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The Use of Food and Drug Administration Approved Medications for Unlabeled (Off-Label) Uses

Abel Torres

Open publisher page 24 citations

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.

About this research paper

What this paper is about

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.

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OpenAlex reports 24 citations for this work. Citation counts describe recorded attention and do not establish research quality.

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Available 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.

Key concepts: Food and drug administration, Medicine, Off-label use, Statutory law, Drug, Drug labeling, Administration (probate law), Drug administration

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