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National Research Support Project (NRSP-7): Southern Region


The objectives of the Minor Use Animal Drug Program are to conduct a national program to obtain minor and specialty animal drug clearances (tolerances, exemptions and registrations) and to facilitate or conduct studies to provide data packets acceptable to the US Food and Drug Administration for approval of such identified drugs.<p> These data cover drug efficacy, drug safety to the target animal species, human safety relative to consumption of food products derived from animals treated these drugs and assessment of the effect introduction of the drug to clinical use will have on the environment. These data are made available by the FDA through published Public Master Files that are announced publicly by notices in the Federal Register or postings on the Center for Veterinary Medicine web site [].<p&gt; Federal regulations require extensive experimental data on efficacy, safety, and residue levels before any drug can be used in a food animal species. Data must be obtained for each animal species for which drug use is intended. <p>At present, most minor species of food animals do not have the benefit of safe and effective drugs, such as are available for cattle, swine, and poultry. This situation has the potential for adverse effects upon both the producers and consumers of animal products. The allocation of projects between the different regions is on basis of regional stake holders, expertise, existing work load and facilities. <p>The Southern Region, which is based at the University of Florida, currently has projects involving anthelminthics, miticides, and coccidiostats. These drugs cover industries/species as diverse as aquaculture, gamebirds, rabbits, and small ruminants<p>. In addition the Southern Region acts as the Information Technology resource for the program hosting the program's web site [] and the project tracking system RUSTi. The direct users of the research results will be the farmers, producers and ranchers of the Southern Region. The potential beneficiaries of this research will be the consumers throughout the United States.

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Non-Technical Summary: Other countries with less stringent approval requirements have a variety of production aids available that producers in the US do not have. Foreign producers of lamb, wool, cheeses, farmed fish, farmed shrimp, honey, and game-birds frequently export those products to the US and it is usually up to the importers to check for tainted foods. For example, two-thirds of the honey consumed in the US is imported and a recent publication revealed significant contamination with banned antibiotics. Nearly 90 percent of the commercially farmed shrimp are imported and one-third of the lamb consumed in the US comes from Australia and New Zealand, some of it raised with the aid of products unavailable to US producers. Clearly efforts must be initiated to provide US animal producers with safe and effective means to compete in a global market, while assuring US consumers a safe and wholesome food supply. 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 FDA's then Bureau of Veterinary Medicine and Bureau of Foods, the US Department of Agriculture, the pharmaceutical industry, and animal producer groups identified the problem as a lack of approved drugs for diseases of minor species and for the principal minor diseases of major species. The committee also identified the principal diseases for which drugs were not available in the minor species. Further, the committee recognized that the livestock industry in the United States relies heavily on the judicious use of drugs for the treatment and prevention of diseases in food animals. Without these drugs, animal suffering and mortality would continue to 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 as well as safe and efficacious in the target animal. The process of generating the safety and efficacy data necessary for FDA approval of a drug is costly and time-consuming. At present, the estimated cost to a pharmaceutical company for research necessary to obtain FDA approval for a new drug exceeds $40 million, and requires 8 to 10 years of concentrated research effort. The addition of a new label claim is also costly, ranging from $4 to $10 million. 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 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. <P> Approach: Federal and state scientists and veterinarians working with the various elements of the Minor Use Animal Drug Program will determine the minor use needs and develop research protocols for FDA/CVM approval. The executor of these protocols will be located in the four regional laboratories, the USDA-ARS components either within their institutions, or at other universities, research institutions or government laboratories. Industry will also be requested to cooperate in all phases of the project. The Regional Coordinators and their staff will collect and assemble the data into petitions for registration. FDA and manufacturers will be asked to aid in this process to insure both conformity with government regulations and industry recommended use patterns. Specifically, a system has been devised to review, evaluate and recommend the feasibility of each animal drug clearance proposal submitted. When a proposal is accepted, the necessary data will be obtained, compiled and submitted to FDA/CVM for establishment of a public master file which will lead to the approval of the drug. The completion of the Minor Use Animal Drug projects mentioned above entails intensive sample collections and sample analyses. Analytical method implementation and validation must be done for each drug for each species. Thousands of serum and tissue samples were analyzed by High Performance Liquid Chromatography (HPLC) for the florfenicol project alone and will need to be repeated for the bridge study or if the study has to be repeated in its entirety. These HPLC analyses were labor intensive and expensive, however, the data generated under GLP's will satisfy the FDA/CVM requirements.

Vickroy, Tom
University of Florida
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