I 
109TH CONGRESS 
1ST SESSION H. R. 3154
To provide incentives for pharmaceutical companies, biotechnology companies, 
and medical device companies to invest in research and development 
with respect to antibiotic drugs, antivirals, diagnostic tests, and vaccines 
that may be used to identify, treat, or prevent an infectious disease, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 30, 2005
Mrs. CUBIN (for herself, Mr. BAIRD, Mr. MATHESON, Mr. BAKER, Mr. 
LAHOOD, Mr. BONNER, Mr. DAVIS of Alabama, Mr. GINGREY, and Mr. 
WELDON of Florida) introduced the following bill; which was referred to 
the Committee on Energy and Commerce, and in addition to the Commit-
tees on the Judiciary and Ways and Means, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To provide incentives for pharmaceutical companies, bio-
technology companies, and medical device companies to 
invest in research and development with respect to anti-
biotic drugs, antivirals, diagnostic tests, and vaccines 
that may be used to identify, treat, or prevent an infec-
tious disease, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Infectious Diseases 
Research and Development Act of 2005’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) Infections caused by resistant bacteria can 
strike anyone, including the young and the old, the 
healthy and the chronically ill. Antibiotic resistance 
is a particularly serious problem for patients whose 
immune systems are compromised, such as people 
with HIV/AIDS and patients in critical care units. 
(2) About 2 million people acquire bacterial in-
fections in United States hospitals each year, and 
90,000 die as a result. About 70 percent of those in-
fections are resistant to at least one drug. The 
trends toward increasing numbers of infection and 
increasing drug resistance show no sign of abating. 
(3) Resistant pathogens lead to higher health 
care costs because they often require more expensive 
drugs and extended hospital stays. The total cost to 
United States society is nearly $5,000,000,000 an-
nually. 
(4) The Institute of Medicine, the Infectious 
Diseases Society of America, and Federal officials 
have identified antibiotic resistance and the dearth
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.
(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
antibiotics, which will slow the evolution of new anti-
microbial resistance. 
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). 
(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