NRSP007: A National Agricultural Program for Minor Use Animal Drugs
Statement of Issues and Justification
Prerequisite Criteria: Mission
Stakeholders identify critical national need in minor use therapeutics - In 1976, the Food and Drug Administration (FDA) initiated an extensive study of the minor use of animal drugs through the efforts of a minor use/minor species drug committee. This committee, comprised of representatives of the FDAs then Bureau of Veterinary Medicine and Bureau of Foods, the U.S. Department of Agriculture (USDA), the pharmaceutical industry, and animal producer groups identified the scope of the problem as a lack of approved drugs for (1) diseases of minor species and (2) the principle minor diseases of major species. The committee identified the principal diseases for which drugs were not available in the minor species. Additionally, the committee recognized that the livestock industry in the United States relies heavily on the judicious use of drugs for the treatment of diseases in food animals. Without these drugs, animal suffering and mortality would greatly increase, as would the cost of producing animal-derived food products. However, before a drug can be marketed for use in a food animal species, it must be shown to be safe to the human consumer of the animal-derived food, and safe and efficacious in the target animal.
The process of generating the safety and efficacy data necessary for FDA/CVM approval of a drug is costly and time-consuming. In 1999, the estimated cost to a pharmaceutical company for research necessary to obtain FDA/CVM approval for a new drug exceeded $20 million, and required 8 to 10 years of concentrated research effort (Ringer et al., 1999). More recently, issues relating to (1) increased costs in the development of analytical methods, (2) concerns over antimicrobial resistance in human medicine, and (3) increased environmental testing have increased veterinary drug approval costs dramatically (Lathers, 2003). Drug approvals are generally species and disease specific and additional label claims also come with considerable added expense. Pharmaceutical company estimates place the cost of adding a label claim to an FDA/CVM approved drug at $2 to $8 million (Brown, 2003).
Because of this substantial investment in time and resources, pharmaceutical companies must be assured that the drug will have a reasonable potential for profit. Therefore most drug approvals are sought only for those animal species that are produced in sufficient numbers to support large volume sales, specifically cattle, swine, chickens and turkeys. There is little economic incentive for pharmaceutical firms to generate data necessary to seek FDA/CVM approval of drugs in minor species; hence, very few drugs are available for management of diseases in these species. Inequities in drug availability represent serious management and economic problems for producers for minor species. Today, more than half of all commercially led pharmaceutical R&D in the veterinary medical field is focused on developing products for companion animals, and the emphasis on this sector is likely to increase in coming years, as companion animals live longer, and more diseases of old age are diagnosed and treated (Lathers, 2003).
The FDA/CVM was aware that veterinarians and livestock producers were using unapproved drugs without the safeguards that approved drugs carry. Such unapproved drug use could not only cause detrimental effects to the animals being treated, but could also lead to the persistence of drug residues in animal products intended for human consumption. A definite need was established for approval of minor use veterinary drugs and the scope of the problem was defined. This need was also affirmed by various grower organizations.
In 1982, the IR-4 Animal Drug Program was established as part of the overall IR-4 Minor Use Pesticide Management Program. Since that time the animal portion established itself as a national means of securing approved drugs and as a conduit between the animal industries and the FDA/CVM.
In December 1990, the USDA/CSRS requested a peer review of the IR-4 program, including both the pesticide portion and the minor use animal component. A reorganization of the minor use animal drug section was one of the recommendations of the Review Team. This Change was carried out with the development of a separate Minor Use Animal Drug Technical Committee that reported to the IR-4 Administrative Advisors.
In 1992, IR-4 Administrative Advisors recommended that with the change from interregional Projects (IRs) to National Research Support Projects (NRSPs), as well as the experience gained under the reorganized IR-4 Project, that the two programs (pesticide and animal) be separated into two projects. In 1993, NRSP-7 was thus created as the Minor Use Animal Drug Program.
Animal producers are the primary stakeholders in the NRSP-7 program, but pharmaceutical companies may be considered significant stakeholders as well. Other groups with interest in minor animal drug use include veterinarians and regulators. The active participation of animal producers and pharmaceutical companies is essential for the success of the program. However, to one degree or another, NRSP-7 involves all stakeholders. NRSP-7 producer stakeholders are represented by the following 58 organizations in 10 categories: American Association of Wildlife Veterinarians, American Association of Zoo Veterinarians, American Farm Bureau, American Feed Industry Association, American Pet Product Manufacturers Association, Inc., American Rabbit Breeders Association, American Sheep Industry Association, American Veterinary Medical Association, Animal Health Institute, Animal Drug Alliance, Arkansas Bait and Ornamental Fish Growers Association, Catfish Farmers of America, Center for Veterinary Medicine, Florida Tropical Fish Farms Association, Inc., Food Animal Concerns Trust, International Association of Aquatic Animal Medicine, International Association of Fish and Wildlife Agencies, North American Deer Farmers Association, North American Gamebird Association, Inc., National Pork Producers Council, National Cattlemen's Beef Association, National Fisheries Institute, National Turkey Federation, Pacific Coast Shellfish Growers Association, and the National Aquaculture Association.
Prerequisite Criteria: How does this NRSP pertain as a national issue?
Stakeholders identify critical national need in minor use therapeutics - In 1976, the Food and Drug Administration (FDA) initiated an extensive study of the minor use of animal drugs through the efforts of a minor use/minor species drug committee. This committee, comprised of representatives of the FDAs then Bureau of Veterinary Medicine and Bureau of Foods, the U.S. Department of Agriculture (USDA), the pharmaceutical industry, and animal producer groups identified the scope of the problem as a lack of approved drugs for (1) diseases of minor species and (2) the principle minor diseases of major species. The committee identified the principal diseases for which drugs were not available in the minor species. Additionally, the committee recognized that the livestock industry in the United States relies heavily on the judicious use of drugs for the treatment of diseases in food animals. Without these drugs, animal suffering and mortality would greatly increase, as would the cost of producing animal-derived food products. However, before a drug can be marketed for use in a food animal species, it must be shown to be safe to the human consumer of the animal-derived food, and safe and efficacious in the target animal.
The process of generating the safety and efficacy data necessary for FDA/CVM approval of a drug is costly and time-consuming. In 1999, the estimated cost to a pharmaceutical company for research necessary to obtain FDA/CVM approval for a new drug exceeded $20 million, and required 8 to 10 years of concentrated research effort (Ringer et al., 1999). More recently, issues relating to (1) increased costs in the development of analytical methods, (2) concerns over antimicrobial resistance in human medicine, and (3) increased environmental testing have increased veterinary drug approval costs dramatically (Lathers, 2003). Drug approvals are generally species and disease specific and additional label claims also come with considerable added expense. Pharmaceutical company estimates place the cost of adding a label claim to an FDA/CVM approved drug at $2 to $8 million (Brown, 2003).
Because of this substantial investment in time and resources, pharmaceutical companies must be assured that the drug will have a reasonable potential for profit. Therefore most drug approvals are sought only for those animal species that are produced in sufficient numbers to support large volume sales, specifically cattle, swine, chickens and turkeys. There is little economic incentive for pharmaceutical firms to generate data necessary to seek FDA/CVM approval of drugs in minor species; hence, very few drugs are available for management of diseases in these species. Inequities in drug availability represent serious management and economic problems for producers for minor species. Today, more than half of all commercially led pharmaceutical R&D in the veterinary medical field is focused on developing products for companion animals, and the emphasis on this sector is likely to increase in coming years, as companion animals live longer, and more diseases of old age are diagnosed and treated (Lathers, 2003).
The FDA/CVM was aware that veterinarians and livestock producers were using unapproved drugs without the safeguards that approved drugs carry. Such unapproved drug use could not only cause detrimental effects to the animals being treated, but could also lead to the persistence of drug residues in animal products intended for human consumption. A definite need was established for approval of minor use veterinary drugs and the scope of the problem was defined. This need was also affirmed by various grower organizations.
In 1982, the IR-4 Animal Drug Program was established as part of the overall IR-4 Minor Use Pesticide Management Program. Since that time the animal portion established itself as a national means of securing approved drugs and as a conduit between the animal industries and the FDA/CVM.
In December 1990, the USDA/CSRS requested a peer review of the IR-4 program, including both the pesticide portion and the minor use animal component. A reorganization of the minor use animal drug section was one of the recommendations of the Review Team. This Change was carried out with the development of a separate Minor Use Animal Drug Technical Committee that reported to the IR-4 Administrative Advisors.
In 1992, IR-4 Administrative Advisors recommended that with the change from interregional Projects (IRs) to National Research Support Projects (NRSPs), as well as the experience gained under the reorganized IR-4 Project, that the two programs (pesticide and animal) be separated into two projects. In 1993, NRSP-7 was thus created as the Minor Use Animal Drug Program.
Animal producers are the primary stakeholders in the NRSP-7 program, but pharmaceutical companies may be considered significant stakeholders as well. Other groups with interest in minor animal drug use include veterinarians and regulators. The active participation of animal producers and pharmaceutical companies is essential for the success of the program. However, to one degree or another, NRSP-7 involves all stakeholders. NRSP-7 producer stakeholders are represented by the following 58 organizations in 10 categories: American Association of Wildlife Veterinarians, American Association of Zoo Veterinarians, American Farm Bureau, American Feed Industry Association, American Pet Product Manufacturers Association, Inc., American Rabbit Breeders Association, American Sheep Industry Association, American Veterinary Medical Association, Animal Health Institute, Animal Drug Alliance, Arkansas Bait and Ornamental Fish Growers Association, Catfish Farmers of America, Center for Veterinary Medicine, Florida Tropical Fish Farms Association, Inc., Food Animal Concerns Trust, International Association of Aquatic Animal Medicine, International Association of Fish and Wildlife Agencies, North American Deer Farmers Association, North American Gamebird Association, Inc., National Pork Producers Council, National Cattlemen's Beef Association, National Fisheries Institute, National Turkey Federation, Pacific Coast Shellfish Growers Association, and the National Aquaculture Association.
Rationale: Priority Established by ESCOP/ESS
Rationale: Relevance to stakeholders
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