{"title":"Telehealth after the Federal COVID-19 Public Health Emergency: Implications and Future Directions.","authors":"Minsoo Kwon, James René Jolin, Carmel Shachar","doi":"10.1017/jme.2024.118","DOIUrl":"10.1017/jme.2024.118","url":null,"abstract":"<p><p>May 11, 2023, marked the end of the federal COVID-19 Public Health Emergency (PHE). During the PHE, regulatory flexibilities allowed telehealth to more effectively connect physicians providing care and patients seeking it. This paper discusses the implications of the end of the PHE on telehealth coverage, payment, reimbursement, and licensure, and exposes inconsistencies and inequities in extant state regulations.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 2","pages":"412-418"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Emanuel Nussli, Miquel Serra-Burriel, Kerstin N Vokinger
{"title":"Comparative Analysis of Drug Shortages in the US and Germany (2016 - 2023).","authors":"Emanuel Nussli, Miquel Serra-Burriel, Kerstin N Vokinger","doi":"10.1017/jme.2024.105","DOIUrl":"10.1017/jme.2024.105","url":null,"abstract":"<p><p>This article analyzes trends in drug shortages in the US and Germany, the largest pharmaceutical market in Europe, between 2016 and 2023. It assesses the commonalities and differences between the countries in terms of active substances in shortage, time duration in shortage, and cyclic trends.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 2","pages":"488-497"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Patent Claim Scope and Biosimilar Competition in the US and EU.","authors":"Doni Bloomfield, Aaron S Kesselheim","doi":"10.1017/jme.2024.133","DOIUrl":"10.1017/jme.2024.133","url":null,"abstract":"<p><p>The US has found it hard to establish competition in the market for biologics, which are therapeutics derived from living cells. In the case of small-molecule drugs, the emergence of direct competition from generic drugs at the end of the exclusivity period has provided the impetus for price competition, leading to lower spending. In 2010, to spur competition in the biologics market, Congress created a simplified pathway for the US Food and Drug Administration (FDA) to approve comparable versions of biologic drugs called biosimilars. Biosimilar competition in the US has nonetheless remained weaker than in European peer countries. For example, as of August 2020, there were 52 biosimilars available in Germany, and only 15 in the US.<sup>1</sup> An important contributor to this \"biosimilar gap\" has been the fact that biosimilars to biologic blockbusters such as adalimumab (Humira) and etanercept (Enbrel) were only (or will only become) commercially available in the US several years after receiving FDA approval, while they were available in Europe years earlier.<sup>2</sup> Through the end of 2021, it took biosimilars a median of 301 days between receiving FDA approval and becoming available for use.<sup>3</sup> In one recent study, the median length of time between when a biologic drug was approved and when its first biosimilar was made available to US patients was 21.5 years.<sup>4</sup> This paucity of competition has contributed to high US spending on biologics. According to the Department of Health and Human Services, in 2022 41% of US drug expenditures was spent on biologics, which represented 16% of US prescriptions.<sup>5</sup>.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 2","pages":"439-442"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"<b>Building Successful Partnerships Between State Health Departments and Attorney General Offices:</b> The Minnesota Example.","authors":"Dana Farley, Carman Leone, Caroline Palmer","doi":"10.1017/jme.2024.37","DOIUrl":"https://doi.org/10.1017/jme.2024.37","url":null,"abstract":"<p><p>In recent years, the Minnesota Attorney General's Office and the Minnesota Department of Health have cultivated a productive partnership to strengthen the state's multidisciplinary response to overlapping health equity and social justice issues. This article describes shared efforts in three areas: post-conviction justice, drug overdose, and human trafficking/exploitation.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 S1","pages":"66-69"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141591912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Federico E Vaca, Emmanuel Fulgence Drabo, Kaigang Li
{"title":"<b>The Phenomenon of Teen Delay in Driving Licensure:</b> Considerations at the Intersection of Mobility and Social Welfare for Emerging Adults.","authors":"Federico E Vaca, Emmanuel Fulgence Drabo, Kaigang Li","doi":"10.1017/jme.2024.42","DOIUrl":"https://doi.org/10.1017/jme.2024.42","url":null,"abstract":"<p><p>In 2021, there were 11.7 million licensed young drivers in the U.S. This is 1.5 million fewer young drivers compared to 2007. The phenomenon of delay in driving licensure among teens has notable implications for opportunities positioning them for life success when transitioning into emerging adulthood and in later life.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 S1","pages":"81-84"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141591920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Pregnant Workers Fairness Act Leaves Agricultural Workers Behind.","authors":"Prashasti Bhatnagar","doi":"10.1017/jme.2024.34","DOIUrl":"https://doi.org/10.1017/jme.2024.34","url":null,"abstract":"<p><p>The new federal Pregnant Workers Fairness Act advances important protections for pregnant workers, but leaves behind agricultural workers, who are overrepresented in hazardous occupational environments. This article highlights the connection between workplace pregnancy discrimination and health inequities. It concludes with a discussion of immigrant-led advocacy efforts to eliminate health inequities and advance health justice.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 S1","pages":"13-16"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141591929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Charity Scott - A Masterful Teacher.","authors":"Diane E Hoffmann","doi":"10.1017/jme.2024.93","DOIUrl":"10.1017/jme.2024.93","url":null,"abstract":"<p><p>In 2006, the University of Maryland Carey School of Law had the privilege of co-hosting the annual Health Law Professors Conference with the American Society of Law, Medicine & Ethics (ASLME). Coincidentally, as director of the Law & Health Care Program at Maryland, I had the opportunity to announce the winner of the Jay Healey Health Law Teachers' Award at the conference. The award is given to \"professors who have devoted a significant portion of their career to health law teaching and whose selection would honor Jay [Healey's] legacy through their passion for teaching health law, their mentoring of students and/or other faculty and by their being an inspiration to colleagues and students.\"<sup>1</sup> Healey, a Professor in the Humanities Department at the University of Connecticut School of Medicine, was the youngest recipient of the Society's Health Law Teachers' Award, which he received in 1990. He was passionate about teaching and had the idea to devote a session each year at the annual conference to teaching health law. It was always a plenary session at which he challenged us to be better teachers. Jay died in 1993, at the age of 46, not long after the Health Law Teachers conference that year, which he attended and which also happened to be held in Baltimore at the University of Maryland School of Law. Thereafter, the award was given in his name.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 2","pages":"224-227"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Charity Scott: Teacher, Mentor, Collaborator, Interdisciplinarian.","authors":"Sylvia B Caley, Lisa Radke Bliss","doi":"10.1017/jme.2024.101","DOIUrl":"10.1017/jme.2024.101","url":null,"abstract":"<p><p>Charity Scott brought health law to Georgia State College of Law in the fall of 1987. Through her faculty appointment, along with her boundless energy and intellectual curiosity, she set herself on an odyssey. She began by teaching a single general health law class. This beginning led to the development of a full curriculum in the field, complete with experiential learning opportunities and a certificate in health law program. In addition to creating learning and career opportunities in health law for law students, her development of the Center for Health, Law and Society created academic opportunities for leading health law faculty.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 2","pages":"243-247"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Critical Public Health Legal Theory: Proposing a New Approach to Public Health Law as a Tribute to Professor Charity Scott.","authors":"Jean C O'Connor","doi":"10.1017/jme.2024.117","DOIUrl":"10.1017/jme.2024.117","url":null,"abstract":"<p><p>It was a great privilege to know Professor Charity Scott. I first met her when I was finishing Emory University's joint law and public health program in the early 2000s, through the Office of General Counsel at the U.S. Centers for Disease Control (CDC), in the early days of CDC's Public Health Law Program, now the Office of Public Health Law Services. In those days, introductions were generous and frequent for excited students beginning their careers, but meeting Professor Scott made an impression on me. She was the first and only female health law professor in the field that I had the opportunity to know in the early years of my career.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 2","pages":"388-390"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kayte Spector-Bagdady, Kerry A Ryan, Amy L McGuire, Chris D Krenz, M Grace Trinidad, Kaitlyn Jaffe, Amanda Greene, J Denard Thomas, Madison Kent, Stephanie Morain, David Wilborn, J Scott Roberts
{"title":"\"A Double-Edged Sword\": A Brief History of Genomic Data Governance and Genetic Researcher Perspectives on Data Sharing.","authors":"Kayte Spector-Bagdady, Kerry A Ryan, Amy L McGuire, Chris D Krenz, M Grace Trinidad, Kaitlyn Jaffe, Amanda Greene, J Denard Thomas, Madison Kent, Stephanie Morain, David Wilborn, J Scott Roberts","doi":"10.1017/jme.2024.123","DOIUrl":"10.1017/jme.2024.123","url":null,"abstract":"<p><p>As the federal government continues to expand upon and improve its data sharing policies over the past 20 years, complex challenges remain. Our interviews with U.S. academic genetic researchers (n=23) found that the burden, translation, industry limitations, and consent structure of data sharing remain major governance challenges.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 2","pages":"399-411"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11870237/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}