Dr. Paul Ruen - The future of Antibiotic Use: Are you, your feed mill and veterinarian ready for January 1, 2017? How did we get here? What does it mean?

The future of Antibiotic Use: Are you,

your feed mill and veterinarian ready

for January 1, 2017?

How did we get here?

What does it mean?

Dr. Paul D. Ruen, DVM

Fairmont Veterinary Clinic, LLP

MN Pork Congress

Minneapolis MN

January 19, 2016

News Headlines:

“80% of U.S. antibiotics wind up in meat”change.org Feb 28, 2011

“Hog farmers overuse antibiotics, government data show”

The Wall Street Journal Mar 16, 2011

“House committee examines antimicrobial use in animal agriculture”

JAVMA Aug 15, 2010

“Citing drug resistance, U.S. restricts more antibiotics for livestock”

The New York Times Jan 4, 2012

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PEW Foundation

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Editorials:

“Denmark’s Drug-Free Pigs”

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PRESIDENT OBAMA

issues a $1.2 billion

National Action Plan for

Combating Antibiotic-

Resistant Bacteria

He could have simply

spent a day with Kaj

Munck, a Danish hog

farmer

By BARRY ESTABROOK

The New York Times April 3, 2015

Television:

“Katie Couric investigates feeding healthy

farm animals antibiotics. Is it creating new

drug-resistant bacteria?” CBS News Feb 9, 2010

? -- Don’t farmers and veterinarians share

values with the public?

Safe food

Contaminated meat / drug residues

Antibiotic-resistant bacteria

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Legislation efforts ---PAMTA:Preservation of Antibiotics for

Medical Treatment Act

• Rep. Louise Slaughter (NY) & Sen. Dianne Feinstein (CA)

• Highlights concerns about resistant bacteria in humans

• Key points

– Eliminate disease prevention and growth-performance uses

– Defines critical drugs as those used in humans

• Would leave us strictly with treatment and control

• Gets introduced every year

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Activists, Congress,

Food and Drug Administration, & the

public want to know and have a say

GAO report, 2011:“Agencies have made limited progress

addressing antibiotic use in animals”

• HHS and USDA have collected some data on antibiotic

use in food animals but these data lack crucial details

necessary to examine trends and understand the

relationship between use and resistance.

Today --- Drug company annual sales amounts

Future --- Use by species and the purpose of use

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Result =

The FDA is moving with urgency

…change is coming

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FDA: Change #1

Guidance #152

• Since 2003 new drugs require veterinary oversight

– Veterinary Feed Directive (VFD)

– Refers to 21 CFR Sec. 530.3(i) VCPR

• Describes a pre-approval risk assessment process

– Data to demonstrate does not promote resistance

• Appendix A…ranks important human drugs

– Critically important, Highly important, Important

• Swine: Pulmotil®, Nuflor®

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FDA: Guidance 152, Appendix AClassified important, highly important, or critical for human health:

Beta lactam penicillin,amoxicillin,ceftiofur

Macrolides tylosin,tilmicosin,lincomycin,tulathromycin

Aminoglycosides neomycin,gentamicin

Fluroquinolones enrofloxacin

Tetracyclines tetracycline,oxytetracycline,chlortetracycline

Sulfonamides various sulfas

Streptogramins virginiamycin

Phenicols florfenicol

Not Classified

Polypeptides bacitracin

Pleuromultilin tiamulin

Quinoxaline carbadox

Phosphoglycolipid bambermycin

Ionophores narasin

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FDA: Change #2

Guidance #209 - Final in 2012

The judicious use of medically important antimicrobials in food-producing animals

should be limited to those uses that…

1. Are considered necessary for assuring animal health

“therapeutic”

2. Include veterinary oversight or consultation

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FDA: Change #3

Guidance 213 - Final in 2013

-Detailed process for implementing #209

-Recommendations for drug sponsors

for voluntarily changing labels

1. Defines drugs that are critically important, highly important, or important to human medical needs = Guidance #152

2. Voluntarily adopt judicious use principlesA. Phase out production uses

B. Move OTC to VFD & Rx, veterinary oversight all feed and water

C. 3 year timeline after final guidance document

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FDA: Change #4

VFD Final Rule - June 2015

- Eliminates production uses of feed antimicrobials

- Affected feed antimicrobials require VFD

- VFD written by veterinarian under valid VCPR

- VFD expiration maximum of 6 months

Transition:

FDA provide education & training for stakeholders

Expect new labels on products by December 2016

VFD full use as labels change

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Summary:

• Veterinary oversight for all use of antimicrobials

• All sponsoring companies have agreed to change labels– 283 affected products

– A disease pathogen needs to be identified to the drug

– Prevention, control, and treatment only

– No production use (adg, f/g)

• VFD’s implement December 2016Updated forms

• Veterinary oversight for all usesNothing over-the-counter

• Next --- FDA wants to monitor amounts used

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