CVM: Protecting human and animal health 2011 Update Renate Reimschuessel CVM/Office of Research.

CVM: Protecting human and animal

health2011 Update

Renate ReimschuesselCVM/Office of Research

CVM’s Vision / MissionCVM’s Vision / Mission

MissionMission

"Protecting Human and Animal Health"

CVM Organizational CVM Organizational ChartChart

Office of the Center DirectorDirector

Bernadette M. Dunham, D.V.M., Ph.D.

Deputy DirectorTracey Forfa, J.D.

Deputy Director for Science PolicyWilliam Flynn, D.V.M., M.S.

Office of the Center DirectorDirector

Bernadette M. Dunham, D.V.M., Ph.D.

Deputy DirectorTracey Forfa, J.D.

Deputy Director for Science PolicyWilliam Flynn, D.V.M., M.S.

Office of ManagementDirector

David E. Wardrop, Jr.

Deputy DirectorRoxanne Schweitzer

Office of ManagementDirector

David E. Wardrop, Jr.

Deputy DirectorRoxanne Schweitzer

Office of New Animal Drug Evaluation

DirectorSteven D. Vaughn, D.V.M.

Deputy Director for Administration

Vacant

Deputy Director forScience & Policy

Elizabeth A. Luddy, D.V.M.

Office of New Animal Drug Evaluation

DirectorSteven D. Vaughn, D.V.M.

Deputy Director for Administration

Vacant

Deputy Director forScience & Policy

Elizabeth A. Luddy, D.V.M.

Office of Surveillance and Compliance

DirectorDaniel G. McChesney, Ph.D.

Deputy DirectorMartine Hartogensis, D.V.M

.

Office of Surveillance and Compliance

DirectorDaniel G. McChesney, Ph.D.

Deputy DirectorMartine Hartogensis, D.V.M

.

Office of ResearchDirector

David White, M.S., Ph.D.

Deputy Director Patrick McDermott, Ph.D.

Office of ResearchDirector

David White, M.S., Ph.D.

Deputy Director Patrick McDermott, Ph.D.

Office of Minor UseMinor Species AnimalDrug Development

DirectorMargaret Oeller, D.V.M.

Office of Minor UseMinor Species AnimalDrug Development

DirectorMargaret Oeller, D.V.M.

Associate Director for

Policy and CommunicationsCatherine P. Beck


Policy and CommunicationsCatherine P. Beck


ManagementDavid E. Wardrop, Jr.


ManagementDavid E. Wardrop, Jr.

CVM’s Core ResponsibilitiesCVM’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 Companion Animal and Minor Species MedicineMinor Species Medicine

~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.

CVM is responsible for regulating drugs, devices and food additives used in companion animals (dogs, cats and horses) and minor animal species…

Animal Health and Animal Animal Health and Animal Food Product SafetyFood Product Safety

Animal Drug Manufacturers (300)

Feed Manufacturers (6,600) Livestock and Poultry

Producers (over 1 million) Specialized Industry/Firms

CVM is also responsible for regulating animal drugs, devices and food additives used in food producing animals.

From: Given to or used on:

8.5 billion chickens & turkeys

160 million cattle & pigs 11 million sheep & goats

Consumed by:

310 million humans in the U.S.

CVM’s Business PrioritiesCVM’s Business PrioritiesRelated to foods:Related to foods:

Transforming Food Safety Practices – Implementing the Food Safety Modernization Act (FSMA)Animal Biotechnology (genetic engineering and cloning)Unapproved Animal DrugsBovine Spongiform Encephalopathy (BSE) Illegal Drug Residues in Animal Derived FoodsAntimicrobial 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-pharmGenetic 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 DrugsUnapproved Animal DrugsThere 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 FocusBSE 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 ResiduesTissue 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 FocusShifting 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.

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 ActivitiesCVM 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

CVM International ActivitiesCVM International Activities

Purpose of the Aquaculture Training Module: (JIFSAN)

Help foreign aquaculture producers understand what drugs & chemicals are allowed (or not) for use in US

Includes: DefinitionsRegulating agenciesLaws & regulationsPolicies & procedures

Helps them understand:Food fish vs. nonfood fishLow Regulatory Priority unapproved drugsExtra label useHACCPImport toleranceMRL’sDrugs approved in other countries

Other CVM Challenges -- Other CVM Challenges -- Antimicrobial ResistanceAntimicrobial Resistance

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).

Provide safe use of antimicrobials in food animals while ensuring that significant human antimicrobial therapies are not compromised or lost

Salmonella

EnterococcusEnterococcus

E. coliE. coli

Recent CVM ActionsRecent 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.

NARMS is a national public health surveillance system that tracks antibiotic resistance in foodborne bacteria.

National Antimicrobial Resistance National Antimicrobial Resistance Monitoring System Monitoring System (NARMS)(NARMS)

CVM’s OFFICE OF RESEARCH

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CVM’s Office of Research CVM’s Office of Research ((OROR))>165 acres>165 acres

8401 Muirkirk Road8401 Muirkirk Road

About 70 staffAbout 70 staff

Large-animal Large-animal housing and surgery housing and surgery suitessuites

Specialized Specialized laboratorieslaboratories

AquacultureAquaculture

PasturesPastures

Feed mixing facilityFeed mixing facility

QuarantineQuarantine facilityfacility

OR Organizational OR Organizational ChartChart

Office of Research

DirectorDavid White, M.S., Ph.D

Deputy DirectorPatrick McDermott, Ph.D.

Office of Research



National Antimicrobial Resistance Monitoring

System (NARMS)

Director

Patrick McDermott, Ph.D.


System (NARMS)

Director


Division of Residue Chemistry

Director

Phil Kijak, Ph.D


Director

Phil Kijak, Ph.D

Division of AppliedVeterinary Medical Research

Director

Jeffrey Ward, D.V.M.Ph.D.


Director


Veterinary LaboratoryResponse Network (Vet-LRN)

Director

Renate Reimschuessel, V.M.D., Ph.D.


Director


Division of Animal and Food Microbiology

Director

Mark Rasmussen, Ph.D.


Director


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CVM Critical Path Projects

1. Development of analytic approaches and methods for proteomic analysis of milk and the biological fluids

2. Evaluation of the potential trans-placental transfer of genetically engineered material from fetus to dam during pregnancy in ruminants

3. The development of methods to identify and characterize various nanoparticles in biological matrices and determine safety in animal edible tissue and by-products

4. Evolution of multidrug resistant plasmids in Salmonella at the DNA sequence level

5. Application of DNA microarray technology to characterize the inflammatory and immunological responses in swine

6. Development of novel molecular typing strategies for determining source attribution of Salmonella infections

7. Developing alternative ivermectin-sensitive model systems & pharmacokinetics of fexofenadine and loperamide in normal and MDR1 mutant collies

8. 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

• 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)

Ensuring the safety and efficacy of drugs for animals, while protecting the food supply is a core mission for CVM.

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Compliance

• Drug Residue Methods • Method Trials and Validation• Pharmacokinetics and Residue Depletion• Screening Tests• Incursion Services

Supporting CVM agency, state and federal efforts to ensure that animal drugs are not misused

OR Organizational OR Organizational ChartChart

Office of Research



Office of Research




System (NARMS)

Director



System (NARMS)

Director



Director

Phil Kijak, Ph.D


Director

Phil Kijak, Ph.D


Director



Director



Director



Director



Director



Director


Vet-LRNVeterinary Laboratory Response Network

• What is the mission?

To promote human and animal health by

collaborating with veterinary diagnostic laboratoriesto provide scientific information,

to build laboratory capacity andto train scientists

investigating CVM regulated products(animal feeds/animal drugs)


How:Develop infrastructure through

Communications network, Cooperative

agreement/Grants/Contracts, Training/Proficiency exercises


• And WHY do we need it?

Contact FDA

Animal is sickLab work

Vet bills

Was it the food?

What does CVM want?

• Veterinary Records

What does CVM want?


• Collect Feed/Drug samples

What does CVM want?


• Collect Feed/Drug samples

• More Tests?

Who Pays?

Necropsy?Histopathology?

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

CVM: Protecting human and animal health 2011 Update Renate Reimschuessel CVM/Office of Research.

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Transcript of CVM: Protecting human and animal health 2011 Update Renate Reimschuessel CVM/Office of Research.