dr. liz wagstrom - the future of antibiotic use in pork production
TRANSCRIPT
The Future of Antibiotic
Use in Pork Production
Liz Wagstrom, DVM, MS, DACVPM
Chief Veterinarian
Topics
• Background
• Legislative
– ADUFA, PAMTA, DATA
• New Antibiotic Regulations
• Lawsuits
• Timelines for Expected Changes
Antibiotic Regulation
• US Food and Drug Administration (FDA)
regulates animal and human antibiotics
– Authority granted under the Food, Drug
and Cosmetic Act
• State pharmacy boards have authority
over veterinary prescribing
• Most state pharmacy boards have little
interest in extending authority to
medicated feed
Antibiotic Label Claims
• Disease Treatment
• Disease Control
• Disease Prevention
– Treatment, Control and Prevention are
considered therapeutic
• 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
swine feed are medically important with
possible exceptions:
• Bacitracin, Carbadox (Medadox), Naracin,
Bambermycin (Flavomycin) and Tiamulin
(Denegard)
Antibiotics in Feed
• Must be used according to label
directions
– No extra-label use for veterinarians
• Veterinary Feed Directive (VFD)
– Veterinary order, similar to Rx
– FDA oversight, not state pharmacy
boards
VFD
• Current requirements
– Written for amount of feed to be
consumed in a time period
– Original copy required within 5 days
– VCPR required
– Keep records for two years
LEGISLATIVE ACTIVITIES
Legislative Activities
• Animal Drug User Fee Act
(ADUFA)
– User fees to support reviews
– Antibiotic reporting
• Drugs with <3 sponsors aggregated
– Renegotiated and reauthorized on a
five year schedule
• Becomes a “vehicle” for other germane
legislation
ADUFA
• ANPR
– User fees
• Negotiated with FDA
– Antibiotic Use Data
• Currently requires sales data
on a calendar year basis
• Sources of additional data
• Trends in use may relate to
trends in resistance
DATA Act
• Delivering Antibiotics
Transparency Act
• “The more we learn, the
graver the threat becomes
from overuse of antibiotics
by industrial-scale farms”
• Requires feed mills to
report all medicated feed
by species, drug and
indication
PAMTA• Preservation of Antibiotics for
Medical Treatment Act (PAMTA)
– Louise Slaughter,
Diane Feinstein
– Ban “routine uses”
of antibiotics in
classes also used
in human medicine
REGULATORY ACTIVITIES
Regulation Publications
• Final Guidance #209
• Draft Guidance #213
• Draft VFD Advanced Notice of
Proposed Rulemaking
Guidance for Industry #209
• Guidance is how the regulatory agency
will conduct their business
– Does not have the force of law, but will be
treated as such
– 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”
Guidance for Industry #213
• Roadmap for implementation of 209
– “Voluntarily” working with sponsors to
discontinue production claims
– Migrate to VFD or Rx label
– Data needed to get a disease
prevention/control/treatment claim at
production doses
Guidance for Industry #213
• Timelines
– Sponsors to meet with FDA within
three months following final rule
– Changes to be implemented within
three years
– If not done voluntarily – action may
be taken under the Food, Drug and
Cosmetic Act
Guidance for Industry #209
• What does it really mean?
– Most growth promotion uses/dosages of
antibiotics used in human medicine will likely
end within 3 – 4 years
• Unsure how many sponsor companies will do
additional research to support new disease
prevention claims
– Feed grade antibiotics that are in classes
used in human medicine will require a VFD
– Water medications and OTC injectables
will be Rx
• Guidance #209 stated that antibiotics
used, or in classes used, in human
medicine needed to be used under
veterinary oversight
• VFD is FDA’s only regulatory
mechanism to demonstrate veterinary
oversight of antibiotics in feed
Veterinary Feed Directive
Veterinary Feed Directive
• FDA held meetings with veterinary and
industry to gather input to make VFD
more user friendly
– Written for up to 6 months for a production site
(dose, duration, refills)
– Approximate number animals treated, not tons
of feed
– Fax, email VFD forms – no originals required
– Records retained for 12 months
LEGAL CHALLENGES
NRDC Lawsuit
• NRDC and other members of Keep
Antibiotics Working brought suit against
FDA
– 1977 Notice of opportunity for hearing
(NOOH) for subtherapeutic uses of
Penicillin and Tetracycline
– Failure to respond to Citizen Petitions
Citizen Petitions
• FDA denied original Citizen Petitions
• In his second order, Judge Katz has
directed the FDA to “evaluate the
safety risks of the petitioned drugs
and either make a finding that the
drugs are not shown to be safe or
provide a reasoned explanation as to
why the Agency is refusing to make
such a finding.”
Further Legal Rulings
• FDA asked for delay on NOOH
process while appeal underway
• Denied
– Must complete hearing process
within approximately 5 years
• If Guidance 213 fully
implemented will be a moot point
Next steps
• USDA and AVMA working with FDA to
understand implementation
– Listening sessions in remote areas
• Sponsor companies evaluating options
• End result – in the next 3-5 years major
changes will likely occur
THANKS, AND QUESTIONS?