IDSA 1 May Proposal

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Working Group on Pandemic Influenza Preparedness


May 1, 2009

Dear Senator:

On behalf of the Working Group on Pandemic Flu Preparedness, we urge you to support
emergency funding for pandemic influenza planning and response.

The recent outbreak of H1N1 (swine flu), which is suspected in the infection of thousands of
people and in the deaths of over 100 worldwide, is the first example in several decades of a novel
virus that is easily transmittable between humans. At least 90 cases, including one death, have
been reported in the U.S. The outbreak should be a wake-up call that, despite tremendous
progress, worldwide preparations are far from complete. As of April 30th:

The Acting Secretary of HHS has declared a Public Health Emergency, which frees up
federal assets to affected areas, allows emergency use authorization (EUA) of
pharmaceutical interventions and laboratory tests, and implements certain liability or
regulatory waivers, if necessary;1
The World Health Organization (WHO) has raised the pandemic alert level increased the
pandemic alert level from four to five, which is “a strong signal that a pandemic is
imminent and that the time to finalize the organization, communication, and
implementation of the planned mitigation measures is short;”2
The Centers for Disease Control and Prevention (CDC) has deployed its staff
domestically and internationally to provide guidance and technical assistance and has
activated its Emergency Operations Center to coordinate the response.3
HHS and the Department of Homeland Security (DHS) have announced the release of
12.5 million courses of antivirals from the Strategic National Stockpile (SNS) to states,
and the Department of Defense is prepositioning an additional seven million treatment
courses of antivirals.4

A Government Accountability Office (GAO) report, while detailing some of the successful
pandemic-related efforts by the Department of Health and Human Services (HHS), points out
that “while these approaches have been significant, considerable more work needs to be done.”
That is why we applaud President Obama for requesting $1.5 billion in emergency
appropriations in response to H1N1. We hope Congress will work with the Administration to
ensure there is sufficient funding to meet the current and future demands of a major outbreak.

The Working Group recommends the President’s request provide $870 million in no-year
funding that was requested, but not yet funded, by the previous Administration in FY 2008
for expanding cell and egg-based vaccine capacity, purchasing antivirals for the federal


1 http://www.hhs.gov/news/press/2009pres/04/20090426a.html (April 26 2009).
2 http://www.who.int/csr/disease/avian_influenza/phase/en/index.html (April 29 2009)
3 http://www.cdc.gov/swineflu/index.htm
4 http://www.dhs.gov/ynews/releases/pr_1240773850207.shtm

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stockpile, and accelerating research and development of rapid diagnostic tests that can be
used to enable doctors and field epidemiologists to quickly evaluate patients for influenza
viruses.
As of January, the federal government had invested $1 billion to expand U.S.-based
vaccine production, with six companies in various stages of expansion.5 Completing this
commitment will ensure these companies complete their expansion and stabilizes the market for
countermeasures. The investment will make certain the U.S. has access to a domestic supply of
medical countermeasures, rather than depending on foreign manufacturers for our protection
during a pandemic. We urge Congress to establish a reserve fund for rapid swine flu vaccine
development and production. If the scientific community determines that an H1N1-specific
vaccine is needed to protect the American people from a later wave of this flu, current funding
levels would not support rapid vaccine production capacity to be able to provide a vaccine for all
Americans.

In order to sustain the nation’s improved pandemic influenza preparedness and realize the
benefit from these projects, the Working Group also requests $350 million for states and
localities to support infrastructure needs critical to the response, including purchasing
equipment, distribution of medical countermeasures from the stockpile, maintenance of 24-
hour staffing for disease reporting hotlines and laboratory capacity, public and clinician
education, and maintaining staff positions recently lost to budget cuts.
The implementation
of effective contingency plans, strategies, and capabilities are required in addition to vaccines to
protect the public’s health in the community and in workplaces. State, local, territorial and tribal
public health agencies are on the front lines of the swine flu outbreak investigation and are being
depended on for surveillance, laboratory testing, and epidemiology. State and local health
departments are the primary means for population-based distribution and administration of
medical countermeasures; initiating disease control and containment procedures; and
coordinating medical services. While $600 million was appropriated in FY 2006 for state and
local pandemic preparedness, all of those funds have been expended, and no additional funds
have been forthcoming.6

Federal funding should also be allocated to replenish and build the SNS with antivirals and
respirators. The Working Group recommends $122 million to complete state antiviral
stockpiles for treatment of people who become ill.
The SNS must maintain a mix of existing
antivirals (Relenza® and Tamiflu®) to provide treatment for a variety of influenza strains and
should be an agile supply source as the development of new antivirals evolves. Over eight
million courses of antivirals are still needed to meet the original stockpile goal of 75 million
treatment courses.

The Working Group requests at a minimum, an additional $563 million for states and
localities to purchase personal protective equipment and antivirals for prophylaxis of
healthcare and critical infrastructure workers. HHS released guidance in 2008 calling for
an additional 109 million courses of antivirals to be stockpiled to prevent illness among
workers who are involved in the pandemic response.
Many private sector companies and
healthcare facilities have begun stockpiling, but additional courses are needed to supplement

5 Pandemic Planning Update VI, U.S. Department of Health and Human Services, January 8, 2009. Available from:
http://pandemicflu.gov/plan/pdf/panflureport6.pdf.
6 Blueprint for a Healthier America, Trust for America’s Health, October 2008, p. 64.

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their efforts. Congress should also insure that sufficient funding is provided to acquire and
stockpile personal protective equipment as recommended in the pandemic preparedness plans.

Through integrated disease surveillance, prevention and control activities, CDC’s Global Disease
Detection (GDD) Program aims to recognize infectious disease outbreaks faster, improve the
ability to control and prevent outbreaks, and to detect emerging microbial threats. We
recommend increasing support for the GDD program. In 2007, the GDD program received
$33.7 million in funding. If the funding were increased to $55 million, four additional
regional detection centers could be established to improve global disease outbreak
detection and control.
Funding supports training in field epidemiology and laboratory methods
and pandemic influenza preparedness and response, including improving and expanding global
surveillance networks, increasing virus isolation and epidemiological data collection through
expansion of capacity; and increasing timely identification, reporting and response to outbreaks.

Our work in preparing for a flu pandemic is far from over. Congress and the Administration must
update plans, invest in research and development, bolster the nation’s public health
infrastructure, replace expiring medical stockpiles, and review the impact of federal strategies as
the science and policies evolve. The Working Group on Pandemic Preparedness appreciates
your continued leadership and looks forward to continuing to work with you to better protect our
nation from this potentially deadly virus.

Sincerely,

3-V Biosciences, Inc.
Center for Infectious Disease Research and
American College of Occupational and
Policy
Environmental Medicine
GlaxoSmithKline
American Lung Association
HX Diagnostics, Inc.
American Osteopathic Association
Infectious Diseases Society of America
American Public Health Association
Juvaris BioTherapeutics, Inc.
American Red Cross
National Association of County and City
Association for Professionals in Infection
Health Officials
Control and Epidemiology (APIC)
Novavax
Association of Public Health Laboratories
RetireSafe
Association of State and Territorial Health
Trust for America’s Health
Officials
United American Nurses, AFL-CIO
Breathe Technologies
VaxInnate
Campaign for Public Health
Xcellerex
Center for Biosecurity, UPMC


Please direct all inquires or comments to Jeff Levi ([email protected]), Kim Elliott
([email protected]), or Rich Hamburg ([email protected]). All can be reached by phone at
202-233-9870. Trust for America’s Health is committed to sharing information with all members
of the Working Group on Pandemic Preparedness or directing specific inquiries to participating
organizations.


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