Legal challenges to the FDA's approval of mifepristone have destabilized patients' ability to access controversial medicines like medication abortion. We argue that federal courts' receptiveness to this litigation undermines the coherence and integrity of prescription drug regulation in the U.S.
{"title":"Battles Over Medication Abortion Threaten the Integrity of Drug Approvals in the U.S.","authors":"Liam Bendicksen, Aaron S Kesselheim","doi":"10.1017/jme.2023.76","DOIUrl":"https://doi.org/10.1017/jme.2023.76","url":null,"abstract":"<p><p>Legal challenges to the FDA's approval of mifepristone have destabilized patients' ability to access controversial medicines like medication abortion. We argue that federal courts' receptiveness to this litigation undermines the coherence and integrity of prescription drug regulation in the U.S.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10556174","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}
Pub Date : 2023-01-01Epub Date: 2024-03-13DOI: 10.1017/jme.2023.154
Megha Garg, Jennifer Oliva, Alice Lu, Marlene Martin, Sarah Hooper
Health systems are integrating medical-legal partnerships (MLPs) into clinical care and increasingly center "complex care" patients. These patients have intersecting medical and social needs and often face systemic inequities that exacerbate their chronic health conditions. This paper describes a role for MLPs in hospital quality initiatives; examines the ethics of MLPs assisting with guardianship and institutionalization of hospital patients including marginalized groups; and advocates for MLP interventions designed to address intersectional and ethical concerns.
{"title":"Hospital-Based Medical-Legal Partnerships for Complex Care Patients: Intersectionality and Ethics Considerations.","authors":"Megha Garg, Jennifer Oliva, Alice Lu, Marlene Martin, Sarah Hooper","doi":"10.1017/jme.2023.154","DOIUrl":"10.1017/jme.2023.154","url":null,"abstract":"<p><p>Health systems are integrating medical-legal partnerships (MLPs) into clinical care and increasingly center \"complex care\" patients. These patients have intersecting medical and social needs and often face systemic inequities that exacerbate their chronic health conditions. This paper describes a role for MLPs in hospital quality initiatives; examines the ethics of MLPs assisting with guardianship and institutionalization of hospital patients including marginalized groups; and advocates for MLP interventions designed to address intersectional and ethical concerns.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10937167/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140111995","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}
Pub Date : 2023-01-01Epub Date: 2024-03-13DOI: 10.1017/jme.2024.20
Matthew Herder
The US Food and Drug Administration's controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer's disease, has motivated multiple policy reforms. Drawing a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA's core priorities and restore the regulatory system's commitment to scientific rigor.
美国食品和药物管理局(FDA)决定加速批准阿杜单抗(aducanumab,Aduhelm)这一治疗阿尔茨海默氏症的药物,这一决定引起了争议,并引发了多项政策改革。通过对其他获得加速审批的药物的案例分析以及对食品及药物管理局高级官员的访谈,我认为改革应该是有依据的,但不是由阿杜库单抗决定的。相反,我们需要进行结构性改革,重塑 FDA 的核心优先事项,恢复监管体系对科学严谨性的承诺。
{"title":"Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform.","authors":"Matthew Herder","doi":"10.1017/jme.2024.20","DOIUrl":"10.1017/jme.2024.20","url":null,"abstract":"<p><p>The US Food and Drug Administration's controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer's disease, has motivated multiple policy reforms. Drawing a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA's core priorities and restore the regulatory system's commitment to scientific rigor.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10937179/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140111988","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}
Pub Date : 2023-01-01Epub Date: 2024-03-13DOI: 10.1017/jme.2024.4
Anjali D Deshmukh
In "Missing the Forest for the Trees: Aduhelm, Accelerated Approvals & the Agency," Dr. Matthew Herder argues that agency capture and politicized discretion drive delays in confirmatory trials of accelerated approval drugs amongst other concerns at US Food and Drug Administration (FDA). In highlighting this important problem and offering nuanced insight into agency workings based in part on interviews with twenty-three unnamed FDA officials and a three-drug case study, Dr. Herder suggests two innovative solutions. However, amidst broader debates balancing agency expertise, data, and delegation, these proposed policy solutions would benefit from more corroborative evidence and consideration of institutional advantages within constitutional limits.
在《只见树木,不见森林:马修-赫德博士(Dr. Matthew Herder)认为,美国食品和药物管理局(FDA)在加速审批药物的确证试验方面存在的其他问题包括:机构俘获和政治化的自由裁量权导致了确证试验的延误。赫德博士强调了这一重要问题,并根据对 23 位未透露姓名的 FDA 官员的访谈和对三种药物的案例研究,提出了对机构运作的细致入微的见解。然而,在平衡机构专业知识、数据和授权的广泛辩论中,这些建议的政策解决方案将受益于更多的确凿证据,以及在宪法限制范围内对机构优势的考虑。
{"title":"Great Trees Require Strong Roots: Evaluating Data and Delegation Doctrine Underlying Proposed Reforms to FDA's Accelerated Approval Program.","authors":"Anjali D Deshmukh","doi":"10.1017/jme.2024.4","DOIUrl":"10.1017/jme.2024.4","url":null,"abstract":"<p><p>In \"Missing the Forest for the Trees: Aduhelm, Accelerated Approvals & the Agency,\" Dr. Matthew Herder argues that agency capture and politicized discretion drive delays in confirmatory trials of accelerated approval drugs amongst other concerns at US Food and Drug Administration (FDA). In highlighting this important problem and offering nuanced insight into agency workings based in part on interviews with twenty-three unnamed FDA officials and a three-drug case study, Dr. Herder suggests two innovative solutions. However, amidst broader debates balancing agency expertise, data, and delegation, these proposed policy solutions would benefit from more corroborative evidence and consideration of institutional advantages within constitutional limits.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10937175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140111994","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}
Pub Date : 2023-01-01Epub Date: 2023-09-01DOI: 10.1017/jme.2023.65
Jason Schnittker
{"title":"The Sociological Context of Incarceration and Health.","authors":"Jason Schnittker","doi":"10.1017/jme.2023.65","DOIUrl":"10.1017/jme.2023.65","url":null,"abstract":"","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10881266/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10185780","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}
Pub Date : 2023-01-01Epub Date: 2024-03-13DOI: 10.1017/jme.2024.9
Alicia Turlington, Jonathan Young, Dina Shek
Medical-Legal Partnerships (MLPs) have been widely acclaimed for promoting health equity and achieving meaningful outcomes. Yet, little to no research has analyzed if this critical work has been done with communities - through meaningful engagement and building power - or if it has been done for communities without their involvement.
{"title":"Quantifying \"Community Power\" and \"Racial Justice\" in the Medical-Legal Partnership Literature.","authors":"Alicia Turlington, Jonathan Young, Dina Shek","doi":"10.1017/jme.2024.9","DOIUrl":"10.1017/jme.2024.9","url":null,"abstract":"<p><p>Medical-Legal Partnerships (MLPs) have been widely acclaimed for promoting health equity and achieving meaningful outcomes. Yet, little to no research has analyzed if this critical work has been done with communities - through meaningful engagement and building power - or if it has been done for communities without their involvement.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140112026","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}
Pub Date : 2023-01-01Epub Date: 2024-03-13DOI: 10.1017/jme.2024.24
Haavi Morreim, Gail Beeman, Emilee Dobish
To provide effective care physicians must attend, not just to medical issues, but also to the social determinants of health - racial factors, food insecurity, housing instability, transportation barriers and beyond. Social determinants also include a largely underrecognized dimension: legal vulnerabilities such as rental evictions and debt adjudications. Yet rarely do medical trainees have an opportunity to witness legal vulnerabilities, firsthand.
{"title":"Social Determinants of Health: As Seen in a Courtroom.","authors":"Haavi Morreim, Gail Beeman, Emilee Dobish","doi":"10.1017/jme.2024.24","DOIUrl":"10.1017/jme.2024.24","url":null,"abstract":"<p><p>To provide effective care physicians must attend, not just to medical issues, but also to the social determinants of health - racial factors, food insecurity, housing instability, transportation barriers and beyond. Social determinants also include a largely underrecognized dimension: legal vulnerabilities such as rental evictions and debt adjudications. Yet rarely do medical trainees have an opportunity to witness legal vulnerabilities, firsthand.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140112028","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}
Pub Date : 2023-01-01Epub Date: 2024-03-04DOI: 10.1017/jme.2024.21
Aaron S Kesselheim
The US government supports drug innovation. It is therefore crucial that it distinguish between high-value and low-value innovation in purchasing expensive prescription drugs and medical devices and ensure the continued discovery of transformative drugs and that patient and taxpayer funds are not wasted.
{"title":"<b>Government Support of Meaningful Drug and Device Innovation:</b> Pathways and Challenges.","authors":"Aaron S Kesselheim","doi":"10.1017/jme.2024.21","DOIUrl":"10.1017/jme.2024.21","url":null,"abstract":"<p><p>The US government supports drug innovation. It is therefore crucial that it distinguish between high-value and low-value innovation in purchasing expensive prescription drugs and medical devices and ensure the continued discovery of transformative drugs and that patient and taxpayer funds are not wasted.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140023142","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}
Pub Date : 2023-01-01Epub Date: 2024-03-04DOI: 10.1017/jme.2023.147
James C Robinson
Pharmacy Benefit Managers (PBM) induce drug manufacturers to offer rebates to insurers and employers by denying coverage through formulary exclusions, impeding physician prescription through prior authorization, and reducing patient drug use through cost sharing. As they tighten these access obstacles, PBMs reduce the net prices received by the manufacturers.
{"title":"<b>Pharmacy Benefit Management:</b> The Cost of Drug Price Rebates.","authors":"James C Robinson","doi":"10.1017/jme.2023.147","DOIUrl":"10.1017/jme.2023.147","url":null,"abstract":"<p><p>Pharmacy Benefit Managers (PBM) induce drug manufacturers to offer rebates to insurers and employers by denying coverage through formulary exclusions, impeding physician prescription through prior authorization, and reducing patient drug use through cost sharing. As they tighten these access obstacles, PBMs reduce the net prices received by the manufacturers.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140023144","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}
Pub Date : 2023-01-01Epub Date: 2024-03-04DOI: 10.1017/jme.2024.18
Aaron Kesselheim, Ameet Sarpatwari, Benjamin Rome
This special JLME symposium addresses ways that federal policy can incentivize innovation in medical therapeutics and make pharmaceuticals more financially accessible.
本次 JLME 专题讨论会探讨了联邦政策如何激励医学治疗创新,并使人们在经济上更容易获得药品。
{"title":"INTRODUCTION: <b>Promoting Drug and Vaccine Innovation and Managing High Prices:</b> Introducing a Special Symposium.","authors":"Aaron Kesselheim, Ameet Sarpatwari, Benjamin Rome","doi":"10.1017/jme.2024.18","DOIUrl":"10.1017/jme.2024.18","url":null,"abstract":"<p><p>This special JLME symposium addresses ways that federal policy can incentivize innovation in medical therapeutics and make pharmaceuticals more financially accessible.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140023150","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}