BACKGROUND

In 1982, a national program for approval of minor use animal drugs was established by USDA and FDA. The 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 CSRS (since renamed CSREES, and currently NIFA). In October of 2017 NRSP-7 was terminated and Minor Use Animal Drug Program NECC1702 was established.

MISSION

The missions of the Minor Use Animal Drug Program (MUADP) are

• to identify animal drug needs for minor species and minor uses in major species
• to generate and disseminate data for safe and effective therapeutic applications
• to facilitate FDA/CVM approvals for drugs identified as a priority for a minor species or minor use

To accomplish these goals, MUADP coordinates the efforts of animal producers, pharmaceutical manufacturers, FDA/CVM, USDA-NIFA state Agricultural Experiment Stations and veterinary medical colleges throughout the country.

INTRODUCTION TO THE MINOR USE ANIMAL DRUG PROGRAM NECC1702

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 Minor Use Animal Drug Program 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/NIFA), other government agencies, universities, State Agricultural Experiment Stations, and veterinary schools to get the job done. In addition to funding research, MUADP 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.
[How the program works...]