Policy for Commercial Support
National Institutes of Health/Foundation for Advanced Education in the Science
Continuing Medical Education Policy for Commercial Support
Sponsors of CME activities often receive financial and other support from non-accredited commercial organizations. Such support can contribute significantly to the quality of CME activities. The following guidelines describe appropriate behavior of sponsors in planning, designing, implementing, and evaluating certified CME activities for which commercial support is received.
- Acceptance of Funds from Commercial Sources.
Funds from a commercial source should be in the form of an educational grant made payable to the sponsor for the support of programming. The only exception is when it is impossible for the sponsor to accept grants. In that case, the educational grant may be paid directly to a third party company. A third party company is considered to be an agent of the organization that contracts for its services. Under the sponsor's direction and control, the agent may accept the educational grant and provide logistical support, including payment of expenses related to the CME activity.
The terms, conditions and purposes of the educational grants must be documented by a signed agreement between the commercial supporter and the sponsor. Acceptance by a sponsor of advice or services concerning speakers, invitees or other educational matters, including content, shall not be among the conditions of providing support by a commercial organization (see [3], Independence of the Sponsor, below). A copy of the letter of agreement should be appended to the CME Application or forwarded to the Office of Education when available. The letter of agreement should be addressed as follows:
[Program Director's Name]
[Title]
[Building XX, Room XX]
[Institute]
National Institutes of Health
Bethesda, MD 20892Re: Educational Grant to the National Institutes of Health to Support
[Name of Conference] - Payments to Faculty.
Payment of reasonable honoraria and reimbursement of out-of-pocket expenses for faculty is customary and proper.
- Independence of the Sponsor.
The design and production of educational activities shall be the ultimate responsibility of the sponsor. Commercial supporters of such activities shall not control the planning, content or execution of the activity. To ensure compliance, the following requirements must be adhered to:
- Assistance with Preparation of Educational Materials. The content of slides and reference materials must remain the ultimate responsibility of the faculty selected by the sponsor. A commercial supporter may be asked to help with the preparation of conference related educational materials, but these materials shall not, by their content or format, advance the specific proprietary interests of the commercial supporter.
- Assistance with Educational Planning. A sponsor may obtain information that will assist in planning and producing an educational activity from any outside source whether commercial or not. However, acceptance by a sponsor of advice or services concerning speakers, invitees or other educational matters, including content, shall not be among the conditions of providing support by a commercial organization.
- Marketing CME Activities. Only the sponsor may authorize a commercial supporter to disseminate information about a CME activity to the medical community. The content of such information is the responsibility of the accredited sponsor, and any such information must identify the educational activity as produced by the sponsor.
- Activities Repeated Many Times. Sponsors who offer commercially supported educational activities that repeat essentially the same information each time they are given, must demonstrate that every iteration of that activity meets all of the requirements of the initial approval.
- Educational Activities or Materials Prepared by Proprietary Entities. When sponsors offer educational activities consisting of concepts or materials prepared by proprietary entities, such activities must adhere to the guidelines provided here and on the CME Application form, especially with regard to the provisions concerning the independence of the sponsor in planning, designing, delivering, and evaluating such activities.
- Acknowledgment of Commercial Support.
Commercial support must be acknowledged in printed announcements and brochures, however, reference must not be made to specific products.
The CME activity must be free of commercial bias for or against any product, if the activity is concerned with commercial products, objective information about these products, based on scientific methods generally accepted in the medical community must be presented.
- Identifying Products, Reporting on Research, and Discussing Unlabeled Uses of Products.
- Generic and Trade Names. Presentations must give a balanced view of therapeutic options. Faculty use of generic names will contribute to this impartiality. If trade names are used, those of several companies should be used rather than only that of a single supporting company.
- Unlabeled Uses of Products. When an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose is discussed during an educational activity, the sponsor shall require the speaker to disclose that the product is not labeled for the use under discussion or that the product is still investigational. Append to CME application a copy of the letter informing speakers of (a) Use of Generic and Trade Names and (b) Unlabeled Uses of Products.
- Reporting Scientific Research. Objective, rigorous scientific research conducted by commercial companies is an essential part of the process of developing new pharmaceutical or other medical products or devices. It is desirable that direct reports of such research be communicated to the medical community. An offer by a commercial entity to provide a presentation reporting the results of scientific research shall be accompanied by a detailed outline of the presentation which shall be used by the sponsor to confirm the scientific objectivity of the presentation. A copy of the outline should be appended to the CME Application.
- Exhibits and Other Commercial Activities.
- Exhibits. When commercial exhibits are part of the overall program, arrangements for these should not influence planning or interfere with the presentation of CME activities. Exhibit placement should not be a condition of support for a CME activity.
- Commercial Activities During Educational Activities. No commercial promotional materials shall be displayed or distributed in the same room immediately before, during, or immediately after an educational activity certified for credit.
- Commercial Supporters at Educational Activities. Representatives of commercial supporters may attend an educational activity, but may not engage in sales activities while in the room where the activity takes place.
- Commercially Supported Social Events. Commercially supported social events at CME activities should not compete with nor take precedence over the educational events.
- Financial Support for Participants in Educational Activities.
- Expenses of Non-Faculty Attendees. In connection with an educational activity certified for credit, the sponsor may not use funds originating from a commercial source to pay travel, lodging, registration fees, honoraria, or personal expenses for non-faculty attendees. Subsidies for hospitality should not be provided outside of modest meals or social events that are held as part of the activity.
- Scholarships for Medical Students, Residents and Fellows. Scholarship or other special funding to permit medical students, residents, or fellows to attend selected educational conferences may be provided as long as the selection of students, residents or fellows who will receive the funds is made either by the academic or training institution, or by the sponsor with the full concurrence of the academic or training institution.
