The use of Food and Drug Administration--approved medications for unlabeled (off-label) uses. The legal and ethical implications.
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.
Torres
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Department of Dermatology and Health Administration, Loma Linda University School of Medicine, Calif.
D026686:Beneficence; D030881:Disclosure; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004989:Ethics; D035082:Federal Government; D033161:Government Regulation; D007349:Insurance, Health, Reimbursement; D026684:Personal Autonomy; D004364:Pharmaceutical Preparations / Q000191:economics; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations