拥抱21世纪的信息共享:定义食品和药物管理局监管生物制药公司与医疗保健专业人员沟通的新范式。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2015-01-01
James M Spears, Jeffrey K Francer, Natale A Turner
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引用次数: 0

摘要

美国食品和药物管理局(FDA)在保护公众健康和尽量减少在美国销售不安全或无效药物的风险方面发挥着独特的作用。然而,对公众健康同样重要的是,卫生保健专业人员需要充分了解他们所开药物的益处和风险。通过这种方式,信息共享对医疗保健服务至关重要。FDA目前对医疗保健通信法律法规的解释禁止生物制药公司与医疗保健专业人员分享FDA批准的药物的某些准确的、数据驱动的信息,以及FDA批准的药物在医学上可接受的替代用途。通常,这些用途是良好医疗实践的标准护理,因此,在联邦医疗保健计划下报销。FDA未能充分描述制造商如何与医疗保健专业人员和处方决策者分享有关此类用途的真实和非误导性信息。这种失败可能阻碍医疗创新,对患者护理产生负面影响,并增加医疗保健成本。为了改善公众健康,FDA应该改革其目前的方法,并为制造商提供一个明确的安全港,关于如何与医疗保健专业人员共享FDA批准的药物的批准用途和医学上可接受的替代用途的数据和信息。本文描述了一种新的监管范式的关键原则。
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Embracing 21st Century Information Sharing: Defining a New Paradigm for the Food and Drug Administration's Regulation of Biopharmaceutical Company Communications with Healthcare Professionals.

The Food and Drug Administration (FDA) plays a unique role in protecting the public health and minimizing the risk of the distribution of unsafe or ineffective medicines in the United States. Perhaps equally as important for public health, however, is the need for healthcare professionals to be well informed about the benefits and risks of the medicines they prescribe. In this way, information sharing is critical to healthcare delivery. FDA's current interpretation of laws and regulations governing healthcare communications prohibits biopharmaceutical companies from sharing certain accurate, data-driven information about FDA-approved uses and medically accepted alternative uses of FDA-approved drugs with healthcare professionals. Often, these uses are the standard of care for good medical practice and are, accordingly, reimbursed under the federal healthcare programs. FDA has failed to describe adequately how manufacturers can share truthful and non-misleading information about such uses with healthcare professionals and formulary decision makers. This failure could impede medical innovation, negatively impact patient care, and increase healthcare costs. To improve public health, FDA should reform its current approach and provide manufacturers with a clear safe harbor on how to share data and information on both approved uses and medically accepted alternative uses of FDA-approved drugs with healthcare professionals. This Article describes key principles for a new regulatory paradigm.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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