June 19, 2007

Anthony S. Fauci, MD

Director

National Institute of Allergy and Infectious Diseases

Building 31, National Institutes of Health,

31 Center Drive, Room 7A03

Bethesda MD 20892-2520

Julie L. Gerberding, MD, MPH

Director, Centers for Disease Control and Prevention &

Administrator, Agency for Toxic Substances and Disease Registry,

Department of Health and Human Services

Room 12316, Building 21

1600 Clifton Road N.E.

Atlanta GA 30333

Dear Drs. Fauci and Gerberding:

We are writing to inform you of the Infectious Diseases Society of America’s

(IDSA) strong endorsement of the “Strategies to Address Antimicrobial

Resistance (STAAR) Act,” which we are told Representative Jim Matheson (D-

UT) plans to introduce this week. IDSA believes the STAAR Act provides a

common-sense and comprehensive approach to addressing antimicrobial

resistance and strengthening antimicrobial and other product discovery.

IDSA members are immensely indebted to both of you for the important work

you have accomplished in advancing the study of infectious diseases and the

practice of medicine. Moreover, we are grateful for the important research and

surveillance efforts related to antimicrobial-resistant organisms that the National

Institutes of Health (NIH) and Centers for Disease Control and Prevention

(CDC) currently support. We believe, however, that more must be done to

address this critical patient safety and public health issue.

To this end, IDSA is very supportive of two research-related provisions

contained in the STAAR Act that are of particular relevance to NIH and CDC.

These provisions, Section 101(i) and 103 (both enclosed), call for the:

1) development of an antimicrobial resistance strategic research plan to

strengthen existing epidemiological, interventional, clinical, translational and

basic research efforts, and

2) creation of a network of 10 or more geographically distributed sites, known as

the Antimicrobial Resistance Clinical Research and Public Health Network.

Page Two – IDSA STAAR Act Letter to Drs. Fauci and Gerberding

The network would perform clinical and basic research devoted to optimizing

antimicrobial therapy, defining natural histories, and testing new products;

conduct public health research and sentinel surveillance to assist in describing and

confirming new resistance patterns; and, test new ideas for improved prevention

and control. These two proposals are further discussed below.

1.) Antimicrobial Resistance Strategic Research Plan

IDSA leaders believe that existing NIH and CDC antimicrobial resistance-related

research activities can be better coordinated, funded, and strengthened. In the

absence of a strategic plan on resistance research and product development,

(including new antimicrobials, diagnostics, biologics and devices), key research

areas remain unaddressed. IDSA strongly supports the STAAR Act’s proposal

that the NIH and CDC develop a strategic research plan that supports a robust,

well-directed, and targeted antimicrobial resistance program and defines high-

priority research needs and addresses scientific challenges. Such a plan would

clarify goals and set benchmarks for evaluating progress particularly in the areas

of:

• basic research to better understand the molecular basis for antimicrobial

resistance;

• epidemiological research to better understand the transmission and emergence

of resistance;

• interventional research to evaluate and determine the best strategies for

preventing the spread of resistance; and

• clinical and translational research to define appropriate antimicrobial therapy

for infectious diseases, to study the effects of antimicrobial therapy for

different diseases and to identify and develop much-needed drugs, biologics,

diagnostics, and devices.

IDSA also hopes NIH and CDC explore mechanisms to coordinate their ongoing

and future activities in the areas of antimicrobial therapy and resistance, including

the possibility of joint Study Sections in relevant areas.

2.) Antimicrobial Resistance Clinical Research and Public Health Network

To support and expand the outcomes envisioned under the strategic research plan,

IDSA believes the NIH and CDC should establish a network that co-locates

research, surveillance, and prevention research activities and leverages off of the

expertise and resources found in existing sites across the country as well as

potential new sites.

Page Three – IDSA STAAR Act Letter to Drs. Fauci and Gerberding

Section 103 of the STAAR Act would accomplish this by establishing the

Antimicrobial Resistance Clinical Research and Public Health Network

(ARCRPHN) to accelerate progress on the understanding and control of

resistance. Per the STAAR Act, these ARCRPHN sites would be

geographically distributed across the United States and could be housed in a

variety of locations, including academic centers. These 10 or more sites would

work closely with the CDC and NIH.

IDSA supports the ARCRPHN concept. We believe that multiple sites are

needed to capture geographic variation and allow broad testing of ideas. Each

site could bring together expertise on surveillance, prevention, and research.

Because many experts in antimicrobial resistance already possess expertise in

all three endeavors, co-locating these activities within the ARCRPHN sites

would create efficiencies and speed translation of surveillance findings into

research, for example. The ARCRPHN sites would act as an important

“extension” of the NIH and CDC.

Of significance, ARCRPHN sites would pursue clinical research with a strong

focus on identifying the optimal duration of antimicrobial therapy as well as

establishing natural histories of infectious disease. IDSA believes that this

type of clinical research is urgently needed. Similar clinical research networks

have been successfully used by NIH to study HIV/AIDS, vaccines, and other

matters requiring rapid, multi-pronged study of complex and urgent issues.

Antimicrobial resistance falls within this category.

IDSA leaders believe the creation of the strategic plan and network described

above would significantly improve and strengthen existing efforts in this

critical area. We see no reason other than constrained funding as to why these

two concepts cannot begin to take shape immediately. Regarding funding,

IDSA is ready to work quickly and aggressively to advocate for funding to

make these ideas a reality—but we realize we cannot make that happen

without the shared support of our friends at the NIH and CDC. We hope we

can all work together to bring these ideas to fruition. IDSA stands ready to

assist you in any way that we can.

Should you have any questions or wish to set up a meeting with IDSA leaders

to further discuss these ideas, please contact Robert J. Guidos, JD, IDSA’s

director of public policy and government relations at 703-299-0202 or

rguidos@idsociety.org.

Page Four – IDSA STAAR Act Letter to Drs. Fauci and Gerberding

Our best regards to you both,

Martin J. Blaser, MD, FIDSA

Immediate Past President

Donald M. Poretz, MD, FIDSA

President-Elect

Enclosure: Sections 101(i) and 103 of the STAAR Act

cc: Clifford Lane, MD, NIAID

Carole Heilman, Ph.D, DMID, NIAID

Dennis Dixon, Ph.D., DMID, NIAID

Barbara Mulach, PhD, DMID/NIAID

Mitchell Cohen, MD, CCID, CDC

Denise Cardo, MD, NCPDCID, CDC

Fred Tenover, Ph.D. (D) ABMM, NCPDCID, CDC

Scott Fridkin, MD, NCPDCID, CDC