Download FDA Guidance 213/VFD - National Pork Board

Changes in antibiotic regulation –
what will it mean on the farm?
Jennifer Koeman, National Pork Board
Harry Snelson, American Association of Swine Veterinarians
Topics
• Background
• Current Antibiotic Regulations
– Label Claims
– VFD
• New Antibiotic Regulations
• What this means on the farm
• What you can do to prepare
Background
Antibiotic Regulation
• US Food and Drug Administration regulates animal
and human antibiotics
• State pharmacy boards have authority over
veterinary prescribing
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
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
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
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
Regulatory Action
Regulatory Action
Regulatory Action
Regulatory Activity
Removal of growth promotion/nutritional efficiency use
Increased veterinary oversight
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
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”
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
Guidance for Industry #209
• “Voluntarily” working with sponsors to
discontinue claims or migrate production claims
to disease prevention
– Guidance #213 gives roadmap on implementation
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
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
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
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
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?
What can you do to prepare?
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
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
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
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.
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
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
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
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
Continue best practices
• Follow VFD label instructions
• Ensure proper withdrawal intervals
• Employ PQA Plus Responsible Antibiotic Use
Practices
Next Steps
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
Questions?
This message funded by America’s Pork Producers and the Pork
Checkoff
White House interest spawns new initiatives
• Executive Order 13676: Combating AntibioticResistant Bacteria—issued by President Barack
Obama on September 18, 2014
White House interest spawns new initiatives
National Strategy
• “Directs Federal agencies to
accelerate response to this
growing threat to the nation’s
health and security.”
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
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 drugresistant threats that affect
people in the U.S. and around
the world.”
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
National Security Priority
• White House Forum on Antibiotic Stewardship
– Key human and animal health constituencies to
improve antibiotic use (antibiotic stewardship)
nationwide