Journal of Legal Medicine最新文献

{"title":"The First 10 Years: Reflecting on Opportunities and Challenges of the Tobacco Products Scientific Advisory Committee of the United States Food and Drug Administration.","authors":"Pebbles Fagan,&nbsp;Thomas Eissenberg,&nbsp;Dina M Jones,&nbsp;Joanna E Cohen,&nbsp;Patricia Nez Henderson,&nbsp;Mark S Clanton","doi":"10.1080/01947648.2020.1868938","DOIUrl":"https://doi.org/10.1080/01947648.2020.1868938","url":null,"abstract":"<p><p><b>Introduction:</b> Tobacco control policies have helped to reduce the health, social, and economic burden of commercial tobacco use worldwide. Little is known about the long-term impact of regulatory policies and functioning bodies that make recommendations to inform policies. The Tobacco Products Scientific Advisory Committee (TPSAC) of the U.S. Food and Drug Administration (FDA) was formed in 2009 to evaluate the safety, health, and dependence of tobacco products and provide related advice and recommendations to the FDA and the Secretary of Health and Human Services. This article describes the first 10 years of the TPSAC activities and reflects on the impact of their service on regulatory actions.<b>Methods:</b> We reviewed public documents from the 2010-2019 TPSAC meetings to examine the purposes, TPSAC decisions, public health participation in meetings, and concordance of the TPSAC recommendations with regulatory actions. Meeting agendas, transcripts, public testimony, and presentations were reviewed to obtain this information.<b>Results:</b> Since 2010, the TPSAC held 25 public meetings with 178 speakers who provided oral public testimony. Sixty-four percent of meetings were held from 2010 to 2012, when three congressionally mandated reports were due on the topics of menthol cigarettes, harmful and potentially harmful constituents in tobacco products, and dissolvable tobacco products. Forty-four percent of meetings focused on menthol cigarettes, 32% on modified risk tobacco products, 16% on harmful and potentially harmful constituents, 12% on dissolvable tobacco, and 4% on tobacco addiction/dependence. FDA regulatory actions were largely nonconcordant with voting decisions by TPSAC.<b>Conclusions:</b> The TPSAC has evaluated an enormous amount of science during the first 10 years, but their influence on regulatory policies has been limited. The TPSAC roles and functioning should be reevaluated to determine how TPSAC can better fulfill its mandate to inform the FDA's regulatory decision making, which could ultimately reduce the burden of tobacco use in the United States.</p>","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1868938","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10501842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ten Years of the Tobacco Control Act in New York City.","authors":"Kevin R J Schroth","doi":"10.1080/01947648.2020.1868939","DOIUrl":"https://doi.org/10.1080/01947648.2020.1868939","url":null,"abstract":"<p><p>This article describes the impact of the 2009 Family Smoking and Prevention Tobacco Control Act (TCA) on local tobacco control through the lens of New York City's experience during the first 10 years after the TCA was enacted, highlighting one meaningful change and an opportunity that has failed to materialize. Much of the analysis regarding the TCA highlights the U.S. Food and Drug Administration's (FDA) new powers and the TCA's impact on a national level. However, the TCA also opened up opportunities for local governments to pursue sound tobacco control policies that previously seemed fraught with high legal risk. This article focuses on two aspects of the TCA. First, the TCA weakened one of the tobacco industry's most reliable litigation weapons-preemption. Second, the TCA authorized the FDA to combat the illicit trade of tobacco products. Despite clear language in the TCA, the FDA has not signaled an inclination to take action regarding illicit trade in the context of tobacco tax evasion.</p>","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1868939","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25541397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ten Years of FDA Tobacco Regulation: Lessons for Public Health Stakeholders.","authors":"Desmond Jenson","doi":"10.1080/01947648.2020.1868940","DOIUrl":"https://doi.org/10.1080/01947648.2020.1868940","url":null,"abstract":"<p><p>In the 10 years that the U.S. Food and Drug Administration (FDA) has been regulating tobacco products, the agency has been plagued with setbacks, some of its own making, and some the result of outside forces. What has been consistently true is that the public health community has not had as much of a voice as it should have until public health groups began filing lawsuits against the FDA. This article examines four areas of FDA regulation over the last decade in an attempt to qualitatively describe the work of the Center for Tobacco Products and identify opportunities for public health groups to have greater advocacy success in the future.</p>","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1868940","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25541401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Progress Report on Opioid Litigation.","authors":"Richard C Ausness","doi":"10.1080/01947648.2020.1868942","DOIUrl":"https://doi.org/10.1080/01947648.2020.1868942","url":null,"abstract":"INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .429 A. The Public Nuisance Issue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 429 B. The Political Question Issue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 431 I. THE OPIOID ADDICTION “EPIDEMIC” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .432 II. THE PLAINTIFFS’ NARRATIVE (AND THE DEFENDANTS’ RESPONSE) . . 433 III. OPIOID LITIGATION: PAST AND PRESENT . . . . . . . . . . . . . . . . . . . . . . . .434 IV. PROSPECTS FOR THE FUTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .442 V. REMAINING QUESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .445 VI. CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .446 ACKNOWLEDGMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1868942","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25541400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medicaid Expansion and Work Requirements in Georgia.","authors":"C David Whitson","doi":"10.1080/01947648.2020.1854136","DOIUrl":"https://doi.org/10.1080/01947648.2020.1854136","url":null,"abstract":"<p><p>Georgia's Section 1115 waiver application, titled \"Georgia Pathways to Coverage,\" seeks to simultaneously expand the state's Medicaid program and condition eligibility on work requirements. Though Section 1115 waivers have become a common vehicle for state Medicaid expansion, the imposition of work requirements is a novel departure. This article explores whether approval of Georgia Pathways to Coverage by the U.S. Department of Health and Human Services can withstand judicial review. Recent precedent, beginning with the seminal <i>Stewart v. Azar</i> case, strongly suggests that a legal challenge would be successful on the merits. The features and justifications of Georgia Pathways to Coverage, examined in light of current data on work requirements in entitlement programs, make it likely that approval of the program would be found arbitrary and capricious under the Administrative Procedure Act. However, unique aspects of Georgia Pathways to Coverage, as compared with similar state waivers, raise significant hurdles related to constitutional standing requirements and the appropriate judicial remedy.</p>","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1854136","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25541814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Symposium Introduction: A Decade of the Tobacco Control Act: Progress, Setbacks, and the Future of Tobacco Control.","authors":"D Douglas Blanke","doi":"10.1080/01947648.2020.1867474","DOIUrl":"https://doi.org/10.1080/01947648.2020.1867474","url":null,"abstract":"<p><p>The landmark symposium, A Decade of the Tobacco Control Act: Progress, Setbacks, and the Future of Tobacco Control, organized by the Public Health Law Center and held in conjunction with the 2019 National Conference on Tobacco or Health, assessed the first 10 years of federal tobacco regulation. In this introduction to the symposium, the Public Health Law Center's executive director provides the context for insights by prominent experts from government, health organizations, and academia, acknowledging the mixed record of U.S. Food and Drug Administration (FDA) regulation to date and suggesting that the agency's ultimate success or failure will be determined by the answers to three fundamental, but still unresolved, questions: What is the true goal of federal regulation? How boldly or cautiously will the FDA approach that goal? And who will the agency serve? The answers to those questions, he argues, will determine the prospects for progress in controlling the nation's leading cause of preventable death.</p>","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1867474","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25541378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In the Supreme Court of the United States Docket No. 18-102.","authors":"Deirdre Cooney,&nbsp;John Moriarty,&nbsp;Emily Sklar,&nbsp;Jodi Hudson","doi":"10.1080/01947648.2020.1868959","DOIUrl":"https://doi.org/10.1080/01947648.2020.1868959","url":null,"abstract":"Table of","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1868959","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25541398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Thinking Outside the Silos: Information Sharing in Medical-Legal Partnerships.","authors":"Jessica Mantel,&nbsp;Leah Fowler","doi":"10.1080/01947648.2020.1854135","DOIUrl":"https://doi.org/10.1080/01947648.2020.1854135","url":null,"abstract":"<p><p>Medical-legal partnerships (MLPs) allow providers to address patients' health-harming legal needs through partnerships with lawyers. MLPs are most successful in addressing the complex needs of vulnerable populations when clinicians, social workers, and other care team members regularly communicate with the MLP lawyer. Privacy laws and professional rules of conduct governing patient/client confidentiality, however, potentially hinder this exchange of patient-client information. MLP attorneys may be reluctant to share relevant information about a client with the medical partner for fear that doing so would breach client confidentiality or result in an ill-advised waiver of attorney-client privilege. Similarly, privacy concerns may lead providers to limit MLP attorneys' access to patients' medical information.Drawing on the real-world experiences of MLP professionals, this article explores whether legal and ethical obligations impede the sharing of patient-client information between MLPs' medical and legal partners. Our research indicates that at present patient/client confidentiality rules generally do not pose a significant barrier to doing so. However, current legal and professional standards may frustrate emerging advanced care coordination models that pair MLPs with care teams that comprehensively address a broad range of social, economic, and behavioral health needs. We therefore recommend continued monitoring and discussion of the issue.</p>","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1854135","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25541816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Next 10 Years of Federal Tobacco Regulation: A Road Map to Protect Public Health and Advance Health Equity.","authors":"Joelle M Lester","doi":"10.1080/01947648.2020.1868941","DOIUrl":"https://doi.org/10.1080/01947648.2020.1868941","url":null,"abstract":"<p><p>After a decade of fits and starts in regulating commercial tobacco products, the U.S. Food and Drug Administration (FDA) has built the infrastructure needed for robust tobacco product regulation. This article lays out a vision for the FDA in its second decade of tobacco product regulation. To realize the promise of the Family Smoking Prevention and Tobacco Control Act, the FDA must move quickly to adopt high-impact tobacco product regulation, define and operationalize the public health standard in a way that advances health equity, and bring all of its authority and resources to bear to reduce health disparities. In addition, the agency must engage more productively with states to reduce and eliminate tobacco use.</p>","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1868941","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25541402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"2019-2020 Southern Illinois University National Health Law Moot Court Competition.","authors":"Richard Ausness","doi":"10.1080/01947648.2020.1868944","DOIUrl":"https://doi.org/10.1080/01947648.2020.1868944","url":null,"abstract":"Memorandum Opinion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .448 Blackstone, District Judge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 448 Factual and Procedural History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .448 Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .451 I. Nonjusticiable Political Question . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 451 II. Public Nuisance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 454 A. Interference with a Right Common to the Public . . . . . . . . . . . . . . . . . . .455 B. Unreasonable Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .456 C. Control Over the Instrumentality That Caused the Harm . . . . . . . . . . . . .457 Conclusion and Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .458 I. Nonjusticiable Political Question . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 459 II. Public Nuisance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 459 I. Nonjusticiable Political Question . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 460 II. Public Nuisance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 462 A. Right Common to the Public . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .463 B. Unreasonable Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .463 C. Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .463","PeriodicalId":44014,"journal":{"name":"Journal of Legal Medicine","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01947648.2020.1868944","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25541399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}