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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Hosts NRSP-7 Semi-Annual

By Meg Oeller, DVM, FDA Liaison to the NRSP-7 Program
FDA Veterinarian Newsletter May/June 2004 Volume XIX, No 3

In the United States there is a critical shortage of approved animal drugs intended for the less common (minor) animal species or for major animal species with less common diseases or conditions, something which the National Research Support Project #7 (NRSP-7) is designed to address.

Veterinarians, pet owners, livestock producers, zoo and wildlife biologists have limited-to-no options for treating these animals if they become ill. The shortage of approved drugs results in animal suffering, loss of animal life, financial loss to those who raise the animals, and potential public health hazards through the transmission of disease-producing organisms from untreated animals to humans.

The U.S. Department of Agriculture with the cooperation of several universities and the Food and Drug Administration’s Center for Veterinary Medicine took steps to deal with this problem. It created the NRSP-7, a program to move much-needed minor use or minor species drugs through the drug approval process.

The purpose of the NRSP-7 minor use animal drug program is to address the shortage of minor use animal drugs by funding and overseeing the efficacy, animal safety, and human food safety research and environmental assessment required for drug approval. Commercial sponsors are able to use these data in conjunction with their own manufacturing and labeling information to pursue a new animal drug approval. The scope of the program includes minor species of agricultural importance, but generally excludes companion animals.

The NRSP participants meet regularly to keep the process on track. The semi-annual meeting of the technical committee and administrative advisors was held on April 26 at the CVM offices in Rockville, Md.

Meeting attendees

The NRSP-7 technical committee is made up of a national coordinator, four regional coordinators, four regional administrative advisors, and liaisons from USDA and FDA.

  • The National Coordinator is Dr. John Babish (Cornell University).
  • The Regional Coordinators are Dr. Arthur Craigmill (University of California, Davis), Dr. Alistair Webb (University of Florida), Dr. Ronald Griffith (Iowa State University), and Dr. Paul Bowser (Cornell University).
  • The administrative advisors are Dr. Kirklyn Kerr (University of Connecticut), Dr. Garry Adams (Texas A&M), Dr. David Thawley (University of Nevada), and Dr. Don Robertson (Kansas State University).
  • The USDA representative is Dr. Larry Miller (Washington, D.C.).
  • I am the FDA liaison (Dr. Meg Oeller, Rockville, Md).

This meeting was also attended by Rosalie (Roz) Schnick, the national New Animal Drug Application coordinator for aquaculture, and by Dr. Mark Feldlaufer of the USDA bee lab in Beltsville, Md., as well as by stakeholders and several reviewers and managers from FDA/CVM.

Stakeholder pesentations

The NRSP-7 program recently underwent its five-year review, and one of the recommendations of the independent review committee was that the NRSP-7 committee do more outreach to stakeholders. To forward that goal, the committee invited Dr. Chris Hayhow from the American Rabbit Breeders Association, Mr. Gene Brandi representing American beekeepers, and Dr. Thomas Bell of the U.S. Fish and Wildlife Service to make presentations at the meeting.

The speakers provided a picture of the rabbit, bee and public aquaculture industries that included husbandry practices and veterinary-drug needs for management and disease treatment. The information they provided was very helpful to the committee.

Demonstration of aquaculture database

Dr. Renate Reimschuessel of the CVM’s Office of Research gave a demonstration of her newly developed database of information about pharmacokinetics of drugs in fish, called FDA “Phish-Pharm.” Phish-Pharm includes information from published literature covering 86 species of fish and shrimp, 117 drugs or chemicals and 12 routes of administration. This database will be available online in the near future and will serve as a reference for scientists involved with aquaculture.

Regional Coordinators’ Reports

NORTHEAST REGION: Dr. Paul Bowser

Dr. Bowser’s projects center on an investigation of the ability to group similar species to demonstrate safety and/or effectiveness of new animal drugs. If it can be shown, for example, that many fish species react in the same way to a drug, then studies could be done in a single species to represent the whole group. This would greatly simplify the approval process for aquaculture drugs. Although many of these projects are intended to support species grouping, the data will be accumulated to support individual drug approvals for the drugs under study. Current projects include oxytetracycline for finfish, sulfadimethoxine/ormetoprim (Romet-30TM) for finfish, florfenicol for finfish, and sulfadimethoxine/ormetoprim (RofenaidTM) for pheasants.

SOUTHERN REGION: Dr. Alistair Webb

Dr. Webb reported that current projects include ivermectin for rabbits, fenbendazole for deer, lasalocid for deer and goats, fenbendazole, nitarsone and zoalene for gamebirds, and crude carp pituitary for fish. Dr. Webb also reported that they are completing the set up of their Good Laboratory Practices certified lab.

NORTH CENTRAL REGION: Dr. Ronald Griffith

The major current project is the controlled intravaginal drug release (CIDR-g) progesterone device for sheep for estrus synchronization. The U.S. sheep industry lists this product as its number one need. Target animal safety and human food safety studies are complete and data analysis is underway. New projects for florfenicol for necrotizing hepatopancreatitis in shrimp and lasalocid for coccidiosis in pheasants are in development. The project for florfenicol in veal calves has been discontinued pending a decision on eligibility for a waiver from the newly imposed FDA user fees.

WESTERN REGION: Dr. Arthur Craigmill

Dr. Craigmill reported on several projects. Several of these are cooperative projects with other regions, such as the CIDR-g for sheep and RofenaidTM for gamebirds. The final report for the effectiveness study for the use of florfenicol for respiratory disease in sheep has been submitted and is under review at CVM. Tissues are currently being analyzed to complete the residue depletion study for that project. The Western Region is also responsible for the nearly completed projects for tylosin and lincomycin for American Foulbrood disease in honeybees and for the project for otolith marking of salmonids with strontium chloride immersion. The project for the use of erythromycin for bacterial kidney disease in salmonids is also in its final stages. A new project for pirlimycin for mastitis in goats is about to begin. Some species grouping work is underway in gamebirds.

Administrative Advisors’ Report

The Administrative Advisors discussed the need for each region to give a 10-minute presentation about the program to the annual meetings of the regional meetings at regional experiment stations. They also encouraged continued outreach to stakeholders.

USDA Representative’s Report

Dr. Miller related that the program’s funding was cut 10 percent in the 2004 budget, but that may be restored in the 2005 budget.

FDA’S NRSP-7 Liaison Report

The Minor Use/Minor Species Animal Health Act of 2004 (the MUMS Bill) has been passed by the Senate. It is currently under consideration by the Energy and Commerce Committee of the House of Representatives. If enacted, this legislation would make incentives available to pharmaceutical sponsors, allow for conditional approval of MUMS drugs, and allow legal marketing of some products for non-food producing animals under an indexing system.

The impact of the Animal Drug User Fee Act was explored. The NRSP-7 program was able to procure a waiver of sponsor fees for fiscal year 2004 based on the fact that all projects are for minor species. Sponsors who use NRSP-7 Public Master Files to support their New Animal Drug Applications will need to request waivers of filing fees prior to submitting their applications. The improved efficiency of drug evaluation from user fees is expected to benefit all applications, whether they are charged fees or not.

National Coordinator’s Report

Dr. Babish reported on the annual report for the program and the results of the five-year review. The committee was complimentary of the program, but recommended more outreach to stakeholders, more use of electronic tracking of projects and higher visibility to solicit increased funding of the program.

Other Reports

Roz Schnick gave a presentation, “Food Fish Industry – Background and Needs.” She described the achievements of the Federal-State Aquaculture Drug Approval Partnership Project. The partnership’s projects include claims for Aqui-STM (anesthetic), Chloramine-T, Copper Sulfate, Florfenicol, Formalin, hydrogen peroxide, potassium permanganate, and oxytetracycline. This group has also conducted studies to support species grouping.

The meeting was an excellent opportunity to provide an update on the status of all aspects of the program as well as an opportunity to expand partnerships with other organizations and stakeholders.

International Workshop

The NRSP-7 program traditionally hosted a workshop on a minor species concern every two years. The last workshop was held in 1996 on the topic of “Drug Approval for Minor Species in the 21st Century.” After 1996, resources were directed toward activities other than the sponsorship of workshops. Now, NRSP-7 in partnership with the FDA/CVM will host an International Workshop for Minor Uses and Minor Species. The meeting will be held at the DoubleTree Hotel in Rockville, Md., October 7-8, 2004. Speakers from Europe, Africa, Japan, China, Australia among others will be presenting information about minor species and drug approvals in their countries. Registration will soon be possible through the CVM or the NRSP-7 websites.

For more information about NRSP-7, please visit the website http://www.nrsp-7.org/ or call Dr. Meg Oeller at (301) 827-3067.

This table presents the active NRSP-7 projects

DrugRoute ofAdministrationSpeciesIndicationRegion
IVERMECTINinjectionrabbitsear mitesS
ERYTHROMYCINoral (feed)salmonidsbacterial kidneydiseaseW
TYLOSINsoluble powderhoney beesAmericanfoulbroodW
LASALOCIDoral (feed)pheasantcoccidiosisNC
PROGESTERONECIDRsheepestrussynchronizationNC
CARP PITUITARYinjectionvarious fishspawningaidS
SULFADIMETHOXINE/
ORMETOPRIM
oral (feed)pheasantsbacterial infectionsand coccidiosisNE
FENBENDAZOLEoral (feed)pheasants,partridges & quailgapeworm, capillariaS
OXYTETRACYCLINEoral (feed)finfishbacterial infectionsNE
LASALOCIDoral (feed)deercoccidiosisS
STRONTIUM CHLORIDEimmersionfinfishotolith markingW
FLORFENICOLoral (feed)finfishbacterial infectionsNE
PIRLIMYCINintramammarygoatsmastitisW
LINCOMYCINsoluble powderhoney beesAmerican foulbroodW
FLORFENICOLinjectionsheeprespiratoryinfectionsW
SULFADIMETHOXINE/ORMETOPRIMoral (feed)finfishbacterial infectionsNE
FLORFENICOLoral (feed)shrimpnecrotizinghepatopancreatitisNC