Attachment 2 - APUA

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Chief Executive Officers

Stuart B. Levy, President

Thomas F. O’Brien, Vice President

Kathleen T. Young, Executive Director

Board of Directors

Stuart B. Levy, Chairperson

Sherwood Gorbach

Gordon W. Grundy

Bonnie Marshall

Mark Nance

Thomas F. O’Brien

Arnold G. Reinhold

Dennis Signorovitch

Philip D. Walson

Scientific Advisory Board

Jacques F. Acar, France

Werner Arber, Switzerland

Fernando Baquero, Spain

Michael L. Bennish, South Africa

Otto Cars, Sweden

Patrice Courvalin, France

Jose Ramiro Cruz, Guatemala

Iwan Darmansjah, Indonesia

Julian Davies, Canada

Abdoulaye Djimde, Mali

Stanley Falkow, USA

Paul Farmer, Haiti

Walter Gilbert, USA

Herman Goossens, Belgium

Sherwood L. Gorbach, USA

Ian M. Gould, Scotland

George Jacoby, USA

Sam Kariuki, Kenya

Ellen L. Koenig, Dominican Republic

Calvin M. Kunin, USA

Jacobo Kupersztoch, USA

Stephen A. Lerner, USA

Jay A. Levy, USA

Donald E. Low, Canada

Scott McEwen, Canada

Jos. W.M. van der Meer, The Netherlands

Richard P. Novick, USA

Ayo Oduola, Switzerland

Iruka Okeke, USA & Nigeria

Maria Eugenia Pinto, Chile

Vidal Rodriguez-Lemoine, Venezuela

José Ignacio Santos, Mexico

Mervyn Shapiro, Israel

K. B. Sharma, India

Atef M. Shibl, Saudi Arabia

E. John Threlfall, United Kingdom

Alexander Tomasz, USA

Thelma E. Tupasi, Philippines

Anne K. Vidaver, USA

Fu Wang, China
Thomas E. Wellems, USA
Bernd Wiedemann, Germany

David Horowitz, Assistant Commissioner for Policy

Division of Dockets Management

United States Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852

Dear Assistant Commissioner Horowitz, December 14, 2009

We are writing on behalf of the Alliance for the Prudent Use of Antibiotics (APUA) due to our concerns about the misuse of antibiotics in food animal production and its negative impact on the treatment of human infections. APUA is a science-based public health organization established in 1981 to preserve the power of antibiotics. Towards this end, we urge you to strengthen regulations to improve surveillance of antimicrobial use in agriculture to help curtail widespread antimicrobial resistance that has devastating effects on human health. Therefore, we strongly support Docket No. FDA-2009-N-0512 (Section 105 of the Animal Drug User Fee Amendments of 2008.)

Current regulations in agriculture are woefully inadequate for obtaining the kind of basic information that is readily available to control antimicrobial use in human medicine. These data are necessary to guide public policy and identify and decrease unnecessary antibiotic uses in agriculture and minimize the heavy selective pressure that fosters emergence of drug-resistant bacteria in agricultural settings.

An APUA report, Antibiotics in Animals and the Impact on Resistance (FAAIR) Project, published in June 2002 in Clinical Infectious Diseases,* presented evidence from national experts and six overarching policy recommendations to improve the safety of antimicrobial practice in food animal production. The most fundamental need identified was for reported quantitative data on specific antimicrobial usage. The panel determined that manufacturers should be required to report agent, formulation, intended animal species and route of administration for all antimicrobials in order to inform public policy decisions to minimize antimicrobial overuse and misuse in agriculture.

In February 2006, these recommendations were corroborated by a separate APUA-convened expert group involving diverse industry, academic and government stakeholders. The group determined that timely information from manufacturers would be more useful for surveillance purposes if all manufacturers were required to report annual data on a single date. Individual stakeholders, in their comments on the need for increased monitoring of antimicrobial use in agriculture, stressed that better data would make risk assessments and models more accurate and provide some of the evidence necessary for effective antimicrobial regulations to be put in place to protect human health from the effects of resistance.**

While the proposed measures in Section 105 would be important steps in surveillance, the practical utility of this data will be immensely broadened in conjunction with a larger federal monitoring effort that would require manufacturers to report antimicrobial use in all food animal products and involve veterinarians and animal owners, who can best track end-user data on antimicrobial use. Such data, when linked with trends of antimicrobial resistance in food animals, would allow for informed policy decisions that would most effectively limit the impact of agricultural use of antimicrobials on resistance in human populations.

Thank you for your attention and proactive stance on this pressing public health threat. We remain available and interested in assisting furtherance of surveillance and regulatory measures to provide data to help assess and evaluate the amount of antibiotics used in food animal production and guide policy interventions to preserve the power of antibiotics for when they are needed most.

Sincerely,

Stuart B. Levy, MD, President, APUA

Kathleen T. Young, Executive Director, APUA

References

*Barza, M. and S. L. Gorbach, guest eds. The Need to Improve Antimicrobial Use in Agriculture: Ecological and Human Health Consequences. Clin Infect Dis 2002:34(Suppl 3): S71-144.

**McEwen, S. A. and P. J. Fedorka-Cray, eds. Animal Antimicrobial Use Data Collection in the United States: Methodological Options. Prev Vet Med 2006:73(2-3): 105-228.

CC:

Genevra Pittman, APUA project assistant

Senator Dianne Feinstein, CA

Senator Tom Harkin, IA

Senator Blanche Lincoln, AK

Congressman Stephen F. Lynch, MA

Congressman Jim Matheson, UT

Congresswoman Louise M. Slaughter, NY

Margaret Hamberg, MD, U.S. Food and Drug Administration

Roberto Kolter, Ph.D., American Society for Microbiology

Robert Guidos, JD, Infectious Diseases Society of America

Padma Natarajan, MPH, MS, Infectious Diseases Society of America

John G. Bartlett, MD, Johns Hopkins School of Medicine

Neil O. Fishman, MD, University of Pennsylvania School of Medicine

75 Kneeland Street, Boston MA, 02111

Phone: 617.636.0966 Fax: 617.636.3999 www.apua.org