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U.S. Department of Health and Human Services

Animal & Veterinary

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NRSP-7 Spring Meeting

by Meg Oeller, DVM, Center for Veterinary Medicine, FDA

CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS for short) again hosted the semiannual meeting of the Minor Use Animal Drug Program, also known as the National Research Support Project #7 (NRSP-7). The meeting was held in Rockville, Md., on March 31 and April 1, 2011. The program, run by the U.S. Department of Agriculture (USDA), is administered by a committee of four Regional Coordinators, four Administrative Advisors, a National Coordinator, and liaisons from USDA and FDA.

NRSP-7 conducts studies on drugs for minor species of agricultural importance, such as fish, pheasants, goats, and sheep that make food or fiber products for people. Very few drugs are approved for use in these species. So, the need for drugs for these animals is great, but the market is too small to provide drug companies with an attractive return on their financial investments. Drug approvals are expensive and can take quite a long time. NRSP-7’s work enables drug companies to pursue approval of drugs for minor species at a low cost.

Most of the studies conducted by NRSP-7 are done to support the safety and effectiveness requirements of the approval process for animal drugs. The information from the studies is collected in a Public Master File (PMF) that, as suggested by the file’s name, is open to the public. Rather than conduct its own studies that are expensive and time-consuming, a drug company can use the studies in a PMF to satisfy FDA’s requirements for drug approval. By using the publicly-available information produced by NRSP-7, the drug company reduces both the time and money it takes to get a drug approved. This gives the drug company more incentive to pursue FDA approval for a drug that is not expected to make the company a lot of money. To date, NRSP-7 has provided data to support 28 drug approvals for minor species.

To start off the recent meeting, Dr. Bernadette Dunham, Director of CVM, welcomed the NRSP-7 committee and participated in a discussion about the federal budget process and the program’s current plans.

Dr. Gary Sherman, the committee’s USDA liaison, spoke about potential changes to the program’s administration and funding.

During the meeting, the committee reviewed the progress of active research projects for drugs for sheep, goats, pheasants, fish, and honey bees. There have been recent successes with CVM’s acceptance of several protocols for studies to be done this year. Also, CVM accepted studies supporting effectiveness, animal safety, human food safety, and environmental safety for a drug for pheasants, goats, sheep, and honey bees. The results of the research eventually will be used to support FDA’s approval of these drugs for uses in these minor species. The committee also discussed plans for future studies to complete these projects.

Currently, NRSP-7 has 14 active research projects, but due to funding constraints, some of these have been put on hold temporarily. Other projects which have been inactive for some time will be terminated.

The Minor Use Animal Drug Program’s next semiannual meeting is planned for fall 2011, again in Rockville, Md.