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增加新药研发和分配的价值和公平性的提案。

A Proposal to Increase Value and Equity in the Development and Distribution of New Pharmaceuticals.

机构信息

Internal Medicine and Pediatrics, 1092Albany Medical College, Albany Medical Center Internal Medicine and Pediatrics, Cohoes, NY, USA.

Management and Health Studies, Siena College, Loudonville, NY, USA.

出版信息

Int J Health Serv. 2022 Jul;52(3):363-371. doi: 10.1177/00207314221100647. Epub 2022 May 12.

DOI:10.1177/00207314221100647
PMID:35546103
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9203670/
Abstract

The process of developing and marketing new pharmaceuticals in the United States is driven by a need to maximize returns to shareholders. This results all too often in the production of new medications that are expensive and of marginal value to patients and society. In line with our heightened awareness of the importance of social justice and public health-and in light of our government's alliance with private companies in bringing us COVID-19 vaccines-we need to reconsider how new pharmaceuticals are developed and distributed. Accordingly, we propose the creation of a new agency of the Food and Drug Administration (FDA) that would direct the whole process. This agency would fund the research and development of high-value medications, closely monitor the clinical studies of these new drugs, and manage their distribution at prices that are value-based, fair, and equitable.

摘要

美国开发和营销新药的过程是由股东回报最大化的需求驱动的。这往往导致生产新的药物,这些药物对患者和社会来说是昂贵的,价值不大。为了与我们对社会正义和公共卫生的重要性的认识保持一致,并且鉴于我们的政府与私营公司合作,为我们带来了 COVID-19 疫苗,我们需要重新考虑新药的开发和分配方式。因此,我们建议创建一个新的食品和药物管理局(FDA)机构,负责指导整个过程。该机构将为高价值药物的研发提供资金,密切监测这些新药的临床研究,并以基于价值、公平和公正的价格管理其分配。

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本文引用的文献

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Independent Oversight of Clinical Trials through Data and Safety Monitoring Boards.通过数据和安全监测委员会对临床试验进行独立监督。
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Estimation of the Share of Net Expenditures on Insulin Captured by US Manufacturers, Wholesalers, Pharmacy Benefit Managers, Pharmacies, and Health Plans From 2014 to 2018.2014 年至 2018 年期间,美国制造商、批发商、药品福利经理、药店和健康计划捕获的胰岛素净支出份额估计。
JAMA Health Forum. 2021 Nov 5;2(11):e213409. doi: 10.1001/jamahealthforum.2021.3409. eCollection 2021 Nov.
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A Radical Treatment for Insulin Pricing.胰岛素定价的激进疗法。
N Engl J Med. 2022 Jun 9;386(23):2157-2159. doi: 10.1056/NEJMp2203001. Epub 2022 Apr 6.
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Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019.2018-2019 年美国和欧洲新型药物的治疗价值评估。
JAMA Netw Open. 2022 Apr 1;5(4):e226479. doi: 10.1001/jamanetworkopen.2022.6479.
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A Patient Price Guide for Prescription Medication.处方药患者价格指南。
Ann Intern Med. 2022 Jun;175(6):885-887. doi: 10.7326/M21-4755. Epub 2022 Mar 22.
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The illusion of evidence based medicine.循证医学的错觉
BMJ. 2022 Mar 16;376:o702. doi: 10.1136/bmj.o702.
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Patient Assistance Programs and the Anti-Kickback Statute: Charting a Pathway Forward.患者援助计划与反回扣法规:规划前进道路
JAMA. 2022 Apr 5;327(13):1231-1232. doi: 10.1001/jama.2022.2043.
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Step Therapy's Balancing Act - Protecting Patients while Addressing High Drug Prices.阶梯治疗的平衡之举——在应对高昂药价的同时保护患者。
N Engl J Med. 2022 Mar 10;386(10):901-904. doi: 10.1056/NEJMp2117582. Epub 2022 Mar 5.
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Updating the Bayh-Dole Act: March-in Rights and Transparency.更新《拜杜法案》:专利权 march-in 权利与透明度
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Switching to Over-the-Counter Availability of Rescue Inhalers for Asthma.将哮喘急救吸入器改为非处方可用。
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