Tracking Aquaculture Drug Development

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Tracking Aquaculture Drug Development

• Rosalie (Roz) Schnick
• Michigan State University
• RozSchnick_at_Centurytel.net
• http//ag.ansc.purdue.edu/aquanic/jsa/aquadrugs/in
  dex.htm
• Presented at the JSA Working Group on Quality
  Assurance in Aquaculture Production, December
  3-4, 2003, Washington, DC

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FEDERAL-STATE AQUACULTURE DRUG APPROVAL
PARTNERSHIP PROJECTSUCCESS STORY IN PROGRESS!
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Federal-State Aquaculture Drug Approval
Partnership Project

• 38 states, 3 Federal agencies, 8 sponsors,
  private sector involvement
• 8 years, ended September 2002
• 12 million
• 8 drugs (AQUI-S?, chloramine-T, copper sulfate,
  florfenicol, formalin, hydrogen peroxide,
  oxytetracycline (oral immersion), potassium
  permanganate)

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SIX DRUGS17 LABEL CLAIMSSUCCESSES SOON
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Successes Soon
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Successes Soon
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Successes Soon
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Recent Completion Highlights

• Chloramine-T Technical Sections
• Mammalian Safety (Sponsor)
• Environmental Safetychemical dilution model for
  effluents (UMESC)
• Human Food Safetyall fish (UMESC)
• Target Animal Safetysalmonids (AADAPP)
• Efficacyslaughter authorization reinstated
• Freedom of Information (FOI) Summaryefficacy/bact
  erial gill disease/all freshwater-reared
  salmonids (AADAPP)

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Recent Completion Highlights

• Florfenicol Technical Sections
• Human Food Safetycatfish (Sponsor)
• Human Food Safetyantimicrobial resistance/all
  fish (Sponsor)
• Target Animal Safetycatfish (UMESC through
  Sponsor)
• Efficacyenteric septicemia/catfish (Sponsor)
• Efficacycoldwater disease/all freshwater-reared
  salmonids (AADAPP)

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Recent Completion Highlights

• Formalin
• Efficacy infection model/saprolegniasisperfected
  (UMESC CVM Office of Research)
• Supplemental NADA packageapproved (Sponsor)
• Hydrogen peroxide Technical Sections
• Environmental Safetyprovisionally complete
  (UMESC)
• Target Animal Safetyall fish eggs (UMESC)
• Efficacysaprolegniasis/all coldwater coolwater
  fish eggs (UMESC)
• Efficacycolumnaris disease/all coolwater fish
  channel catfish (UMESC)

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Recent Completion Highlights

• Oxytetracycline (oral) Technical Sections
• Human Food Safetyall fish (UMESC)
• Target animal safetycoolwater warmwater fish
  (UMESC)
• FOI SummaryColdwater disease/all
  freshwater-reared salmonids (AADAPP)
• Oxytetracycline (immersion) Technical Sections
• Data packagemarking/all fish (NRSP-7)
• NADA packagefinal stages (Sponsor)

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OTHER DRUGS UNDER DEVELOPMENT
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Other Therapeutants Under Development

• Emamectin benzoate (Slice)sea liceSponsor
  expending time funds to meet CVM requirements
• Erythromycinbacterial kidney diseasealmost
  complete University of Idahoworking on
  antimicrobial resistance studies in response to
  CVM
• N-Halamine (MC)columnaris disease,
  Ichthyophthirius, AeromonasNew INAD early
  development stage

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Other Therapeutants Under Development

• Potassium permanganateIchthyophthiriusSNARCsome
  data generated Sponsorproduct chemistry
  readied for resubmission
• Pycezeexternal fungal and bacterial
  infectionsearly development stage Sponsormet
  with CVM

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Other Therapeutants Under Development

• Romet-30 Romet-TC
• furunculosis/salmonids enteric
  septicemia/catfishapproved Sponsor
• Resolved palatability issue
• Needs no supplemental NADA for Type B medicated
  feed (Romet-TC)
• Is considering development for other diseases and
  species

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Anesthetic Under Development

• AQUI-S? with potential for zero withdrawal
  timesponsor is pursuing an approval in the US
• Sponsor met with CVM June 4, 2003
• SponsorRD Plan in development
• Efficacy, target animal safety,
• human food safety studies underway
• NEED FUNDS FOR RADIOLABELED
• MATERIAL CONFIRMATORY METHOD
• Initial approvalall salmonids

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Procedures Needing Anesthetics

• Rested harvestcultured fish
• Artificial spawningcaptured cultured fish
  shellfish
• Marking, tagging, measuring, sexingcaptured
  cultured fish
• Grading sortingcultured fish
• Vaccinationcultured fish
• Transportcaptured cultured fish shellfish
• Research, surgery, veterinary practicecaptured
  cultured fish shellfish

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Who Needs Zero Withdrawal Anesthetic?

• All federal state agencies involved in
• Fish shellfish culture
• Commercial recreational fisheries
• Fisheries restoration
• Threatened endangered aquatic species
• All private fish shellfish aquaculture
  industries

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Spawning Aids Under Development

• Crude carp pituitarytarget animal safety study
  ready for submission efficacy environmental
  safety accepted for all fish Sponsor not
  pursuing product chemistry revision
• LHRHanew INAD underway
• Ovaplant and Ovaprimearly development stage
  met with CVM
• ReproBoostearly development stage
• Other undisclosed spawning aids

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Gender Manipulation Aid Under Development

• 17 alpha-methyltestosteronefunding for remaining
  technical sections for initial approval for
  tilapia
• Efficacy studies submitted (Cornell University)
  to be submitted (Auburn University)
• Environmental studyfunded entity selected
• Stability studies funded
• entity selected

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Other Marking Aids Under Development

• Calceinearly development stage
• Strontium chlorideearly development stage

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OTHER DEVELOPMENTS
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More Activity by Sponsors

• Chemical or small pharmaceutical sponsors
  represented at Bozeman meeting in July 2003
• Axcentive bvchloramine-T
• AQUI-S New Zealand LTDAQUI-S?
• Bellwether ConsultingPyceze
• Bimeda Inc.erythromycin
• MinnTechMinnCare
• Phelps Dodge Refining Corporationcopper sulfate
• Eka Chemicals Inchydrogen peroxide
• Western Chemicals IncCalcein, formalin

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More Activity by Sponsors

• Major pharmaceutical sponsors represented at
  Bozeman meeting in July 2003
• AlpharmaRomet-30 Romet-TC, oxytetracycline
  immersion, sulfamerazine, others possible
• Intervetvarious drugs possible
• NovartisPyceze, others possible
• Schering-Ploughflorfenicol and Slice

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Minor Use Minor Species (MUMS)Legislation

• Introduced again in 108th Congress
• (HR-2079 S-741)
• Consumer activist groups flooding Congress with
  misinformation
• Need for letters from both public
• private aquaculture
• Requests to Fish Chiefs for action
• Passed Senate HELP Committee
• 11/21/03 hope for passage soon

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EPA Effluents Guidelines Plan

• Draft rule in Federal Register in September 2002
• Responses to draft rule in January 2003
• Provided EPA with white papers on judicious use
  of drugs and chemicals
• Provided EPA with actual volume of antibiotics
  used in 2001 2002
• Draft final rule due soon

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Public Fish Production Database

• Data valuable to potential sponsorsmarketing
• Includes all FWS, NW tribes, and 44 states (state
  exceptions AK, CT, NE, NM, RI, and WV)
• Covers 2001-2002 data
• User friendlycan access by
• state, species, grouping, etc.
• Available at http//ag.ansc.purdue.edu/aquanic/jsa
  /aquadrugs/index.htm

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Cooperative Agreement in DevelopmentPublic
Aquaculture Drug Approvals

• U.S. Fish Wildlife Service
• U.S. Geological Survey
• U.S. Department of Agriculture
• International Association for Fish Wildlife
  Agencies
• Includes National Aquaculture NADA Coordinator
  under North Central Regional Aquaculture Center

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Funding Needs for National Aquaculture NADA
Coordinator

• Starting 10/1/03Reduced to 3/4 time due to lack
  of funds for fulltime (need funds this year to
  cover shortfall)
• May 2004 to April 20053/4 time as funds permit
• May 2005 to April 20061/2 to 3/4 time as funds
  permit
• May 2006 to April 20071/4 to 1/2 time as funds
  permit
• May 2007 and beyond1/4 time or special projects
  as funds permit
• Developed white paper on funding needs for
  October 1, 2003 to September 30, 2005

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Congratulations in Order!

• Dr. William (Bill) Gingerich
• Received USDIs Meritorious Service
  Awardoutstanding science contributions to
  fishery restoration efforts throughout the
  Nation
• Includes work on aquaculture drug
  approval-oriented research
• Second highest honor award from USDI
• Presented September 25, 2003

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Recent Personnel Changes at CVMVery Positive!!

• Steve VaughnDirector, Office of New Animal Drug
  Evaluation (ONADE)
• Bernadette Dunham, Deputy Director, ONADE
• Joan GotthardtDirector, Division of Therapeutic
  Drugs for Food Animals
• Don PraterLeader, Aquaculture Drugs Team
• Ruth BarrattReviewer, Aquaculture Drugs Team

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OPTIMISM REIGNS SUPREMEFOR AQUACULTURE DRUG
APPROVALS!!!