FDA Antibiotic Guidance - Dr. Jennifer Koeman, National Pork Board; Dr. Harry Snelson, American Association Swine Veterinarians, from the 2015 World Pork Expo, June 3 - 5, 2015, Des Moines, IA, USA. More presentations at http://www.swinecast.com/2015-world-pork-expo

1. Changes in antibiotic regulation –
what will it mean on the farm?
Jennifer Koeman, National Pork Board
Harry Snelson, American Association of Swine Veterinarians

2. Topics
• Background
• Current Antibiotic Regulations
– Label Claims
– VFD
• New Antibiotic Regulations
• What this means on the farm
• What you can do to prepare

3. Background

4. Antibiotic Regulation
• US Food and Drug Administration regulates
animal and human antibiotics
• State pharmacy boards have authority over
veterinary prescribing

5. Antibiotic Label Claims
• Disease Treatment
• Disease Control
• Disease Prevention
– Treatment, Control and Prevention are considered
therapeutic
– FDA has said they are necessary for animal health and
welfare
• Growth Promotion or Improvement of Nutritional
Efficiency

6. Antibiotic Classes
• Medically important (as defined by FDA)
– Same, or in same classes, as antibiotics used to treat
humans
– Most antibiotics approved for use in animal feed are
medically important with possible exceptions:
• Swine: bacitracin, mecadox, narasin, bambermycin, and
tiamulin

7. Antibiotics in Feed
• Must be used according to label directions
– No extra-label use for veterinarians
• Veterinary Feed Directive (VFD)
– Veterinary order, similar to a prescription
– FDA oversight, not state pharmacy boards

8. Veterinary Feed Directive
• Current requirements
– Written for amount of feed to be consumed in a time
period
– Original copy required to the feed mill within 5 days
– VCPR
– Refills not straightforward
– Keep records (mill, veterinarian, farmer) for two years

9. Regulatory Action

11. Regulatory Action

12. Regulatory Action

13. Regulatory Activity
Removal of growth promotion/nutritional efficiency use
Increased veterinary oversight

14. Guidance for Industry #209
• Guidance is how the regulatory agency will
conduct their business
– Does not have the force of law, but provides the
agency’s position on regulatory matters
– Voluntary is relative

15. Guidance for Industry #209
• “Production uses” (growth promotion and
nutritional efficiency) of antibiotics in classes used
in human medicine are injudicious
– Does not call them unsafe
• Requires other uses of these same classes of
antibiotics be under “veterinary oversight”

16. FDA medically important
• All swine antibiotics will be affected under
Guidance 209 except
– Bacitracin
– Carbadox
– Bambermycin
– Ionophores
– Tiamulin
These antibiotics will remain
available for growth promotion
and/or over-the-counter (OTC) in
feed and water

17. Guidance for Industry #209
• “Voluntarily” working with sponsors to
discontinue claims or migrate production claims
to disease prevention
– Guidance #213 gives roadmap on implementation

18. Guidance for Industry #213
• Animal Health sponsors
have all agreed to
voluntarily surrender their
approvals for growth
promotion, and move
remaining therapeutic uses
under VFD or prescription
for affected products
– Implementation to be
completed by end of 2016

19. FDA Guidance 213/VFD
• Guidance #213 and VFD finalized
• Growth Promotion and Nutritional Efficiency
labels will be removed by Dec. 2016
– “Medically Important”
• Disease Prevention, Control and Treatment will be
VFD in feed, Rx in water

20. Guidance for Industry
• What does it really mean?
– Most growth promotion uses will end within 3 years
– Most feed grade antibiotics will no longer be available
over-the-counter but will require a veterinary “order”
– Antibiotics in water will require a prescription

21. What does this really mean?
• Significant regulatory step that will result in
changes on how antibiotics are used on the farm
• Once those labels are changed, it will be illegal to
utilize these antibiotics to promote growth
• Producers will need a VFD or prescription to use
these products in feed and water

22. How will this affect pork producers?
• Producers are going to lose some antibiotics or
uses of antibiotics
• Increased costs and increased time
• Producers will need a close relationship with their
veterinarian – access to rural veterinarians?

23. What can you do to prepare?

24. What can you do to prepare?
• Swine veterinarians and producers are familiar
with the VFD process
• However, there will be changes to the number of
products requiring a VFD and the frequency with
which VFDs will need to be written
• Veterinarians will continue to work closely with
their clients to ensure the ongoing judicious use of
antibiotics

25. Work with your veterinarian
• Secure a good working relationship with your
herd veterinarian and build familiarity with your
production system.
• Critical as drugs transition to VFD
– Currently two VFD drugs – pulmotil and nuflor
– All medically important feed grade abtics will require a
VFD on January, 2017

26. VFD proposed final rule
• 2 year record maintenance –
– vet, distributor, client
– Records maintained as paper or electronic
• Expiration date
– As per approved label or, if no labelled date,
– Vet assigned not to exceed 6 months
– VFD feed cannot be fed beyond the expiration date
• VCPR
– Comply with state requirements
– FDA codified VCPR (21CFR530) if no or inadequate
state regs

27. VFD proposed final rule
• VCPR – minimum requirements:
– the veterinarian engage with the client to assume
responsibility for making clinical judgments about
patient health
– have sufficient knowledge of the patient by virtue of
patient examination and/or visits to the facility where
the patient is managed, and
– provide for any necessary follow-up evaluation or
care.

28. VFD proposed final rule
• Refills
– authorization to obtain and feed additional VFD feed
in the same total quantity and under the same
conditions of the existing VFD by the expiration date of
the VFD
– vet can assign refills IF refills are allowed on the
product label
– Currently, no products have a label approval for refills
• VFD estimates the number of animals receiving
the feed not the amount of feed
• VFD cannot be used to estimate on-farm abtic use

29. Evaluate herd health protocols
• Sit down with your veterinarian to evaluate all
animal-health management protocols and herd
vaccination programs
– Veterinarians can work with producers to develop
strategies to minimize disease risk through facility
design, pig flows, vaccination protocols, herd health
monitoring, disease surveillance and appropriate
diagnostics

30. Understand product changes
• Review all swine medications currently being used
within the operation
• Discuss which products are affected by veterinary
feed directives and prescriptions and how the
process will work on the farm
– Veterinarians can provide guidance on judicious
antibiotic use and help ensure compliance with the
new guidelines and regulations

31. Be vigilant with record-keeping
• Walk through the record-keeping requirements
and strategies
– Record keeping is, and will continue to be, a key
aspect of on-farm antibiotic use
– VFD final rule requires veterinarians, distributors and
producers to retain the VFD for 2 years

32. Continue best practices
• Follow VFD label instructions
• Ensure proper withdrawal intervals
• Employ PQA Plus Responsible Antibiotic Use
Practices

33. Next Steps

34. Industry Efforts
• Outreach and education to producers and
veterinarians
– State meetings
– Numerous industry communications planned
– AASV outreach
– PQA Plus® to reflect changes
• Working with other organizations to assure
consistent understanding of VFD rule
• Honing research priorities

35. This message funded by America’s Pork Producers and the Pork
Checkoff
Questions?

36. White House interest spawns new initiatives
• Executive Order 13676: Combating Antibiotic-
Resistant Bacteria—issued by President Barack
Obama on September 18, 2014

37. White House interest spawns new initiatives

38. National Strategy
• “Directs Federal agencies to
accelerate response to this
growing threat to the nation’s
health and security.”

39. PCAST
• Surveillance
– Want White House coordination
• Stewardship
– Development of alternatives for
animal use
– Supportive of FDA process, for
now
• Continued Development of
Antibiotics
– Calling for public private
partnerships

40. National Action Plan
• “roadmap to guide the Nation
in rising to this challenge”
• “guide activities by the U.S.
Government…is also designed
to guide action by public
health, healthcare, and
veterinary partners in a
common effort to address
urgent and serious drug-
resistant threats that affect
people in the U.S. and around
the world.”

41. National Security Priority
• Defense, Agriculture, Health and Human Services
to lead interagency task force
– State, Justice, Homeland Security, USAID, Veterans
Affairs, Environmental Protection, National Security
Council
• CARB Advisory Panel
– Stakeholders and experts to advise the agencies on the
implementation of the CARB action plan

42. National Security Priority
• White House Forum on Antibiotic Stewardship
– Key human and animal health constituencies to
improve antibiotic use (antibiotic stewardship)
nationwide