Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use

Author:

Rodwin Marc A.

Abstract

The Food and Drug Administration (FDA) authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as off-label prescribing. This occurs when physicians prescribe a drug for a therapeutic purpose other than the one approved by the FDA; treat patients in a different age cohort or gender than the population on which it was tested; or prescribe a different dose, for a different duration of use, or a different mode of administration than indicated on the label.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference85 articles.

1. 41. Parkinson Pipeline Project, available at (last visited April 16, 2013)

2. 79. Some states allow physicians to dispense drugs. The income that dispensing physicians earn is a function of the difference between their reimbursement and the cost of purchasing the drug, as well as administration of their dispensary. Like pharmaceutical firms, dispensing physicians have an incentive to prescribe off-label when it is profitable. We should therefore also end dispensing physicians' economic incentive to prescribe off-label. Similar rules should regulate drug-dispensing institutions, which are closely affiliated with physicians (such as freestanding pharmacies in which physicians invest), so that physicians do not have an incentive to prescribe medications off-label.

3. 54. The other violations included: Overcharging government health programs, monopoly/ antitrust, the Medicare and Medicaid Anti-Kickback act, concealing stud findings, poor manufacturing practices, financial violations, illegal distribution, and environmental violations.

4. Off-label prescribing in oncology

5. 58. Id. The $2.75 billion Pfizer has paid in off-label penalties from 2004 to 20010 is slightly more than 1 percent of its revenue of $245 billion from 2004 to 2008.

Cited by 28 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Off-Label Use vs Off-Label Marketing;JACC: Basic to Translational Science;2023-03

2. Off-Label Use vs Off-Label Marketing of Drugs;JACC: Basic to Translational Science;2023-02

3. Structural Problems in the Practice of Psychiatric Research;Philosophy and Medicine;2023

4. Management guideline for the off-label use of medicine in China (2021);Expert Review of Clinical Pharmacology;2022-09-11

5. Institutional corruption in the criminal justice system: The case of Ferguson;Crime, Law and Social Change;2022-06-01

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3