Technical and Schedule Impacts of Environmental Assessments on the Drug Development Process

Abstract

The Food and Drug Administration (FDA) requires environmental assessments for evaluating and approving investigational new drug applications (INDAs) and new drug applications (NDAs) to comply with the FDA's National Environmental Policy Act (NEPA) (1969) implementation process. The FDA requires environmental fate and effects studies to predict the environmental impacts of a drug and an environmental assessment report as part of its environmental review process under NEPA. In this paper, the potential environmental exposure pathways for human and animal health drugs are presented, together with a rationale for conducting the various studies required by FDA. A case study is also presented on conducting environmental fate and effects studies and preparing environmental assessment under FDA guidelines, with emphasis on the schedule and personnel. The option of conducting the studies in-house or at a contract research laboratory are discussed and a list of criteria for selecting a contract research laboratory is presented.