CVM:
Protecting human and animal
health
2011 Update
Renate Reimschuessel
CVM/Office of Research
CVM’s Vision / Mission
Mission
"Protecting Human and Animal Health"
CVM Organizational
Chart
Office of the Center Director
Associate Director
for
Management
David E. Wardrop, Jr.
Director
Bernadette M. Dunham, D.V.M., Ph.D.
Deputy Director
Tracey Forfa, J.D.
Associate Director
for
Policy and Communications
Catherine P. Beck
Deputy Director for Science Policy
William Flynn, D.V.M., M.S.
Office of Management
Director
David E. Wardrop, Jr.
Deputy Director
Roxanne Schweitzer
Office of New Animal
Drug Evaluation
Director
Steven D. Vaughn, D.V.M.
Deputy Director for
Administration
Vacant
Deputy Director for
Science & Policy
Elizabeth A. Luddy, D.V.M.
Office of Surveillance
and Compliance
Director
Daniel G. McChesney, Ph.D.
Deputy Director
Martine Hartogensis, D.V.M
.
Office of Research
Director
David White, M.S., Ph.D.
Deputy Director
Patrick McDermott, Ph.D.
Office of Minor Use
Minor Species Animal
Drug Development
Director
Margaret Oeller, D.V.M.
CVM’s Core Responsibilities
New Animal Drug Review
Animal Generic Drug Review
Post-approval monitoring of animal drugs and feeds, and
marketed animal devices
Animal Feed – Human Food – Pet Food -- Protection/Safety
Compliance related actions
Research to support regulatory decision-making
Companion Animal and
Minor Species Medicine
CVM is responsible for regulating drugs, devices and food additives
used in companion animals (dogs, cats and horses) and minor animal
species…
~72 million dogs & 82 million cats
~7 million horses
Minor Species include all animals other than the
following 7 Major Species: cattle, swine,
chickens, turkeys, horses, dogs and cats.
Animal Health and Animal
Food Product Safety
CVM is also responsible for regulating animal drugs, devices and food
additives used in food producing animals.
From:
Given to or used on:
Consumed by:
Animal Drug Manufacturers
(300)
Feed Manufacturers (6,600)
Livestock and Poultry
Producers (over 1 million)
Specialized Industry/Firms
8.5 billion chickens &
turkeys
160 million cattle & pigs
11 million sheep & goats
310 million humans
in the U.S.
CVM’s Business Priorities
Related to foods:
Transforming Food Safety Practices – Implementing the
Food Safety Modernization Act (FSMA)
Animal Biotechnology (genetic engineering and cloning)
Unapproved Animal Drugs
Bovine Spongiform Encephalopathy (BSE)
Illegal Drug Residues in Animal Derived Foods
Antimicrobial Resistance (includes the National Antimicrobial
Resistance Monitoring System [NARMS])
Turtles (Salmonella sp.)
International Activities
Potential for GE Animals
• Biopharm
• Research
• Xenotransplant, scarce
cells, tissues, organs
• Disease resistance
• Animal derived food products
Genetic Engineering – Bio-pharm
“Bio-pharm” animals also present a unique set of challenges.
These are animals used to make human biologics or other
therapeutics... (e.g. ATryn – human anticoagulant – a therapeutic protein
produced in milk of GE goats.)
CVM is still sorting through Compliance
requirements.
Sponsors are required to submit an
application to CVM for review of the
animal component. Other product
Centers – CBER and CDER will review
the human therapeutic.
Many sponsors do not realize that they are required to consult with
or submit applications to CVM.
Unapproved Animal Drugs
There are many unapproved drug products, including those that
are compounded outside of what is allowed under AMDUCA,
which places a strain on the marketplace
These products may have a long history of use but have not
gone through the FDA drug approval process to demonstrate
safety and effectiveness
CVM is currently soliciting comments through a Federal
Register Notice that asks for input on potential legal homes for
these unapproved drug products. Comment period closed on
April 19th
Over 240 comments have been received.
The majority of the comments refer to restrictions on
compounding and most people are very opposed to the
potential of losing the ability to compound from bulk.
BSE Inspections – Shifting Focus
This has been a very successful program
with a consistent compliance rate of over
90%
CVM would now like to shift some of our
focus and resources to drug residue work.
Most of the Center’s residue-related
efforts are currently focused on inspection
of Food Safety Inspection Service (FSIS)
identified animals presented at slaughter
with violative drug residues. Resources
currently allow for inspection of less than
50% of the violations reported to the
Agency.
Tissue Residues
CVM and CFSAN are now participating in
an interagency working group with
representatives from USDA’s Food
Inspection Safety Service (FSIS) and
representatives of the Environmental
Protection Agency (EPA) to develop a more
consistent and collaborative approach to
identifying and addressing tissue residues.
Shifting Focus
Future efforts will also branch out into a milk sampling
assignment which is currently making its way through the
clearance process to test the hypothesis of whether poor
on farm practices leading to drug residues in tissues are
also leading to drug residues in milk.
CVM International Activities
With leadership and resources from FDA’s Office of International
Programs, CVM carried out a number of capacity building
projects overseas, including animal drug workshops.
Representatives from CVM are key participants in a number
of important Codex Alimentarius Activities:
Chair of Codex Committee on Residues of
Veterinary Drugs in Foods.
Participating on Codex Task Force on
Antimicrobial Resistance.
Participating in Codex Electronic Working Group
on Animal Feeding.
CVM International Activities
• In process to becoming an Official Collaborating Center with the
OIE.
• CVM has ongoing surveillance and Global Monitoring of the Safety
of Feed and Feed Ingredients.
• CVM manages the U.S. NARMS Program and Integration of the
World Health Organization – Global Food borne Infections Network.
• Provides expertise and content for International Capacity Building
Project: Training Module on Aquaculture Drug Use
Purpose of the Aquaculture Training Module: (JIFSAN)
Help foreign aquaculture producers understand what
drugs & chemicals are allowed (or not) for use in US
Includes:
Definitions
Regulating agencies
Laws & regulations
Policies & procedures
Helps them understand:
Food fish vs. nonfood fish
Low Regulatory Priority unapproved drugs
Extra label use
HACCP
Import tolerance
MRL’s
Drugs approved in other countries
Other CVM Challenges -Antimicrobial Resistance
Provide safe use of antimicrobials in food animals while ensuring that
significant human antimicrobial therapies are not compromised or lost
Increasing resistance to antibiotic treatment
in bacteria that infect humans raises
concerns about the role that drug use in
food-producing animals may play in the
emergence of resistant bacteria.
Monitoring resistance among enteric
pathogens in both animals and humans
through National Antimicrobial Resistance
Monitoring System (NARMS).
E. coli
Recent CVM Actions
• Availability of Draft Guidance (#209) –
‘‘The Judicious Use of Medically Important
Antimicrobial Drugs in Food-Producing Animals”
• Advance Notice of Proposed Rulemaking Veterinary Feed Directive.
National Antimicrobial Resistance
Monitoring System (NARMS)
NARMS is a national public health
surveillance system that tracks
antibiotic resistance in foodborne
bacteria.
CVM’s OFFICE OF RESEARCH
CVM’s Office of Research (OR)
>165 acres
8401 Muirkirk Road
About 70 staff
Large-animal
housing and surgery
suites
Specialized
laboratories
Aquaculture
Pastures
Feed mixing facility
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Quarantine facility
OR Organizational
Chart
Office of Research
Director
David White, M.S., Ph.D
Deputy Director
Patrick McDermott, Ph.D.
National Antimicrobial
Resistance Monitoring
System (NARMS)
Division of Residue
Chemistry
Division of Animal
and Food Microbiology
Division of Applied
Veterinary Medical Research
Veterinary Laboratory
Response Network (Vet-LRN)
Director
Director
Director
Director
Director
Patrick McDermott, Ph.D.
Phil Kijak, Ph.D
Mark Rasmussen, Ph.D.
Jeffrey Ward, D.V.M.
Ph.D.
Renate Reimschuessel, V.M.D.,
Ph.D.
CVM Critical Path Projects
1.
2.
3.
4.
5.
6.
7.
8.
Development of analytic approaches and methods for proteomic analysis
of milk and the biological fluids
Evaluation of the potential trans-placental transfer of genetically
engineered material from fetus to dam during pregnancy in ruminants
The development of methods to identify and characterize various
nanoparticles in biological matrices and determine safety in animal edible
tissue and by-products
Evolution of multidrug resistant plasmids in Salmonella at the DNA
sequence level
Application of DNA microarray technology to characterize the
inflammatory and immunological responses in swine
Development of novel molecular typing strategies for determining source
attribution of Salmonella infections
Developing alternative ivermectin-sensitive model systems &
pharmacokinetics of fexofenadine and loperamide in normal and MDR1
mutant collies
Replacing obsolete regulatory methods for veterinary drug residues in
animal derived foods including development of equivalence data between
new and obsolete methods (bridging study)
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Premarket/Drug Review
Ensuring the safety and efficacy of drugs for animals, while protecting
the food supply is a core mission for CVM.
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•
•
•
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Animal Drug Safety and Efficacy (fish disease models)
Antimicrobial Resistance Mechanisms (risk assessment)
Immunopharmacology (proteomics)
Metabolism and Residue Depletion (MUMS)
Method Trials (evaluation of reg. methods)
Replacement of Obsolete Methods (bridging studies)
Microbiological Methods (AST of aquatic pathogens)
Pharmacokinetics/Pharmacodynamics (spp. differences)
Pharmacogenomics (predicting safety)
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Compliance
Supporting CVM agency, state and federal efforts to ensure that
animal drugs are not misused
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Drug Residue Methods
Method Trials and Validation
Pharmacokinetics and Residue Depletion
Screening Tests
Incursion Services
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OR Organizational
Chart
Office of Research
Director
David White, M.S., Ph.D
Deputy Director
Patrick McDermott, Ph.D.
National Antimicrobial
Resistance Monitoring
System (NARMS)
Division of Residue
Chemistry
Division of Animal
and Food Microbiology
Division of Applied
Veterinary Medical Research
Veterinary Laboratory
Response Network (Vet-LRN)
Director
Director
Director
Director
Director
Patrick McDermott, Ph.D.
Phil Kijak, Ph.D
Mark Rasmussen, Ph.D.
Jeffrey Ward, D.V.M.
Ph.D.
Renate Reimschuessel, V.M.D.,
Ph.D.
Vet-LRN
Veterinary Laboratory Response Network
• What is the mission?
To promote human and animal health
by
collaborating with veterinary diagnostic laboratories
to provide scientific information,
to build laboratory capacity and
to train scientists
investigating CVM regulated products
(animal feeds/animal drugs)
Vet-LRN
Veterinary Laboratory Response Network
How:
Develop infrastructure through
Communications network,
Cooperative agreement/Grants/Contracts,
Training/Proficiency exercises
Vet-LRN
Veterinary Laboratory Response Network
• And WHY do we need it?
Lab work
Animal is sick
Vet bills
Contact FDA
Was it the food?
What does CVM want?
• Veterinary Records
What does CVM want?
• Veterinary Records
• Collect Feed/Drug samples
What does CVM want?
• Veterinary Records
• Collect Feed/Drug samples
• More Tests?
Necropsy?
Histopathology?
Who Pays?
Need a system to help investigate potential
pet/livestock food/medicine related disease
Need a system to help investigate potential
pet/livestock food related disease
• CVM is developing a new network
similar to the FERN system (smaller)
Where does Vet-LRN fit in?
• We don’t need to re-invent the wheel
Small program
2 People in Office of Research,
1 Person in Office of Surveillance and Compliance
1 Contractor
March 2011 stakeholder input
Veterinary Diagnostic Laboratories
Develop contacts with CVM
Describe capabilities
Describe needs
Who all is interested?
What makes Vet-LRN unique?
Vet-LRN diagnostic labs will help with the
surveillance of veterinary cases unlikely to come
into food testing laboratories on a routine basis.
Vet-LRN will analyze diagnostic samples from
livestock and companion animals exposed to
adulterated/contaminated food and drugs
Vet-LRN wants to work with the other networks, not
in isolation
Vet-LRN will fund projects outside the current
mission of other networks