American Journal of Law & Medicine最新文献_第6页

Shattering the Mirage: The FDA's Early COVID-19 Pandemic Response Demonstrates a Need for Reform to Restore Agency Credibility. 粉碎海市蜃楼:FDA对COVID-19大流行的早期反应表明需要改革以恢复机构信誉。

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-12-01 DOI: 10.1017/amj.2023.1

Christina Fuleihan

{"title":"Shattering the Mirage: The FDA's Early COVID-19 Pandemic Response Demonstrates a Need for Reform to Restore Agency Credibility.","authors":"Christina Fuleihan","doi":"10.1017/amj.2023.1","DOIUrl":"https://doi.org/10.1017/amj.2023.1","url":null,"abstract":"The power afforded to the administrative state is heavily reliant on public trust and the perception of evidence-based agency decision-making. Organizational reputation is key to preserving regulatory power. However, recent investigations reveal that existing scientific integrity policies may not be sufficient to preserve the credibility of many federal agencies. In fact, a significant number of career scientists across various entities - including the FDA - have observed unreported incidents of political interference. While political influence exerted by the executive branch to set policy goals and determine agency priorities can be beneficial, political pressures must not undermine public trust in scientific agencies. Recently, public perception regarding the FDA's COVID-19 response threatened to weaken the agency's longstanding reputation as the gold standard of review. The COVID-19 pandemic publicized vulnerabilities that exist across agencies, as well as those that are unique to the FDA. The FDA's evolution as an increasingly public health-focused agency that must function in the landscape of politicized science exposes the agency to a greater risk of political interference. After all, the FDA's involvement in public health requires increased participation in non-ideal, value-based decision-making. Throughout its history, the FDA has managed to maintain its reputation through its firm responses to scandal. The COVID-19 pandemic provides a platform for the FDA to - once again - look introspectively and institute safeguards addressing vulnerabilities that plagued the agency's pandemic response. This Article examines the FDA's early COVID-19 response to propose reforms that promote meaningful transparency, public accountability, and scientific integrity.","PeriodicalId":7680,"journal":{"name":"American Journal of Law & Medicine","volume":"48 4","pages":"307-342"},"PeriodicalIF":0.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9310241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Balancing Act in Regulation Between the FDA and the Court's Role in Promoting Children's Health: In re: Gerber Products Company Heavy Metals Baby Food Litigation. 食品药品监督管理局和法院在促进儿童健康中的角色之间的监管平衡法案:关于格柏产品公司重金属婴儿食品诉讼。

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-12-01 DOI: 10.1017/amj.2023.8

Daniela Del Campo

引用次数: 0

Recalibrating Transplant Eligibility Criteria: Ensuring Equitable Access to Organ Transplantation for Intellectually Disabled Persons. 重新调整移植资格标准:确保智障人士公平获得器官移植。

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-12-01 DOI: 10.1017/amj.2023.3

Adam Peña

{"title":"Recalibrating Transplant Eligibility Criteria: Ensuring Equitable Access to Organ Transplantation for Intellectually Disabled Persons.","authors":"Adam Peña","doi":"10.1017/amj.2023.3","DOIUrl":"https://doi.org/10.1017/amj.2023.3","url":null,"abstract":"The American with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act have made little progress towards preventing disability-based discrimination within the organ transplant evaluation process. Intellectual and developmental disabilities (I/DD) pose a unique problem for transplant teams and transplant physicians because I/DDs can simultaneously be a legitimate contraindication for transplantation and a mechanism for invidious discrimination against intellectually disabled persons. A culprit for ongoing disability-based discrimination is a transplant center's authority to develop its own eligibility criteria. While medical criteria for eligibility are generally well-settled, psychosocial criteria - an amorphous constellation of risk factors for post-transplant success - can serve as a facially neutral disguise for social worth determinations of individuals with I/DDs. Consequently, individuals with I/DDs are unjustifiably denied eligibility for organ transplantation and transplant-related services.This Article begins by identifying the pitfalls of current federal antidiscrimination legislation. It then discusses the foreseen benefits and drawbacks of House Resolution (H.R.) 8981, a recently proposed federal bill, that expressly prohibits disability-based discrimination within the organ transplant evaluation process. The Article ends by offering potential solutions for professional organizations and transplant centers that aim to provide for equitable access to organ transplantation and transplant-related services for intellectually disabled individuals.","PeriodicalId":7680,"journal":{"name":"American Journal of Law & Medicine","volume":"48 4","pages":"380-411"},"PeriodicalIF":0.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9314744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Synthetic Biology: State Regulation in the Biomedical Context. 合成生物学:生物医学背景下的国家监管。

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-12-01 DOI: 10.1017/amj.2023.7

Julia Watson

{"title":"Synthetic Biology: State Regulation in the Biomedical Context.","authors":"Julia Watson","doi":"10.1017/amj.2023.7","DOIUrl":"https://doi.org/10.1017/amj.2023.7","url":null,"abstract":"Synthetic biology is an emerging, interdisciplinary research field with much promise for biomedicine. Broadly defined as \"the design and construction of new biological systems to perform specific tasks,\" researchers and clinicians are using synthetic biology to develop targeted treatments for cancer, coronaviruses, and so forth. Because of the experimental nature of synthetic biology, regulation is necessary. Current federal frameworks, such as the Food, Drug, and Cosmetics Act, The Toxic Substances Act of 1976, Institutional Review Boards, and self-regulation are not enough. As a result, states have a unique opportunity to develop statutory and regulatory frameworks to develop a pathway for regulating synthetic biology. In developing legislation, state lawmakers should look to build a comprehensive framework that addresses businesses selling technology for synthesizing DNA codes, monitors orders for synthetic DNA, and develops statewide documentation systems. Additionally, public health information on treatments using synthetic biology can help to educate the public and reduce the prevalence of misconceptions about the technology. In the absence of federal regulation, states should step into the synthetic biology regulatory space to ensure that their citizens are not harmed by therapies developed using synthetic biology.","PeriodicalId":7680,"journal":{"name":"American Journal of Law & Medicine","volume":"48 4","pages":"447-468"},"PeriodicalIF":0.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9309574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Hairdos and Help-seeking: Mandatory Domestic Violence Training for Salon Workers. 发型与求助:沙龙工作人员的强制性家庭暴力培训。

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-12-01 DOI: 10.1017/amj.2023.6

Julia Novick

引用次数: 0

Opioid Litigation: Lessons Learned from a Retail Pharmacy Settlement. 阿片类药物诉讼:从零售药房和解中吸取的教训。

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-12-01 DOI: 10.1017/amj.2023.9

Shannon A Gonick

引用次数: 0

AMJ volume 48 issue 4 Cover and Back matter AMJ第48卷第4期封面和封底

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-12-01 DOI: 10.1017/amj.2023.11

引用次数: 0

Straight Teeth and Misaligned Interests: Courtrooms Are Crowded with SmileDirectClub Litigation. 整齐的牙齿和错位的利益:法庭上挤满了SmileDirectClub诉讼。

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-12-01 DOI: 10.1017/amj.2023.5

Chaninah Zweihorn

{"title":"Straight Teeth and Misaligned Interests: Courtrooms Are Crowded with SmileDirectClub Litigation.","authors":"Chaninah Zweihorn","doi":"10.1017/amj.2023.5","DOIUrl":"https://doi.org/10.1017/amj.2023.5","url":null,"abstract":"SmileDirectClub markets, manufactures, and delivers clear plastic dental aligners directly to the consumer: no dental office necessary. This well-known business strategy-cut costs by cutting out the middleman-has in several instances caught the attention of state dental regulators. While the dental boards consider some of SmileDirectClub's practices to be violative of state dental practice law, the corporation has fought back in federal court, charging dental regulators with antitrust violations and with denying SmileDirectClub its constitutional rights.The Supreme Court, as noted by SmileDirectClub, has insisted that a self-regulating state professional board is not itself the state, so a board's actions might be subject to federal antitrust law. In the SmileDirectClub cases, however, state regulators have acted as required by state legislatures and as expressed in state dental practice acts. The boards' activities here are therefore cloaked in the states' immunity to antitrust litigation and should be treated deferentially by federal courts. Furthermore, judicial review of the substance of every regulation to which SmileDirectClub objects is inappropriate under principles of constitutional law. In the interest of public safety, courts should permit state dental regulators to fulfill their mandates and ensure that all dental providers comply with state health regulations.","PeriodicalId":7680,"journal":{"name":"American Journal of Law & Medicine","volume":"48 4","pages":"420-434"},"PeriodicalIF":0.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9314742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Drug Abuse and Crime – The Challenges to Nation Building 毒品滥用与犯罪——国家建设面临的挑战

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-11-01 DOI: 10.47672/ajl.1262

Mary Imelda Obianuju Nwogu

{"title":"Drug Abuse and Crime – The Challenges to Nation Building","authors":"Mary Imelda Obianuju Nwogu","doi":"10.47672/ajl.1262","DOIUrl":"https://doi.org/10.47672/ajl.1262","url":null,"abstract":"Purpose: Drug abuse and crime are very strongly linked and connected, one may precede the other. The close connect between drug use and criminal behaviour is supported by many studies. Drug use or abuse and crimes are prevalent among the youths, who are the age range most needed for productive work and nation building or development. Drugs decrease cognitive operations, making it difficult, and at times impossible for the young person to develop a functional set of values and ideals. Consequently drug and crimes pose very great and grave challenges to nation building and development of the society. \u0000Methodology: Several books, journals, internet materials and case laws reviewed have analyzed drug use/abuse by the youths, stated the consequences and decried it. \u0000Findings: Unfortunately, this has not received adequate, sufficient or and commensurate attention the world over, worse still in developing countries of the world as Nigeria. It has negatively affected the behavior and conduct of users particularly the younger generation and consequently a clog to nation building. \u0000Recommendations: It is recommended that drug abuse and crimes can be drastically reduced or completely eradicated by good training and nurturing of the child by political and social institutions; putting in place adequate legal framework with effective enforcement mechanism; proper education of the public. By Comity of nations giving adequate attention to curbing the use of drugs, drug abuse and drug addiction.","PeriodicalId":7680,"journal":{"name":"American Journal of Law & Medicine","volume":"62 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76380653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 4

An Examination of the Nigerian Gas Law and Policy: Facilitating Domestic Gas 尼日利亚天然气法律和政策审查:促进国内天然气

IF 0.6 4区社会学

American Journal of Law & Medicine Pub Date : 2022-10-20 DOI: 10.47672/ajl.1237

Bodisere T Timitimi

{"title":"An Examination of the Nigerian Gas Law and Policy: Facilitating Domestic Gas","authors":"Bodisere T Timitimi","doi":"10.47672/ajl.1237","DOIUrl":"https://doi.org/10.47672/ajl.1237","url":null,"abstract":"The Federal Government of Nigeria based on its sizable gas reserves, identified the need for accelerated development of the gas industry as a focal strategy for achieving the national aspiration of aggressive GDP growth. Endowed with energy resources, Nigeria has about 188tcf of proven reserves. Active power plants are mainly gas-fired, but they face feedstock shortages, as a result of a dearth of infrastructure investment. Nigeria’s gas industry is still in its infant stage unlike the UK and US. Oil and gas companies have historically flared natural gas into the environment mainly because it was considered an oil by-product and not an economic product. The development of a domestic market today is the top of the government's agenda. The Federal Government recently approved the Nigerian National Gas Policy 2017. The goal as highlighted in the policy is the commercialization of gas to boost the economy, electricity undoubtedly being central to economic growth. This paper discusses, gas pricing, unbundling and open access and the Domestic Gas Obligation. The purpose of this study is to highlight various areas of improvement and provide an analysis of existing laws and policy. Results suggest that market liberalization and increase in private sector involvement are the two strengths agreed upon. In addition, the participants concur on the importance of increasing share of LNG in the total natural gas supply.","PeriodicalId":7680,"journal":{"name":"American Journal of Law & Medicine","volume":"2 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2022-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88749557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0