Minor Use Minor Species Update - Federation of Animal Science ...

MINOR SPECIES UPDATE
Federation of
Animal Science Societies
Washington, D.C.
April 28, 2008
Meg Oeller, DVM
Office of Minor Use & Minor Species
1

TODAY’S S TOPICS
Background
Minor Use Minor Species (MUMS)
Policies & Programs
Office of Minor Use & Minor Species
Animal Drug Development
(OMUMSADD)
Small Numbers
NRSP-7 7 Program Update
2

BACKGROUND
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Drug Approval
is Expensive
4

The Problem
Minor uses and minor species
markets are too small to be
economically worthwhile for
pharmaceutical sponsors to
seek FDA approval for drugs
for these markets.
5

Definitions
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What’s s Minor
Minor Species
– ALL animals
other than
humans that
aren’t major
species
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Major Species
Cattle
Swine
Chickens
Turkeys
Dogs
Cats
Horses
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Minor Use in a Major Species
The intended use of a
drug in a major
species for an
indication that occurs
infrequently and in
only a small number of
animals, , or in limited
geographic areas and
in only a small number
of animals annually
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MINOR USE & MINOR SPECIES
POLICIES & PROGRAMS
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How Are Drugs Available for
Minor Uses & Minor Species
Approvals – Not many of these
Extra-label Use – Not for medicated
feeds (Regulations 21 CFR 530)
Compliance Policy Guide 615.115 for
extra-label use of medicated feeds for
minor species
Provisions of the Minor Use & Minor
Species Animal Health Act of 2004
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Provisions of the MUMS Act
Definitions
Exclusivity for
residue studies
Conditional Approval
Indexing
Designation
Established Office
of MUMS Animal
Drug Development
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Conditional Approval
13

Conditional Approval
Allows early marketing to get some return
on investment for sponsors
Drug must meet all approval requirements
to current standard except for
effectiveness at time of Conditional Approval
Sponsor has up to 5 years (annual renewals)
to complete effectiveness section to the full
standard to receive a complete approval
In effect now – Proposed rule in development
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Indexing
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Why
These are the products that cannot
practically use the drug approval
process – too varied, too inherently
valuable, too rare, etc.
For example: zoo animals, lab
animals, pet birds, ornamental fish,
and pocket pets
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Indexing Summary
Legally-Marketed Unapproved Animal Drug
Index (the Index)
Applies to non-food (or early life stages)
minor species only – no transgenics
3-step process - eligibility
- acceptance of expert panel
- request for indexing
Inclusion on Index based on report of an
outside expert panel (FDA must agree)
Problems can result in removal from Index
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Indexing Status
Proposed rule published August 22, 2006
Comments received from 6 organizations
Final Rule published December 6, 2007
Went into effect February 19, 2008
Process is fully described in the rule
http://www.fda.gov/OHRMS/DOCKETS/
98fr/E7-23580.pdf
Hired Dr. Joan Gotthardt to head up the
program (Hooray!)
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Designation
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Designation
Like human “Orphan Drugs”
Incentives - eligibility for grants
- 7 years marketing exclusivity
Sponsors may request designation for a
specific drug/dosage form/intended use
Once a designation is granted, no other
identical designation may be granted
Sponsor must provide annual reports to
show progress toward approval
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Designation Status
Final rule published 7/26/2007
- Went into effect 10/9/2007
So far, have granted 53 designations
* 46 for aquaculture uses
* 4 for small ruminants
* 2 for minor use in dogs
* 1 for minor use in horses
http://www.fda.gov/cvm/MUMSDrugDesg.htm
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SMALL NUMBERS
Remember, Minor Use
status depends on
the disease or
condition
affecting only a
“small number”
of animals annually
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So, What is a Small Number
Based on Human Orphan Drug
Model (conditions affecting fewer
than 200,000 people annually)
7 major species => 7 different
“small numbers”
Different approaches used to
determine these numbers for
companion and food-producing
animals
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Where Can You See them
Just published a Proposed Rule to
suggest these numbers ( Federal
Register - March 18, 2008)
http://a257.g.akamaitech.net/7/257/
2422/01jan20081800/edocket.access.
gpo.gov/2008/pdf/E8-5385.pdf
We would appreciate your
comments
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These are the small numbers
PROPOSED
50,000 Horses
70,000 Dogs
120,000 Cats
310,000 Cattle
1,450,000 Pigs
14,000,000 Turkeys
72,000,000 Chickens
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OFFICE OF MINOR USE &
MINOR SPECIES ANIMAL
DRUG DEVELOPMENT
(OMUMSADD)
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What’s s up in OMUMSADD
Problem solving…
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Responsibilities of OMUMS
Drafting of implementing regulations
& Guidance Documents
Designation of MUMS drugs
Administration of grants
(in the planning stages now)
Indexing
Minor Use determinations (User fees)
Liaison to NRSP-7 7 (USDA)
Liaison to minor use / minor species
stakeholders
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Current Staffing
o
o
o
o
Bernadette Dunham
now Center Director
Meg Oeller Acting
OMUMS Director
Joan Gotthardt
Director of Indexing
Andrew Beaulieu –
contractor & guru
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Staffing Plan for OMUMSADD
Office Director
Contractor
(½ time)
Director
of
Indexing
Veterinary
Medical Officer
for NRSP-7
Veterinary
Medical Officer
for Indexing
Consumer Safety
Officer
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NRSP-7 7 UPDATE
31

NRSP-7
National Research Support Project #7
USDA program to facilitate
approvals for minor species for
animals of agricultural importance
Generates public data for use
by commercial sponsors
Contact information on website
32

NRSP-7 7 News
Albendazole approved for
Liver flukes in goats!!!!
Significant progress on
other projects
33

Current NRSP-7 7 Stats
27 Approvals
4 Complete PMFs available
14 Active projects in progress
Active projects for rabbits,
goats, various fish, bees,
sheep, quail, pheasants, and
partridges
34

Current NRSP-7 7 Sheep Projects
Public Master File:
– Amoxicillin/bacterial
infections
Projects in progress:
– Intravaginal progesterone
(CIDR)/induction of estrus
– Florfenicol/respiratory
infections (on hold)
35

Current NRSP-7 7 Goat Projects
Public Master Files:
– Ivermectin/GI parasites
– Levamisole/GI parasites
– Clorsulon/flukes
Projects in progress:
– Intravaginal progesterone (CIDR)
– Tulathromycin/respiratory infection
36

Current NRSP-7 7 Fish Projects
Erythromycin/BKD/
salmonids
Carp Pituitary/spawning/
finfish
Oxytetracycline/vibriosis/
finfish
Strontium chloride/marking/
finfish
Sulfa/ormetoprim/finfish
Florfenicol/infections/
finfish
37

Current NRSP-7 7 Gamebird
Projects
In Progress:
– Fenbendazole –
pheasants/partridges/quail
– Lasalocid - pheasants
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Current NRSP-7 7 Misc Projects
Honey bees:
– Lincomycin/American
foulbrood
Rabbits:
– Ivermectin/ear mites
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Projects just getting started
Lasalocid for coccidiosis in deer
Fenbendazole for GI parasites in deer
GnRHa/Domperidone as a spawning
aid for ornamental fish
Metomidate for sedation of ornamental
fish
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For further information…
NRSP-7 – http://www.nrsp7.org
FDA/CVM Minor Use & Minor Species info:
http://www.fda.gov/cvm/index/mums/
minortoc.htm
or call me at (240) 276-9005
or email me: margaret.oeller@fda.hhs.gov
or Dr. Gotthardt: joan.gotthardt@fda.hhs.gov
or Dr. Beaulieu: andrew.beaulieu@fda.hhs.gov
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Any Questions
THANK YOU!
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