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Inaugural Eric M. Blumberg Memorial Lecture. 埃里克-布伦贝格(Eric M. Blumberg)首届纪念讲座。
IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
Annamarie Kempic
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引用次数: 0
Legal considerations for social media marketing by pharmaceutical industry. 医药行业社会化媒体营销的法律考量。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2014-01-01
Y Tony Yang, Brian Chen

Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.

社交媒体营销是医药产品直接面向消费者广告的下一个前沿领域,但对于监管行动来说,这是一个未知的领域。随着社交媒体使用的爆炸式增长,以及制药公司越来越善于利用社交媒体营销的机会,美国食品和药物管理局(FDA)迫切需要发展自己的能力,以监控和参与社交媒体营销。为了应对FDA可能采取的行动,制药公司的营销、法规遵从和法律人员必须密切合作,设计对FDA关注敏感的举措。本文将讨论FDA关于社交媒体广告法规的现状,其历史起源,实施的挑战,以及它们可能的未来方向。
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引用次数: 0
We really need to talk: adapting FDA processes to rapid change. 我们真的需要谈谈:调整FDA流程以适应快速变化。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Sara Lykken

The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.

快速发展的现代商业领域对传统的监管范式造成了压力。本文追溯了FDA危机应对监管的历史演变,并提供了一些例子,说明过去产生的定义和程序继续受到新产品作为市场进入者的挑战,有些是出于善意,有些则不是,采取行动,在实际产品和营销控制与消费者可能期望的控制之间造成脱节。然后,本文探讨了在快速创新的环境中面临类似挑战的其他联邦机构所使用的一些技术,并从分析中得出了改进FDA警告信系统的建议。
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引用次数: 0
Credible deterrence: FDA and the Park Doctrine in the 21st century. 可信威慑:21世纪的FDA和公园主义。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Patrick O'Leary

One of FDA's most powerful enforcement tools is strict liability criminal prosecution of corporate officers under the Park Doctrine. Recent comments by high-ranking FDA officials about using this power more aggressively and recent cases apparently making good on this promise have spurred commentators to call for the doctrine's demise. Critics argue that strict liability for corporate officers violates fundamental notions of fairness and the appropriate relationship between guilt and liability in criminal law. As a response to these critics, this article argues that the Park Doctrine continues to serve a valuable purpose in deterring conduct that endangers the public health and that structural, political, and practical limitations on FDA's use of Park prosecutions have been, and will continue to be, effective protections against the abuses critics fear. This article proposes a model for understanding why and how FDA uses its prosecutorial powers and assesses a sample of recent high-profile prosecutions under this model to argue that the modern "escalation" of Park prosecutions is in fact a continuation of FDA's historical policy.

FDA最有力的执法工具之一是根据Park原则对公司官员进行严格责任刑事起诉。最近FDA高级官员关于更积极地使用这一权力的评论,以及最近明显兑现这一承诺的案例,促使评论员呼吁该原则的消亡。批评人士认为,公司管理人员的严格责任违反了公平的基本概念以及刑法中罪责之间的适当关系。作为对这些批评的回应,本文认为,Park原则在阻止危害公众健康的行为方面继续发挥着有价值的作用,并且对FDA使用Park起诉的结构、政治和实际限制已经并将继续有效地防止批评者所担心的滥用行为。本文提出了一个模型来理解FDA为什么以及如何使用其检察权,并在此模型下评估了最近高调起诉的样本,以论证Park起诉的现代“升级”实际上是FDA历史政策的延续。
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引用次数: 0
Chinese regulation of off-label use of drugs. 中国对超说明书用药的监管。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Feng Ma, Nan Lou

China has significant gaps and weaknesses in its regulatory oversight of the off-label use of drugs. As in the United States, the off-label prescribing of drugs is not prohibited in China if there is a sound scientific basis. Physicians are allowed to prescribe off-label drugs based on their medical judgment if they follow certain requirements. There is some constraint on the right to prescribe by the imposition of malpractice liability if patients are harmed from improper off-label prescribing. However, damages awarded to successful plaintiffs are usually insignificant compared to malpractice damage awards in the U.S. Advertisement of off-label use is prohibited in China. All drug advertisements in China are subject to pre-approval, and must be based on information included in the approved package insert. However, the term "advertisement" is poorly defined. As a result, non-advertisement promotion of drugs for on-label or off-label use exist in a unregulated gray area. To better address the problem of inappropriate off-label promotion and use, China should (i) regulate both drug advertisements and non-advertisement promotion under a standard requiring off-label use to have a sound scientific basis, (ii) introduce harsher regulatory penalties, and (iii) increase compensation available for victims of medical malpractice. Such reform would not only discourage improper off-label use by introducing penalties (or increasing existing penalties) for improper promotion, but would also provide reasonable compensation for victims harmed by off-label use.

中国在药品说明书外使用的监管方面存在重大差距和弱点。和美国一样,如果有充分的科学依据,中国也不禁止超说明书开处方。如果医生遵循一定的要求,他们可以根据自己的医学判断开出标签外药物。如果患者因不当的超说明书处方而受到伤害,则医疗事故责任的施加对其开药权有一定的限制。然而,与美国的医疗事故损害赔偿相比,胜诉原告获得的损害赔偿通常微不足道。在中国,所有药品广告都必须经过预先批准,并且必须以批准的说明书中的信息为依据。然而,“广告”这个词的定义很差。因此,非广告推广药物的标签或标签外使用存在于一个不受监管的灰色地带。为了更好地解决不适当的超说明书推广和使用问题,中国应(i)根据要求超说明书使用具有可靠科学依据的标准对药品广告和非广告推广进行监管,(ii)引入更严厉的监管处罚,以及(iii)增加对医疗事故受害者的赔偿。这种改革不仅将通过对不当促销实行处罚(或增加现有处罚)来阻止不当的超说明书使用,而且还将为因超说明书使用而受到伤害的受害者提供合理的赔偿。
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引用次数: 0
Your business in court and at Federal agencies: 2011-2012. 2011-2012年,你在法庭和联邦机构的业务。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
John B Reiss, Dawn Crowder, Brittany McCabe, Marisa DeFeo, Marta Rifin, Meghan Talbot

FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws.

FDA的透明度努力仍在继续,包括部长采取了八项措施来改善获取FDA信息和活动的途径。一个持续存在的问题是处方药短缺,这可能是由于越来越多的制造商召回。FDA发布了更多的器械指南,以提高监管清晰度。涉及药品和器械的执法增加,包括GMP和GLP的执法以及对互联网索赔的监督。最高法院裁定,仿制药制造商可能会导致FDA修改错误列出的使用代码,药品细节人员可能不会获得加班费。FDA启动了《食品安全和现代化法案》的实施,包括两个用于供应链追踪的试点跟踪系统,以确定收集数据的速度。fda发布了新的膳食补充剂指南。美国食品和药物管理局未能对烟草业施加图形标签要求,但确定它可以将电子烟作为烟草进行监管。该机构发布了在化妆品中使用纳米材料的指导方针,并审查了防晒产品的有效性。FDA在美国经济的更大领域被赋予了更多的权力,但其资源并没有相应增加。制药业因涉嫌违反《药品回扣法》、《反回扣法》、《批发价格法》和《标签外使用法》而支付了大笔款项。政府继续使用负责任的公司官员原则,让公司经理对他们不知情的公司行为负责。公司应该有一个有效的健全的合规计划。联邦贸易委员会和证券交易委员会继续进行监督活动,包括证券交易委员会执行《反海外腐败法》。产品责任诉讼的辩护继续与联邦法律优先于州法律的问题作斗争。
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引用次数: 0
Does Sackett foreshadow the end of non-reviewability for FDA warning letters? Sackett是否预示着FDA警告信不可复审的终结?
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Katelyn DeRuyter

FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedure Act (APA). The Supreme Court's analysis in Sackett v. EPA suggests the legal tides might be shifting. In Sackett, the Court held that an Environmental Protection Agency (EPA) compliance order was considered final agency action subject to judicial review under the APA. While there are differences between compliance orders and warning letters, both inform regulated parties of non-compliance with federal law and are highly valued measures of inducing "voluntary compliance." Sackett should provide precedent for future litigation over judicial reviewability of warning letters.

FDA警告信被认为是非最终机构行为,因此不受行政程序法(APA)下的司法审查。最高法院在Sackett诉EPA案中的分析表明,法律潮流可能正在转变。在Sackett案中,法院认为环境保护署(EPA)的合规命令被认为是根据《行政程序法》接受司法审查的最终机构行动。虽然合规令和警告信之间存在差异,但两者都通知受监管方不遵守联邦法律,并且是诱导“自愿遵守”的高度重视措施。Sackett应该为未来关于警告信的司法可复审性的诉讼提供先例。
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引用次数: 0
America, you are digging your grave with your spoon--should the FDA tell you that on food labels? 美国,你是在用勺子自掘坟墓——食品药品监督管理局应该在食品标签上告诉你吗?
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Melissa M Card

R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.

雷诺兹烟草公司诉食品药品管理局案。讨论了食品和药物管理局颁布的图形图像是否侵犯了烟草公司的第一修正案权利。虽然烟草公司对这些图形图像提出异议,但烟草公司并没有对有关香烟有害影响的九项文字声明的颁布提出异议。这一无争议的授权为FDA进一步扩大其监管计划打开了大门。如果美国食品药品监督管理局(FDA)可以强制要求对香烟的不良影响进行文字说明,那么为了对抗肥胖危机,FDA是否可以强制要求对糖的不良影响进行文字说明呢?本文提出了关于糖的不良影响的三个文本陈述,以定义中央哈德逊下可接受和不可接受的强迫商业言论形式之间的界限。建立这条界线确保商业言论原则不会剥夺FDA向消费者提供准确信息的权力。虽然本文提出了三个文本陈述,但本文主张其中一个文本陈述可能是解决肥胖危机的最佳方案。所选择的文本声明作为一个有效的解决方案,因为它向消费者提供有意义的信息,使消费者能够对他们的食品做出健康的决定,并鼓励制造商修改他们的产品。
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引用次数: 0
United States v. Caronia: The increasing strength of commercial free speech and potential new emphasis on classifying off-label promotion as "false and misleading". 美国诉卡罗尼亚:商业言论自由的力量日益增强,并可能重新强调将标签外促销分类为“虚假和误导”。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Marc J Scheineson, Guillermo Cuevas

The authority of the United States Food and Drug Administration (FDA) to prohibit off-label promotion of drug products suffered another serious setback in United States v. Caronia. Viewing a legal system where physicians can prescribe prescription pharmaceuticals for unapproved uses legally in their practice of medicine, the Federal appeals court affirmed the commercial free speech rights of manufacturers to use truthful, non-misleading speech about lawfully marketed products. As a result of this case, and others upon which the decision is based, FDA is likely to challenge manufacturer promotion more carefully, and only if it can demonstrate that claims are not truthful, but are false or misleading, or otherwise deprive the prescriber of adequate directions for use.

美国食品和药物管理局(FDA)禁止标签外促销药品的权力在美国诉卡罗尼亚案中再次遭受严重挫折。考虑到医生在行医过程中可以合法地为未经批准的用途开出处方药的法律制度,联邦上诉法院确认了制造商对合法销售的产品使用真实、无误导性言论的商业言论自由权。由于这个案例,以及其他决定的基础,FDA可能会更谨慎地质疑制造商的宣传,只有当它能证明声称是不真实的,而是虚假的或误导的,或者以其他方式剥夺处方者充分的使用说明。
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引用次数: 0
Beyond cheeseburgers: the impact of commonsense consumption acts on future obesity-related lawsuits. 超越芝士汉堡:常识性消费行为对未来肥胖相关诉讼的影响。
IF 0.2 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Pub Date : 2013-01-01
Cara L Wilking, Richard A Daynard

Since 2004, 25 states have passed Commonsense Consumption Acts (CCAs) to shield the food industry from civil liability for claims arising from obesity-related health harms. These laws continue to be introduced. CCAs have generally been discussed in terms of "tort reform." For this article, we conducted a systematic analysis of the content of all 25 state laws and found that the potential impact of CCAs goes well beyond obesity-related tort reform to limits on state Attorney General (AGs) authority and significant reforms to future statutory consumer protection claims by AGs, individuals and classes of consumers. Moreover, every CCA state had pre-existing legal protections against frivolous litigation-greatly undercutting arguments made by CCA proponents.

自2004年以来,已有25个州通过了《常识消费法案》(CCAs),以保护食品工业免受因肥胖相关健康危害而引起的民事责任。这些法律还在继续出台。cca通常被称为“侵权改革”。在本文中,我们对所有25个州法律的内容进行了系统分析,发现cca的潜在影响远远超出了与肥胖相关的侵权改革,限制了州总检察长(AGs)的权力,并对AGs、个人和消费者阶层的未来法定消费者保护索赔进行了重大改革。此外,每个CCA州都有预先存在的法律保护措施,以防止无聊的诉讼——这大大削弱了CCA支持者的论点。
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引用次数: 0
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Food and drug law journal
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