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U.S. Department of Health and Human Services

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NRSP-7 Minor Use Research Program Holds Semi-Annual Meeting to Reach Out to Stakeholders

by Dr. Meg Oeller, Director, Office of Minor Use and Minor Species Animal Drug Development, and Dr. John Babish, NRSP-7 National Coordinator
FDA Veterinarian Newsletter May / June 2008 Volume XXIII, No III

The U.S. Department of Agriculture’s National Research Support Project #7 (NRSP-7) held its Spring Meeting for 2008 in April at the Food and Drug Administration’s Center for Veterinary Medicine in Rockville, MD. The committee that runs the NRSP-7 program used the opportunity to invite stakeholders (see related article, “Importance of Minor Species to Re-gional, U.S. Economy”) and legislative affairs professionals to come to the table to discuss the importance of minor spe-cies to the U.S. economy and the importance of the NRSP-7 program to the various minor species groups that benefit from its work.

The purpose of the NRSP-7 Minor Use Animal Drug Program is to address the shortage of minor species animal drugs by providing funding and overseeing effectiveness, target animal safety, and human food safety research and the envi-ronmental assessment required for the approval of a New Animal Drug Application. Pharmaceutical companies then are able to use these data at no cost in conjunction with their own manufacturing and labeling information to support an appli-cation for approval of a new animal drug for an intended use in the minor species.

The major species are horses, cattle, swine, dogs, cats, chickens, and turkeys. All other species, except humans, are minor species. The scope of the program includes minor species of agricultural importance and generally excludes com-panion animals.

Why is NRSP-7 needed?

Minor species and minor uses represent small markets when compared to the value of markets for major food-producing animals such as poultry, cattle, and swine or for companion animals such as dogs, cats, and horses. The costs of studies to support drug approval cannot be easily recovered from such small markets. The work done by NRSP-7 and other public research entities makes it possible for pharmaceutical sponsors to get their products approved at a much re-duced cost.

Despite incentives for companies to increase drug availability for these minor species, there are few to no drugs ap-proved for their use. Much work remains to be done for the benefit of the numerous fish species in U.S. aquaculture, for sheep and goats, gamebirds, deer, rabbits, honey bees and other even less common species.

What is the mission of the NRSP-7 program?

The committee that runs the NRSP-7 program (see “The NRSP-7 Committee”) meets twice yearly to assess the status of ongoing projects and to select new ones.

At the April 2008 meeting, Dr. John Babish and Dr. Garry Adams provided the attendees with a complete history of the NRSP-7 program and described its ongoing problems with inadequate funding, increasing costs, and more rigorous regu-latory requirements that have evolved over the program’s 25-year existence.

They described the mission of NRSP-7 as fourfold: 1) identify animal drug needs for minor species and minor uses in major species, 2) generate and 3) disseminate data for safe and effective therapeutic applications, and 4) facilitate FDA/CVM approvals for drugs identified as a priority for a minor species or minor use.

To accomplish these goals, NRSP-7 functions through coordinated efforts among animal producers, pharmaceutical manufacturers, CVM, USDA/Cooperative State Research, Education, and Extension Service (CSREES), universities, State Agricultural Experiment Stations, and veterinary medical colleges throughout the country.

Dr. Gary Sherman described the funding methods of the program and the complexities of the budget process. He also described the activities of USDA/CSREES. Its mission is to advance knowledge for agriculture, the environment, human health and wellbeing, and communities.

Dr. Meg Oeller, FDA liaison to NRSP-7, provided additional information about the mission and organization of NRSP-7 and the relationship between NRSP-7 and CVM.

The meeting was also attended by CVM Director Dr. Bernadette Dunham. In a presentation, she described new and ongoing programs within CVM that are intended to facilitate the drug approval process for minor uses and minor species. She stressed the importance of the partnership between all interested parties as the best way to achieve success.

In addition, other members of CVM also participated in the meeting to help increase understanding between the scien-tific reviewers on the regulatory side and the scientists and producers responsible for the studies intended to support ap-proval of these needed products.

What are the plans for regaining funding?

For many years, the program has operated on the same limited funding of approximately $500,000 a year. This is a very small budget, given the large number of needed projects and the high cost of studies to support new animal drug ap-provals. For the past few years, the funding has been severely cut, and the future of the program is in peril.

Several legislative affairs professionals attended the meeting to discuss their efforts to support the NRSP-7.

Mr. John Hamilton, (ANR Federal Relations Liaison of UC Davis), Ms. Dianne Miller (Director of the Federal Govern-ment Relations for Cornell University), and Mr. Dustin Bryant (Meyers and Associates, for Texas A&M University) gave updates on the lobbying efforts of the institutions participating in NRSP-7 as well as the status of the 2008 Farm Bill. Dr. Mark T. Lutschaunig (Director, Governmental Relations Division of the American Veterinary Medical Association) empha-sized the importance of NRSP-7 and the support that the American Veterinary Medical Association has for the program.

The attendees discussed possible future lobbying efforts and stakeholder participation. Action items included further contacts with stakeholder lobbyists to emphasize the need to support funding for NRSP-7 in the USDA budget and to support inclusion of the program in the 2008 Farm Bill. (The lobbying efforts were not successful, and the NRSP-7 pro-gram was not include in the 2008 Farm Bill.)
Progress of the program

Each of the Regional Coordinators described the accomplishments and ongoing work of NRSP-7 in their region.

  • NORTHEAST REGION: An outline of aquaculture “species grouping” research conducted in the Northeastern Region was provided by Dr. Paul Bowser. His work has focused on human food safety (tissue residue elimination studies) in tilapia, walleye, hybrid striped bass, and summer flounder. Results to date indicate species grouping is a viable method for the reduction of animals used in research.
    In addition to modeling species grouping, these studies will be used to extend the label indications for oxytetracy-cline, sulfadimethoxine/ormetoprim, and florfenicol.
  • NORTH CENTRAL REGION: Dr. Ronald Griffith described the North Central Region’s active projects. These include the ?CIDR-g, a progesterone implant used to synchronize estrus cycles in sheep and goats. ?A study at North Dakota State using the CIDR-g resulted in 100 percent synchronization, the highest in comparison to any other technique. At this time, the project for sheep is nearly complete. Only the human food safety component remains to be accepted. The project for goats is earlier in its progress. The target animal safety study has been accepted, and a milk residue study is close to submission to CVM for review.
    Tulathromycin for respiratory disease in sheep and goats is also under study. The current status in goats is that the target animal safety study is nearing completion, protocols for effectiveness have been submitted for review, and the protocol for the residue depletion study has been accepted. The Western region is working in partnership on this project and is currently concentrating on the analytical method.
    Lasalocid is being studied for treatment of coccidiosis in ring-necked pheasants. The effectiveness study was com-pleted at the University of Georgia last fall. The first draft of the study report was submitted this spring. The target ani-mal safety protocol has been submitted, and the study was planned for the summer at the University of Georgia. The human food safety protocol will be submitted in the near future.
  • SOUTHERN REGION: Dr. Alistair Webb presented an overview of efforts in the Southern Region, focusing on project tracking, game bird projects, and the NRSP-7 Web site. This region is also completing the work for public master files for fenbendazole in pheasants and quail and for ivermectin for rabbits.
  • WESTERN REGION: Dr. Lisa Tell began her presentation by reviewing the historical NRSP-7 accomplishments of the Western Region. Work in this region has led to approval of indications for drugs for reindeer, big horn sheep, sheep, fin-fish, goats, and honey bees.
    Current projects include erythromycin for treatment of bacterial kidney disease in salmonids, lincomycin for treatment of American foulbrood in honey bees, the CIDR-g for goats, and strontium chloride for skeletal marking of fish.
    Lastly, a detailed description was presented of the region’s study of the pharmacokinetics of ceftiofur crystalline free acid (CCFA) in non-lactating domestic goats (Capra aegagrus hircus) following a single subcutaneous injection. The study demonstrated that a single subcutaneous injection of CCFA did not result in any adverse effects, and the serum concentration of CCFA remained above therapeutic concentrations for at least 4 days.

A Summary of the successes of the program

The NRSP-7 has published 33 Public Master Files that have supported 27 new animal drug approvals during its 25-year history; an average of 1.3 completed files per year. The approvals have been accomplished through strategic part-nerships and the efficient use of resources so that the mean expenditure per approval is approximately $450,000, or 10 percent to 40 percent of the usual cost to industry.

Work done as part of the NRSP-7 led to five peer-reviewed publications in 2007. Publication of research is common for the members of the program.

NRSP-7 currently supports 14 active projects with 41 potential projects on the Animal Drug Request List. If adequate funding is secured, there is an opportunity for a great deal more to be done for the minor species that are so important and yet so underserved when it comes to availability of safe and effective products for their benefit.

The NRSP-7 Committee

John Babish........................................... The National Coordinator (Cornell University)
Paul Bowser........................................... Northeast Regional Coordinator (Cornell University)
Ronald Griffith........................................ North Central Regional Coordinator (Iowa State University)
Lisa Tell.................................................. Western Regional Coordinator (University of California, Davis)
Alistair Webb......................................... Southern Regional Coordinator (University of Florida)
Garry Adams.......................................... Chairman of Administrative Advisors (Texas A&M)
David Thawley........................................ Administrative Advisor Western Region (University of Nevada)
John Baker............................................. Administrative Advisor North Central Region (Michigan State University)
Kirklyn Kerr............................................. Administrative Advisor Northeast Region (University of Connecticut) He was unable to attend this meeting.
Gary Sherman........................................ USDA/CSREES Liaison (Washington, DC)
Meg Oeller.............................................. FDA Liaison (Rockville, MD)

Report from NRSP-7 Meeting…