The VFD: Past and Present
Heather Fowler, VMD MPH PhD DACVPM
Director, Producer and Public Health
National Pork Board
January 24, 2019
Pre-VFD
FDA Guidance for Industry #209 and 213
• Growth promotion and nutritional efficiency labels removed January 1, 2017 for
medically important (MI) antibiotics
• ELDU in animal feed is illegal
• Disease Treatment, Control and Prevention will require a veterinary order (VFD-feed
or Rx-water)
 Required to be used for a specific, known disease or syndrome
 No refills
 6 month expiration
3
Antibiotics - 2016 Advertising Creative
Remember “USCARE” this Year
• Six Key Steps to Take Now
• Easy to Remember
• Call to Action
Producer Awareness
• 4-Page Fact Sheet
• 10-Panel Pocket Brochure
• 12-Page Pork Industry
Guide for Responsible
Use of Antibiotics (PQA
Plus® supplement)
Producer Antibiotic Resource Center
• Antibiotic Resource Center located: www.pork.org/antibiotics
– All resources
– FAQs
– Additional clarifications from FDA
Post-VFD
One Health and Antibiotic Stewardship
• Multidisciplinary approach to
continuously improving in the
AMR space
• Requires collaborations among
agencies, institutions, etc.
• National Pork Board has taken
a leadership role in the
antibiotic use and resistance
discussion
Pew Charitable Trusts
Pew Charitable Trusts Discussions
• Brought together by Pew Charitable Trusts and Farm Foundation
• Coalition of industry partners and key stakeholders
• Goal: Develop universal standards on antimicrobial stewardship
• Quarterly meetings to discuss progress and further development of
a stewardship framework
Pew Charitable Trusts
• Dec 18: Press Release highlighting achievements of all participants
– Participants named release: NPPC, NPB
– Other groups: Elanco Animal Health, Hormel Foods, Jennie-O Turkey
Store, McDonald’s Corporation, National Milk Producers Federation,
National Turkey Federation, Smithfield Foods, Inc., Tyson Foods, Walmart
Inc., and Zoetis.
• Next Steps TBD Continuous Improvement!
CDC AMR Challenge
Challenge Accepted
• Year long stewardship campaign led
by the CDC
• NPB updated policy and position
statement removing redundancy and
restating commitment to stewardship
• Visited with several groups at the CDC
to identify opportunities for
collaboration
• Participated in Global One Health Day
NPB Position Statement
• Last updated in June 2015
• Removed redundancy
• Fine tuned message into a
position statement only
• Reinforced commitment to
antimicrobial stewardship
US Food and Drug Administration (FDA)
FDA Sales Report, December 2018
• Sales of MIA decreased by 33% in the
past year, 43% since 2015
– NMIA also decreased by 5% in the past year
• Overall sales decreased by 22%
• Tetracycline represents the largest
quantity of antibiotic (class) sold
– Sales of this class declined 15%
• Sales in swine decreased by 35% and 7%
for medically important and not
medically important antibiotics
respectively
• Lowest values since reporting starting in
2009
FDA five year plan, 2019-2023
• Move all medically important antibiotics under the oversight of the
veterinarian
• Review and update information on the duration of use for drugs
where it currently lacking
• Address stewardship concerns in the companion pet (cat/dog/etc.)
space
• Encourage development of alternative to antimicrobials
• Improve stewardship across all species through education and
outreach
FDA five year plan, 2019-2023
• Publish a summary assessment of the VFD pilot inspections conducted in
fiscal years 2016 – 2018
– Integrate VFD compliance into Drug Residue Inspection Program
• Engage international partners on activities to combat AMR
– Provide technical assistance to developing countries
• Develop a system to collect on farm use data
– Requires the development of use metrics (a meaningful denominator)
• Expand NARMS to other animal and bacterial species, expand sampling
• Publish reports that integrate available information
Raised Without Antibiotics
• Worked with AASV and the NPB Animal
Welfare Committee to develop new
material for producers considering a
transition to RWA
• Veterinary student intern conducted
assessments and drafted form to be
reviewed and finalized by a panel of
veterinarians as well as NPB and AASV
staff
• Brief, one page self-assessment tool
available for download on the pork store
Learn more about volunteer opportunities at the National Pork Board
https://www.pork.org/about/get-involved/
Get Involved!
This message funded by America’s Pork Producers
CORE COMPONENTS OF ANTIBIOTIC STEWARDSHIP
PROGRAMS
Foundation Implementation Evaluation
Know what to do, why,
and communicate actions
Implement foundation of
knowledge
Continuous Assessment
of stewardship practices
Commitment and
culture
Know about antibiotic
stewardship and why it is
needed
Caregivers understand
and embrace their role in
stewardship
Demonstrate commitment
to stewardship
Veterinarian guidance
and partnership
Understand VCPR and its
importance
Have a valid VCPR and
animal health plan in
place
Demonstrate that
veterinarian has an
appropriate oversight role
Disease prevention
strategies
Know spectrum of options
to prevent diseases
Implement appropriate
husbandry, biosecurity
and other prevention
practices
Demonstrate protocols
and prevention practices
Optimal treatment
approaches
Know how to recognize
signs of disease and
when and how to seek
veterinary engagement
Have sound diagnostic
treatment practices and
protocols in place
Demonstrate that disease
treatment outcomes are
monitored
Record Keeping Understand importance
and value of accurate
Have appropriate record
keeping systems in place
Demonstrate actionable
record keeping
Implementation Guidelines
Stewardship programs should meet the following principles:
• Provide transparency & build trust
• Deliver meaningful, objective & actionable information
• Ensure stewardship activities are consistent in approach
• Afford accountability to all stakeholders
• Drive continuous improvement & long-term sustainability
• Ensure responsible, truthful and transparent communication
among stakeholders
Stewardship Definition
“Antibiotics are an essential tool in maintaining the health and well-being of
humans and animals. A comprehensive approach to antibiotic stewardship is
required to protect their efficacy, as well as ensure food safety and security.
Because of the resistance challenge, antibiotic use in all settings needs to be
carefully and responsibly managed. Essential to antibiotic stewardship and
animal well-being are appropriate veterinary oversight; minimizing the need for
antibiotics through biosecurity, good husbandry practices and other disease
prevention strategies; optimizing treatment efficacy through sound decision-
making; and appropriate drug selection and use. ”
Source: Pew Charitable Trusts

The Veterinary Feed Directive: Past and Present

  • 1.
    The VFD: Pastand Present Heather Fowler, VMD MPH PhD DACVPM Director, Producer and Public Health National Pork Board January 24, 2019
  • 2.
  • 3.
    FDA Guidance forIndustry #209 and 213 • Growth promotion and nutritional efficiency labels removed January 1, 2017 for medically important (MI) antibiotics • ELDU in animal feed is illegal • Disease Treatment, Control and Prevention will require a veterinary order (VFD-feed or Rx-water)  Required to be used for a specific, known disease or syndrome  No refills  6 month expiration 3
  • 4.
    Antibiotics - 2016Advertising Creative
  • 5.
    Remember “USCARE” thisYear • Six Key Steps to Take Now • Easy to Remember • Call to Action
  • 6.
    Producer Awareness • 4-PageFact Sheet • 10-Panel Pocket Brochure • 12-Page Pork Industry Guide for Responsible Use of Antibiotics (PQA Plus® supplement)
  • 7.
    Producer Antibiotic ResourceCenter • Antibiotic Resource Center located: www.pork.org/antibiotics – All resources – FAQs – Additional clarifications from FDA
  • 8.
  • 9.
    One Health andAntibiotic Stewardship • Multidisciplinary approach to continuously improving in the AMR space • Requires collaborations among agencies, institutions, etc. • National Pork Board has taken a leadership role in the antibiotic use and resistance discussion
  • 10.
  • 11.
    Pew Charitable TrustsDiscussions • Brought together by Pew Charitable Trusts and Farm Foundation • Coalition of industry partners and key stakeholders • Goal: Develop universal standards on antimicrobial stewardship • Quarterly meetings to discuss progress and further development of a stewardship framework
  • 12.
    Pew Charitable Trusts •Dec 18: Press Release highlighting achievements of all participants – Participants named release: NPPC, NPB – Other groups: Elanco Animal Health, Hormel Foods, Jennie-O Turkey Store, McDonald’s Corporation, National Milk Producers Federation, National Turkey Federation, Smithfield Foods, Inc., Tyson Foods, Walmart Inc., and Zoetis. • Next Steps TBD Continuous Improvement!
  • 13.
  • 14.
    Challenge Accepted • Yearlong stewardship campaign led by the CDC • NPB updated policy and position statement removing redundancy and restating commitment to stewardship • Visited with several groups at the CDC to identify opportunities for collaboration • Participated in Global One Health Day
  • 15.
    NPB Position Statement •Last updated in June 2015 • Removed redundancy • Fine tuned message into a position statement only • Reinforced commitment to antimicrobial stewardship
  • 16.
    US Food andDrug Administration (FDA)
  • 17.
    FDA Sales Report,December 2018 • Sales of MIA decreased by 33% in the past year, 43% since 2015 – NMIA also decreased by 5% in the past year • Overall sales decreased by 22% • Tetracycline represents the largest quantity of antibiotic (class) sold – Sales of this class declined 15% • Sales in swine decreased by 35% and 7% for medically important and not medically important antibiotics respectively • Lowest values since reporting starting in 2009
  • 18.
    FDA five yearplan, 2019-2023 • Move all medically important antibiotics under the oversight of the veterinarian • Review and update information on the duration of use for drugs where it currently lacking • Address stewardship concerns in the companion pet (cat/dog/etc.) space • Encourage development of alternative to antimicrobials • Improve stewardship across all species through education and outreach
  • 19.
    FDA five yearplan, 2019-2023 • Publish a summary assessment of the VFD pilot inspections conducted in fiscal years 2016 – 2018 – Integrate VFD compliance into Drug Residue Inspection Program • Engage international partners on activities to combat AMR – Provide technical assistance to developing countries • Develop a system to collect on farm use data – Requires the development of use metrics (a meaningful denominator) • Expand NARMS to other animal and bacterial species, expand sampling • Publish reports that integrate available information
  • 20.
    Raised Without Antibiotics •Worked with AASV and the NPB Animal Welfare Committee to develop new material for producers considering a transition to RWA • Veterinary student intern conducted assessments and drafted form to be reviewed and finalized by a panel of veterinarians as well as NPB and AASV staff • Brief, one page self-assessment tool available for download on the pork store
  • 21.
    Learn more aboutvolunteer opportunities at the National Pork Board https://www.pork.org/about/get-involved/ Get Involved!
  • 22.
    This message fundedby America’s Pork Producers
  • 24.
    CORE COMPONENTS OFANTIBIOTIC STEWARDSHIP PROGRAMS Foundation Implementation Evaluation Know what to do, why, and communicate actions Implement foundation of knowledge Continuous Assessment of stewardship practices Commitment and culture Know about antibiotic stewardship and why it is needed Caregivers understand and embrace their role in stewardship Demonstrate commitment to stewardship Veterinarian guidance and partnership Understand VCPR and its importance Have a valid VCPR and animal health plan in place Demonstrate that veterinarian has an appropriate oversight role Disease prevention strategies Know spectrum of options to prevent diseases Implement appropriate husbandry, biosecurity and other prevention practices Demonstrate protocols and prevention practices Optimal treatment approaches Know how to recognize signs of disease and when and how to seek veterinary engagement Have sound diagnostic treatment practices and protocols in place Demonstrate that disease treatment outcomes are monitored Record Keeping Understand importance and value of accurate Have appropriate record keeping systems in place Demonstrate actionable record keeping
  • 25.
    Implementation Guidelines Stewardship programsshould meet the following principles: • Provide transparency & build trust • Deliver meaningful, objective & actionable information • Ensure stewardship activities are consistent in approach • Afford accountability to all stakeholders • Drive continuous improvement & long-term sustainability • Ensure responsible, truthful and transparent communication among stakeholders
  • 26.
    Stewardship Definition “Antibiotics arean essential tool in maintaining the health and well-being of humans and animals. A comprehensive approach to antibiotic stewardship is required to protect their efficacy, as well as ensure food safety and security. Because of the resistance challenge, antibiotic use in all settings needs to be carefully and responsibly managed. Essential to antibiotic stewardship and animal well-being are appropriate veterinary oversight; minimizing the need for antibiotics through biosecurity, good husbandry practices and other disease prevention strategies; optimizing treatment efficacy through sound decision- making; and appropriate drug selection and use. ” Source: Pew Charitable Trusts

Editor's Notes

  • #4 Second main bullet has extra space before parenthesis. 6-month expiration
  • #5 This resource center was part of a year long campaign aimed at preparing producers for the implementation of the VFD.
  • #6 Furthermore, US. Care, not u scare, outlined ways for producer to bhegin to change their practices in preparation for the implementation of VFD
  • #7 Producer awareness was raised via the use of fact sheets, producers, and supplemental materials in the PQA Plus program.
  • #8 This aim was accomplished through the development and distribution of resources put together by the pork board as seen on the antibiotics resource center
  • #12 This past Friday, September 22nd the Pew Charitable Trust held a one day workshop to continue the discussion on antimicrobial stewardship started at a previous meeting earlier in the year. The group consisted of industry stakeholders representing most of the barn yard as well as agencies representing industry customers and consumers. The overall goal was to develop universal standards on antimicrobial stewardship. The meeting was spent reviewing a definition of stewardship drafted at a prior meeting as well as reviewing the components of a stewardship plan that would apply across the board (LET ME KNOW IF YOU WANT COPIES OF THESE DOCUMENTS). The meeting ended with the formation of three different subcommittees that will continue to develop the stewardship program, discuss the group’s identify, as well as a communication plan for describing the efforts and the program to customers and consumers. A follow up meeting will likely take place q quarter. Heather will be serving on the stewardship program development subcommittee. The date of the next meeting has yet to be determined.
  • #13 This past Friday, September 22nd the Pew Charitable Trust held a one day workshop to continue the discussion on antimicrobial stewardship started at a previous meeting earlier in the year. The group consisted of industry stakeholders representing most of the barn yard as well as agencies representing industry customers and consumers. The overall goal was to develop universal standards on antimicrobial stewardship. The meeting was spent reviewing a definition of stewardship drafted at a prior meeting as well as reviewing the components of a stewardship plan that would apply across the board. The meeting ended with the formation of three different subcommittees that will continue to develop the stewardship program, discuss the group’s identify, as well as a communication plan for describing the efforts and the program to customers and consumers. A follow up meeting will likely take place q quarter. Heather will be serving on the stewardship program development subcommittee. The date of the next meeting has yet to be determined.