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U.S. Department of Health and Human Services

Animal & Veterinary

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Office of Minor Use Minor Species Animal Drug Development (OMUMS): NRSP-7 Spring Meeting

By Dr. Meg Oeller, OMUMS, with Contributions by Dr. Melanie McLean, Senior Writer/Editor, Communications

CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS for short) 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 25 and 26, 2010.  The program, run by the U.S. Department of Agriculture (USDA), consists of a committee of four Regional Coordinators, four Administrative Advisors, a National Coordinator, and liaisons from USDA and FDA. 

NRSP-7’s research focus is on drugs for minor species of agricultural importance, such as fish, sheep, and goats that make food or fiber products for people.  Although the need for drugs for these animals is big, the market is not a lucrative one for drug companies.  OMUMS and NRSP-7 work with drug companies to help them pursue approval of drugs for minor species despite the small return on investment.   

Most of the studies conducted by NRSP-7 are done to support different sections 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 gave an update on FDA issues that may affect the program, including personnel changes at FDA and CVM, proposed federal legislation, and some priority issues for FDA. 

Dr. Gary Sherman, the committee’s USDA liaison, spoke about changes at USDA and NRSP-7’s efforts to secure and increase funding.  The program is now under the National Institute of Food and Agriculture which was established in 2008 by the Farm Bill.  The Institute has five priority areas and the work of NRSP-7 is important in at least two of these areas, Food Safety, and Global Food Security and Hunger.

During the meeting, the committee reviewed the progress of active research projects for drugs for sheep, goats, pheasants, fish, rabbits, and honey bees.  The results of the research will be used to support FDA approval for these drugs for uses in minor species.  The committee also discussed proposals for several new projects.

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

While in Rockville for the meeting, the committee met with several CVM personnel who review drug studies in animals.  They discussed protocol design and ways to improve final study reports to make the reports more complete and easier for CVM to review.   

NRSP-7’s next semiannual meeting is planned for fall 2010 in Washington, DC.