THE MINOR USE ANIMAL DRUG PROGRAM

NATIONAL RESEARCH SUPPORT PROJECT NO. 7
A Cooperative Effort for Approval of
MINOR USE ANIMAL DRUGS

INTRODUCTION TO THE NRSP-7 MINOR USE ANIMAL DRUG PROGRAM

The shortage of drugs for minor food animal uses is a problem well recognized by animal producers, veterinarians, animal scientists, and regulators. Minor animal drug uses are analogous to human orphan drug uses, for which the market is insufficient to justify costly research expenditures by a pharmaceutical firm to obtain Food and Drug Administration (FDA) approval. Minor uses include drugs for a wide variety of minor species, such as sheep, goats, rabbits, game birds, ratites, fish, and deer. Minor uses also include diseases in major species (e.g., cattle, swine, chickens, and turkeys) that occur infrequently or in limited geographical locations. The National Research Support Project No. 7 (NRSP-7) is designed 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. The scope of the program includes animals of agricultural importance and generally excludes companion animals. The program coordinates with animal producers, drug manufacturers, FDA’s Center for Veterinary Medicine (CVM), The U.S. Department of Agriculture Cooperative State Research, Education, and Extension Service (USDA/CSREES), other government agencies, universities, State Agricultural Experiment Stations, and veterinary schools to get the job done. In addition to funding research, NRSP-7 periodically holds special workshops, and to provide a forum for exchange of ideas among minor species producers, drug manufacturers, researchers, and government agencies on approaches to disease problems and drug priorities.

BACKGROUND

In 1982, a national program for approval of minor use animal drugs was cooperatively established by USDA and FDA. The Minor Use Animal Drug Program was part of the Interregional Project Number 4 (IR-4) for clearance of pests for both plants and animals until 1993, when a separate National Research Support Project Number 7 was established by USDA-CSRS (currently USDA- CSREES). This program facilitates drug approvals for minor animal species such as sheep, goats, veal, calves, rabbits, game birds, ratites, deer, bison and all aquaculture species and for use in minor diseases. Cooperation with pharmaceutical companies to sponsor animal drug research projects is vital to the program. The major contribution to NRSP-7 is the cost borne by the pharmaceutical industry for the registration of drugs for a major species, estimated at $20 million or more per approved drug. By using the proprietary data package from a major species, studies can be initiated to obtain drug approvals for use in a minor species. Through this efficient and safe process the average cost to the program for an approved drug for a minor species has been only approximately $200,000. The program is funded at $550,000 for 1999 which is only enough to support research for two or three drug approvals per year on average across a diversity of species and drug approval needs. The program funding is only available for about one in every five requests for drug approval research assistance. Also the recent federal legislation (Animal Medical Drug Use Clarification Act known as AMDUCA) which legalized the extra-label drug by veterinarians, has significant impacts on the use of approved animal drugs. Extra-label use primarily refers to the use of an animal drug product by a veterinarian for a species not listed on the drug label to treat animals that are immediately threatened or suffering. However, this legislation does not allow for extra-label use of a drug for medication in feed, which is the common route of drug administration for most aquaculture species.

ORGANIZATION OF NRSP-7

The program is composed of a Technical Committee and four Administrative Advisors. The Administrative Advisors are Experiment Station Directors who provide liaison between the Directors of the State Agricultural Experiment Stations, USDA/CSREES, FDA/CVM, various animal organizations, and others coordinating the efforts of this program. The Administrative Advisors provide advice on policy, budget, and administrative matters. The Technical Committee is composed of the following representatives:

National Animal Drug Coordinator;
Regional Animal Drug Coordinator from each of four regions;
Administrative Advisors (non-voting); USDA/CSREES representative (non-voting); FDA/CVM representative (non-voting).

The Technical Committee conducts the affairs of NRSP-7 Minor Use Animal Drug Program, including such matters as prioritizing projects, planning workshops, and funding and overseeing the progress of individual drug projects.

HOW NRSP-7 OPERATES

Research for the Minor Use Animal Drug Program is funded through a USDA special research grant and administered by NRSP-7. NRSP-7 also receives support from pharmaceutical firms, universities, and State Agricultural Experiment Stations. Research projects are initiated by requests (usually from researchers or animal producers) to the program’s regional coordinators to address a particular minor use drug need. These requests, known as ADRs (Animal Drug Requests), are prioritized according to financial and regulatory feasibility, importance to the animal industry, and the pharmaceutical manufacturer’s commitment to the minor use drug approval.

Animal Drug Request Prioritization Form

Once a request is accepted as a research project, study protocols are developed. Research is conducted in accordance with FDA’s Good Laboratory Practices regulation. Minor Use Animal Drug Approval Process A successful research project is submitted to FDA’s Center for Veterinary Medicine as a public master file, and the availability of the data in the public master file is published in the Federal Register. A pharmaceutical sponsor may then reference, at no cost, the data in the public master file to support a new animal drug application for the minor use. The final step in the process is FDA approval of this application from the pharmaceutical sponsor, so that the product may be labeled and sold for the minor use.

The NRSP7 1996-1997 Annual Report can be downloaded from the www at:

http://bluehen.ags.udel.edu/homepage/nrsp7/nrsp7_annual_report_96-97.htm

AQUACULTURE ISSUES

The NRSP-7 program has received 75 aquaculture requests since its inception. Represented species include alligators, brown trout, catfish, eels, lobster, shrimp, salmonids, white sea bass and striped bass. This number of requests represents nearly 25 percent of all drug requests received by NRSP-7. Although the majority of the aquaculture drug requests relate to therapeutic uses in food fish, studies of otolith marking and spawning aids have been considered and funded. Additionally, support of studies in tropical or ornamental fish would be considered on a state by state basis.

Currently there are eight active projects related to aquaculture in the NRSP-7 program. The following are those active aquaculture projects being supported.

DRUG SPECIES INDICATION

For more information about the NRSP-7 program contact one of the following persons:

The NRSP-7 activities are also coordinated with the federal Joint Subcommittee on Aquaculture’s (JSA) Working Group on Quality Assurance in Aquaculture Production which has been functioning since 1990 to facilitate the approval of critical new animal drugs for the aquaculture industry. One result of this multi-agency, public-private sector coordination effort was the creation of the National New Animal Drug Application Coordinator for Aquaculture position which is currently filled by Rosalie Schnick. She is also aware of numerous initiatives and ongoing efforts on new animal drug approvals for aquaculture and can be reached at rozschnick@aol.com for additional assistance or information.