517 - American Medical Association

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AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES

Resolution: 517

(A-05)

Introduced by: California Delegation

Subject: Flu Vaccine Supply

Referred to: Reference Committee E

(Daniel W. van Heeckeren, MD, Chair)

Whereas, There is always the risk of a devastating flu pandemic on a yearly basis; and

Whereas, This year, the flu shot was not readily available to all who could benefit and possibly not available to all those who absolutely should have it; and

Whereas, There are more current ways to manufacture the flu virus vaccine that would arguably be safer and faster than using the current technology of chicken eggs; and

Whereas, New technology could also decrease the amount of lead time needed to produce the vaccine and thus would allow the vaccine to be produced closer to the fall when more accurate predictions could be made regarding the strains that will be prevalent in communities and thus put into the inoculation; and

Whereas, There currently is little incentive in the private sector to produce vaccines due to limited potential to recoup the large amount of money that would be necessary to do the research and necessary clinical trials if the current manufacturing methods were changed; and

Whereas, An affordable, available and safe supply that is distributed fairly is desirable; therefore be it

RESOLVED, That our American Medical Association urge the federal government to support the development of new vaccines employing new technologies and to continue to support adequate distribution to ensure that there will be an affordable, available and safe supply of all vaccines, including flu, on an annual basis. (Directive to Take Action)

Fiscal Note: Lobby accordingly at estimated staff cost of $4,580.

Received: 5/6/05

Resolution: 517 (A-05)

Page 2

RELEVANT AMA POLICY

D-100.993 Drug and Vaccine Shortages

Our AMA will: (1) ask the Secretary of Health and Human Services to: (a) establish a departmental task force to explore the causes of drug, diagnostic agent, and vaccine shortages and maldistribution and to identify appropriate solutions to these problems (including liability, reimbursement, and availability to the most vulnerable populations) so that the health of the public is adequately protected;. This task force should include (but is not limited to) representatives from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Agency for Health Care Research and Quality (AHRQ); (b) require this task force to seek the input of the pharmaceutical industry, wholesalers/distributors, physician and pharmacy organizations, and consumers in addressing the problem of drug, diagnostic agent, and vaccine shortages; and (c) as part of this initiative, commission one or more studies by an appropriate body of experts to identify and recommend solutions for the underlying breakdowns in both the drug, diagnostic agent, and vaccine manufacturing and distribution systems that lead to shortages; (2) work with the FDA to expand its list of "medically necessary products" to be more inclusive of important medicines, vaccines, and diagnostic agents; and will urge the FDA to monitor production, inventory, and planned cessation of production of "medically necessary products" in order to more effectively intervene when the public health is threatened. (3 ) will work with the FDA to educate physicians on how to report potential drug and vaccine shortages to the Agency; (4) in collaboration with the Federation, the

FDA, the CDC, the pharmaceutical industry, and pharmacy associations, will determine the feasibility, including costs, of establishing an effective means to communicate timely information about drug and vaccine shortages, including information about alternative therapies, to physicians; and (5) report back to the HOD at 2002 Annual Meeting. (BOT Rep. 7, I-01)

D-440.989 Influenza Vaccine

Our AMA will: (1) work with third party payers, including the Centers for Medicare and Medicaid

Services, to establish a fair reimbursement price for the flu vaccine; and (2) encourage the manufacturers of influenza vaccine to publish the purchase price by June 1st each year. (Res.

414, I-01)

D-440.990 Influenza Vaccine Delays and the 2001-2002 Influenza Season: Update

(1) Our AMA will continue to work with the Centers for Disease Control and Prevention, other federal agencies, and other stakeholders involved in the production, distribution, and administration of influenza vaccine to: (a) resolve the specific problems (i.e., distributors engaging in price inflation, mass vaccinators who do not comply with Advisory Committee on

Immunization Practices [ACIP] recommendations, and inadequate Medicare/Medicaid reimbursement) identified in the implementation of the current plan to address influenza vaccine delays in 2001-2002; and (b) address the long-term goal of adequate vaccine supplies to meet

Healthy People 2010 goals which will include increasing the industrial base for vaccine production and expanding the current limited protection from liability for both manufacturers and those that administer vaccines. (2) Our AMA Board of Trustees will report back to the House of

Delegates at the 2002 Annual Meeting regarding the current status of our AMA’s activities to address issues of price instability, vaccine availability, and liability related to the flu vaccine.

(BOT Rep. 28, I-01; Reaffirmation I-04)

See also:

D-440.992 Production and Distribution of the Influenza Vaccine: Delays and Shortages

D-440.993 Influenza Vaccine Availability And Distribution

H-440.896 Influenza Vaccine Availability and Distribution

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