National Antimicrobial Resistance Monitoring System (NARMS) Internal Review and Recommendations

1
National Antimicrobial Resistance Monitoring
System (NARMS)Internal Review and Recommendations
Submitted by the NARMS Internal Review Committee
to the FDA Science Board March 31, 2006
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Background

• In food animals, antimicrobials are used for the
  control, prevention and treatment of infectious
  bacterial diseases as well as for enhancing
  growth and feed efficiency purposes
• An undesired consequence of this use is the
  potential development of antimicrobial resistant
  zoonotic bacterial pathogens and subsequent
  transmission to humans
• Recognizing this potential health hazard, WHO,
  FAO and OIE recommend that countries implement
  monitoring programs aimed at determining the
  occurrence of antimicrobial resistance in
  bacteria from animals, foods and humans

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NARMS

• The National Antimicrobial Resistance Monitoring
  System (NARMS) is a national collaborative
  network between the FDA, CDC and USDA as well as
  public health laboratories in all 50 states and
  local health departments in three major cities
• NARMS was developed to monitor changes in
  susceptibility/resistance of select zoonotic
  bacterial pathogens and commensal organisms
  recovered from animals, retail meats and humans
  to antimicrobial agents of human and veterinary
  importance
• NARMS monitors susceptibility/resistance
  phenotypes using three testing sites including
• FDA/CVM (retail meat and poultry)
• CDC (humans)
• USDA (animal/slaughter)

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NARMS Goals

• Generate descriptive data on the extent and
  temporal trends of antimicrobial
  susceptibility/resistance in enteric organisms
  from human and animal populations
• Provide information to veterinarians, physicians,
  stakeholders and public health authorities on
  emerging, unusual or high levels of bacterial
  drug resistance so that timely action can be
  taken to protect public health

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NARMS Goals

• Design follow-up epidemiology and research
  studies to better understand the emergence and
  transfer of antimicrobial drug resistance
• Prolong the lifespan of approved antimicrobials
  by promoting prudent use

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NARMS Reviews

• CDC NARMS review
• August 12-13, 2003
• Focused on only the CDC component
• External review report is provided in Appendix I
• NARMS expert review
• June 23-24, 2005
• Focused on all 3 NARMS components
• FDA
• USDA
• CDC
• Expert review results are provided in Appendix II

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NARMS Internal Review Committee

• Charged with conducting a self assessment and
  preparing recommendations for the FDA Science
  Boards review
• FDA-CVM
• FDA-CDER
• FDA-OC
• USDA
• CDC
• Identified four key areas for the FDA Science
  Board Review
• Sampling
• Epidemiological and microbiological research
• Harmonization of data reporting
• Coordination with international surveillance

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NARMS Review

• NARMS is a very strong program and is an
  important part of national public health
  surveillance in the United States
• It has broad support from diverse sectors and
  numerous stakeholders
• It has matured since its inception in 1996 and
  would benefit from the input of the FDA Science
  Board on its key elements and future directions

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NARMS Information

• NARMS internal review and recommendations
• Contains background and information with regards
  to the four key areas we would like your input on
• Sampling
• Epidemiological and microbiological research
• Harmonization of data reporting
• Coordination with international surveillance
• Structure of each section
• Introduction
• Description
• CDC external review comments
• NARMS (all arms) expert review comments
• Strengths and limitations
• Recommendations of the Internal Review Committee

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NARMS Information

• Five appendices
• CDC external review of human arm
• FDA-CVM expert review of all arms
• NARMS internal review committee members
• research references for work conducted by NARMS
• Examples of tables and figures for NARMS
  integrated report
• Relevant background materials
• CAHFSE Collaboration for animal health, food
  safety, and epidemiology (USDA)
• FoodNet (CDC)
• Guidance 152 Evaluating the safety of
  antimicrobial new animal drugs with regard to
  their microbiological effects on bacteria of
  human health concern (FDA)
• Presentations from NARMS expert review in June,
  2005

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Questions for the FDA Science Board

• Are there inherent biases in the sampling
  strategies employed in NARMS? If so, how can they
  be improved to ensure that the data and our
  interpretations are scientifically sound given
  current resources?

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Questions for the FDA Science Board

• Are there epidemiological and/or microbiological
  research studies that would better serve the
  goals of NARMS and the regulatory work of FDA?

13
Questions for the FDA Science Board

• Are our current plans for data harmonization and
  reporting appropriate? If not, what alternative
  approaches would you consider and what should be
  the top priorities for harmonization and
  reporting?

14
Questions for the FDA Science Board

• Are the current NARMS international activities
  adequate to maintain a significant collaboration
  with worldwide efforts to mitigate the spread of
  antimicrobial-resistant foodborne bacteria?

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NARMS Internal Review Committee Members

• Tom Chiller (FDA/CDC)
• Susan Dewitt
• Paula Fedorka-Cray (USDA)
• Joshua Hayes
• Elvira Hall-Robinson
• Ibrahim Kamara
• Beth Karp

• Patrick McDermott
• John Powers (FDA/CDER)
• Jane Robens (USDA)
• Gerald Rushin
• Linda Tollefson (FDA/OC)
• David White
• Linda Youngman

We would also like to extend our thanks to
Marcella Pratt, John Marzilli, and CVM/CMT