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1 AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES

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4 Resolution: 220
5 (A-09)
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7Introduced by: Utah Delegation
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9Subject: Follow-on Biologic Medications
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11Referred to: Reference Committee B
12 (Monica C. Wehby, MD, Chair)
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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
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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
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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
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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
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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
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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
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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)
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49Fiscal Note: Implement accordingly at estimated staff cost of $4,580.
50Received: 05/06/09

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 3 Resolution: 220 (A-09)
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1RELEVANT AMA POLICY
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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)
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