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 Ruen, Fairmont Veterinary Clinic, from the 2016 Minnesota Pork Congress, January 18 - 20, 2016, Minneapolis, MN, USA. More presentations at http://www.swinecast.com/2016-minnesota-pork-congress

1. 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

2. 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
FVC
PEW Foundation
Ruen, 2016 MN Pork Congress

3. Editorials:
“Denmark’s Drug-Free Pigs”
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Ruen, 2016 MN Pork Congress
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

4. 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
FVC
Ruen, 2016 MN Pork Congress

5. 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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Ruen, 2016 MN Pork Congress

6. FVC
Ruen, 2016 MN Pork Congress
Activists, Congress,
Food and Drug Administration, & the
public want to know and have a say

7. 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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Ruen, 2016 MN Pork Congress

8. Result =
The FDA is moving with urgency
…change is coming
Ruen, 2016 MN Pork Congress
FVC

9. 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®
FVC
Ruen, 2016 MN Pork Congress

10. FDA: Guidance 152, Appendix A
Classified 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
FVC
Ruen, 2016 MN Pork Congress

11. 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
FVC
Ruen, 2016 MN Pork Congress

12. 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 principles
A. Phase out production uses
B. Move OTC to VFD & Rx, veterinary oversight all feed and water
C. 3 year timeline after final guidance document
FVC
Ruen, 2016 MN Pork Congress

13. 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
FVC
Ruen, 2016 MN Pork Congress

14. 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 2016
Updated forms
• Veterinary oversight for all uses
Nothing over-the-counter
• Next --- FDA wants to monitor amounts used
FVC
Ruen, 2016 MN Pork Congress