{"title":"Free Speech and Scientific Exchange: Testing the Limits of FDA's Authority to Regulate Manufacturer Scientific Discussions","authors":"S. Whitelaw, D. Kulkarni","doi":"10.18060/27438","DOIUrl":"https://doi.org/10.18060/27438","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43705581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The Securities and Exchange Commission’s enforcement agenda regularly includes charges of trading based on material nonpublic information about a clinical drug trial conducted to obtain FDA approval to market a new drug. Almost half of the recent cases have been accompanied by a criminal indictment. In an academic setting, researchers and those who advise them, unlike employees of public companies, are not generally given training about the risks of securities trading. Recent developments in the law might be applied in connection with clinical trial information in ways that would not have been foreseen until recently. It is time for a comprehensive analysis of how the law of insider trading may be applied to the important endeavor of clinical drug trials. Clinical trials should not be sullied by conflicts created by unlawful trading. This Article begins with the basic principles of insider trading, followed by a summary of how clinical trials are conducted and regulated. It then turns to the ways in which nonpublic information material to the stock price of the sponsor of the trial might be used to trade or tip. The analysis that follows identifies a number of situations where use or disclosure of material nonpublic information about a trial could be unlawful. Employees of sponsors of the trial, clinical investigators, and even the subjectsparticipating in a trial could run afoul of the prohibition on insider trading, such as when information has been used in breach of a confidentiality agreement or exchanged between an investigator and a trial participant, exchanged among trial participants, gleaned from attending medical conferences, and obtained in other settings specific to this industry. Presenting the full potential reach of the law facilitates taking steps to avoid violating the law. The analysis demonstrates that anyone involved in a clinical drug trial must be attuned to the risks of misusing material nonpublic information, including in scenarios not yet pursued by the SEC. By understanding the potential reach of the law, those involved in or who learn information about a specific trial can take steps to avoid or minimize the risk of liability. The Article concludes with recommendations to achieve this end. The Article thus presents a complete case study of an industry-specific application of insider trading law, with recommendations that can be applied to other industries.
美国证券交易委员会（Securities and Exchange Commission）的执法议程经常包括根据有关临床药物试验的重大非公开信息进行交易的指控，该试验旨在获得美国食品药品监督管理局（FDA）的新药上市批准。在最近发生的案件中，几乎有一半附有刑事起诉书。在学术环境中，与上市公司的员工不同，研究人员和顾问通常不会接受有关证券交易风险的培训。法律的最新发展可能会以直到最近才预见到的方式适用于临床试验信息。现在是时候全面分析内幕交易法如何适用于临床药物试验的重要努力了。临床试验不应被非法交易造成的冲突所玷污。本文从内幕交易的基本原则开始，然后总结临床试验是如何进行和监管的。然后，它转向了与试验赞助商股价有关的非公开信息材料可能被用于交易或提示的方式。以下分析确定了使用或披露有关审判的重大非公开信息可能是非法的一些情况。试验发起人、临床研究人员的员工，甚至试验参与者的员工，都可能违反禁止内幕交易的规定，例如当信息被用于违反保密协议，或在研究人员和试验参与者之间交换，在试验参与者之间交流，从参加医学会议中收集，并在该行业特定的其他设置中获得。充分展示法律的潜在影响有助于采取措施避免违法。分析表明，任何参与临床药物试验的人都必须意识到滥用重大非公开信息的风险，包括在美国证券交易委员会尚未采取行动的情况下。通过了解法律的潜在影响范围，参与或了解特定试验信息的人可以采取措施避免或最大限度地降低责任风险。该条最后提出了实现这一目的的建议。因此，本文对内幕交易法在特定行业的适用进行了完整的案例研究，并提出了适用于其他行业的建议。
{"title":"Insider Trading in the Clinical Trial Setting","authors":"A. Horwich, Crista M. Brawley","doi":"10.18060/27435","DOIUrl":"https://doi.org/10.18060/27435","url":null,"abstract":"The Securities and Exchange Commission’s enforcement agenda regularly includes charges of trading based on material nonpublic information about a clinical drug trial conducted to obtain FDA approval to market a new drug. Almost half of the recent cases have been accompanied by a criminal indictment. In an academic setting, researchers and those who advise them, unlike employees of public companies, are not generally given training about the risks of securities trading. Recent developments in the law might be applied in connection with clinical trial information in ways that would not have been foreseen until recently. It is time for a comprehensive analysis of how the law of insider trading may be applied to the important endeavor of clinical drug trials. Clinical trials should not be sullied by conflicts created by unlawful trading. This Article begins with the basic principles of insider trading, followed by a summary of how clinical trials are conducted and regulated. It then turns to the ways in which nonpublic information material to the stock price of the sponsor of the trial might be used to trade or tip. The analysis that follows identifies a number of situations where use or disclosure of material nonpublic information about a trial could be unlawful. Employees of sponsors of the trial, clinical investigators, and even the subjectsparticipating in a trial could run afoul of the prohibition on insider trading, such as when information has been used in breach of a confidentiality agreement or exchanged between an investigator and a trial participant, exchanged among trial participants, gleaned from attending medical conferences, and obtained in other settings specific to this industry. Presenting the full potential reach of the law facilitates taking steps to avoid violating the law. The analysis demonstrates that anyone involved in a clinical drug trial must be attuned to the risks of misusing material nonpublic information, including in scenarios not yet pursued by the SEC. By understanding the potential reach of the law, those involved in or who learn information about a specific trial can take steps to avoid or minimize the risk of liability. The Article concludes with recommendations to achieve this end. The Article thus presents a complete case study of an industry-specific application of insider trading law, with recommendations that can be applied to other industries.","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49121570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Spreading a Digital Disease: The Circuit Split on Data Breaches and Its Effects on the Health Sector","authors":"Nicole B. Perkins","doi":"10.18060/27442","DOIUrl":"https://doi.org/10.18060/27442","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43212726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The existing hundreds of thousands of unused frozen embryos, coupled with the skyrocketing rate of divorce, raise numerous moral, legal, social, and religious dilemmas. Among the most daunting problems are the moral and legal status of the frozen embryo; what should its fate be in the event of conflicts between the progenitors?; and whether contractual regulation of frozen embryos is valid andenforceable. This Article applies relational ethics, drawing on, inter alia, the relational contract to resolve such intertwined dilemmas. Applying this theory, this Article will challenge the conventional dichotomous conceptualization of the frozen embryo as either a person or a nonperson. This Article will discuss why the legal and moral status of the frozen embryo should be determined as a derivative of the desired or undesired relationship between the progenitors, articulated in a mandatory disposition agreement. The progenitor who is interested in using the frozen embryo and bringing the child into the world defines it as a person, whereas the progenitor who opposes its usage determines its status as a nonperson – an object. Consequently, this Article argues that in the event of an explicit disposition agreement, the contract should govern whether the frozen embryo will be used, discarded, adopted and/or earmarked for research. The relational contract provides adequate contractual devices to address any problems arising from changed circumstances or changes of heart. In those cases where there is no explicit disposition agreement, or when the explicit agreement does not stipulate what should be done with the embryos under special or unanticipated circumstances, the party interested in using the embryo should prevail. The recalcitrant progenitor, who is not interested in using the embryo and becoming a parent, should not be subject to a legal determination of parental status and its attendant responsibilities.
{"title":"From (Moral) Status (of the Frozen Embryo) to (Relational) Contract and Back Again to (Relational Moral) Status","authors":"Yehiezkel Margalit","doi":"10.18060/27436","DOIUrl":"https://doi.org/10.18060/27436","url":null,"abstract":"The existing hundreds of thousands of unused frozen embryos, coupled with the skyrocketing rate of divorce, raise numerous moral, legal, social, and religious dilemmas. Among the most daunting problems are the moral and legal status of the frozen embryo; what should its fate be in the event of conflicts between the progenitors?; and whether contractual regulation of frozen embryos is valid andenforceable. This Article applies relational ethics, drawing on, inter alia, the relational contract to resolve such intertwined dilemmas. Applying this theory, this Article will challenge the conventional dichotomous conceptualization of the frozen embryo as either a person or a nonperson. This Article will discuss why the legal and moral status of the frozen embryo should be determined as a derivative of the desired or undesired relationship between the progenitors, articulated in a mandatory disposition agreement. The progenitor who is interested in using the frozen embryo and bringing the child into the world defines it as a person, whereas the progenitor who opposes its usage determines its status as a nonperson – an object. Consequently, this Article argues that in the event of an explicit disposition agreement, the contract should govern whether the frozen embryo will be used, discarded, adopted and/or earmarked for research. The relational contract provides adequate contractual devices to address any problems arising from changed circumstances or changes of heart. In those cases where there is no explicit disposition agreement, or when the explicit agreement does not stipulate what should be done with the embryos under special or unanticipated circumstances, the party interested in using the embryo should prevail. The recalcitrant progenitor, who is not interested in using the embryo and becoming a parent, should not be subject to a legal determination of parental status and its attendant responsibilities.","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135961468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regulating the Marketing of Foods to Minors","authors":"S. Salbu","doi":"10.18060/27437","DOIUrl":"https://doi.org/10.18060/27437","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46063834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Taxation and Telehealth: Would a Telehealth Exclusive Facility Owned by a Nonprofit Hospital be Exempt from Property Tax in Indiana?","authors":"John P. Hughes","doi":"10.18060/27440","DOIUrl":"https://doi.org/10.18060/27440","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48173280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Climate change is no longer an abstract problem for future generations. It is an immediate threat to human life and health, the tangible effects of which can be seen and felt around the world. The news is teeming with examples of climate disasters. In March 2022, an Antarctic ice shelf the size of Rome collapsed due to abnormally high temperatures. In 2021, there were four major disasters that cost over $20 billion each. The average temperatures from 2010 to 2019 were the highest on record, and July 2021, was the hottest month in recorded history. Nearly one third of the world’s population is exposed to deadly heat waves for more than twenty days out of the year. These are just a few examples of how climate change is already having a disastrous impact on the world. In its 2021 report, the United Nations’ Intergovernmental Panel on Climate Change warned that many of the changes to our climate caused by carbon emissions will be irreversible for hundreds or thousands of years to come. The World Health Organization has dubbed climate change as the biggest threat to humanity, and climate change is projected to lead to an additional 250,000 deaths per year between 2030 and 2050. Climate litigation is one strategy being used to address the impacts of climate change. While climate litigation has seen some success in other countries, climate
{"title":"An Argument for Multi-District Climate Litigation","authors":"Sidney M. Lewellen","doi":"10.18060/27441","DOIUrl":"https://doi.org/10.18060/27441","url":null,"abstract":"Climate change is no longer an abstract problem for future generations. It is an immediate threat to human life and health, the tangible effects of which can be seen and felt around the world. The news is teeming with examples of climate disasters. In March 2022, an Antarctic ice shelf the size of Rome collapsed due to abnormally high temperatures. In 2021, there were four major disasters that cost over $20 billion each. The average temperatures from 2010 to 2019 were the highest on record, and July 2021, was the hottest month in recorded history. Nearly one third of the world’s population is exposed to deadly heat waves for more than twenty days out of the year. These are just a few examples of how climate change is already having a disastrous impact on the world. In its 2021 report, the United Nations’ Intergovernmental Panel on Climate Change warned that many of the changes to our climate caused by carbon emissions will be irreversible for hundreds or thousands of years to come. The World Health Organization has dubbed climate change as the biggest threat to humanity, and climate change is projected to lead to an additional 250,000 deaths per year between 2030 and 2050. Climate litigation is one strategy being used to address the impacts of climate change. While climate litigation has seen some success in other countries, climate","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46770327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Indiana's Efforts to Reduce Maternal Mortality: Necessary, but Insufficient","authors":"Kasey Barnes","doi":"10.18060/27439","DOIUrl":"https://doi.org/10.18060/27439","url":null,"abstract":"","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46639801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The article examines issues relating to nonmedical exemptions to vaccination as a condition of public-school attendance. The article contends that the public health impacts of exemptions may be mitigated through the application of existing state frameworks relating to procedural tightening, counseling and persuasion, assessments of sincerity and good faith, the application of public emergency laws, and transparency. The article identifies best practices in each of these frameworks. The article concludes that nonmedical exemptions are unlikely to be eliminated.As such, public health and educational authorities must act to prevent further erosion of the benefits associated with vaccination.
{"title":"Nonmedical Exemptions to Public School Vaccination Mandates in the Post-Pandemic World: Solutions Within Existing State Frameworks","authors":"L. Dhooge","doi":"10.18060/27168","DOIUrl":"https://doi.org/10.18060/27168","url":null,"abstract":"The article examines issues relating to nonmedical exemptions to vaccination as a condition of public-school attendance. The article contends that the public health impacts of exemptions may be mitigated through the application of existing state frameworks relating to procedural tightening, counseling and persuasion, assessments of sincerity and good faith, the application of public emergency laws, and transparency. The article identifies best practices in each of these frameworks. The article concludes that nonmedical exemptions are unlikely to be eliminated.As such, public health and educational authorities must act to prevent further erosion of the benefits associated with vaccination.","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46879057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Over the last four decades, race-conscious admission policies have been the subject of heated judicial and social controversy. In 1978, in the case Regents of the University of California v. Bakke, the consideration of race was held to be permissible to serve the compelling interest of promoting diversity in higher education. Since then, this issue has come up before the Supreme Court severaltimes. In October 2022, the Supreme Court of the United States heard oral arguments in two cases—Students for Fair Admissions v. President & Fellows of Harvard College and Students for Fair Admissions v. University of North Carolina. In the Harvard case, Students for Fair Admissions (“SFFA”), a conservative organization led by Edward Blum, argues that Harvard discriminates against Asian American applicants, thereby violating Title VI of the Civil Rights Act of 1964. In both the Harvard College and University of North Carolina cases, SFFA argues that the Supreme Court should overrule Grutter v. Bollinger, a case that cemented the proposition that narrowly tailored admission policies that consider race to achieve diversity are constitutional. On a second level, SFFA argues that both Harvard’s and UNC’s policies are not narrowly tailored due to their rejection of workable race-neutral alternatives.Part I of this Article provides an overview of past litigation concerning affirmative action policies. Part II discusses the two cases Students for FairAdmissions v. President & Fellows of Harvard College and Students for Fair Admissions v. University of North Carolina that are up for consideration before the Supreme Court. Part III discusses the importance of diversity in the medical workforce, and the potential impact of the SFFA lawsuits on medical practice. Part IV discusses arguments that may become important in these cases, potentialoutcomes of this litigation, and what the future of higher education looks like ifrace is prohibited from being considered in university admissions.
在过去的四十年里，有种族意识的录取政策一直是司法和社会激烈争议的主题。1978年，在加州大学校务委员会诉巴克案中，考虑种族是被允许的，以服务于促进高等教育多样性的迫切利益。从那以后，这个问题多次出现在最高法院面前。2022年10月，美国最高法院听取了两起案件的口头辩论——学生公平录取诉总统;哈佛学院研究员和公平录取学生组织诉北卡罗来纳大学案。在哈佛一案中，由爱德华·布鲁姆(Edward Blum)领导的保守派组织“学生公平录取”(Students for Fair Admissions，简称“SFFA”)认为，哈佛歧视亚裔美国申请者，因此违反了1964年《民权法案》第六章。在哈佛学院和北卡罗来纳大学的案件中，SFFA都认为最高法院应该驳回Grutter v. Bollinger一案，该案巩固了一个主张，即考虑种族以实现多样性的狭隘录取政策是符合宪法的。在第二个层面上，SFFA认为，哈佛大学和北卡罗来纳大学的政策都不是狭隘的，因为它们拒绝了可行的种族中立的替代方案。本文第一部分概述了过去有关平权行动政策的诉讼。第二部分讨论了公平录取学生组织诉总统案。哈佛学院的研究员和公平录取学生诉北卡罗来纳大学的案子正在最高法院审理中。第三部分讨论了医疗人员多样性的重要性，以及SFFA诉讼对医疗实践的潜在影响。第四部分讨论了在这些案件中可能变得重要的论点，这场诉讼的潜在结果，以及如果种族被禁止在大学录取中被考虑，高等教育的未来会是什么样子。
{"title":"Gutting Grutter: The Effect of the Loss of Affirmative Action on Diversity Among Physicians","authors":"Asees Bhasin, Gregory Curfman","doi":"10.18060/27167","DOIUrl":"https://doi.org/10.18060/27167","url":null,"abstract":"Over the last four decades, race-conscious admission policies have been the subject of heated judicial and social controversy. In 1978, in the case Regents of the University of California v. Bakke, the consideration of race was held to be permissible to serve the compelling interest of promoting diversity in higher education. Since then, this issue has come up before the Supreme Court severaltimes. In October 2022, the Supreme Court of the United States heard oral arguments in two cases—Students for Fair Admissions v. President & Fellows of Harvard College and Students for Fair Admissions v. University of North Carolina. In the Harvard case, Students for Fair Admissions (“SFFA”), a conservative organization led by Edward Blum, argues that Harvard discriminates against Asian American applicants, thereby violating Title VI of the Civil Rights Act of 1964. In both the Harvard College and University of North Carolina cases, SFFA argues that the Supreme Court should overrule Grutter v. Bollinger, a case that cemented the proposition that narrowly tailored admission policies that consider race to achieve diversity are constitutional. On a second level, SFFA argues that both Harvard’s and UNC’s policies are not narrowly tailored due to their rejection of workable race-neutral alternatives.Part I of this Article provides an overview of past litigation concerning affirmative action policies. Part II discusses the two cases Students for FairAdmissions v. President & Fellows of Harvard College and Students for Fair Admissions v. University of North Carolina that are up for consideration before the Supreme Court. Part III discusses the importance of diversity in the medical workforce, and the potential impact of the SFFA lawsuits on medical practice. Part IV discusses arguments that may become important in these cases, potentialoutcomes of this litigation, and what the future of higher education looks like ifrace is prohibited from being considered in university admissions.","PeriodicalId":87436,"journal":{"name":"Indiana health law review","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134983762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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