company should not control how the provider spends

the funding, 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 or

otherwise 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 of

educational programs for which physicians may receive CME credit. May a

company 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, a

company 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 sponsored

by a company should be modest and clearly subordinate to the amount of time

spent at other aspects of the meeting. In addition, companies should be mindful

of standards set forth by ACCME or other accrediting bodies that may apply in

these 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 public a

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 statement

that ﬁnancial support for CME is intended to support education on a full range

of treatment options and not to promote a particular medicine. In addition, the

company 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.

Q22. Under the Code, may a company make a charitable contribution such as

purchasing a table at a fundraising dinner or a foursome slot at a fundraising

golf tournament?

A. Yes, but the company may not invite healthcare professionals to attend the event

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 ﬁde

services 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, and the fair

market value of the item represents reasonable compensation for the services

provided, 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 compensation and 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 healthcare

professionals?

A. Although 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 any

of a physician’s employees from those directly with the physician. Therefore, the

Code 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 that

develop formularies or clinical practice guidelines?

A. Yes. 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 speaker

should require the health care professional to disclose to the committee the

existence and nature of his or her relationship with the company. This disclosure

requirement should extend for at least two years beyond the termination of any

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 subsequent

interactions with the committees on which they are members.

950 F Street, NW

Suite 300

Washington, DC 20004