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?