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A tale of two transparency attempts at FDA. 这是FDA两次透明度尝试的故事。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Laurence Tai

This Article describes and evaluates two elements of the FDA's recent operations implicating information transparency: the Transparency Initiative and a reduction in the agency's FOIA backlog. After discussing the legal context for information disclosure at the FDA and these two transparency attempts, this Article identifies two reasons that the first has fallen short of expectations compared to the second: unlike the reduction in the FOIA backlog, the Transparency Initiative had legal constraints that it did not adequately address, along with political appointee leadership. These principles may be more generally useful for understanding how to stimulate institutional change in administrative agencies.

本文描述并评估了食品和药物管理局最近涉及信息透明度的两个要素:透明度倡议和减少该机构的《信息自由法》积压。在讨论了食品药品监督管理局信息披露的法律背景和这两项透明度尝试之后,本文指出了与第二项相比,第一项不如预期的两个原因:与《信息自由法》积压的减少不同,透明度倡议有法律限制,它没有充分解决,以及政治任命的领导。这些原则对于理解如何刺激行政机构的体制变革可能更普遍有用。
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引用次数: 0
The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis. FDA,避孕药上市批准和产品责任诉讼:Depo-Provera和骨质疏松的风险。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
William Green

The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss.

1992年,FDA批准了一种注射避孕药Depo-Provera,条件是其制造商在批准后进行骨质疏松症风险的研究。然后在2004年,该机构修改了该药的标签,包括一个关于骨质疏松风险的黑盒子警告。本文将分析FDA的Depo-Provera批准和标签修订过程:该机构对Upjohn新药申请的接受,其生育和孕产妇健康咨询委员会对人体临床研究和批准建议的审查,Depo-Provera的上市批准,以及2004年药品标签修订。然后,本文将分析2004年后由声称因使用该药而受伤的妇女提起的产品责任诉讼。没有一个案例在制造商的简易判决动议中幸存下来,因为这些女性无法通过专家和医生的证据证明fda批准的标签不足以告知她们的医生骨质疏松症的风险,不充分的警告导致了骨质疏松症或骨质减少,并且这些伤害是可以赔偿的。因此,制造商已经能够使用FDA标签、国家产品责任法和学习中介原则来避免责任。结论将考虑这些产品责任案件的教训,为其他妇女谁接受了Depo-Provera和骨密度损失。
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引用次数: 0
New governance: can user-promulgated certification schemes provide safer, higher quality food? 新治理:用户颁布的认证方案能提供更安全、更高质量的食品吗?
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Tacy Katherine Hass

This article explores whether private regulation of food safety may fill in the gaps of statutory food reforms such as the Food Modernization Safety Act. The relatively new economic school of thought labeled "New Governance" centers around non-state actors acting not just as the object of but also as the creators of the norms regulating their own behavior. This regime may not only enable more efficient food safety regulations in the domestic setting, but also in the international context, as cooperation between non-state actors may overcome the traditional frictions between nations regarding regulatory schemes. It seems, therefore, as one example of "New Governance" rules, that third-party certification schemes may indeed play a vital and successful role in achieving a higher level of quality and safety for foods imported into the United States.

本文探讨食品安全的私人监管是否可以填补食品现代化安全法等法定食品改革的空白。相对较新的经济学派被称为“新治理”,其核心是非国家行为体,它们不仅是规范自身行为的对象,而且是规范自身行为的创造者。这种制度不仅可以在国内环境中实现更有效的食品安全法规,而且可以在国际环境中实现更有效的食品安全法规,因为非国家行为体之间的合作可以克服国家之间关于监管计划的传统摩擦。因此,作为“新治理”规则的一个例子,第三方认证计划似乎确实在实现进口到美国的食品的更高质量和安全水平方面发挥了至关重要和成功的作用。
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引用次数: 0
The critical path from pump to pancreas: the impact of FDA regulation on the development of a closed-loop diabetes management system. 从泵到胰腺的关键路径:FDA法规对糖尿病闭环管理系统发展的影响。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Rachel M Sanchez

Breakthrough medical tools and technologies are rapidly becoming available in countries across the world, but cannot be purchased in the United States, where these innovative products still await FDA approval. The artificial pancreas is a prime example of such medical technologies, as one of these device systems has been available in over 40 countries outside of the United States for more than 3 years. The term "artificial pancreas" refers to any one of a group of closed-loop device systems designed to protect type 1 diabetics against dangerous diabetes episodes, while also reducing the risk of diabetes-related complications by enabling tighter glycemic control. The following paper will provide an overview of diabetes, a brief history of diabetes management, the technological challenges of creating a fully functional closed-loop diabetes management system, and the role of FDA in the development of the artificial pancreas.

突破性的医疗工具和技术正在世界各国迅速普及,但在美国却无法购买,这些创新产品仍在等待FDA的批准。人工胰腺是这种医疗技术的一个主要例子,因为这些设备系统之一已经在美国以外的40多个国家使用了3年多。“人工胰腺”一词指的是一组闭环装置系统中的任何一个,旨在保护1型糖尿病患者免受危险的糖尿病发作,同时通过加强血糖控制来降低糖尿病相关并发症的风险。下面的文章将提供糖尿病的概述,糖尿病管理的简史,创建全功能闭环糖尿病管理系统的技术挑战,以及FDA在人工胰腺发展中的作用。
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引用次数: 0
Does science speak clearly and fairly in trade and food safety disputes? The search for an optimal response of WTO adjudication to problematic international standard-making. 在贸易和食品安全争端中,科学能清晰公正地发言吗?寻求WTO裁决对有问题的国际标准制定的最佳反应。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Kuei-Jung Ni

Most international health-related standards are voluntary per se. However, the incorporation of international standard-making into WTO agreements like the SPS Agreement has drastically changed the status and effectiveness of the standards. WTO members are urged to follow international standards, even when not required to comply fully with them. Indeed, such standards have attained great influence in the trade system. Yet evidence shows that the credibility of the allegedly scientific approach of these international standard-setting institutions, especially the Codex Alimentarius Commission (Codex) governing food safety standards, has been eroded and diluted by industrial and political influences. Its decision-making is no longer based on consensus, but voting. The adoption of new safety limits for the veterinary drug ractopamine in 2012, by a very close vote, is simply another instance of the problematic operations of the Codex. These dynamics have led skeptics to question the legitimacy of the standard setting body and to propose solutions to rectify the situation. Prior WTO rulings have yet to pay attention to the defect in the decision-making processes of the Codex. Nevertheless, the recent Appellate Body decision on Hormones II is indicative of a deferential approach to national measures that are distinct from Codex formulas. The ruling also rejects the reliance on those experts who authored the Codex standards to assess new measures of the European Community. This approach provides an opportunity to contemplate what the proper relationship between the WTO and Codex ought to be. Through a critical review of WTO rulings and academic proposals, this article aims to analyze how the WTO ought to define such interactions and respond to the politicized standard-making process in an optimal manner. This article argues that building a more systematic approach and normative basis for WTO judicial review of standard-setting decisions and the selection of technical experts would be instrumental to strengthening the mutual supports between the WTO and international standard-setting organizations, and may help avoid the introduction of a prejudice toward a justified science finding.

大多数与健康有关的国际标准本身都是自愿的。然而,将国际标准制定纳入WTO协议,如SPS协议,极大地改变了标准的地位和有效性。世贸组织成员被敦促遵守国际标准,即使没有被要求完全遵守这些标准。事实上,这些标准在贸易体系中产生了很大的影响。然而,有证据表明,这些国际标准制定机构,特别是管理食品安全标准的食品法典委员会(食典委)所谓的科学方法的可信度,已受到工业和政治影响的侵蚀和削弱。它的决策不再基于共识,而是基于投票。2012年,以非常接近的票数通过了兽药莱克多巴胺的新安全限量,这只是食典委有问题操作的又一个例子。这些动态导致怀疑论者质疑标准制定机构的合法性,并提出纠正这种情况的解决方案。WTO先前的裁决尚未注意到食品法典决策过程中的缺陷。然而,最近上诉机构关于激素II的决定表明,对不同于食典委配方的国家措施采取了恭恭敬敬之的态度。该裁决还拒绝依赖起草食品法典标准的专家来评估欧共体的新措施。这种方法提供了一个机会来思考世贸组织和食品法典之间的适当关系应该是什么。通过对WTO裁决和学术建议的批判性回顾,本文旨在分析WTO应如何定义这种相互作用,并以最佳方式应对政治化的标准制定过程。本文认为,为世贸组织对标准制定决定的司法审查和技术专家的选择建立一个更系统的方法和规范基础,将有助于加强世贸组织与国际标准制定组织之间的相互支持,并有助于避免引入对合理科学发现的偏见。
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引用次数: 0
A comparative legal analysis of social media advertising of drugs in Germany and the United States. 德国和美国社交媒体药品广告的比较法律分析。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Bianca Buechner

Pharmaceutical companies use social media such as Facebook and Twitter more and more to advertise their products. Advertising of medicinal products especially in social media is a critical issue confronting patient protection, competition law and ethical concerns in direct-to-consumer advertising. Advertising in the World Wide Web must take into account national and international regulations, depending on which user from which country will have access to the information posted. Different legal requirements, if any, regulate the advertising of medicinal products. This paper discusses, challenges and compares the requirements and regulations of advertising medicinal products in social media, such as Facebook, in the United States on a federal level and the European Union with Germany as a reference Member State. Social media are very active and fast moving. Therefore, it is challenging and necessary at the same time to set guidelines and regulations for the use of social media in drug advertising. This paper is a first step toward promoting an international, consistent approach when talking about regulating advertising of medicinal products in social media.

制药公司越来越多地使用Facebook和Twitter等社交媒体来宣传他们的产品。医药产品的广告,特别是在社交媒体上的广告,是直接面向消费者的广告中患者保护、竞争法和伦理问题所面临的一个关键问题。万维网上的广告必须考虑到国家和国际法规,这取决于哪个国家的哪个用户可以访问所发布的信息。不同的法律要求(如果有的话)规范药品广告。本文从联邦层面对美国和以德国为参考成员国的欧盟在Facebook等社交媒体上对药品广告的要求和法规进行了讨论、挑战和比较。社交媒体非常活跃,发展迅速。因此,制定社交媒体在药品广告中的使用的指导方针和法规是具有挑战性的,同时也是必要的。在谈论规范社交媒体上的药品广告时,这篇论文是促进国际一致方法的第一步。
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引用次数: 0
The success of the citizen suit: protecting consumers from inaccurate food labeling by amending the Federal Food, Drug, and Cosmetic Act. 公民诉讼的成功:通过修改《联邦食品、药品和化妆品法》保护消费者免受不准确食品标签的侵害。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
James Springer

The Federal Food, Drug, and Cosmetic Act ("FDCA"), amended in 1990 by the Nutrition Education and Labeling Act ("NLEA"), established a national framework for the administration and promulgation of uniform food labeling standards. Specifically, the NLEA created affirmative obligations for the food--requiring detailed disclosure of food content and strict adherence to regulations governing the use of health and nutritional claims on food packaging. To accomplish these goals, Congress tasked the Food and Drug Administration ("FDA") with the sole responsibility of the enforcement of these new requirements. Under the statutory framework of the FDCA, the United States Supreme Court ("Court") has held that there is no private right of action, of which extended to the enforcement of NLEA standards. This interpretation has left individuals with no federal outlet for relief in the enforcement of federal food labeling standards. Adherence to this interpretation is especially concerning when the FDA currently faces exponential growth in administrative responsibilities while simultaneously experiencing employment reduction, a $206 million "Sequester," and a recent government-wide shutdown. As a result, the American people are left to depend on an Agency that is struggling with drastic resource reduction while being accountable for ever increasing enforcement responsibilities. To ensure consumer protection, this Article argues that Congress should amend the FDCA to include a citizen suit provision in order to provide individuals with a right of private action for the enforcement of NLEA standards. Borrowing from the successes realized under similar citizen suit provisions found in environmental legislation, this Article argues that a citizen suit provision is amendable to the FDCA and would relieve fiscal pressures, strengthen the current enforcement framework of the FDCA, encourage more robust enforcement by the FDA and states, and ensure uniform interpretation of NLEA standards.

《联邦食品、药品和化妆品法》(“FDCA”)于1990年由《营养教育和标签法》(“NLEA”)修订,为管理和颁布统一的食品标签标准建立了国家框架。具体而言,《国家食品法》为食品规定了肯定义务——要求详细披露食品成分,并严格遵守有关在食品包装上使用健康和营养声明的规定。为了实现这些目标,国会责成食品和药物管理局(“FDA”)全权负责执行这些新要求。在FDCA的法定框架下,美国最高法院(“法院”)认为不存在私人诉讼权利,其延伸到NLEA标准的执行。这一解释使得个人在执行联邦食品标签标准时没有联邦救济渠道。当FDA目前面临行政责任的指数级增长,同时经历裁员、2.06亿美元的“自动减支”和最近的政府全面关闭时,坚持这一解释尤其值得关注。其结果是,美国人民只能依靠一个在资源急剧减少的情况下挣扎的机构,同时还要对日益增加的执法责任负责。为保障消费者权益,本文认为国会应修改FDCA,纳入公民诉讼条款,以便为个人提供执行NLEA标准的私人诉讼权利。借鉴环境立法中类似的公民诉讼条款所取得的成功,本文认为公民诉讼条款可以修改FDCA,并将缓解财政压力,加强FDCA的现行执行框架,鼓励FDA和各州更有力地执行,并确保NLEA标准的统一解释。
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引用次数: 0
Assisted reproductive technologies: advances in medical practice or human subject research? 辅助生殖技术:医学实践的进步还是人体实验研究的进步?
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Stefanie L Rokosz

Although human subject research is regulated by federal agencies, the differences between research and innovative clinical practice are often blurred. Research and innovative practices share the similar goals of obtaining additional knowledge and improving medical treatment. Research, however, is more specifically defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Aprocedure consistent with this definition is subject to distinct federal regulations and other ethical procedural safeguards. When unregulated innovative practices, not neatly fitting within this definition of research, are first implemented, safeguards do not necessarily exist because use of these procedures is primarily guided by individual physician judgment. Recognizing that the application of innovative advancements in ART may very well benefit numerous prospective infertile patients and may initially appear to be safe and effective, these new and novel procedures may be associated with yet unknown long-term risks and safety concerns unless more formal scientific study is conducted to support efficacy and safety.

虽然人体研究是由联邦机构监管的,但研究和创新临床实践之间的区别往往是模糊的。研究和创新实践有着相似的目标,即获得更多的知识和改善医疗。然而,研究被更具体地定义为“一种系统的调查,包括研究开发、测试和评估,旨在发展或促进可推广的知识。”符合此定义的程序受不同的联邦法规和其他道德程序保障的约束。当不受监管的创新实践(不完全符合研究的定义)首次实施时,保障措施不一定存在,因为这些程序的使用主要由医生个人判断指导。我们认识到,应用抗逆转录病毒技术的创新进展可能会使许多潜在的不孕症患者受益,并且最初可能看起来是安全有效的,但这些新的和新颖的程序可能伴随着未知的长期风险和安全问题,除非进行更正式的科学研究来支持其有效性和安全性。
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引用次数: 0
The 2013 Harvey Wiley lecture: the food and drug community. 2013年哈维·威利讲座:食品和药品社区。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Richard M Cooper
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引用次数: 0
Meet your meat: The argument for increasing education and public outreach regarding the regulation and safety of animal biotechnology. 遇见你的肉:关于动物生物技术的监管和安全,加强教育和公众宣传的论点。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Kaitlin M Ball

Biotechnology has evolved beyond the realm of child's guess-and-check to a precise science, and now promises to help solve some of the globe's most pressing challenges, including food insecurity and environmental degradation. Beyond this, biotechnology also represents an important part of the American intellectual property landscape. Unlike transgenic plants, no transgenic animals have yet to reach the American dinner table, despite the fact that transgenic animals offer cheap, healthy, and an environmentally friendly source of protein. AquaBounty's AquAdvantage Salmon, which counts itself among the most heavily regulated product in the Food and Drug Administration's history, suffers greatly from negative stigma from special interest groups and the media. This article will examine the important role of biotechnology in America's intellectual property market, the regulation of the AquAdvantage Salmon, and transgenic animal products more generally, before FDA, as well as some of misinformation about AquAdvantage that has been presented to the American public. This article additionally advocates for FDA to adopt a more proactive public outreach role in explaining to the American public, in terms accessible to the layperson, what a transgenic animal product is, how FDA regulates transgenic animal products, and why FDA feels these products are safe for human consumption. In doing so, this article hopes to establish that FDA is best suited to provide the American public with objective facts surrounding this highly stigmatized product.

生物技术已经从儿童的猜测和检验发展成为一门精确的科学,现在有望帮助解决一些全球最紧迫的挑战,包括粮食不安全和环境恶化。除此之外,生物技术也是美国知识产权领域的重要组成部分。与转基因植物不同的是,尽管转基因动物提供了廉价、健康、环保的蛋白质来源,但目前还没有转基因动物登上美国人的餐桌。AquaBounty的AquAdvantage三文鱼被认为是美国食品和药物管理局(Food and Drug Administration)历史上监管最严格的产品之一,它深受特殊利益集团和媒体的负面指责。本文将探讨生物技术在美国知识产权市场中的重要作用,对AquAdvantage三文鱼的监管,以及FDA之前更广泛的转基因动物产品,以及一些关于AquAdvantage的错误信息,这些信息已经呈现给美国公众。本文还主张FDA采取更积极主动的公共宣传作用,向美国公众解释什么是转基因动物产品,FDA如何监管转基因动物产品,以及为什么FDA认为这些产品对人类消费是安全的。在这样做的过程中,本文希望建立FDA最适合向美国公众提供有关这种高度污名化产品的客观事实。
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引用次数: 0
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Food and drug law journal
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