Transcript Pork Industry Antibiotics Update

Pork Industry Antibiotics Update
Jennifer Koeman, DVM, MSc, MPH, DACVPM
Director, Producer and Public Health
Changes in Antibiotic Regulation –
What Will It Mean On the Farm?
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
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
What does this really mean?
• Most growth promotion uses will end by Dec 2016
• 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?
National Strategy
White House interest spawns new initiatives
White House interest spawns new initiatives
• Executive Order 13676: Combating AntibioticResistant Bacteria—issued by President Barack
Obama on September 18, 2014
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
Marketplace
McDonald’s Global Vision
• Four criteria
– Overall similar to FDA Guidance 209
– Restricted to prevention and treatment uses with
veterinary oversight
• Six judicious use principals
– Align with PQA Plus
McDonald’s Global Vision
• Verification criteria to effect meaningful change
• Reducing the use of medically-important
antimicrobials in food animals
What does this mean?
• All swine antibiotics affected except:
FDA
•
•
•
•
•
Bacitracin*
Carbadox
Bambermycin
Ionophores
Tiamulin*
*On WHO list
WHO/MCD
• Carbadox
• Bambermycin
• Ionophores
McDonald’s U.S. Poultry Policy
• McDonald’s will only source chicken raised
without antibiotics important to human medicine
What does this mean?
• All swine antibiotics prohibited for any use except:
FDA
•
•
•
•
•
Bacitracin
Carbadox
Bambermycin
Ionophores
Tiamulin*
WHO/MCD
• Carbadox
• Bambermycin
• Ionophores
What does this mean?
• Dual use or human drugs prohibited
• Would leave swine industry with no treatment for
pneumonia (mycoplasma or bacterial), Strep suis,
H. parasuis, E.coli scours, and illeitis
• Only treatments allowed would be for swine
dysentery and Salmonella choleraesuis
Not All Species Are the Same
• Ionophores are a unique class of antimicrobials
that are not used in human medicine are not
believed to select for cross-resistance to human
antibiotics
• Ionophores are used in poultry to control
coccidiosis (primary disease that leads to other
secondary diseases)
Not All Species Are the Same
• The pork industry does not have an analogous
product that cures the variety of illnesses that
ionophores do in poultry
• Products used in the swine industry are either
– Related to antibiotic classifications that are
used in human medicine or
– Have the potential for developing crossresistance
Helping Producers Prepare
Helping Producers Prepare
• Antibiotics resource page
www.pork/org/antibiotics
• Checkoff newsletter and magazine
Checkoff Newsletter May/June 2015
Checkoff Magazine Summer 2015
Industry Efforts
• National Pork Board Antibiotics Position
Statement and Policy
• National Pork Board Three-Point Antibiotic
Stewardship Plan
• Allocate up to $1.4 million in funding of scientific
research and antibiotic risk assessment studies,
producer education and consumer awareness
programs
Checkoff Stewardship Plan
Priority Research Areas for 2016
1. Analysis and assessment of preventive uses of
antibiotics at therapeutic doses in pork
production to optimize swine health and public
health. For example, this may include
2. Analysis and assessment of specific animal
population antibiotic treatment versus individual
animal treatment in pork production to optimize
swine health and public health.
Priority Research Areas for 2016 cont.
3. Evaluation of on-farm challenges to antibiotic
record keeping and identification ofstrategies to
improve antibiotic record keeping practice for
continuous improvement of responsible
antibiotic use on the farm.
4. Characterization and assessment of the
environmental fate of antibiotics, antibiotic
metabolites, antibiotic resistant bacteria and
antibiotic resistant genes on swine farms.
Priority Research Areas for 2016 cont.
5. Exploration of strategies to protect herd health
and minimize the need for antibiotics.
Questions?
This message funded by America’s Pork Producers