Background Information on Biologics ...

The AADAP Program of the U.S. Fish & Wildlife Service is dedicated to assisting in the acquisition of new approved drugs and chemicals for the use in aquatic species. These drugs and chemicals are required for the control, prevention and/or treatment of diseases or other conditions in aquatic species, and as such are an integral part of aquatic animal health management. Although such factors as optimal water quality and rearing conditions are unquestionably essential to the overall health of aquatic species being reared under artificial conditions, therein lies an inherent problem; artificial conditions, regardless of the quality, can be conducive to disease outbreaks. Consequently, drugs and chemicals, as well as other means of intervention may be required to moderate the morbidity and/or mortality that may result from a disease outbreak.

Although the historic focus of AADAP and other partner groups has been on generating data required for the approval of drugs regulated by the FDA's Center for Veterinary Medicine (CVM), there is another unique group of products that could also be broadly classified as "drugs." This other group of compounds, called biologics, can also be used in the diagnosis, cure, mitigation, treatment, or prevention of animal diseases. However, biologics are not regulated by CVM, but instead they fall under the jurisdiction of the U.S. Department of Agriculture's Center for Veterinary Biologics, located in Ames, Iowa.

Within the past decade or so the global aquaculture community, like that of the human health community, has recognized some of the potential down-sides of antibiotic drugs, and in particular the potential for the development of antibiotic resistance and the diminution over time of the drug's effectiveness. Such resistance development may not only be a threat to the aquaculture species per se, but it also has the perceived potential to be a direct threat to people as a result of resistance being passed to human pathogens, thereby rendering certain human antibiotics ineffective. Hence, there has recently been a renewed focus on alternatives, such as biologics, to antibiotic therapy.

Biologics (which do not have the potential to induce antibiotic resistance in pathogens) include a wide range of medicinal products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, and may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies (Wikipedia contributors. Biologics [Internet]. Wikipedia, The Free Encyclopedia; 2007 Sep 23, 21:00 UTC [cited 10 Dec 2007]. Available from: http://en.wikipedia.org/w/index.php?title=Biologics&oldid=159875009.

The U.S. Department of Agriculture's Center for Veterinary Biologics (which regulates these products) defines biologics to include vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin.

Refer to the other menu items, under the "Biologics" button above, for more information on biologics.