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Re-Framing Biotechnology Regulation. 重新构建生物技术法规。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2017-01-01
Alison Peck

Biotechnology is about to spill the banks of federal regulation. New genetic engineering techniques like CRISPR-Cas9 promise revolutionary breakthroughs in medicine, agriculture, and public health—but those techniques would not be regulated under the terms of the Coordinated Framework for Regulation of Biotechnology. This revolutionary moment in biotechnology offers an opportunity to correct the flaws in the framework, which was hastily patched together at the advent of the technology. The framework has never captured all relevant technologies, has never satisfied the public that risk is being effectively managed, and has never been accessible to small companies and publicly-funded labs that increasingly are positioned to make radical, life-saving innovations. This Article offers a proposal for new legislation that would reshape biotechnology regulation to better meet these goals. Key reforms include tying regulation to risk rather than technology category; consolidating agency review; capturing distinct regulatory expertise through inter-agency consultations; creating a clearinghouse to help guide applicants and disseminate information; setting up more comprehensive monitoring of environmental effects; and providing federal leadership to fill key data gaps and address socio-economic impacts.

生物技术即将溢出联邦监管的银行。CRISPR-Cas9等新的基因工程技术有望在医学、农业和公共卫生领域取得革命性突破,但这些技术不会受到《生物技术监管协调框架》的监管。生物技术的这一革命性时刻提供了一个机会来纠正框架中的缺陷,这些缺陷是在技术出现时匆忙拼凑起来的。该框架从未涵盖所有相关技术,从未让公众满意风险正在得到有效管理,也从未让越来越多的小公司和公共资助的实验室能够使用,而这些公司和实验室正越来越多地准备进行激进的、挽救生命的创新。本文提出了一项新的立法建议,该建议将重塑生物技术监管,以更好地实现这些目标。关键改革包括将监管与风险而非技术类别挂钩;加强机构审查;通过机构间磋商获取独特的监管专业知识;建立信息交流中心,帮助指导申请人和传播信息;建立更全面的环境影响监测;为填补关键数据缺口和解决社会经济影响提供联邦领导。
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引用次数: 0
FDA-Required Tobacco Product Inserts & Onserts–and the First Amendment. fda要求烟草产品说明书和说明书-以及第一修正案。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2017-01-01
Eric N Lindblom, Micah L Berman, James F Thrasher

In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be interpreted and applied to follow and promote the statute’s purposes and objectives. The paper’s rigorous analysis of existing First Amendment case law relating to compelled commercial speech also provides useful guidance for any government efforts either to compel product disclosures or to require government messaging in or on commercial products or their advertising, whether done for remedial, purely informational, or behavior modification purposes.

2012年,一家联邦上诉法院驳回了FDA要求在香烟上印制健康警告的规定,认为这违反了第一修正案对商业言论的保护。烟草产品插页和广告可以更容易地避免第一修正案的限制,同时向烟草使用者提供更广泛的信息,并可以有效地支持和鼓励戒烟。本文考察了FDA要求有效插入和保护的权力,并展示了FDA如何设计和支持它们以避免第一修正案的问题。通过这一过程,本文就如何解释和应用《烟草控制法》的关键条款以遵循和促进法规的宗旨和目标提供了有益的见解。本文对现行《第一修正案》案例法中有关强迫商业言论的严格分析,也为政府强制产品披露或要求在商业产品或其广告中或广告上发布政府信息的任何努力提供了有用的指导,无论这些努力是为了补救、纯粹的信息,还是为了改变行为。
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引用次数: 0
Proposed Industry Best Practices in Development and Marketing of Medical Foods for the Management of Chronic Conditions and Diseases while Awaiting Regulation. 慢性病和疾病管理中医疗食品开发和销售的建议行业最佳实践,等待监管。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2017-01-01
Bruce Burnett, Robert M Levy

Ideal therapeutics have low toxicity and can effectively manage condition(s) or disease(s). The Food & Drug Administration (FDA) marketing category of therapeutics called “medical foods” (MFs) meets such a definition. Medical foods have existed in Federal law since passage the Orphan Drug Act in 1988, which created a category of nutritional therapeutics separate from drugs. Unfortunately, MFs are not widely understood by the medical community or utilized in all patients who need them due to lack of a FDA-approval process, unclear and contradictory guidance especially with regard for need for an investigational new drug (IND) application, and no clear regulations regarding their development and marketing. The goals of this article are to propose “Best Practices” to guide the medical food industry in the development and marketing of products as well as to serve as a starting point for suggestions regarding further FDA regulation so that therapeutics which are shown to be generally recognized as safe (GRAS), provide food ingredients to meet a distinctive nutritional requirement for a specific condition/disease and are proven effective for the management for that condition/disease can be used to benefit patients who need them.

理想的治疗方法具有低毒性,并能有效地控制病情或疾病。美国食品和药物管理局(FDA)销售的治疗类药物被称为“医疗食品”(MFs),符合这样的定义。自1988年通过《孤儿药法案》(Orphan Drug Act)以来,医疗食品就一直存在于联邦法律中,该法案创建了一个与药物分开的营养疗法类别。不幸的是,由于缺乏fda批准程序,缺乏不明确和相互矛盾的指导,特别是在研究性新药(IND)申请方面的需要,以及没有明确的关于其开发和营销的规定,MFs并没有被医学界广泛理解,也没有被所有需要它们的患者使用。本文的目标是提出“最佳实践”,以指导医疗食品行业的产品开发和营销,并作为FDA进一步监管建议的起点,以便证明通常被认为是安全的治疗方法(GRAS)。提供食物成分,以满足特定病症/疾病的独特营养需求,并被证明对该病症/疾病的管理有效,可用于使需要它们的患者受益。
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引用次数: 0
Sunlight and Other Disinfectants: Disclosure Obligations under the Federal Securities and Drug Regulatory Regimes. 阳光和其他消毒剂:联邦证券和药物监管制度下的披露义务。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2017-01-01
Joseph G Milner

Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and public markets, SEC and FDA send conflicting signals about the information drug companies need to disclose to the public. While SEC primarily regulates by mandating public disclosure, FDA has historically regulated drugs through its pre-approval process and has only recently begun to add disclosure mechanisms to its regulatory regime. Moreover, a trio of federal statutes requires FDA to keep sensitive information submitted by drug companies confidential. The regimes’ distinct priorities and approaches create tensions that surface when publicly traded drug companies must decide whether and how to publicly disclose information related to drug development. This paper surveys the two agencies’ conflicting priorities and regulations and explores the resulting problems that can arise for drug companies. It recommends that Congress liberalize statutory restraints on FDA’s ability to disclose sponsor-submitted confidential information in order to help alleviate the tensions between these regimes and provide the public with more accurate information about drug companies and their products.

药物开发需要耐心。除了开发过程本身固有的不确定性之外,美国药物开发商还必须遵守美国食品和药物管理局(FDA)监督的监管批准程序。因为这个过程需要时间,药物开发也需要资金。寻求在美国资本市场融资的制药公司必须遵守美国证券交易委员会(SEC)管理的证券制度。尽管作为消费者和公共市场的保护者,SEC和FDA扮演着相似的角色,但在制药公司需要向公众披露的信息方面,它们发出了相互矛盾的信号。美国证券交易委员会主要通过强制公开披露来进行监管,而美国食品和药物管理局历来通过其预批准程序来监管药品,直到最近才开始在其监管制度中加入披露机制。此外,三项联邦法规要求FDA对制药公司提交的敏感信息保密。当上市的制药公司必须决定是否以及如何公开披露与药物开发有关的信息时,两国政权不同的优先事项和方法造成了紧张关系。本文调查了这两个机构相互冲突的优先事项和法规,并探讨了由此产生的可能给制药公司带来的问题。它建议国会放宽对FDA披露赞助商提交的机密信息能力的法定限制,以帮助缓解这些制度之间的紧张关系,并向公众提供有关制药公司及其产品的更准确信息。
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引用次数: 0
Outsource Power, Import Safety? Challenges and Opportunities of the U.S.-China Food Safety Regulatory Cooperation. 外包电力,进口安全?中美食品安全监管合作的挑战与机遇。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2017-01-01
Ching-Fu Lin

The United States has a high stake in China’s serious food safety problem, as food products of Chinese origin have dominated the U.S. food market in numerous areas and continue to grow. The conclusion of the U.S.-China Food Safety Agreement (“the Agreement”) has allowed FDA to strengthen regulatory cooperation with its Chinese counterpart in various aspects. The Agreement also paves the way for the implementation of the new regulatory tools incorporated in FSMA, especially in the cross-border context. However, both the Agreement and FSMA have certain crucial limitations that may create future hurdles to effective implementation in the U.S.-China cooperation. This paper therefore endeavors to first examine China’s governance challenges over food safety, with a focus on the 2009 Food Safety Law, the 2015 Amendment, and the fundamental problem of “thin” rule of law. This paper moves to analyze the U.S.-China Food Safety Agreement, reviewing the agreement’s strengths and weaknesses. It further assesses FSMA’s innovative institutional design to regulate imported food products and its limitations. However, both the U.S.-China Food Safety Agreement and FSMA arguably create a regulatory dilemma for FDA when addressing imported food safety, due to structural mismatch between the broad scope of power granted to FDA and the long chain of power outsourcing to governments or private companies as primary “regulators.” Neither the Agreement nor FSMA give FDA adequate capacity to closely oversee such “agents” along the chain of power outsourcing. Framing the U.S.-China food safety cooperation as a multilayer structure that “outsources power” to “import safety,” this paper concludes by stressing the need for a robust accountability and effective mechanism for U.S.-China food safety cooperation.

中国严重的食品安全问题与美国利害攸关,因为中国食品在许多领域主导了美国食品市场,并在继续增长。《美中食品安全协定》(以下简称《协定》)的签订使食品药品监督管理局得以加强与中国食品药品监督管理局在各方面的监管合作。该协议还为实施纳入FSMA的新监管工具铺平了道路,特别是在跨境背景下。然而,《协定》和《食品安全协定》都有某些关键的限制,可能会对美中合作的有效实施造成未来的障碍。因此,本文试图首先审视中国在食品安全方面面临的治理挑战,重点关注2009年的《食品安全法》、2015年的《食品安全法》修正案,以及“单薄”法治的根本问题。本文分析了中美食品安全协议,回顾了该协议的优点和缺点。它进一步评估了FSMA监管进口食品的创新制度设计及其局限性。然而,《美中食品安全协议》和《食品安全sma》在解决进口食品安全问题时都可能给FDA造成监管困境,因为FDA被授予的广泛权力范围与作为主要“监管者”的政府或私营公司的权力外包长链之间存在结构性不匹配。该协议和FSMA都没有赋予FDA足够的能力来密切监督电力外包链上的这些“代理商”。本报告将美中食品安全合作描述为一个将权力“外包”给“进口安全”的多层结构,最后强调需要建立一个强有力的问责制和有效的美中食品安全合作机制。
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引用次数: 0
A Recipe for Justice: Support for a Federal Food Justice Interagency Working Group. 正义的处方:支持联邦食品司法跨部门工作组。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2017-01-01
Melanie Pugh

Systemic social justice issues are characterized as having complex and far-reaching causes. Food justice is one such an issue. Food justice is defined as “justice for all [people] in the food system,” from agricultural production to consumer products. Policies seeking to remedy systemic social justice issues often need to include the attention of many levels of government and coordination across multiple agencies to move issues forward. That is why finding a model for interagency collaboration that has evidenced success, especially over the long-term, is inspiring and worth mirroring.This Comment compares food justice to the environmental justice movement, and proposes modeling a federal, interagency program to address food justice based on the Environmental Protection Agency’s Environmental Justice Interagency Working Group (EJ IWG). This Comment includes an overview of the food justice movement, and argues that the U.S. Department of Agriculture (USDA), despite its history of civil rights violations, would be the best federal agency to lead an interagency working group because it administers essential rural development and consumer programs. It also explores whether the model employed by the Environmental Protection Agency’s EJ IWG is a viable model for a food justice program at the USDA, and what features of the EJ IWG would suit such a food justice interagency working group.

系统性社会正义问题的特点是具有复杂和深远的原因。食品公平就是这样一个问题。粮食公正被定义为“粮食系统中所有人的公正”,从农业生产到消费品。寻求纠正系统性社会正义问题的政策往往需要各级政府的关注和多个机构之间的协调,以推动问题的发展。这就是为什么找到一个证明成功的跨部门合作模式,特别是长期合作模式,是鼓舞人心的,值得效仿。本评论将食品正义与环境正义运动进行了比较,并建议在环境保护局环境正义跨部门工作组(ejwg)的基础上建立一个联邦跨部门计划的模型,以解决食品正义问题。本评论包括对食品正义运动的概述,并认为尽管美国农业部(USDA)有侵犯民权的历史,但它将是领导跨部门工作组的最佳联邦机构,因为它管理着重要的农村发展和消费者项目。它还探讨了环境保护署的EJ工作组所采用的模式是否适用于美国农业部的食品司法项目,以及EJ工作组的哪些特点适合这样一个跨部门的食品司法工作组。
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引用次数: 0
Killing U.S. Slowly: Curing the Epidemic Rise of Cancer Drug Prices. 慢慢杀死美国:治愈癌症药物价格上涨的流行病。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2017-01-01
Emily K White

In August 2015, more than 110 U.S. oncologists published an article detailing the deleterious effects of rising cancer drugs prices and calling for numerous reforms to our prescription drug system. These prices are the result of decades of political maneuvering; they reflect the way our country has chosen to pay for healthcare, to foster and reward innovation, and to promote a national free market system. While these choices have resulted in immense profits for pharmaceutical companies—and subsidized the development of prescription drugs globally—they have also left many cancer patients unable to afford their medications. And, without providing significant improvements in life expectancy, the rising prices of cancer drugs seem like an unreasonable burden on U.S. healthcare spending. A multitude of reforms have been proposed. At the federal level, many of the reforms seek to amend existing regulatory regimes, such as allowing Medicare to negotiate drug prices, reforming the patent system, and allowing patients to import drugs from other countries. The pharmaceutical and biotechnology industries have pushed back against almost all of them. Some of these proposals are more ambitious than others; some more likely to succeed. With costs rising every day, policy makers, legislators, and industry professionals need to focus their attention on those reforms that are attainable and will result in sustainable, reduced prescription drug prices. This paper discusses various U.S. regulatory frameworks that impact prescription drug prices and evaluates proposed reforms to these frameworks in terms of which ones are most likely to succeed.

2015年8月,110多名美国肿瘤学家发表了一篇文章,详细阐述了癌症药物价格上涨的有害影响,并呼吁对我们的处方药体系进行大量改革。这些价格是几十年来政治操纵的结果;它们反映了我们国家选择支付医疗保健、培育和奖励创新以及促进国家自由市场体系的方式。虽然这些选择为制药公司带来了巨大的利润,并补贴了全球处方药的发展,但它们也使许多癌症患者无法负担他们的药物。而且,在预期寿命没有显著改善的情况下,抗癌药物价格的上涨似乎是美国医疗保健支出的一个不合理负担。提出了许多改革措施。在联邦一级,许多改革寻求修改现有的监管制度,例如允许联邦医疗保险协商药品价格,改革专利制度,允许患者从其他国家进口药品。制药和生物技术行业已经对几乎所有这些政策进行了反击。其中一些提议比其他提议更雄心勃勃;有些人更有可能成功。由于成本每天都在上升,政策制定者、立法者和行业专业人士需要将注意力集中在那些可以实现的改革上,这些改革将导致处方药价格的可持续下降。本文讨论了影响处方药价格的各种美国监管框架,并根据哪些框架最有可能成功评估对这些框架的拟议改革。
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引用次数: 0
THE CHICKEN AND THE EGG - ANIMAL WELFARE, FOOD SAFETY AND FEDERALISM. 鸡和蛋——动物福利、食品安全和联邦制。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2016-08-01
Rita-Marie Cain Reid
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引用次数: 0
FDA's Troubling Failures to Use its Authority to Regulate Genetically Modified Foods. 美国食品药品监督管理局未能有效管理转基因食品。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2016-08-01
Leslie Francis, Robin Kundis Craig, Erika George
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引用次数: 0
FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence. FDA在子部分H批准中的灵活性:评估有效性证据的数量。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2016-08-01
Frank J Sasinowski, Alexander J Varond

This article examines the strength of scientific and clinical evidence for FDA's nineteen non-AIDS, non-cancer Subpart H approval determinations over the Accelerated Approval program's twenty-four year existence. The authors researched the bases for FDA's determinations when an unvalidated surrogate or intermediate clinical endpoint is "reasonably likely to predict clinical benefit." The four key factors set forth in FDA's "Guidance for Industry, Expedited Programs for Serious Conditions - Drugs and Biologics" were applied to past Subpart H approvals. For the nineteen precedents, the authors found wide variances between the quantum and quality of evidence on each of the four factors, indicating that a lack of evidence on any single factor was not disqualifying in and of itself. The results of this study, therefore, show that FDA exercises extraordinarily more regulatory flexibility than either FDA's foundational statutes or even FDA' s most recent 2014 Expedited Programs Guidance explicitly express. Given recent legislative exhortations and the increasing promise of personalized medicine and translational sciences, the authors conclude that Subpart H should be further explored and utilized. The authors provide a detailed analysis of the orecedents established in the nineteen approvals.

本文考察了FDA加速审批项目24年来19项非艾滋病、非癌症批准的科学和临床证据的强度。作者研究了FDA确定未经验证的替代药物或中间临床终点“合理可能预测临床获益”的依据。FDA“行业指南,严重疾病加速计划-药物和生物制品”中规定的四个关键因素适用于过去的H部分批准。对于19个先例,作者发现四个因素中每一个的证据数量和质量存在很大差异,这表明缺乏任何一个因素的证据本身并不会取消资格。因此,这项研究的结果表明,与FDA的基础法规甚至FDA最近的2014年快速项目指南明确表达的相比,FDA行使了更大的监管灵活性。鉴于最近的立法劝告和个性化医疗和转化科学的日益增加的承诺,作者得出结论,子部分H应进一步探索和利用。作者对19个批准中建立的先例进行了详细的分析。
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引用次数: 0
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Food and drug law journal
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