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Pharmacogenomics: history, barriers, and regulatory solutions. 药物基因组学:历史、障碍和监管解决方案。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Sarah Blankstein

Pharmacogenomics is the branch of pharmacology which looks at the influence of genetic variation on drug response, connecting particular genetic markers with the effectiveness or safety of a drug. Pharmacogenomic products promise to improve medical treatment, lower health care costs, and make the new drug pipeline for FDA approval more efficient. In the last fifteen years, the FDA has approved pharmacogenomic drugs to treat a variety of cancers, HIV-AIDS, and coronary artery disease. Yet, progress in the field of pharmacogenomics has lagged behind the optimistic predictions of many researchers and policymakers. A lack of clear regulatory guidance dealing with pharmacogenomic products has been a major barrier to progress in the field. The FDA has, however, made some headway. In a series of guidance documents released between 2005 and 2011, the FDA has clarified much of its policy with respect to the development, approval, and labeling of pharmacogenomic products. Despite these efforts, many regulatory questions remain unanswered. This paper highlights a number of these regulatory gaps and provides recommendations to address them in a way which encourages increased development and clinical uptake of pharmacogenomic products.

药物基因组学是药理学的一个分支,它研究遗传变异对药物反应的影响,将特定的遗传标记与药物的有效性或安全性联系起来。药物基因组学产品有望改善医疗,降低医疗成本,并使新药管道更有效地获得FDA的批准。在过去的15年里,FDA已经批准了药物基因组学药物来治疗各种癌症、艾滋病和冠状动脉疾病。然而,药物基因组学领域的进展落后于许多研究人员和决策者的乐观预测。缺乏关于药物基因组学产品的明确监管指导一直是该领域取得进展的主要障碍。然而,FDA已经取得了一些进展。在2005年至2011年间发布的一系列指导文件中,FDA明确了其关于药物基因组学产品开发、批准和标签的大部分政策。尽管做出了这些努力,但许多监管问题仍未得到解答。本文强调了一些这些监管缺口,并提供了建议,以鼓励增加药物基因组学产品的开发和临床应用。
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引用次数: 0
"You Say Tomato, I Say Solanum Lycopersicum Containing Beta-ionone and Phenylacetaldehyde": an Analysis of Connecticut's GMO Labeling Legislation. “你说番茄,我说含有β -离子酮和苯乙醛的茄属番茄”:对康涅狄格州转基因标签立法的分析。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Travis Nunziato

"You Say Tomato, I Say Solanum Lycopersicum Containing Beta-ionone and Phenylacetaldehyde" discusses the importance of requiring labels on products that contain genetically modified organisms, focusing on Connecticut's GMO Labeling statutes, as it is they are the first of their kind in the nation. The article will compare Connecticut's law to the legislation found in Australia, highlighting the positive aspects of Connecticut's bill and identifying its key weaknesses, namely the "trigger clause" found in the statute. Part I will provide an overview of Genetic Modification and provide a brief history of Biotechnology. It will also provide a brief overview of the federal regulatory framework in biotechnology, as well as evaluate the United States Food and Drug Association's role of regulating genetic modification. Part I will conclude by discussing how the American public has shown that labeling GMOs is important, and something that should occur. Part II of this article will explore Connecticut's recent legislation requiring labels on products that contain GMOs. Part III will explore Australia's legislation requiring labels on products containing GMOs, comparing Australia's law to Connecticut's legislation.

“你说番茄,我说茄属番茄含有β -离子酮和苯乙醛”讨论了要求对含有转基因生物的产品进行标签的重要性,重点是康涅狄格州的转基因生物标签法规,因为这是全国第一个此类法规。本文将比较康涅狄格州的法律与澳大利亚的立法,突出康涅狄格州法案的积极方面,并确定其主要弱点,即法规中的“触发条款”。第一部分将提供基因改造的概述和提供生物技术的简史。它还将简要概述联邦生物技术管理框架,并评估美国食品和药物协会在管理基因改造方面的作用。第一部分将以讨论美国公众如何表明转基因生物标签是重要的,以及应该采取的措施来结束。本文的第二部分将探讨康涅狄格州最近的立法,要求在含有转基因生物的产品上贴标签。第三部分将探讨澳大利亚要求在含有转基因生物的产品上贴标签的立法,并将澳大利亚的法律与康涅狄格州的立法进行比较。
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引用次数: 0
Of poops and parasites: unethical FDA overregulation. 粪便和寄生虫:不道德的FDA过度监管。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Kenneth A Young

Therapies born out of the Hygiene Hypothesis--such as helminthic therapy and fecal bacteriotherapy--provide a compelling example of the FDA's institutional blindness. Unlike the traditional pharmaceutical model of treatment, therapies based in the Hygiene Hypothesis purport to resolve or alleviate conditions by reintroducing organisms once thought to be wholly negative. While questions of negative effects and safety remain in the former, they are largely absent in the latter. Nonetheless, the FDA has chosen to regulate the use of both helminthic therapy and fecal bacteriotherapy. Such restriction of doctor-patient autonomy in the name of efficacy is costly and unethical.

从卫生假说中诞生的疗法,如蠕虫疗法和粪便细菌疗法,为FDA的制度盲目性提供了一个令人信服的例子。与传统的药物治疗模式不同,基于卫生假说的疗法旨在通过重新引入曾经被认为是完全负面的生物体来解决或缓解疾病。虽然前者仍然存在负面影响和安全性问题,但后者基本上不存在这些问题。尽管如此,FDA还是选择对蠕虫疗法和粪便细菌疗法的使用进行监管。这种以疗效为名限制医患自主权的做法代价高昂,而且是不道德的。
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引用次数: 0
GMO Reignited in Science but Not in Law: A Flawed Framework Fuels France's Stalemate. 转基因生物在科学上重新点燃,但在法律上却没有:一个有缺陷的框架加剧了法国的僵局。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Patricia B Robbins

Following a statement released by a multitude of prominent scientists contesting the idea that there is a consensus on the safety of genetically modified organisms ("GMO"), this article addresses the European Union's ("EU") GMO regulatory framework, which has reluctantly permitted France to maintain an illegal ban on. MON8 10 for over a decade now. It notes that while the statement did nothing more than reignite the debate on GMO, much could and should be done to improve the framework to accommodate for the lack of true scientific understanding about the effects of GMO. This article identifies the specific areas of weakness in the EU GMO regulatory framework and recommends specific alterations. It concludes that although France's MON810 ban is illegal under existing law, the country's fears are neither unfounded nor unsupported and that the EU should work to alter its existing legal structure to parallel today's scientific uncertainty regarding GMO safety.

在众多著名科学家发表声明,反对人们对转基因生物(“GMO”)的安全性达成共识的观点之后,本文讨论了欧盟(“EU”)转基因生物监管框架,该框架勉强允许法国维持非法禁令。mon810已经有十多年了。报告指出,尽管这份声明只不过是重新点燃了关于转基因生物的辩论,但在改进框架以适应对转基因生物影响缺乏真正科学理解的情况方面,我们可以也应该做很多事情。本文指出了欧盟转基因生物监管框架的具体弱点,并提出了具体的修改建议。它的结论是,尽管法国的MON810禁令在现行法律下是非法的,但该国的担忧并非毫无根据,也不是没有根据,欧盟应该努力改变其现有的法律结构,以适应当今关于转基因生物安全性的科学不确定性。
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引用次数: 0
Origins of the prohibition against off-label promotion. 禁止标签外促销的起源。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Terry S Coleman

The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretations and regulatory provisions relied on by the government to take enforcement action against off-label promotion are the incidental by-products of initiatives undertaken by FDA through administrative action and litigation early in its implementation of the Federal Food, Drug, and Cosmetic Act. The actions were designed to obtain FDA authority over therapeutic claims made in advertising, even though Congress had assigned authority over advertising to the Federal Trade Commission, and to establish a prescription-only drug system, even though FDA lacked statutory authority for such a system. The principal purpose of both efforts was to prevent inappropriate self-medication. This article describes the history of those strategies, including expansion of the definition of the term "labeling" to encompass matter that was initially regarded as advertising; creation of the rule that the labeling of drugs must have adequate directions for all "intended" uses; and construction of the prescription-only drug system in a manner that allowed FDA to use the statutory requirement for labeling to have "adequate directions for use" to prohibit the off-label promotion of prescription drugs.

美国食品和药物管理局(FDA)执行的法规并没有明确禁止推广未经批准的药物和医疗器械,但政府已经为这种“标签外”推广收取了数十亿美元的罚款。政府对标签外促销采取执法行动所依赖的法定解释和监管规定是FDA在实施《联邦食品、药品和化妆品法》的早期通过行政行动和诉讼采取的主动行动的附带副产品。这些行动的目的是为了获得FDA对广告中宣称的治疗功效的授权,尽管国会已经将广告授权给了联邦贸易委员会(Federal Trade Commission),并建立一个仅限处方的药物系统,尽管FDA缺乏这样一个系统的法定权力。这两种努力的主要目的都是为了防止不适当的自我用药。本文描述了这些策略的历史,包括扩展“标签”一词的定义,以涵盖最初被视为广告的物质;制定药品标签必须对所有“预期”用途有充分说明的规则;以及仅限处方药品制度的构建,允许FDA使用法定的标签要求来“充分的使用说明”,以禁止处方药的标签外促销。
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引用次数: 0
Buckman extended: federal preemption of state fraud-on-the-FDA statutes. 巴克曼提出:联邦政府优先处理州对食品药品监督管理局的欺诈行为。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Christine A Gaddis

A number of states have enacted statutes that provide protection to drug manufacturers in product liability actions. Additionally, several of these states have enacted "fraud-on-the-FDA" statutory provisions, which remove statutory protection afforded to drug manufacturers in product liability actions if plaintiffs can provide evidence that the drug manufacturer made misrepresentations to the FDA during the process of obtaining marketing approval for the drug. Currently, the federal circuits are in disagreement over whether these state "fraud-on-the-FDA" statutes should be federally preempted. This issue warrants resolution for drug manufacturers, private citizens, and state legislatures. This Comment will discuss the history and role of the FDA's authority in drug and medical device regulation; federal preemption generally and the Supreme Court's decisions that considered whether state law failure to warn claims are federally preempted in the context of drugs and medical devices; the Supreme Court's decision in Buckman v. Plaintiffs' Legal Committee, where the Court held that claims that a medical device manufacturer made fraudulent representations to the FDA were federally preempted because such claims interfered with the relationship between the FDA and the entities it regulated, state fraud-on-the-FDA statutory provisions, and the existing circuit split regarding whether those statutes should be federally preempted; the potential resolutions to the circuit split; and will conclude and advocate that the Supreme Court's Buckman holding be applied to federally preempt state fraud-on-the-FDA statutes because such statutes involve the relationship between a federal agency and the entity it regulates and thus undermine the FDA's authority.

许多州颁布了法规,在产品责任诉讼中为药品制造商提供保护。此外,这些州中有几个州制定了“FDA欺诈”的法定条款,如果原告能够提供证据证明药品制造商在获得药品上市批准的过程中向FDA做出虚假陈述,则取消了在产品责任诉讼中给予药品制造商的法定保护。目前,联邦巡回法院在这些州的“fda欺诈”法规是否应该被联邦优先考虑的问题上存在分歧。这个问题需要药品制造商、普通公民和州立法机构来解决。本评论将讨论FDA在药品和医疗器械监管方面的权力的历史和作用;联邦优先购买权和最高法院关于在药品和医疗器械方面,州法律未对索赔提出警告是否属于联邦优先购买权的裁决;最高法院在巴克曼诉原告法律委员会案中作出的判决,法院认为医疗器械制造商向FDA作出欺诈性陈述的索赔应被联邦优先考虑,因为此类索赔干扰了FDA与其监管实体之间的关系,州FDA欺诈法律规定,以及现有的巡回法院关于这些法规是否应被联邦优先考虑的分歧;电路分裂的潜在解决方案;并将得出结论并主张最高法院对巴克曼案的裁决适用于联邦优先处理州对食品药品监督管理局欺诈的法规,因为此类法规涉及联邦机构与其监管实体之间的关系,从而削弱了食品药品监督管理局的权威。
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引用次数: 0
Public-private interactions in global food safety governance. 全球食品安全治理中的公私互动。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Ching-Fu Lin

In response to an apparent decline in global food safety, numerous public and private regulatory initiatives have emerged to restore public confidence. This trend has been particularly marked by the growing influence of private regulators such as multinational food companies, supermarket chains and non-governmental organizations (NGOs), who employ private standards, certification protocols, third-party auditing, and transnational contracting practices. This paper explores how the structure and processes of private food safety governance interact with traditional public governance regimes, focusing on Global Good Agricultural Practices (GlobalGAP) as a primary example of the former. Due to the inefficiency and ineffectiveness of public regulation in the face of global problems, private governance in food safety has gradually replaced states' command-and-control regulation with more flexible, market-oriented mechanisms. The paper concludes by emphasizing the importance of constructive regime interaction instead of institutional boundary building to global food safety governance. Public and private ordering must each play a role as integral parts of a larger, dynamic and evolving governance complex.

为了应对全球食品安全的明显下降,出现了许多公共和私人监管举措,以恢复公众信心。跨国食品公司、连锁超市和非政府组织(ngo)等私营监管机构的影响力越来越大,这一趋势尤为明显。这些机构采用私营标准、认证协议、第三方审计和跨国承包做法。本文探讨了私人食品安全治理的结构和过程如何与传统的公共治理机制相互作用,重点关注全球良好农业规范(GlobalGAP)作为前者的一个主要例子。由于公共监管在面对全球性问题时效率低下和无效,食品安全领域的私人治理逐渐以更灵活的、以市场为导向的机制取代了国家的命令和控制监管。最后,本文强调了建设性的制度互动而不是制度边界建设对全球食品安全治理的重要性。公共和私人秩序必须各自作为更大的、动态的和不断发展的治理复合体的组成部分发挥作用。
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引用次数: 0
Compensating Pharmaceutical Injuries in the Absence of Fault. 无过错药品损害赔偿。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Marc A Rowin

Adverse drug events cause significant injuries to consumers. Between half and three-quarters of these injuries are uncompensated under tort law because they are not due to negligence or fraud. This article argues that fundamental fairness and sound economics favor holding manufacturers of pharmaceutical products financially responsible for pharmaceutical injuries unless there is clear fault by another party. It reviews the experience of vaccine and pharmaceutical injury compensation programs internationally. It proposes the creation of an administrative compensation system for the United States that would compensate pharmaceutical injuries.

药物不良事件对消费者造成重大伤害。根据侵权法,这些伤害中有一半到四分之三没有得到赔偿,因为它们不是由于疏忽或欺诈造成的。本文认为,基本的公平和健全的经济学倾向于让药品制造商对药品伤害承担经济责任,除非另一方有明显的过错。它回顾了国际上疫苗和药物伤害赔偿项目的经验。它建议在美国建立一个行政赔偿制度,赔偿药物伤害。
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引用次数: 0
Menu labeling: the unintended consequences to the consumer. 菜单标签:对消费者的意想不到的后果。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Ellen A Black

The Affordable Care Act requires certain restaurants to provide nutritional information on their menus and menu boards, which is referred to as menu labeling. Menu labeling presupposes that providing consumers with the nutritional information about their food will cause them to reconsider their food choices by picking healthier food options over less healthy options, thereby reducing the nation's high obesity rate. However, several studies have shown that consumers do not make healthier food choices even when armed with menu labeling. The issue then becomes whether menu labeling provides a correlative benefit to consumers or whether there are unintended consequences that ultimately harm consumers.

《平价医疗法案》要求某些餐馆在菜单和菜单板上提供营养信息,这被称为菜单标签。菜单标签的前提是向消费者提供食物的营养信息,这会使他们重新考虑他们的食物选择,选择更健康的食物,而不是不健康的食物,从而降低国家的高肥胖率。然而,几项研究表明,即使有了菜单标签,消费者也不会做出更健康的食品选择。那么问题就变成了菜单标签是否为消费者提供了相关的利益,或者是否有意想不到的后果最终伤害了消费者。
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引用次数: 0
You say "lean finely textured beef," I say "pink slime". 你说"精瘦细腻的牛肉"我说"粉色粘液"
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Rita-Marie Cain Reid

In 2012, American Broadcasting Companies, Inc. (ABC) broadcast a segment on its evening news show regarding the manufacture of "lean finely textured beef" by Beef Products, Inc. (BPI). The broadcast, as well as follow-up reports and social media communications, repeatedly referred to the product as "pink slime," a term originated by a United States Department of Agriculture (USDA) employee for the processed meat. The market backlash against the product was immediate and intense. Ultimately, BPI closed three processing plants, cut hundreds of jobs, and filed for bankruptcy. BPI sued ABC and others for food libel, defamation, and tortious interference. This research analyzes those claims and defenses and discusses the future of such cases.

2012年,美国广播公司(ABC)在晚间新闻节目中播出了一段关于牛肉产品公司(beef Products, Inc., BPI)生产“精瘦牛肉”的内容。该广播,以及后续报道和社交媒体传播,一再将这种产品称为“粉红粘液”,这个词是由美国农业部(USDA)的一名员工发明的,负责加工肉类。市场对这款产品的反应迅速而强烈。最终,BPI关闭了三家加工厂,削减了数百个工作岗位,并申请破产。BPI以食品诽谤、诽谤和侵权干涉为由起诉ABC和其他公司。本研究分析了这些主张和辩护,并讨论了此类案件的未来。
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引用次数: 0
期刊
Food and drug law journal
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