Individual Patient Treatment Use of Unapproved Drugs: A New Option for the Seriously Ill

Abstract

ABSTRACTA landmark 1997 U.S. Court of Appeals ruling on the right of an individual to use an unapproved drug had highlighted the controversy about this right. Subsequently, the Food and Drug Administration (FDA) authorized individual patient access to investigational new drugs though Treatment Investigational New Drugs (INDs). This commentary describes applicable law and issues that apply to the debate over individual patient access to unapproved drugs, including the issue of who should pay for the use of experimental drugs in patient care outside of a study.