of antibiotic research and development as increasing 
threats to United States public health. 
(5) Without innovative public policy and addi-
tional financial support, fewer and fewer antibiotics 
will be available to treat the increasing number of 
drug-resistant and dangerous microbes that threaten 
Americans and the global community. 
(6) The pipeline of new antibiotics is drying up. 
Major pharmaceutical companies are losing interest 
in the antibiotics market because these drugs simply 
are not as profitable as drugs that treat chronic 
(long-term) conditions and lifestyle issues. 
(7) Drug research and development is expen-
sive, risky, and time-consuming. An aggressive re-
search and development program initiated today 
would likely require 10 or more years and an invest-
ment of $800,000,000 to $1,700,000,000 to bring a 
new drug to market. 
(8) Resistant bacterial infections are not only a 
public health problem; they have national and global 
security implications as well. 
(9) The Institute of Medicine in its 2004 report 
entitled ‘‘The Threat of Pandemic Influenza’’ stated 
that the United States is not adequately prepared to 
deal with the next pandemic of influenza. 
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(10) The Centers for Disease Control and Pre-
vention estimates that, without adequate prepara-
tion, 100,000 to 250,000 deaths could occur in the 
United States from a mild pandemic of influenza. 
(11) The limited influenza vaccine market and 
few dedicated manufacturers pose a substantial chal-
lenge to the Nation’s preparedness efforts. Cur-
rently, there are two manufacturers of influenza vac-
cine for the United States market. In 2004, the 
Food and Drug Administration suspended a manu-
facturer’s license due to bacterial contamination. 
This action led to a shortage of injectable influenza 
vaccine in the United States. 
(12) New rapid diagnostics would greatly re-
duce the cost and time needed to conduct clinical 
trials for new anti-infectives. For many infectious 
diseases, there currently are no rapid diagnostic 
tests available to assist in identifying eligible pa-
tients for clinical trials. Cutting costs and time will 
serve as incentives for greater investment in this 
area. In addition, new rapid diagnostics will permit 
physicians to diagnose specific bacterial infections in 
their patients. This will enable physicians to pre-
scribe the most appropriate therapies, including 
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antibiotics, which will slow the evolution of new anti-
microbial resistance. 
(13) Extensively drug-resistant tuberculosis 
(XDR–TB) is highly drug-resistant not only to first 
line anti-tuberculosis drugs, but also to second line 
oral and even injectable drugs. In 2004, there were 
about 424,000 new cases of multi-drug resistant tu-
berculosis. Four percent of all multi-drug resistant 
tuberculosis cases in the United States fit the defini-
tion of XDR–TB. The Advisory Council for the 
Elimination of Tuberculosis (ACET) has warned 
that XDR–TB poses ‘‘an imminent airborne biologi-
cal threat’’ to the United States and requires imme-
diate action. 
SEC. 3. DEFINITIONS. 
In this Act: 
(1) The term ‘‘antibiotic drug’’ has the meaning 
given to that term in section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321). 
(2) The term ‘‘antiviral’’ means a drug or bio-
logical product intended for human use that impedes 
the reproduction of a virus. 
(3) The term ‘‘biological product’’ has the 
meaning given to that term in section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
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(4) The term ‘‘device’’ has the meaning given to 
that term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
(5) The term ‘‘diagnostic test’’ means a device 
or product used to detect the presence, concentra-
tion, or characteristics of an infectious human dis-
ease. 
(6) The term ‘‘drug’’ has the meaning given to 
that term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
(7) The term ‘‘qualified infectious disease prod-
uct’’ means any antibiotic drug, antiviral, diagnostic 
test, or vaccine that is developed for the purpose of 
treating, detecting, preventing, or identifying— 
(A) a qualifying pathogen (for the period 
beginning on the date of the enactment of this 
Act and ending on commencement of the period 
described in subparagraph (B)); or 
(B) an infectious pathogen identified by 
the Commission under section 319E–1(b) of the 
Public Health Service Act, as added by section 
10 of this Act (for the period beginning on the 
date on which the Commission on Infectious 
Diseases Product Development first identifies 
infectious pathogens under such section). 
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