FDA-CVM Activities Regarding
Antimicrobial Resistance and
Food-producing Animals
Bridging the Gap
Between Animal Health an...
Topics


Background



FDA‟s ongoing strategy
 Guidance

 Draft

guidance for industry (GFI) #213

 Veterinary



fo...
Antimicrobial Resistance – In Perspective


Complex, multi-factorial issue




Acquired vs. naturally occurring

Use as...
Antibiotic Use in Animal Agriculture


Has been the subject of scientific and policy debate for
decades



Consumers, pu...
FDA Measures to Address AR Risks


Since late 1980‟s – All “new” antibiotics have been
approved as Rx or VFD



1996 – N...
Remaining Concerns


Although a process is in place (with implementation of GFI
152 in 2003) to provide assurance that ne...
Focus of Recent Activities


Steps to assure that existing antibiotics (including those
that predate 2003 Guidance 152 as...
Judicious Use of Antimicrobials


Guidance 209 – „„The Judicious Use of Medically
Important Antimicrobial Drugs in Food-P...
Judicious Use: Guidance 209


Focus is on initiating steps to assure that
medically important antimicrobial drugs are use...
Judicious Use: Guidance 209


Two key principles outlined in Guidance 209:
1.

Limit use of medically important antimicro...
Draft Guidance 213: Overview


Published April 2012



Provides more detailed guidance on
implementation of key principl...
Draft Guidance 213: Medical Importance


Proposed definition of medically important
 Those

drugs currently listed in Ap...
Draft Guidance 213: Affected Drugs


Medically important antimicrobials



Administered in feed/water



Approved for p...
Draft Guidance 213: Affected Drugs


Examples include:


Aminoglycosides




Lincosamides




Virginiamycin

Sulfona...
Draft Guidance 213: New Uses


Stakeholder input revealed concerns that
removing production uses might negatively impact
...
Draft Guidance 213: Timeline


Implementation timeframe
3

months after finalization of Guidance 213


3

Hear from dr...
Veterinary Oversight


One of two key principles described in
Guidance 209:
 Limit

the use of medically important
antim...
Veterinary Oversight


Primary objective is to include veterinarian
in decision-making process
 Does

not require direct...
Veterinary Feed Directive


Existing framework for veterinary oversight of feed
use drugs is the veterinary feed directiv...
Veterinary Feed Directive


The proposal to increase veterinary oversight of
feed use antimicrobials has raised concerns ...
Updating VFD Process


Changes intended to make process more efficient



Critically evaluated all current requirements
...
Next Steps - GFI 213 & VFD


Comment period closed July 12, 2012
 Comments



have been analyzed

Publish final Guidanc...
Public Meetings


Worked with USDA to plan series of listening
sessions
 Primary

focus on mechanisms for helping
assure...
Other AR-related activities


Enhancing antimicrobial resistance data
 NARMS



Enhancing antimicrobial sales/use data
...
Enhancing NARMS Program


Comments previously received from FDA‟s
Science Board included:
 Sampling

needs to be nationa...
NARMS: Examining sampling strategies


5 on-farm pilot studies initiated
in September 2011




New slaughter sampling i...
Antimicrobial Sales Data: ADUFA 105


ADUFA Section 105 introduced
as part of 2008 Animal Drug
User Fee Amendment
reautho...
Antimicrobial Sales Data: Limitations


Sales do not necessarily represent end-use





Complex distribution channels
...
Enhancing Antimicrobial Sales/Use Data


Advance notice of proposed rulemaking (ANPRM)
published July 27, 2012



Public...
Enhancing Antimicrobial Sales/Use Data


Enhancements to existing sales/distribution data




Developing rulemaking (e....
Related CVM Websites


Judicious Use of Antimicrobials:




NARMS




http://www.fda.gov/AnimalVeterinary/SafetyHealt...
Thank You

32
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Dr. Craig Lewis - FDA Activities Regarding Antimicrobial Resistance and Food-Producing Animals

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FDA Center for Veterinary Medicine Activities Regarding Antimicrobial Resistance and Food-Producing Animals - Dr. Craig Lewis, Veterinary Medical Officer, U.S. Food and Drug Administration Center for Veterinary Medicine, from the 2013 NIAA Symposium Bridging the Gap Between Animal Health and Human Health, November 12-14, 2013, Kansas City, MO, USA.

More presentations at http://www.trufflemedia.com/agmedia/conference/2013-niaa-antibiotics-bridging-the-gap-animal-health-human-health

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  • As we developed the strategy, feedback from producers: potential health consequences of removing these uses. I.e., potential therapeutic benefits (in addition to production uses)
  • Time for drug companies to make changes, 2) time for producers/vets/distributors to plan/adjust, 3) time for FDA to complete VFD streamlining…Enable us to phase in over a defined period of time that also allows time for these changes to be implemented efficiently and effectivelyRecognize this will result in changes…allow adjustment
  • Mention AVMA…?
  • Understand vets are already involved. Helps ensure appropriate diagnosis, selection of appropriate therapy…Last 25 years, new drugs not been OTC; this change brings the OLD products into alignment; …Save “Compelling why”…Provide medical expertise to maximize therapeutic benefit to animals while minimizing public health risk
  • Background on VFD—what it is…Coronary to rxLaw = Congress (not FDA); briefly clarify laws vsregs
  • As we’ve sought comment on plans to transition…concerns from a variety of stakeholders that existing requirements require improvementsNeed to be fixed to transition…
  • (standing order…)
  • Dr. Craig Lewis - FDA Activities Regarding Antimicrobial Resistance and Food-Producing Animals

    1. 1. FDA-CVM Activities Regarding Antimicrobial Resistance and Food-producing Animals Bridging the Gap Between Animal Health and Human Health November 13, 2013 Craig A. Lewis, DVM, MPH, DACVPM Veterinary Medical Officer Center for Veterinary Medicine (CVM) U.S. Food and Drug Administration (FDA) 1
    2. 2. Topics  Background  FDA‟s ongoing strategy  Guidance  Draft guidance for industry (GFI) #213  Veterinary  for industry (GFI) #209 Feed Directives Other AR-related activities  NARMS  Antimicrobial sales/use data 2
    3. 3. Antimicrobial Resistance – In Perspective  Complex, multi-factorial issue   Acquired vs. naturally occurring Use as a driver of resistance  All uses (human, animal, horticultural, other) are part of the picture  Gaps in our understanding of the issue remain – the science continues to evolve  But, these complexities and uncertainties don‟t mean that steps can‟t be identified to mitigate risk 3
    4. 4. Antibiotic Use in Animal Agriculture  Has been the subject of scientific and policy debate for decades  Consumers, public health advocates, Congress, and others continue to be concerned about public health impacts  Rather than continue debate, identify measures that address public health concern and that continue to assure animal health needs are met 4
    5. 5. FDA Measures to Address AR Risks  Since late 1980‟s – All “new” antibiotics have been approved as Rx or VFD  1996 – National Antimicrobial Resistance Monitoring System (NARMS) established  1997 – Extralabel use of fluoroquinolones and glycopeptides prohibited  2003 – FDA established framework for assessing antimicrobial resistance risks as part of drug approval (Guidance 152) 5
    6. 6. Remaining Concerns  Although a process is in place (with implementation of GFI 152 in 2003) to provide assurance that new antibiotic products are safe  Concerns remain about products that pre-date current assessment process 6
    7. 7. Focus of Recent Activities  Steps to assure that existing antibiotics (including those that predate 2003 Guidance 152 assessment process) are used as judiciously as possible  These include:  2005 – withdrawal of enrofloxacin in poultry – initiated “judicious use” effort with issuance of draft guidance 209  2010 – prohibited certain extralabel uses of cephalosporins  2012 7
    8. 8. Judicious Use of Antimicrobials  Guidance 209 – „„The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals‟‟  Published  Finalized as draft in June 2010 April 2012  Describes overall policy direction 8
    9. 9. Judicious Use: Guidance 209  Focus is on initiating steps to assure that medically important antimicrobial drugs are used as judiciously as possible  Antimicrobials must continue to be available to combat disease in animals  including  treatment, control, and prevention Goal: preserve availability of effective drugs (for both humans and animals) 9
    10. 10. Judicious Use: Guidance 209  Two key principles outlined in Guidance 209: 1. Limit use of medically important antimicrobial drugs to those uses considered necessary for assuring animal health (i.e., therapeutic purposes) 2. Increase veterinary involvement/consultation 10
    11. 11. Draft Guidance 213: Overview  Published April 2012  Provides more detailed guidance on implementation of key principles in Guidance 209  Definition  Process  Data of medically important for updating product labels required to obtain approval of new uses  Proposed implementation timeline 11
    12. 12. Draft Guidance 213: Medical Importance  Proposed definition of medically important  Those drugs currently listed in Appendix A of Guidance 152 (regardless of their ranking)  Guidance 152 provides guidance on evaluating the potential effects of antimicrobial new animal drugs on non-target bacteria as part of the new animal drug application process  Appendix A describes a process for ranking antimicrobial drugs with regard to their relative importance in human medicine 12
    13. 13. Draft Guidance 213: Affected Drugs  Medically important antimicrobials  Administered in feed/water  Approved for production uses  Available OTC 13
    14. 14. Draft Guidance 213: Affected Drugs  Examples include:  Aminoglycosides   Lincosamides   Virginiamycin Sulfonamides   Penicillin G procaine Streptogramins   Tylosin, Erythromycin Penicillins   Lincomycin Macrolides   Streptomycin (water), Spectinomycin (water) Sulfamethazine Tetracyclines  Chlortetracycline, oxytetracycline 14
    15. 15. Draft Guidance 213: New Uses  Stakeholder input revealed concerns that removing production uses might negatively impact animal health  Potential new therapeutic uses  Therapeutic  Includes  Any = treatment, control, prevention data required to obtain approval of new uses new uses expected to:  Demonstrate therapeutic effectiveness  Have defined dosing duration  Include veterinary oversight 15
    16. 16. Draft Guidance 213: Timeline  Implementation timeframe 3 months after finalization of Guidance 213  3 Hear from drug sponsors as to their intentions years after finalization of Guidance 213  Target for implementing changes to use conditions of affected products  VFD  streamlining Intent is to implement revised VFD regulation within 3-year timeframe, but will adjust timeframe as necessary if VFD changes not yet in effect 16
    17. 17. Veterinary Oversight  One of two key principles described in Guidance 209:  Limit the use of medically important antimicrobial drugs to those uses that include veterinary oversight/consultation 17
    18. 18. Veterinary Oversight  Primary objective is to include veterinarian in decision-making process  Does not require direct veterinarian involvement in drug administration  Practically, this means changing marketing status from OTC to Rx or VFD 18
    19. 19. Veterinary Feed Directive  Existing framework for veterinary oversight of feed use drugs is the veterinary feed directive (VFD)  In 1996 Congress passed Federal Law stating that medicated feeds which require veterinary oversight are designated VFDs  In 2001 FDA finalized regulations for distribution and use of VFDs 19
    20. 20. Veterinary Feed Directive  The proposal to increase veterinary oversight of feed use antimicrobials has raised concerns about VFD requirements - including:  Limited experience with process  Administrative burden  Veterinary workforce limitations  Increased costs to producers  Impacts on feed industry 20
    21. 21. Updating VFD Process  Changes intended to make process more efficient  Critically evaluated all current requirements  Information required on VFD form  Transmitting VFD  Recordkeeping  Specificity requirements of order 21
    22. 22. Next Steps - GFI 213 & VFD  Comment period closed July 12, 2012  Comments  have been analyzed Publish final Guidance 213 and proposed VFD regulation  An FDA priority for 2013  Both documents currently in clearance at OMB  Final Guidance 213 will “start clock”  Proposed VFD rule will be open for public comment before revisions and publication of final rule 22
    23. 23. Public Meetings  Worked with USDA to plan series of listening sessions  Primary focus on mechanisms for helping assure access to vet services in remote or under served locations  In Spring 2013 held meetings in 5 locations identified by USDA 23
    24. 24. Other AR-related activities  Enhancing antimicrobial resistance data  NARMS  Enhancing antimicrobial sales/use data  ADUFA  2012 105 ANPRM 24
    25. 25. Enhancing NARMS Program  Comments previously received from FDA‟s Science Board included:  Sampling needs to be nationally representative  Sampling biases occur as processing plants are not randomly selected  On-farm data are essential in understanding movement of resistance from farm to fork 25
    26. 26. NARMS: Examining sampling strategies  5 on-farm pilot studies initiated in September 2011   New slaughter sampling initiated in March 2013   Explore feasibility of a preharvest (live animal) sampling approach for NARMS Worked with FSIS to acquire intestinal samples at slaughter Goal is a representative and sustainable animal sampling scheme 26
    27. 27. Antimicrobial Sales Data: ADUFA 105  ADUFA Section 105 introduced as part of 2008 Animal Drug User Fee Amendment reauthorization  Requires FDA to collect and publicly report annual summaries of antimicrobial sales intended for use in foodproducing animals  Provides measure of total weight of antimicrobials entering livestock distribution channels 27
    28. 28. Antimicrobial Sales Data: Limitations  Sales do not necessarily represent end-use    Complex distribution channels Not all product ultimately used No way to distinguish how much intended for individual species or for a particular indication   Most approvals for multiple species/indications Confidential business information (CBI) protection requirements  Prevent publication of sales with less than 3 distinct sponsors 28
    29. 29. Enhancing Antimicrobial Sales/Use Data  Advance notice of proposed rulemaking (ANPRM) published July 27, 2012  Public input requested on:   Format of FDA‟s annual summary   Enhancements to existing sales/distribution data Other sources of information on use Comment period extended  Closed November 26, 2012 29
    30. 30. Enhancing Antimicrobial Sales/Use Data  Enhancements to existing sales/distribution data   Developing rulemaking (e.g. requiring sponsor estimates of sales by species) Format of FDA‟s annual summary    Evaluating alternative formats that provide additional information while protecting CBI FR Notice published September 26, 2013 seeking public comments on proposed additional tables Other sources of information on use  Collaboration with USDA and CDC to collect on-farm antimicrobial use data that can be linked to shifts in resistance patterns 30
    31. 31. Related CVM Websites  Judicious Use of Antimicrobials:   NARMS   http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance /JudiciousUseofAntimicrobials/default.htm http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance /NationalAntimicrobialResistanceMonitoringSystem/default.htm ADUFA 105 Reports:  http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/u cm042896.htm 31
    32. 32. Thank You 32

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