A national partner-based program designed to manage all aspects of drug submissions to the Food and Drug Administration for use in Federal, state, Tribal and private aquaculture programs has been established in the U.S. Fish and Wildlife Service=s National Fish Hatchery System, Director Steve Williams announced today.
APublic and private aquaculture in the United States has struggled for years because of a severe shortage of FDA-approved drugs for use in aquatic species,@ Williams said. AThis Service-directed program B the Aquatic Animal Drug Approval Partnership B will go a long way to correct that situation.@
Currently, only a handful of drugs is approved for use in aquatic species, and use of those is restricted to life stages of certain species. That situation has jeopardized the health of aquatic species held in captivity, including those that are key to restoration, recovery and management activities undertaken by the Service and the agency=s partners.
Williams said that the successful control of treatable diseases in all animals, including humans, requires having more than one drug available for any given ailment because reliance on a single drug may quickly render that medicine ineffective.
Public aquaculture facilities and private fish farms in the United States now raise more than 100 species of aquatic animals, and FDA-approved drugs to treat disease in the majority of these species are non-existent. The Service program will provide the means to assist all Federal, State, Tribal and private aquatic animal culturists in meeting animal disease-management requirements.
The AADAP program will lead a coordinated effort to gather data, analyze results, compile final study reports, disseminate information and manage all other aspects that are required of submissions to the FDA to support new animal drug approvals for aquatic species.
The AADAP program builds on a long-standing partnership between the Service=s National Investigational New Animal Drug Office in Bozeman, Montana, and more than 50 Federal, State, Tribal and private agencies and organizations. The AADAP program will help expand the work of the Bozeman facility and will lead a national effort to assemble the complex data packages required by the FDA for new aquatic animal drugs.
ANot only do the activities under this program fully support the Interior Secretary=s strategies, but they support the President=s national objectives as well,@ Williams said. AThe bottom line is that it=s about healthier fish, solid private and public partnerships and good value to the taxpayers.@
The President has emphasized Acitizen-centered, results-oriented and market-based@ objectives in partnerships of the specialized and limited market for fish culture drugs. However, the cost of the applied research and development needed for FDA approval often prevents pharmaceutical companies from conducting the research. The new partnership led by the Service allows the R&D costs to be spread among the States, Tribes, and private aquaculture community that benefit. R&D results allow the pharmaceutical companies to complete the application and approval process, and manufacture the approved drugs at an affordable cost.
The U.S. Fish and Wildlife Service is the principal Federal agency responsible for conserving, protecting and enhancing fish, wildlife and plants and their habitats for the continuing benefit of the American people. The Service manages the 95-million-acre National Wildlife Refuge System, which encompasses 540 national wildlife refuges, thousands of small wetlands and other special management areas. It also operates 69 national fish hatcheries, 64 fishery resource offices and 78 ecological services field stations. The agency enforces Federal wildlife laws, administers the Endangered Species Act, manages migratory bird populations, restores nationally significant fisheries, conserves and restores wildlife habitat such as wetlands, and helps foreign governments with their conservation efforts. It also oversees the Federal Aid program that distributes hundreds of millions of dollars in excise taxes on fishing and hunting equipment to state fish and wildlife agencies.
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For more information about the U.S. Fish and Wildlife Service,
visit our home page at http://www.fws.gov
