LACK OF APPROVED PHARMACEUTICS
RESTRAINS U.S. GOAT INDUSTRY
National Institute for Animal Agriculture
Small Ruminant Commi...
WHAT IS THE GOAT “INDUSTRY”?
It involves goats, goat producers,
processors and companies that
manufacture/sell goat-relate...
GOAT INDUSTRY: THE GOATS
Meat
Goats
KIK
O
BOER
SPANIS
H
MYOTONI
C
GOAT INDUSTRY: THE GOATS
Dairy
Goat
s
Lamancha
Alpin
e
Nubian Nigerian
Dwarf
GOAT INDUSTRY: THE GOATS
Dairy
Goat
s
Oberhas
li
Toggenbu
rg
Saane
n
Sabl
e
GOAT INDUSTRY: THE GOATS
Fiber
Goats
Angora (produce
mohair)
Cashmere
GOAT INDUSTRY: THE GOATS
Browsing (selective
herbivory)Any breed of goat can adapt to this function,
They should not be an...
GOAT INDUSTRY: THE GOATS
Companion
Animals
GOAT INDUSTRY: THE GOATS
Companion Animals: Pack
Goats
GOAT INDUSTRY: THE PEOPLE
Operate Commercial or Extensive
Dairy, Meat or Fiber Herds
GOAT INDUSTRY: THE PEOPLE
Operate Intensively
Managed Dairy or Meat
Herds
GOAT INDUSTRY: THE PEOPLE
Operate Seedstock
Operations (usually
smaller in scale)
GOAT INDUSTRY: THE PEOPLE
Biomedical
Research
•Animal Model for human disease
(Rheumatoid arthritis, HIV, Trauma,
Orthoped...
GOAT INDUSTRY: THE PEOPLE
Transgenic goats – used as
bioreactors•Anti-thrombin (Atryn) – TC Biotherapeutics, to
treat deep...
GOAT INDUSTRY: THE PEOPLE
Small flock producers:
 Sustainable
 Diversified
 Organic
 Homestead
GOAT INDUSTRY: THE PEOPLE
Youth Projects:
 Family Hobby
 Science Literacy for
youth
GOAT INDUSTRY: THE PEOPLE
Youth Show Projects:
 4H
 FFA
 Youth Market Jackpot
shows
GOAT INDUSTRY: THE PRODUCTS
Dairy Products: you can find any dairy product in a “goats
milk” version
GOAT INDUSTRY: THE PRODUCTS
Goat Meat: Is popular for
 Ethnic markets
 Upscale restaurants
 Health conscious
consumers ...
GOAT INDUSTRY: THE PRODUCTS
GOAT INDUSTRY: THE PRODUCTS
Beautiful, Natural
Fibers:
Mohair, from Angora Goats
Cashmere, can be
combed or shorn
from Cas...
GOAT INDUSTRY: THE PRODUCTS
Goat’s milk soap and skin care products
GOAT INDUSTRY: THE PRODUCTS
 Fire Mitigation
 Noxious weeds
 Ecosystem
Maintenance
 Habitat restoration
GOAT INDUSTRY: THE PRODUCTS
 International Development
GOAT INDUSTRY: THE PRODUCTS
Leather
GOAT INDUSTRY: THE CHALLENGE
Drug Category Cattle Swine Chickens Turkeys Sheep Goats
Anesthetics 0 0
Antibiotics 139 46.50...
GOAT INDUSTRY: THE CHALLENGE
Types of Drugs
Needed:
Antibiotics
Antiparasitics
(internal &
external)
Anti
inflammatorie...
GOAT INDUSTRY: THE CHALLENGE
If there aren’t labeled drugs for goats, then
what?
Extra-Label Drug Use (ELDU)
Provides a m...
NRSP-7 *MINOR USE ANIMAL DRUG PROGRAM*
To identify animal drug needs for minor species and minor uses in major
species
T...
ROUTE TO VETERINARY DRUG APPROVAL
Very expensive and time consuming
Sponsors must demonstrate:
Target Animal Safety**
Ef...
MINOR USE/MINOR SPECIES LAW
MUMS
Legislation:Public Law: Minor Use and Minor
Species Animal Health Act of 2004
MUMs offi...
PROJECTS IN PROGRESS
 CIDRs
 Target Animal Safety Packet Complete
 Human Food Safety Packet Complete
 Efficacy Studies...
WITHOUT THESE PROGRAMS, THE GOAT INDUSTRY IS AT A
DISADVANTAGE
52.5
143
15
U.S.A.
Australia
Europe
Trade Barriers:
Other c...
GOAT DRUG APPROVALS IN EUROPE VS U.S.
230
162
130
96
81
59 53
45 42
22 18 15
0
20
40
60
80
100
120
140
160
180
200
220
240
Estrus Synchronization
Products Distributed for Use
on Goat Dairies
in France (sponges);
CIDRs are available in NZ and
oth...
BUT, WAIT! IT GET’S WORSE
 There is no funding in the current budget
for NRSP-7
MUADP [NRSP-7]
National Research Support ...
HOW STAKEHOLDERS CAN HELP!
Participate in research that
supports getting FDA drug
approval
Contact your Congressional
Me...
KEY HOUSE MEMBERS FOR
AGRICULTURE APPROPRIATIONS
Jack Kingston, GA
Tom Latham, IA
Jo Ann Emerson, MO
Robert Aderholt, AL
C...
KEY SENATE MEMBERS FOR
AGRICULTURE APPROPRIATIONS
Roy Blunt (MO)
Thad Cochran (MS)
Mitch McConnell (KY)
Susan Collins (ME)...
KEY MEMBERS FOR THE FARM BILL
Senator John Barrasso, WY
Proposed Farm Bill Authorization for
MUADP in 2007
Senator Debbie ...
OTHER MINOR SPECIES AFFECTED
 Sheep
 Deer
 Elk
 Bison
 Fish
 Other aquatic
species
 Honey bees
 Llamas
 Alpacas
EVEN CATTLE WILL BE AFFECTED
 Minor Use in Major
Species
 Veal Calves
 Southern Texas:
Ivermectin MUADP
project for era...
THANK YOU FOR YOUR SUPPORT!
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Tom Boyer - Lack of Approved Pharmaceutics Restrains U.S. Goat Industry

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Lack of Approved Pharmaceutics Restrains U.S. Goat Industry - Tom Boyer, President, American Goat Federation, from the 2012 Annual Conference of the National Institute for Animal Agriculture, March 26 - 29, Denver, CO, USA.

More presentations at: http://www.trufflemedia.com/agmedia/conference/2012-decreasing-resources-increasing-regulation-advance-animal-agriculture

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Tom Boyer - Lack of Approved Pharmaceutics Restrains U.S. Goat Industry

  1. 1. LACK OF APPROVED PHARMACEUTICS RESTRAINS U.S. GOAT INDUSTRY National Institute for Animal Agriculture Small Ruminant Committee Meeting, March 27, 2012 Tom Boyer, President American Goat Federation
  2. 2. WHAT IS THE GOAT “INDUSTRY”? It involves goats, goat producers, processors and companies that manufacture/sell goat-related goods and services.
  3. 3. GOAT INDUSTRY: THE GOATS Meat Goats KIK O BOER SPANIS H MYOTONI C
  4. 4. GOAT INDUSTRY: THE GOATS Dairy Goat s Lamancha Alpin e Nubian Nigerian Dwarf
  5. 5. GOAT INDUSTRY: THE GOATS Dairy Goat s Oberhas li Toggenbu rg Saane n Sabl e
  6. 6. GOAT INDUSTRY: THE GOATS Fiber Goats Angora (produce mohair) Cashmere
  7. 7. GOAT INDUSTRY: THE GOATS Browsing (selective herbivory)Any breed of goat can adapt to this function, They should not be animals in production
  8. 8. GOAT INDUSTRY: THE GOATS Companion Animals
  9. 9. GOAT INDUSTRY: THE GOATS Companion Animals: Pack Goats
  10. 10. GOAT INDUSTRY: THE PEOPLE Operate Commercial or Extensive Dairy, Meat or Fiber Herds
  11. 11. GOAT INDUSTRY: THE PEOPLE Operate Intensively Managed Dairy or Meat Herds
  12. 12. GOAT INDUSTRY: THE PEOPLE Operate Seedstock Operations (usually smaller in scale)
  13. 13. GOAT INDUSTRY: THE PEOPLE Biomedical Research •Animal Model for human disease (Rheumatoid arthritis, HIV, Trauma, Orthopedics, etc.) •Produce antibodies •Goat Reagents •Transgenic goats
  14. 14. GOAT INDUSTRY: THE PEOPLE Transgenic goats – used as bioreactors•Anti-thrombin (Atryn) – TC Biotherapeutics, to treat deep vein thrombosis •Spider silk – University of Utah, for bio-matrices and sutures •Human butyrylcholinesterase – PharmAthene, for protection against nerve gas damage •Human granulocyte colony stimulating factor– Brazil, stimulates white blood cells •Human Lysozyme – UC Davis, has antimicrobial effect on gut flora Founder doe of Human Lysozyme transgenic Pro-nuclear gene injection Spider silk
  15. 15. GOAT INDUSTRY: THE PEOPLE Small flock producers:  Sustainable  Diversified  Organic  Homestead
  16. 16. GOAT INDUSTRY: THE PEOPLE Youth Projects:  Family Hobby  Science Literacy for youth
  17. 17. GOAT INDUSTRY: THE PEOPLE Youth Show Projects:  4H  FFA  Youth Market Jackpot shows
  18. 18. GOAT INDUSTRY: THE PRODUCTS Dairy Products: you can find any dairy product in a “goats milk” version
  19. 19. GOAT INDUSTRY: THE PRODUCTS Goat Meat: Is popular for  Ethnic markets  Upscale restaurants  Health conscious consumers TABLE 1. COMPARISON OF GOAT MEAT TO OTHER MEATS 3 OZ COOKED (roasted) CALORIES (gm) FAT (gm) SAT'D FAT (gm) PROTEIN (gm) IRON (gm) Goat (1) Beef (2) Pork (2) Lamb (2) Chicken (2) 122 245 310 235 120 2.58 16.00 24.00 16.00 3.50 0.79 6.80 8.70 7.30 1.10 23 23 21 22 21 3.2 2.9 2.7 1.4 1.5
  20. 20. GOAT INDUSTRY: THE PRODUCTS
  21. 21. GOAT INDUSTRY: THE PRODUCTS Beautiful, Natural Fibers: Mohair, from Angora Goats Cashmere, can be combed or shorn from Cashmere Goats
  22. 22. GOAT INDUSTRY: THE PRODUCTS Goat’s milk soap and skin care products
  23. 23. GOAT INDUSTRY: THE PRODUCTS  Fire Mitigation  Noxious weeds  Ecosystem Maintenance  Habitat restoration
  24. 24. GOAT INDUSTRY: THE PRODUCTS  International Development
  25. 25. GOAT INDUSTRY: THE PRODUCTS Leather
  26. 26. GOAT INDUSTRY: THE CHALLENGE Drug Category Cattle Swine Chickens Turkeys Sheep Goats Anesthetics 0 0 Antibiotics 139 46.50% 126 66.70% 31 15.20% 46 42.20% 28 58.30% 11 73.30% Antiinflammatory Agents 10 3.30% 1 0.50% Antiparasitics 61 20.40% 30 15.90% 172 84.30% 42 38.50% 11 22.90% 4 26.70% Growth Promoter 11 3.70% 8 4.20% 21 19.30% Hormonal Agents 48 16.10% 5 2.60% 2 4.20% Minerals, Nutrients or Vitamins 4 1.30% 11 5.80% 2 4.20% All Other Classes 26 8.70% 8 4.20% 1 0.50% 5 10.40% Total Approved (A)NADAs 299 100% 189 100% 204 100% 109 100% 48 100% 15 100% There are only 15 approved drugs labeled for use in goats!
  27. 27. GOAT INDUSTRY: THE CHALLENGE Types of Drugs Needed: Antibiotics Antiparasitics (internal & external) Anti inflammatories Analgesics Reproductive management Anesthetics
  28. 28. GOAT INDUSTRY: THE CHALLENGE If there aren’t labeled drugs for goats, then what? Extra-Label Drug Use (ELDU) Provides a means for use of many FDA approved drugs in goats Applies to both Over the Counter and Prescription Medications Not the gold standard (no dosing or human food safety studies) Legal responsibility lies within the veterinarian Not available for medicated feeds Cannot be used for production purposes
  29. 29. NRSP-7 *MINOR USE ANIMAL DRUG PROGRAM* To identify animal drug needs for minor species and minor uses in major species To generate and disseminate data for safe and effective therapeutic applications To facilitate FDA/CVM approvals for drugs identified as a priority for a minor species or minor use To accomplish these goals, MUADP coordinates the efforts of animal producers, pharmaceutical manufacturers, FDA/CVM, USDA-NIFA state Agricultural Experiment Stations and veterinary medical colleges throughout the country.
  30. 30. ROUTE TO VETERINARY DRUG APPROVAL Very expensive and time consuming Sponsors must demonstrate: Target Animal Safety** Effectiveness** Human Food Safety** (meat & milk residues) Environmental and User Safety Good Manufacturing Practices The FDA Drug Approval Process **Study Portions Usually Performed by the Minor Use Animal Drug Program
  31. 31. MINOR USE/MINOR SPECIES LAW MUMS Legislation:Public Law: Minor Use and Minor Species Animal Health Act of 2004 MUMs office is based at FDA Intent of Legislation Allow early marketing to recover investment costs Provides alternative legal means to market drugs Provides incentives to encourage drug approval** (this one most directly applies to minor species)
  32. 32. PROJECTS IN PROGRESS  CIDRs  Target Animal Safety Packet Complete  Human Food Safety Packet Complete  Efficacy Studies Pending  Tulathromycin (Draxxin)  Target Animal Safety Packet Complete  Human Food Safety Pending  Efficacy Protocol Pending  Florfenicol (Nuflor)  Ceftiofur Crystalline Free Acid Sterile Suspension (Excede®) for treating respiratory disease
  33. 33. WITHOUT THESE PROGRAMS, THE GOAT INDUSTRY IS AT A DISADVANTAGE 52.5 143 15 U.S.A. Australia Europe Trade Barriers: Other countries have many more drugs approved for use in goats
  34. 34. GOAT DRUG APPROVALS IN EUROPE VS U.S. 230 162 130 96 81 59 53 45 42 22 18 15 0 20 40 60 80 100 120 140 160 180 200 220 240
  35. 35. Estrus Synchronization Products Distributed for Use on Goat Dairies in France (sponges); CIDRs are available in NZ and other countries for small ruminants. Without this tool, US producers cannot provide year-around products.
  36. 36. BUT, WAIT! IT GET’S WORSE  There is no funding in the current budget for NRSP-7 MUADP [NRSP-7] National Research Support Project No. 7 There is no funding in the current budget for FARAD
  37. 37. HOW STAKEHOLDERS CAN HELP! Participate in research that supports getting FDA drug approval Contact your Congressional Member and let them know the importance of the Minor Use Animal Drug Program Ask for agriculture appropriations in the 2013- 2014 budget Ask for MUADP authorization in the upcoming Farm Bill Contact your Agriculture Experiment Station Director and let them know about the importance of Veterinary School – Large Animal Surgery Laboratory
  38. 38. KEY HOUSE MEMBERS FOR AGRICULTURE APPROPRIATIONS Jack Kingston, GA Tom Latham, IA Jo Ann Emerson, MO Robert Aderholt, AL Cynthia Lummis, WY Alan Nunnelee, MS Tom Graves, GA Sam Farr, CA Rosa DeLauro, CT Sanford Bishop, GA Marcy Kaptur, OH
  39. 39. KEY SENATE MEMBERS FOR AGRICULTURE APPROPRIATIONS Roy Blunt (MO) Thad Cochran (MS) Mitch McConnell (KY) Susan Collins (ME) Jerry Moran (KS) John Hoeven (ND) Herb Kohl (WI) Tom Harkin (IA) Dianne Feinstein (CA) Tim Johnson (SD) Ben Nelson (NE) Mark Pryor (AR) Sherrod Brown (OH)
  40. 40. KEY MEMBERS FOR THE FARM BILL Senator John Barrasso, WY Proposed Farm Bill Authorization for MUADP in 2007 Senator Debbie Stabenow Chairwoman of the Senate Committee on Agriculture, Nutrition and Forestry Chelsea Render (Veterinary Student in Senator Stabenow’s office)
  41. 41. OTHER MINOR SPECIES AFFECTED  Sheep  Deer  Elk  Bison  Fish  Other aquatic species  Honey bees  Llamas  Alpacas
  42. 42. EVEN CATTLE WILL BE AFFECTED  Minor Use in Major Species  Veal Calves  Southern Texas: Ivermectin MUADP project for eradication of cattle tick fever EVEN CATTLE WILL BE AFFECTED
  43. 43. THANK YOU FOR YOUR SUPPORT!

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