AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES Resolution: 303 (A-05) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 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)