Inspire Code of Conduct: Promotional Interactions with Health Care Professionals

The Pharmaceutical Research and Manufacturers of America (PhRMA) voluntary Code on Interactions with Healthcare Professionals is designed to assist manufacturers in complying with applicable laws and ethical obligations. Parts of this policy are based upon the PhRMA Code, which addresses gifts, conferences, meals, entertainment, and other areas. Other portions of this policy are based upon the Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers and related authorities.

Knowledge of and compliance with this policy is a requirement of employment for Inspire employees who interact with HCPs in the promotion of our marketed products. Failure to comply with this policy will result in disciplinary action up to and including termination. Before engaging in any activity of which you are unsure, please contact your Regional Sales Director for guidance.

A. Educational and Practice-Related Items
In general, items for the personal benefit of HCPs are prohibited, as are cash or gift certificates (unless the certificate is designated solely for a medically relevant item). Only two types of items can appropriately be given to HCPs, and different rules cover each.

1) Items benefiting the HCP's patients: Medically-relevant gifts (valued at $100 or less) primarily benefiting patients are acceptable, but only if provided on an occasional basis.

2) Items benefiting the HCP's practice: Only reminder items of nominal value (pens, notepads, etc. with product name) can be provided. Promotional reminder items are to be developed and approved by Marketing, Clinical, Legal and Compliance functions. Promotional reminder items are not to be developed by the field. The following are examples of acceptable and unacceptable items:

B. Meals and Entertainment
Occasional, modest meals, as judged by local standards, are permitted provided that they are accompanied by a presentation or scientific or educational discussion and provided that the venue is conducive to such an informational exchange. Take-out meals and meals for non-HCPs (including spouses, guests or families) are not permitted. Individual representatives should not invite HCPs to sporting events, concerts or shows, or provide them with recreational activities such as golf, skiing, fishing, hunting, spa, etc. Entertainment and recreational events are not allowed, unless the HCP is providing legitimate services to the Company such as bona fide consultation with a signed consulting agreement (see below), or the HCP is being trained at a speaker-training meeting and meets other speaker-trainee requirements (consulting contract and the like). In these situations, any entertainment or recreation must be modest and subordinate in time and focus to the educational and scientific activities of the meeting. The following are examples of acceptable and unacceptable meals/entertainment:

C. Conferences/Educational Meetings (including CME)
CME or other third-party scientific and educational conferences or professional meetings can contribute to patient care, and therefore, financial support is permitted. All Company contributions to defray the costs for meals, tuition, etc. must be paid directly to the third-party organizing group. The organizing group, not the Company, should control content, faculty, materials, venue, etc. The Company can directly host modest, appropriate meals or receptions if the organizer guidelines are met AND the time spent at the meal or reception is clearly less than time spent at educational programs. This section covers third party professional meetings, such as national or regional medical associations or specialty societies, or organizations with an educational mission, such as universities. These should be distinguished from meetings by customers, such as a group of private physicians, to which Company contributions would be inappropriate.

D. Consulting Arrangements
Reasonable compensation (including reasonable travel expenses) may be paid to HCPs who provide legitimate consulting services to the Company. Documentation should be maintained of the method for calculating the fair market value of the consultant's services. In addition, the consulting arrangement must include:

• Written signed contract (provided by Home Office and executed in accordance with Company policies and procedures).
• There must be a legitimate need for the consultant's services, identified in advance and stated in the written contract.
• The criteria for selecting the consultant must be related to the purpose of the services (for example, consultants should be chosen for their medical expertise, and not as an inducement to prescribe products). Consultants must be selected by clinical as well as any marketing or sales personnel.
• The number of consultants retained cannot exceed the number needed to achieve the identified purpose of the consulting agreement.
• All consultants must be utilized, and all of their services must be documented.
• The venue and circumstances of any meetings with consultants should be conducive to their services; any social events, including modest entertainment or recreational activities, must be clearly secondary (proportionally in time and purpose).
  

The Company cannot pay for non-HCPs (including spouses or families) to attend consultant meetings. If non-HCPs (including spouses or families) attend meetings, it is at the HCP's personal expense.

E. Speaker Training Programs
HCPs who participate in programs intended to recruit and train speakers for Company-sponsored speakers programs may receive reasonable compensation for their time and reasonable travel expenses, provided that:

• All speaker-trainees meet the same criteria as consultants, as stated above, for example, no more speakers should be trained than the Company anticipates using, fair market value must be documented, etc.
• The speakers receive extensive training on our products and on FDA's requirements for communications on such products.
• The training will result in the participants providing a valuable and needed service to the Company.
  

F. Educational Grants
The Company may provide grants to support bona fide educational activities, as well as to support independent research initiatives of legitimate interest to the Company. Grants should not be tied or related to the prescribing or recommending of Company products, and they may not be made to fund activities that are part of a customer's normal business activities.

1) Educational grants may be provided to support activities, held at an appropriate location, where (a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse, and (b) the main objective for bringing attendees together is to further their knowledge on the topic(s) being presented. Unrestricted educational grants are prohibited; grants may be made only to support specific educational activities.

Educational grants may not be provided to individual physicians or physician practice groups, or to support programs not meeting the independence requirements of the Food and Drug Administration (FDA).

2) Research grants may be provided if the research: is designed to answer legitimate scientific or regulatory questions; is conducted by appropriately trained individuals selected based upon their credentials as opposed to their prescribing patterns; is not duplicative of existing research; and involves more than minor record keeping tasks on the part of the researcher.

All grant requests must be in writing, using approved grant application forms provided by the Home Office and executed in accordance with Company policies and procedures.

G. Preceptorships
Preceptorships are one-on-one training sessions with physicians or other HCPs who order or prescribe Inspire or related products. During such sessions, pursuant to a written agreement, the physician or other HCP educates Company representatives concerning daily practice issues, including disease treatment, case management, therapy selection, and the like. Fair market value payments for preceptorship training may be made to HCPs who provide bona fide, necessary, and non-duplicative training and education to Company representatives, when the preceptorship is documented in advance by a written agenda, defined curriculum, and specified learning objectives. Payment to HCPs is inappropriate for "shadowing" arrangements, in which the Company representative does not interact with the HCP. As part of the agreement, physicians or other HCPs conducting training must agree to obtain all necessary patient consents in writing.

H. Promotional Materials
Promotional materials are developed and approved by Marketing, Clinical, Legal and Compliance functions. Only approved materials that have been provided by the Home Office are allowed for product promotion. Altering approved materials in any way or distributing materials developed by the field are not allowed.

I. Inquiries About Off-Label Uses
If a healthcare professional asks about off-label uses of our products, sales and marketing personnel should respond that they cannot provide any information relating to uses that are not in the package insert and then direct her/him to contact a clinical representative at the Home Office. Proactively offering off-label information, soliciting off-label questions or promoting any Company products for off-label uses are not allowed.

Page last updated: 01-Feb-2008

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