NAGA News May/June 201518

T he shortage of drugs for food-producing minor species is a problem well recognized by

animal producers, veterinarians, ani-mal scientists, and regulators. Minor food-producing species include animals such as game birds, sheep, goats, rabbits, ratites, fish, and deer; the major food-producing spe-cies are cattle, swine, chickens, and turkeys. The market for drugs used in minor food-producing species is often insufficient to justify costly research expenditures by a pharma-ceutical firm to obtain Food and Drug Administration (FDA) approval.

The National Research Support Project #7 (NRSP-7), also known as the Minor Use Animal Drug Program (MUADP), is designed to address the shortage of minor use animal drugs by funding and overseeing the ef-fectiveness, target animal safety, and human food safety research and environmental assessment required for FDA approval. The scope of the program includes animals of agri-cultural importance and generally excludes companion animals. The missions of NRSP-7 are:

• to identify animal drug needs for minor species and minor uses in major species (rare diseases)

• to generate and disseminate data for safe and effective therapeu-tic applications

• to facilitate FDA/Center for Veterinary Medicine (CVM) approvals for drugs identified as a priority for a minor species or minor use

To accomplish these goals, NRSP-7 coordinates the efforts of animal producers, pharmaceutical manu-facturers, FDA/CVM, USDA state Agricultural Experiment Stations and veterinary medical colleges through-out the country.

HOW NRSP-7 WORKSResearch is funded through a USDA special research grant and admin-

istered by NRSP-7. NRSP-7 also receives support from pharmaceu-tical 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. The form to make a drug request is available on the NRSP-7 website, www.nrsp-7.org. These requests are prioritized according to financial and regulatory feasibility, importance to the animal industry, and the phar-maceutical manufacturer’s commit-ment to the minor use drug approval.

Once a request is accepted as a research project, study protocols are developed. NRSP-7 then conducts studies to address four of the re-quired technical sections: effective-ness, target animal safety, human food safety, and environmental im-pact. All safety studies are conducted in accordance with FDA’s Good Laboratory Practices regulations. Successful studies are submitted to FDA/CVM and placed in a public mas-ter file on the FDA website, www.fda.gov. A pharmaceutical sponsor may then reference, at no cost, the data in the public master file to sup-port 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.

ORGANIZATIONThe NRSP-7 technical commit-tee, which is made up of a National Coordinator, four Regional Coordinators, four regional Administrative Advisors, and liaisons from USDA and FDA, conducts the affairs of the program, including such matters as prioritizing projects, planning workshops, and funding and

overseeing the progress of individual drug approval projects.

ACCOMPLISHMENTSSince the first drug approval in 1984 under the former IR-4 pro-gram, NRSP-7 has been responsible for generating data to support 29 drug approvals (New Animal Drug Applications) for minor species. These approvals include drugs of importance to the game bird industry such as:

• amprolium for coccidiosis in pheasants

• thiabendazole for gapeworm in pheasants

• bacitracin for ulcerative enteritis in quail

• monensin for coccidiosis in quail• salinomycin for coccidiosis in

quail• sulfadimethoxine/ormetoprim

for coccidiosis in chukar partridges• lasalocid for coccidiosis in chukar

partridges

CURRENT PROJECTSNRSP-7 is currently conducting research to support the approval of six drugs, two of which are for use in game birds. Investigations are ongo-ing for the use of fenbendazole Type A medicated feed for the following two indications:

(1) For the removal and control of adult Syngamus trachea (gapeworm) in pheasants

(2) For the treatment of adult Heterakis gallinae and adult Capillaria spp. in quail

Lasalocid Type A medicated feed is being investigated for the control of coccidiosis associated with Eimeria spp. in pheasants. For each of these game birds projects, two of the four required technical sections have been completed by NRSP-7 and work is presently ongoing to complete the public master files.

Survival with Proper Medications by Amy Omer

NRSP-7: Opportunities For New Animal Drug Approval

“Hum

or keeps us alive. Hum

or and food. Don’t forget food. You can go a w

eek without laughing.” ―

Joss Whedon

19NAGA NewsMay/June 2015

The NRSP-7 approval process for Fenbendizole use in pheasants has been in progress for the last 15 years, and has not been an easy road. There have been several bumps in the road and even road blocks over those 15 years.

It starts with a need. Fenbendizole is certainly a needed product for effec-tive worming in pheas-ants, but it is currently only approved for use in livestock and household pets as an anti-parasite medication trade named Safeguard. It is commonly used as an extralabel drug as a treatment for gapeworm in pheasants.

To date the required proposal has been submitted and approved. A study has been set up on test sites chosen to do the research. The test sites must follow the study guide-lines set up by the NRSP-7, keeping meticulous records and notes on all details including feed delivered, feed consumed, symptoms before and after treatment. The testing sites and

feed companies keep these records and submit them to the NRSP-7.

After these records are submitted to the NRSP-7, the data is compiled and studied. Every detail must be

scrutinized and every ques-tion answered. New questions often arise and further testing and even new studies may be required. This is the step that takes the longest to complete and can frustrate test sites

and researchers alike. It is so detail oriented it can take years to get through. And if the chain is broken, the process must be started over at the very beginning.

Once all the data has been ana-lyzed and Fenbendizole has been deemed safe for animals and humans alike, it can finally be legalized for use in game birds. There is no doubt the process is slow, sometimes moving at a snail’s pace. There has been a renewed emphasis on this project in the last 2 years. We hope, the pace will pick up, and to see results in the near future. H

Survival with Proper Medications by Chris Theisen

Fenbendizole Approval Process for Use in Pheasants

INVOLVEMENT OF THE GAME BIRD INDUSTRY

Animal producers are primary stakeholders of the NRSP-7 program and their active participation is es-sential to the program’s success. Game bird producers can assist the program by actively letting NRSP-7 know your industry’s drug needs and priorities, by participating in drug trials, and by encouraging indus-try leaders to support the pro-gram. Organizations like the North American Gamebird Association as well as the various state and regional game bird associations work to represent and promote the interests of the game bird industry. Continued support of these organizations can provide a unified method by which to voice the needs of your industry.

To initiate a drug request or for general questions about the NRSP-7 program please visit the following website: www.nrsp-7.org or contact Amy Omer at FDA/CVM, 240-402-0564, amy.omer@fda.hhs.gov. H

Here is a “ just for fun” hunt.Hidden in the text or adver-tising of the NAGA News is a handful of pheasant tail feath-ers. Last issue there were feath-ers on pages 16, 18, 21 and 33.

See how many you can find, and contact Peg Ballou

with your best guess. To help you identify this feather, here is a non-hidden copy.

Have you “liked” the North American Gamebird Association Facebook page yet?

We can use this as an extra com-munication tool to keep you in-formed of breaking and pertinent news, as well as member informa-tion that is not contained in the NAGA News…