Code Of Pharmaceutical Marketing Practices

The member companies of the Pharmaceutical Research & Manufacturers of America (PhRMA) have worked together to create guidelines for the ethical promotion of prescription pharmaceutical products.

The pharmaceutical industry undertakes:

• that all products it makes available for prescription purposes to the public are backed by the fullest technological service and have full regard for the needs of public health: to produce pharmaceutical products under adequate procedures and strict quality assurance;

• To have the claims for substances and formulations on valid scientific evidence, thus determining the therapeutic indications and conditions of use;

• To provide scientific information with objectivity and good taste, with scrupulous regard for truth, and with clear statements with respect to indications, contraindications, tolerance, and toxicity;

• To use complete candor in dealing with public health officials, health-care professionals, and the public, and to comply with the regulations and policies issued by the Food and Drug Administration.

• Information on pharmaceutical products should be accurate, fair, and objective, and presented in such a way as to conform not only to legal requirements but also to ethical standards and to standards of good taste.

• Information should be based on an up-to-date evaluation of all the available scientific evidence and should reflect this evidence clearly.

• No public communication should be made with the intent of promoting a pharmaceutical product as safe and effective for any use before the required approval of the pharmaceutical product for marketing for such product is obtained.

• Particular care should be taken that essential information as to pharmaceutical products' safety, contraindications, and side effects or toxic hazards is appropriately and consistently communicated subject to the legal, regulatory, and medical practices of the United States.

• Medical representatives should be adequately trained and possess sufficient medical and technical knowledge to present information on their company's products in an accurate and responsible manner.

• Symposia, congresses, and the like are indispensable for the dissemination of knowledge and experience. Scientific objectives should be the principal focus in arranging such meetings, and entertainment and other hospitality should not be inconsistent with such objectives.

• Scientific and technical information should fully disclose properties of the pharmaceutical product as approved in the United States based on current scientific knowledge and FDA regulations.

• Samples may be supplied to the medical and allied professions to familiarize them with the products or to enable them to gain experience with the product in their practice. The requirements of the Prescription Drug Marketing Act of 1987 should be observed.

The PhRMA Board also includes these four position statements as an adjunct to the PhRMA Code of Pharmaceutical Marketing Practices.

Gifts, hospitality or subsidies offered to physicians by the pharmaceutical industry ought not to be accepted if acceptance might influence or appear to others to influence the objectivity of clinical judgment. A useful criterion in determining acceptable activities and relationships is: Would you be willing to have these arrangements generally known? Independent institutional and organizational continuing medical education providers that accept industry-supported programs should develop and enforce explicit policies to maintain complete control of program content. Professional societies should develop and promulgate guidelines that discourage excessive industry-sponsored gifts, amenities, and hospitality to physicians at meetings. Physicians who participate in practice-based trials of pharmaceuticals should conduct their activities in accord with basic precepts of accepted scientific methodology.

The PhRMA Board of Directors also adopted, as part of the PhRMA Code of Pharmaceutical Mar keting Practices, the following guidelines on gifts given to physicians from industry as set forth in the Opinion of the Council on Ethics and Judicial Affairs.

Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted.

Individual gifts of minimal value are permissible as long as the gifts are related to the physician's work. (e.g., pens and notepads).

Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company's sales representative may create a relationship which could influence the use of the company's products, any subsidy should be accepted by the conference sponsor, who in turn can use the money to reduce the conference's registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference.

Subsidies from industry should not be accepted to pay for the costs of travel, lodging, or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians' time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as a part of a conference or meeting. It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging, and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging, and meal expenses. Token consulting or advisory arrangements cannot be used to justify compensating physicians for their time or their travel.

Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution.

No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician's prescribing practices. In addition, when companies underwrite medical conferences or lectures other then their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures.

(SEE ALSO: Advertising and the Alcohol Industry; Advertising and Tobacco Use)

Charles M. Rongey

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