303 - American Medical Association

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AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES
Resolution: 303
(A-05)
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Introduced by:
Medical Student Section
Subject:
Educating Medical Students About the Pharmaceutical Industry
Referred to:
Reference Committee C
(Harry S. Jonas, MD, Chair)
Whereas, Our American Medical Association has policy on direct-to-consumer pharmaceutical
advertising guidelines and guidelines on how physician-patient relationships must be adapted
due to direct-to-consumer advertising (AMA Policies H-105.988 and E-5.015); and
Whereas, Our AMA has policy stating, “Physicians should be free to use either the generic or
brand name in prescribing drugs for their patients, and physicians should supplement medical
judgments with cost considerations in making this choice” (H-125.984); and
Whereas, Our AMA has established guidelines for physicians to follow regarding physicianindustry relationships, including policy specifically relating to accepting gifts from the
pharmaceutical industry (E-8.061); and
Whereas, Curricula in many medical schools do not sufficiently contain educational modules
regarding these integral issues relating to the pharmaceutical industry; therefore be it
RESOLVED, That our American Medical Association reaffirm Policies D-295.957 and D140.981 (Reaffirm HOD Policy); and be it further
RESOLVED, That our AMA strongly encourage medical schools to include unbiased curricula
concerning the impact of direct-to-consumer marketing practices employed by the
pharmaceutical industry as they relate to the physician-patient relationship (Directive to Take
Action); and be it further
RESOLVED, That our AMA strongly encourage medical schools to include unbiased information
in their curricula concerning the pharmaceutical industry regarding (1) the cost of research and
development for new medications, (2) the cost of promoting and advertising new medications,
(3) the proportion of (1) and (2) in comparison to their overall expenditures, and (4) the basic
principles in the decision making process involved in prescribing medications, specifically using
evidence based medicine to compare outcomes and cost effectiveness of generic versus
proprietary medications of the same class. (Directive to Take Action)
Fiscal Note: Staff cost estimated at less than $500 to implement.
Received: 5/3/05
Resolution: 303 (A-05)
Page 2
RELEVANT AMA POLICY
H-105.988 Direct-to-Consumer Advertising (DTCA) of Prescription Drugs
(1) Our AMA considers acceptable those product-specific direct-to-consumer advertisements (DTCA) that follow
the guidelines for such advertisements that were developed by the AMA, in consultation with the FDA, in 1993.
These guidelines also apply to DTC A of FDA approved medical devices, and are as follows: (a) The
advertisement should be disease-specific and enhance consumer education; (b) The ad should convey a clear,
accurate and responsible health education message (i.e., information on the prevention or treatment of a disease,
disorder, or condition); (c) In all cases, the ad should refer patients to their physicians for more information; (d)
The ad should not encourage self-diagnosis and self-treatment, but should identify the consumer population at
risk; (e). Discussion of the use of the drug product for the disease, disorder, or condition should exhibit fair
balance; (f) Warnings, precautions, and potential adverse reactions associated with the drug product should be
clearly explained so as to facilitate communication between physician and patient; (g) No comparative claims can
be made for the product. In the interest of fair balance, alternative non-drug management options for the disease,
disorder, or condition can be included; (h) The brief summary information should be presented in language that
can be understood by the consumer; (i) The advertisement must comply with applicable FDA rules, regulations,
policies and guidelines as provided by their Division of Drug Marketing, Advertising and Communications; (j). The
ad should be part of a manufacturer’s education program that would include collateral materials to educate both
physician and consumer; and (k) The manufacturer should not run concurrent incentive programs for physician
prescribing and pharmacist dispensing... (BOT Rep. 38 and Sub. Res. 513, A-99; Reaffirmed: CMS Rep. 9,
Amended: Res. 509, and Reaffirmation I-99; Appended & Reaffirmed: Sub. Res. 503, A-01; Reaffirmed: Res. 522,
A-02; Reaffirmed: Res. 914, I-02; Reaffirmed: Sub. Res. 504, A-03; Reaffirmation A-04)
E-5.015 Direct-to-Consumer Advertisements of Prescription Drugs
The medical profession needs to take an active role in ensuring that proper advertising guidelines are enforced
and that the care patients receive is not compromised as a result of direct-to-consumer advertising. Since the
Food and Drug Administration (FDA) has a critical role in determining future directions of direct-to-consumer
advertising of prescription drugs, physicians should work to ensure that the FDA remains committed to advertising
standards that protect patients’ health and safety... Issued June 1999 based on the report "Direct-to-Consumer
Advertisement of Prescription Drugs," adopted December 1998 (Food and Drug Law Journal. 2000; 55: 119-24).
H-125.984 Generic Drugs
Our AMA believes that: (1) Physicians should be free to use either the generic or brand name in prescribing drugs
for their patients, and physicians should supplement medical judgments with cost considerations in making this
choice... (CSA Rep. 6, A-02)
E-8.061 Gifts to Physicians from Industry
Many gifts given to physicians by companies in the pharmaceutical, device, and medical equipment industries
serve an important and socially beneficial function. For example, companies have long provided funds for
educational seminars and conferences. However, there has been growing concern about certain gifts from
industry to physicians. Some gifts that reflect customary practices of industry may not be consistent with the
Principles of Medical Ethics... Issued 1992. Updated December 2000 and June 2002, (Food and Drug Law
Journal, 2001;56(1):27-40).
D-295.957 Medical Student and Resident Physician Education about Pharmaceutical Advertising to Health
Professionals
Our AMA will encourage all medical schools and residency programs to educate their students and resident
physicians on the possible effects of pharmaceutical advertising and interaction with health professionals and on
alternative unbiased sources of information about pharmaceutical products through the AMA curriculum, "What
You Should Know About Gifts to Physicians From Industry." (Res. 302, A-04)
D-140.981 Ethical Guidelines on Gifts to Physicians from Industry
Our AMA shall: (1) communicate to all medical school deans and residency program directors the importance of
including education on ethical guidelines regarding gifts to physicians from industry within the ethics curriculum of
their medical student and housestaff education programs; (2) communicate to all medical school deans and
residency program directors the content of CEJA Opinion E-8.061 and shall recommend that it or another
nationally-recognized ethical guideline be used as the basis for educational content on this issue; and (3)
recommend to all medical school deans and residency program directors that appropriate policies be developed
for medical students, housestaff and faculty in their respective institutions regarding the issue of gifts to
physicians from industry. (Res. 13, A-02)
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