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Challenges with the development and approval of pharmaceuticals for fish

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Abstract

With an increase in consumer recognition of the health benefits associated with seafood consumption, the volume of fisheries and aquaculture products consumed by the average American is expected to rise. With a concomitant expectation for high-quality products, aquaculture is likely to become a greater source of consumed fish. As the US aquaculture industry grows, so does the need to provide veterinary services. As with any intensive farming system, appropriate medications are needed to maintain animal health and to manage fish populations. This article introduces some of the challenges associated with drug approvals for aquatic species and describes how the process of development and regulation of drugs for use in aquatic animals differs from that associated with uses in terrestrial species.

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References

  1. Harvey DJ.Aquaculture Outlook. United States Department of Agriculture Electronic Outlook Report From the Economic Research Service Web site. Available at: http://usda.mannlib.cornell.edu/reports/erssor/livestock/ldp-aqs/2003/aqs18.pdf. Accessed February 12, 2004.

  2. Davis JT.Crawfish Production. Athens, GA: Warnell School of Forest Resources, University of Georgia. Available at: www.forestry.uga.edu/warnell/service/library/ats-4. Accessed February 12; 2004.

  3. Carlberg JM, Van Olst JC, Massingill MJ. Hybrid striped bass: an important fish in US aquaculture.Aquaculture [serial online]. 2000;26:Number 5. Available at: www.aquaculturemag.com/siteenglish/printed/archives/issues00/500a.html. Accessed February 12, 2004.

  4. Fisheries of the United States 2001 resources page. National Marine Fisheries Service, Fisheries Statistics and Economics Division Web site. Available at: www.st.nmfs.gov/st1/fus/fus01/. Accessed February 12, 2004.

  5. American Farm Bureau.Farm Facts [online booklet]. Available at: www.fb.org. Accessed February 12, 2004.

  6. National Marine Fisheries Service. Trade and Commercial Services Web site. Available at: www.nmfs.noaa.gov/trade/main.html. Accessed February 12, 2004.

  7. FDA/CVM. Drugs approved for use in aquaculture. FDA Center for Veterinary Medicine Web site. Available at: http://www.fda.gov/cvm/index/aquaculture/appendixa6.htm. Accessed February 12, 2004.

  8. FDA Office of Regulatory Affairs. Compliance Policy Guide, Chapter 6, Subchapter 615. Extra-label use of medicated feeds for minor species. FDA Web site. Available at: www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg615-115.html. Accessed February 12, 2004.

  9. Inglis V, Ronald JR, Niall RB, eds.Bacterial Diseases of Fish. New York, NY: Halsted Press; 1993.

    Google Scholar 

  10. Stoskopf MK.Fish Medicine. Philadelphia, PA: WB Saunders Company; 1993.

    Google Scholar 

  11. Plumb JA.Health Maintenance and Principal Microbial Diseases of Cultured Fish. Ames, IA: Iowa State University Press: 1999.

    Google Scholar 

  12. Roberts RJ, Shepherd CJ.Handbook of Trout and Salmon Diseases. 3rd ed. Oxford, UK: Fishing News Books; 1997.

    Google Scholar 

  13. Sindermann CJ. Parasitic crustaceans. In:Principal Diseases of Marine Fish and Shellfish. San Diego, CA: Academic Press Inc; 1990:155–169.

    Google Scholar 

  14. Stone J, Sutherland IH, Ferguson HW, Sommerville C, Endris R. Safety and efficacy of emamectin benzoate administered in-feed to Atlantic salmon,Salmo salar L, smolts in freshwater as a preventative treatment against infestations of sea lice,Lepeophtheirus salmonis (Krøyer).Aquaculture [serial online]. 2002;210:21–34. Available at: <|www.sciencedirect.com/science/journal/00448486|>. Accessed February 12, 2004.

    Article  CAS  Google Scholar 

  15. Animal Health Institute Keep animals healthy. Animal Health Institute Web site. Available at: www.ahi.org. Accessed February 12, 2004.

  16. AVMA. Minor Use and Minor Species Health Act. American Veterinary Medical Association Web site. Available at: http://www.avma. org/scienact/mums/default.asp. Accessed October 20, 2004.

  17. National Archives and Records Administration. Code of Federal Regulations Web site. Available at: www.access.gpo.gov/nara/cfr/ cfr-table-search.html#pagel. Accessed February 12, 2004.

  18. Stehly GR, Meinertz JR, Gingerich WH. Effects of temperature on the elimination of benzocaine and acetylated benzocaine residues from the edible fillet of Rainbow Trout (Oncorhynchus mykiss).Food Addit Contam. 2000;17:387–392.

    Article  PubMed  CAS  Google Scholar 

  19. Burka IF, Hammell KL, Horsberg TE, Johnson GR, Rainnie DJ, Speare DJ. Drugs in salmonid aquaculture: a review.J Vet Pharmacol Ther. 1997;20:333–349.

    Article  PubMed  CAS  Google Scholar 

  20. Kilmartin J, Cazabon D, Smith P. Investigations of the toxicity of ivermectin for salmonids.Bull Eur Assoc Fish Pathol. 1997;17:58–61.

    Google Scholar 

  21. Frasca, S, Draghi A, Popov VL, Stanton JB, Brown CC, Bebak-Williams J, Tsongalis GJ, West AB. Molecular characterization of the chlamydia-like bacterium associated with epitheliocystis in Atlantic salmon (Salmo salar). US Geological Survey, 28th Eastern Fish Health Workshop, April 21–25, 2003; Kearneysville, WV. Available at: www.lsc. usgs.gov/fhb/workshops/28/25.htm. Accessed February 12, 2004.

  22. Nowak BF, Clark A. Prevalence of epitheliocystis in Atlantic salmon,Salmo salar L, farmed in Tasmania, Australia.J Fish Dis. 1999;22:73–78.

    Article  Google Scholar 

  23. Darwish A, Plumb JA, Newton JC. Histopathology and pathogenesis of experimental infection withEdwardsiella tarda in channel catfish.J Aquat Anim Health. 2000;12:255–266.

    Article  Google Scholar 

  24. Van Der Kraak G, Chang JP, Janz DM. Reproduction. In: Evans DH, ed.The Physiology of Fishes: 2nd ed. Boca Raton, FL: CRC Press; 1998;465–488.

    Google Scholar 

  25. McGeachin RB, Robinson EH, Neill WH. Effect of feeding high levels of an drogens on the sex ratio ofOreochromis aureus.Aquaculture. 1987;61:317–321.

    Article  CAS  Google Scholar 

  26. Tayamen MM, Shelton WL. Inducement of sex reversal inSarotherodon niloticus (Linnaeus).Aquaculture. 1978;14:349–354.

    Article  Google Scholar 

  27. Goetz FW, Donaldson EM, Hunt GA, Dye HM. Effects of estradiol-17β and 17α-methyltestosterone on gonadal difference in the Coho salmon,Oncorhynchus kisutch.Aquaculture. 1979;17:267–278.

    Article  CAS  Google Scholar 

  28. Bye VJ, Lincoln RF. Commercial methods for the control of sexual maturation in Rainbow Trout (Salmo gairdneri R.).Aquaculture. 1986;57:299–309.

    Article  Google Scholar 

  29. Chevassus B, Krieg F. Effect of the concentration and duration of methyltestosterone treatment on masculinization rate in the Hrown trout (Salmo trutta).Aquat Living Resour. 1992;5:325–328.

    Article  Google Scholar 

  30. Feist G, Yeoh C, Fitzpatrick MS, Schreck CB. Production of functional sex-reversed male Rainbow Trout with 17α-methyltestosterone and 11β-hydroxyandrostenedione.Aquaculture. 1995;131:145–152.

    Article  CAS  Google Scholar 

  31. Cousin-Gerber M, Berger G, Boisseau C, Chevassus B. Effect of methyl-testosterone sex differentiation and gonad morphogenesis in Rainbow TroutOncorhynchus mykiss.Aquat Living Resour. 1989;2:225–230.

    Article  Google Scholar 

  32. JSA. United States Joint Subcommittee on Aquaculture Web site. Available at: http://ag.ansc.purdue.edu/aquanic/jsa/. Accessed February 12, 2004.

  33. Federal Register Environmental Documents resources page. US Environmental Protection Agency Web site. Effluent Limitations Guidelines and New Source Performance Standards for the Concentrated Aquatic Animal Production Point Source Category; Notice of Data Availability. Available at: http://www.epa.gov/fedrgstr/EPA-WATER/2003/December/Day-29/w31867.htm. Accessed February 12, 2004.

  34. National Marine Fisheries Service. Anadromous Fish. National Marine Fisheries Service Web site. Available at: www.nmfs.noaa.gov/habitat/habitatprotection/anadromousfish.htm. Accessed February 12, 2004.

  35. Clarke WC. Smolting. In: Stickney RR, ed.Encyclopedia of Aquaculture. New York, NY: John Wiley & Sons Inc; 2000:879–884.

    Google Scholar 

  36. Robinson E, Avery J. Farm Raised Catfish. Thad Cochran National Warmwater Aquaculture Center Web site. Available at: www.msstate.edu/dept/tcnwac/publications.htm. Accessed February 12, 2004.

  37. FDA/CVM. FDA Veterinarian Newsletter, Jan/Feb 2002. FDA Center for Veterinary Medicine Web site. Available at: www.fda.gov/cvm/index/fdavet/2002/2002toc.html. Accessed February 12, 2004.

  38. Gingerich WH, Stehly GR, Clark KJ, Hayton WL. Crop grouping: a proposal for public aquaculture.Vet Hum Toxicol. 1998;40:(suppl 2):24–31.

    PubMed  Google Scholar 

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Authors and Affiliations

  1. Food and Drug Administration, Center for Veterinary Medicine, 7500 Standish Place, HFV-131, Rockville, MD, 20855

    Susan Storey

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  1. Susan Storey
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Correspondence to Susan Storey.

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Published: September 22, 2005.

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Storey, S. Challenges with the development and approval of pharmaceuticals for fish. AAPS J 7, 32 (2005). https://doi.org/10.1208/aapsj070232

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  • DOI: https://doi.org/10.1208/aapsj070232

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