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The Legal and Ethical Implications

Abel Torres, MD, JD

Arch Dermatol. 1994;130(1):32-36.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

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.

BACKGROUND

One prescribes a drug in the hope that medication will benefit the person to whom it is given. Yet, every drug has the potential to cause effects on the body that can be beneficial or adverse.¹ Adverse reactions can range in seriousness from relatively mild to fatal.¹ One estimate showed that adverse drug reactions are responsible for 1.0% to 3.5% of admissions to medical wards.² One government estimate showed that 130 000 US hospital— based deaths per year were caused by adverse drug reactions.³ These adverse reactions can occur with proper use (idiosyncratic) . . . [Full Text PDF of this Article]

Author Affiliations
From the Department of Dermatology and Health Administration, Loma Linda (Calif) University School of Medicine.

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