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

摘要: Physicians increasingly use Food and Drug Administration (FDA)-approved drugs (medication) for unlabeled (off-label) indications. The ethical legal implications of these actions are not always clear. In this article, I examine the common law federal statutory regulations concerning issue also explore some financial issues involved. BACKGROUND One prescribes a drug in hope that medication will benefit person to whom it is given. Yet, every has potential cause effects on body can be beneficial or adverse. 1 Adverse reactions range seriousness from relatively mild fatal. estimate showed adverse responsible 1.0% 3.5% admissions medical wards. 2 government 130 000 US hospital— based deaths per year were caused by reactions. 3 These occur with proper (idiosyncratic)