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Research Support to the Federal-State Drug Approval Partnership Project

The efficiency and cost of public fish production is dramatically affected by the lack of approved drugs and chemicals for aquaculture. In 1994, a Partnership Project initiative formed to cooperatively fund and carry out the research required to gain broad approvals for eight high-priority aquaculture drugs (therapeutants and anesthetics). Acting on behalf of the 50 states, the Partnership comprised the U.S. Geological Survey (Biological Resources Division), the U.S. Fish and Wildlife Service, and the International Association of Fish and Wildlife Agencies.

Science staff at the Upper Midwest Environmental Sciences Center, La Crosse, Wisconsin, the Stuttgart National Aquaculture Research Center (U.S. Department of Agriculture), and the U.S. Fish and Wildlife Service work cooperatively with Federal and state partners, drug sponsors, and the Center for Veterinary Medicine (CVM, U.S. Food and Drug Administration) to develop required data sets to ensure the broadest possible drug approvals for fish species reared in public aquaculture.

This project has the following purpose:

1. Ensure that data required for approval by CVM for the eight priority drugs are developed in a timely, logical, and cost effective manner.
2. Coordinate the administration of all Project contracts.
3. Track and report the progress of all studies to Federal and State cooperators.
4. Assemble and submit New Animal Drug Application technical sections to the CVM for review.

The initial project was completed in December 2002 but by consent of Project Cooperators and State natural resource agencies the effort to gain broad approvals for a variety of aquaculture drugs continues today. It is expected that by 2006 New Animal Drug Applications will be approved by CVM for five of the eight Project drugs for 13 initial disease treatment claims. Additional new approvals and claims are assured in years 2007 to 2009.

Principal Investigator: Mark Gaikowski