Federal-state aquaculture drug registration partnership: A success story in the making

Abstract

During the past 20 years, aquaculture has grown both as a vital tool for fisheries management and as a viable industry. But now a crisis has arisen from the Food and Drug Administration's (FDA) increased regulation of drug use in aquaculture in response to public concerns about human food safety, human health, and environmental effects. Lack of approved drugs and chemicals has dramatically reduced the effectiveness and increased the cost of fish production for natural resource management agencies. To make badly needed therapeutants available, the FDA is requiring an array of specialized laboratory research studies and clinical field trials. Pharmaceutical manufacturers are reluctant to undertake any major efforts to gain approval of aquaculture drugs because each (i.e., use on one species for one purpose) is estimated to cost a minimum of $3.5 million. Hence, the expenditure is not warranted by the apparent market potential. Only three therapeutants and one anesthetic are currently approved and available to hatchery managers.