The use of Food and Drug Administration-approved medications for unlabeled (off-label) uses. The legal and ethical implications

Abstract

Physicians increasingly use Food and Drug Administration (FDA)-approved drugs (medication) for unlabeled (off-label) indications. The ethical and legal implications of these actions are not always clear. In this article, I examine the common law and federal statutory regulations concerning this issue and also explore some of the ethical and financial issues involved.

Part of CIRS Nexus · Curated by Lauren Lowenstein, The Biotoxin Lady