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1 1 AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES 2 3 4 Resolution: 220 5 (A-09) 6 7Introduced by: Utah Delegation 8 9Subject: Follow-on Biologic Medications 10 11Referred to: Reference Committee B 12 (Monica C. Wehby, MD, Chair) 13 14 15Whereas, The increased availability of generic medications over the last several years has 16clearly lowered the cost of medicines, improved the ability of patients to afford their medications, 17and improved the ability of physicians to get patients on the medications that they need; and 18 19Whereas, There is currently an important category of medications known as biologics with no 20legal pathway to allow for generic or follow-on versions of these important medications to come 21to market after the period of US Food and Drug Administration exclusivity ends and their patents 22expire; and 23 24Whereas, Biologic medications are currently much more expensive than most other kinds of 25medications costing hundreds of dollars per dose, and tens of thousands of dollars per year, (for 26example Procrit® for Anemia, $13,884 per year; Enbrel® for Rheumatoid Arthritis $20,046 per 27year; Pegasys® for Hepatitis C, $27,072 per year; and Avastin® for Cancer $113,750 per year); 28and 29 30Whereas, Many patients, both insured and uninsured, are unable to get the biologic medications 31they need because of the extremely high cost, and the high costs of these medications adds to 32the overall cost of health insurance itself, reducing the number of those who can afford it; and 33 34Whereas, Our AMA has as one of its legislative advocacy priorities the expansion of coverage 35for the uninsured and increased access to medical care in general; therefore be it 36 37RESOLVED, That pharmaceutical companies should be allowed to make follow-on biologic 38medications available to physicians and their patients in a reasonable period of time with a 39reasonably predictable pathway to bring them to market (New HOD Policy); and be it further 40 41RESOLVED, That our American Medical Association advocate for enactment of federal law that 42would establish a pathway for follow-on biologic medications to be allowed on the market, with 43two guiding principles: 1) a reasonable time frame for US Food and Drug Administration 44exclusivity and patent expiration with a straightforward regulatory process for follow-on biologic 45competitors to be brought to market, and 2) the protection of patient safety in both the original 46branded products and all follow-on products that are brought to market. (Directive to Take 47Action) 48 49Fiscal Note: Implement accordingly at estimated staff cost of $4,580. 50Received: 05/06/09

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3 Resolution: 220 (A-09) 4 Page 2 5 6 1RELEVANT AMA POLICY 2 3H-110.997 Cost of Prescription Drugs 4Our AMA: (1) supports programs whose purpose is to contain the rising costs of prescription 5drugs, provided that the following criteria are satisfied: (a) physicians must have significant input 6into the development and maintenance of such programs; (b) such programs must encourage 7optimum prescribing practices and quality of care; (c) all patients must have access to all 8prescription drugs necessary to treat their illnesses; (d) physicians must have the freedom to 9prescribe the most appropriate drug(s) and method of delivery for the individual patient; and (e) 10such programs should promote an environment that will give pharmaceutical manufacturers the 11incentive for research and development of new and innovative prescription drugs; (2) reaffirms 12the freedom of physicians to use either generic or brand name pharmaceuticals in prescribing 13drugs for their patients and encourages physicians to supplement medical judgments with cost 14considerations in making these choices; (3) encourages physicians to stay informed about the 15availability and therapeutic efficacy of generic drugs and will assist physicians in this regard by 16regularly publishing a summary list of the patient expiration dates of widely used brand name 17(innovator) drugs and a list of the availability of generic drug products; (4) encourages 18expanded third party coverage of prescription pharmaceuticals as cost effective and necessary 19medical therapies; (5) will monitor the ongoing study by Tufts University of the cost of drug 20development and its relationship to drug pricing as well as other major research efforts in this 21area and keep the AMA House of Delegates informed about the findings of these studies; (6) 22encourages physicians to consider prescribing the least expensive drug product (brand name or 23FDA A-rated generic); and (7) encourages all physicians to become familiar with the price in 24their community of the medications they prescribe and to consider this along with the 25therapeutic benefits of the medications they select for their patients. (BOT Rep. O, A-90; Sub. 26Res. 126 and Sub. Res. 503, A-95; Reaffirmed: Res. 502, A-98; Reaffirmed: Res. 520, A-99; 27Reaffirmed: CMS Rep. 9, I-99; Reaffirmed: CMS Rep.3, I-00; Reaffirmed: Res. 707, I-02; 28Reaffirmation A-04; Reaffirmed: CMS Rep. 3, I-04; Reaffirmation A-06) 29 30

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