New animal drug approvals and the United States aquaculture industry: a partnership for growth

Abstract

Aquaculture, for better or worse, depends in part on drugs for the prevention, control and eradication of a variety of diseases. The US Food and Drug Administration's Centre for Veterinary Medicine, through the Federal Food, Drug and Cosmetic Act, strictly controls the approval and use of drugs in animals, including aquatic animals. Laws and regulations exist that regulate the investigational use and approval of new animal drugs for all animals. However, in reality, these mandates must be uniquely interpreted for aquatic species. Very few drugs are approved for use in aquatic species. There is a growing effort by non-traditional sponsors (aquaculturists as opposed to pharmaceutical firms) to gain approvals for several new animal drugs. Simultaneously, the federal government, including the Centre for Veterinary Medicine, is working aggressively with the private and public aquaculture sectors to facilitate submission and subsequent approval of new animal drug applications. The drug approval procedures and requirements for aquatic animals are discussed. Special attention is given to their similarities and differences, relative to traditional terrestrial animals.