FDA Perspective on Gathering Antimicrobial Use Data in Animals - Dr. Craig A. Lewis, DVM, MPH, DACVPM, VMO, Center for Veterinary Medicine, U.S. Food and Drug Administration , from the 2015 NIAA Annual Conference titled 'Water and the Future of Animal Agriculture', March 23 - March 26, 2015, Indianapolis, IN, USA. More presentations at http://www.trufflemedia.com/agmedia/conference/2015_niaa_water_future_animal_ag

1. FDA Perspective on
Gathering Antimicrobial
Use Data in Animals
NIAA Antibiotics Council
March 24, 2015
Craig A. Lewis, DVM, MPH, DACVPM
Center for Veterinary Medicine (CVM)
U.S. Food and Drug Administration (FDA)
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2. Outline
 The Need for On-farm Use Data
 FDA’s Judicious Use Strategy
 Multifactorial Assessment
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3. The Need for On-farm Use Data
 Assessing the impacts of stewardship and policy
initiatives on antimicrobial use and resistance
remains a high priority
 Shared by many stakeholders
 Additional information regarding on-farm
antimicrobial use and resistance is needed to
provide more meaningful metrics to supplement
existing data
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4. FDA Guidance for Industry (GFI) #213
 Policy Objectives:
1. Eliminate the use of medically important antimicrobials for
production indications (such as “increased rate of weight gain” or
“improved feed efficiency”)
2. Require veterinary oversight of therapeutic uses of these drugs in
the feed and water of food-producing animals
 Timeline: 3 years (ends December 12, 2016)
 Important step towards addressing concerns about
the use of antimicrobials in food-producing
animals
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5. GFI #213: Key Implementation Phases
1) Assessing industry engagement (Dec. 2013 – June 2014)
 All 26 companies provided written commitment
2) Aligning affected drug products (June 2014 – Dec. 2016)
 Target is to align all products by Dec. 2016
 Expect most will occur through synchronous change in Dec. 2016
 Biannual progress reports leading up to Dec. 2016
3) Assessing impacts (June 2016 – Beyond)
 Would not expect to see impacts until after product changes are in place
(Dec. 2016)
 Multi-factorial assessment process under development
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6. GFI #213: Multi-factorial Assessment
A. Data on quantity antibiotics sold/distributed (since 2009)
 Annual summary substantially enhanced (Oct. 2014)
 Rulemaking underway to obtain additional detail on animal species (target
for NPRM is April 2015)
B. On-farm use and resistance data (under development)
 Developing approach for collecting such data through ongoing
collaboration with USDA and CDC
 Implementation dependent on additional funding
C. Resistance data for foodborne bacteria (since 1996)
 Enhancements made to animal sampling
 Proposed expansion of retail meat sampling and use of whole genome
sequencing 6

7. GFI #213: Multi-factorial Assessment
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Assessing Impacts
of GFI #213
Sales Data
On-farm
(use and
resistance)
NARMS

8. Assessing Impacts
of Product Changes
(December 2016 – Beyond)
Aligning Affected Products
(June 2014 - December 2016)
GFI #213: Important Milestones
Early 2015:
Public
meeting on
on-farm data
collection
strategy
Late 2015:
Implement
on-farm data
collection
plan
End of 2016:
All changes
implemented
2017:
Changes in
use practices
begin
2018:
Publish first
assessment
showing
changes in
sales and
use practices
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9. Thank You
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