{"title":"A Crispr Future for Gene-Editing Regulation: a Proposal for an Updated Biotechnology Regulatory System in an Era of Human Genomic Editing.","authors":"Tracey Tomlinson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Recent developments in gene-editing technology have enabled scientists to manipulate the human genome in unprecedented ways. One technology in particular, Clustered Regularly Interspaced Short Pallindromic Repeat (CRISPR), has made gene editing more precise and cost-effective than ever before. Indeed, scientists have already shown that CRISPR can eliminate genes linked to life-threatening diseases from an individual's genetic makeup and, when used on human embryos, CRISPR has the potential to permanently eliminate hereditary diseases from the human genome in its entirety. These developments have brought great hope to individuals and their families, who suffer from genetically linked diseases. But there is a dark side: in the wrong hands, CRISPR could negatively impact the course of human evolution or be used to create biological weaponry. Despite these possible consequences, CRISPR remains largely unregulated due to the United States's outdated regulatory scheme for biotechnology. Moreover, human embryo research, which is likely critical to maximizing the therapeutic applications of CRISPR, is not easily undertaken by scientists due to a number of federal and state restrictions aimed at preventing such research. This Note examines the possible benefits and consequences of CRISPR and discusses the current regulations in both the fields of biotechnology and human embryo research that hamper the government's ability to effectively regulate this technology. Ultimately, this Note proposes a new regulatory scheme for biotechnology that focuses on the processes used to create products using CRISPR, rather than the products themselves, with a focus on enabling ethical research using human embryos to maximize the potential benefits of CRISPR.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2018-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36565320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Dignity and Social Meaning: Obergefell, Windsor, and Lawrence as Constitutional Dialogue","authors":"S. Sanders","doi":"10.2139/SSRN.3153661","DOIUrl":"https://doi.org/10.2139/SSRN.3153661","url":null,"abstract":"The Supreme Court’s three most important gay and lesbian rights decisions – Obergefell v. Hodges, United States v. Windsor, and Lawrence v. Texas – are united by the principle that gays and lesbians are entitled to dignity. Beyond their tangible consequences, the common constitutional evil of state bans on same-sex marriage, the federal Defense of Marriage Act, and sodomy laws was that they imposed dignitary harm. \u0000This Article explores how the gay and lesbian dignity cases exemplify the process by which constitutional law emerges from a social and cultural dialogue in which the Supreme Court actively participates. In doing so, it draws on the scholarly literatures on dialogic judicial review and the role of social meaning in constitutional law. It illuminates how the Supreme Court interprets democratic preferences and constructs social meaning in order to apply fundamental Constitutional norms to emerging legal claims. \u0000Contrary to the speculations of some commentators, “dignity” in these cases did not operate as some new form of constitutional right. Rather, the identification and protection of dignitary interests served as the unifying principle for a process, unfolding in three cases over thirteen years, through which constitutional law was brought into alignment with evolving public attitudes and policy preferences. The dignity decisions should be understood as majoritarian, not acts of judicial will. They were broadly accepted, because the Court’s insights about the status of gays and lesbians in American society were consistent with dramatic and long-term changes in culture and public attitudes. As culture and attitudes evolved, so did the social meaning of anti-gay laws. Sodomy laws and marriage restrictions, once accepted as presumptively constitutional protections of tradition and public morality, increasingly came be understood as impositions of stigma and humiliation -- the kind of expressive harms that the Constitution forbids.","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2018-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43587537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Race and Assisted Reproduction: Implications for Population Health.","authors":"Aziza Ahmed","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Article emerges from Fordham Law Reviews Symposium on the fiftieth anniversary of Loving v. Virginia, the case that found antimiscegenation laws unconstitutional. Inspired by the need to interrogate the regulation of race in the context of family, this Article examines the diffuse regulatory environment around assisted reproductive technology (ART) that shapes procreative decisions and the inequalities that these decisions may engender. ART both centers biology and raises questions about how we imagine our racial futures in the context of family, community, and nation. Importantly, ART demonstrates how both the state and private actors shape family formation along racial lines. By placing a discussion about race and ART in the context of access to new health technologies, this Article argues that assisted reproduction has population-level effects that mirror broader racial disparities in health. In turn, this Article intervenes in a bioethics debate that frequently ignores inequalities in access when thinking through the consequences of ART. Part I presents a case study of the Sperm Bank of California (SBC) to demonstrate how ART represents a new mode of governing the family that facilitates and encourages the formation and creation of monoracial families. Part II borrows a public health analytic, the 'burdens of disease,\" to explain how the (re)production of monoracial families has consequences for health at the population level, especially when placed in the context of racially disparate access to ART services. Ultimately, this Article concludes that ART, as it is currently accessed and utilized, maintains racial orders with regard to health given the inequality in access to these services.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2018-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36300597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"United States v. Caronia: Off-Label Drug Promotion and First Amendment Balancing.","authors":"Daniel P Rabinowitz","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Off-label drug promotion is commonplace in the United States, but it is not without its dangers. While the Food, Drug, and Cosmetic Act does not explicitly ban off-label promotion, the Food & Drug Administration (FDA)--in order to protect consumers from unsafe and ineffective drugs--has taken steps to regulate it. The FDA does so through its intended-use regulation, which lists the types of evidence the FDA can consider in determining whether a drug is misbranded. It is a crime to sell a misbranded drug into interstate commerce or to conspire to do so. On September 25, 2015, the FDA proposed an amendment to the regulation, which has drawn opposition from various industry groups due to its potential to restrict the type of speech that is often used in off-label promotion. The First Amendment challenge to the proposed amendment rests on United States v. Caronia, in which the FDA was prevented from using truthful, nonmisleading speech to convict a pharmaceutical representative of a conspiracy to sell a misbranded drug. This Note examines whether the amendment to the regulation is permissible under Caronia. It first contends that the regulation does not facially violate the First Amendment. It further argues that the rule is constitutional and does not pose the same First Amendment issue as was seen in Caronia as long as the FDA implements it with care. This Note concludes by exploring various ways that the FDA can constitutionally regulate off-label drug promotion under the proposed rule.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2018-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36300595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Protection of Patients Under the Clayton Act.","authors":"Elizabeth S Kraus","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The vast consolidation among health-care providers in the aftermath of the Affordable Care Act's enactment has led to much debate over the benefits of mergers in the health-care industry. In 2016, the Federal Trade Commission filed motions in federal court to enjoin three hospital mergers in various parts of the country. This amounted to more challenges to hospital mergers in a single year than any year in recent history. Though two of these motions succeeded at the district court level, both were overturned on appeal, which led many to wonder what the effect of these decisions would be on future health-care mergers. While many fear that hospital mergers lead to higher prices for consumers, there are also those who contend that mergers lead to efficiencies, which allow merging parties to utilize resources more effectively, increase the quality of patient care and coordination, and potentially save lives. This Note argues that the possibility of quality-enhancing or life-saving efficiencies is worth the risk that consumers see increased prices. To allow mergers that may realize these types of efficiencies, antitrust enforcement agencies and courts must begin placing greater weight on merging parties' efficiency arguments by easing the current standard. Additionally, in light of new research suggesting that cross-market health-care mergers, or mergers between providers in different geographic markets, affect bargaining dynamics between providers and insurers, this Note argues that parties' relative bargaining power must be considered in agencies' and courts' analyses of the competitive landscape relevant to a merger.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2018-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36302239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regulating Rare Disease: Safely Facilitating Access to Orphan Drugs.","authors":"Julien B Bannister","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>While approximately one in ten Americans suffers from a rare disease, only 5 percent of rare diseases have a U.S. Food and Drug Administration (FDA) approved treatment. Congressional and regulatory efforts to stimulate the development of rare-disease treatments, while laudable, have not resolved the fundamental issues surrounding rare-disease treatment development. Indeed, small patient populations, incomplete scientific understanding of rare diseases, and high development costs continually limit the availability of rare-disease treatments. To illustrate the struggle of developing and approving safe rare-disease treatments, this Note begins by discussing the approval of Eteplirsen, the first drug approved for treating a rare disease called Duchenne muscular dystrophy. After exploring the current drug regulation system and how this impacts the availability of rare-disease treatments, this Note examines the 21st Century Cures Act's patient experience data provisions and the currently pending Trickett Wendler Right to Try Act. Ultimately, the unmet therapeutic needs of rare-disease patients can be met while protecting patient safety. This Note reasons that, if carefully implemented, the 21st Century Cures Act and the Trickett Wendler Right to Try Act could work in tandem to safely facilitate patient access to rare-disease treatments.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2018-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36302235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Role of Direct-Injury Government-Entity Lawsuits in the Opioid Litigation.","authors":"Edgar Aliferov","doi":"10.2139/SSRN.3127840","DOIUrl":"https://doi.org/10.2139/SSRN.3127840","url":null,"abstract":"The opioid epidemic has ravaged the United States, killing over 100 Americans every day and costing the nation upward of $90 billion a year. All branches and levels of the government have pursued measures to combat the epidemic and reduce its societal costs. Perhaps the most interesting response is the emergence of direct-injury government-entity lawsuits, which seek to recover damages from opioid companies that facilitated prescription pill addictions. Cities, counties, and states across the country are suing opioid manufacturers and distributors in unprecedented numbers. This Note explores the role of direct-injury government-entity claims as compared to other forms of civil litigation employed in the opioid crisis. It highlights the obstacles faced by parens patriae actions, individual lawsuits, class actions, and aggregate actions in general. This Note argues that direct injury government claims have important advantages over other forms of civil litigation because they overcome certain defenses related to victim blame worthiness and because they function as inherently representative actions that bypass the certification requirements of traditional aggregate actions.","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2018-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47813526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Intuitive Appeal of Explainable Machines","authors":"Andrew D. Selbst, Solon Barocas","doi":"10.2139/SSRN.3126971","DOIUrl":"https://doi.org/10.2139/SSRN.3126971","url":null,"abstract":"Algorithmic decision-making has become synonymous with inexplicable decision-making, but what makes algorithms so difficult to explain? This Article examines what sets machine learning apart from other ways of developing rules for decision-making and the problem these properties pose for explanation. We show that machine learning models can be both inscrutable and nonintuitive and that these are related, but distinct, properties. \u0000 \u0000Calls for explanation have treated these problems as one and the same, but disentangling the two reveals that they demand very different responses. Dealing with inscrutability requires providing a sensible description of the rules; addressing nonintuitiveness requires providing a satisfying explanation for why the rules are what they are. Existing laws like the Fair Credit Reporting Act (FCRA), the Equal Credit Opportunity Act (ECOA), and the General Data Protection Regulation (GDPR), as well as techniques within machine learning, are focused almost entirely on the problem of inscrutability. While such techniques could allow a machine learning system to comply with existing law, doing so may not help if the goal is to assess whether the basis for decision-making is normatively defensible. \u0000 \u0000In most cases, intuition serves as the unacknowledged bridge between a descriptive account and a normative evaluation. But because machine learning is often valued for its ability to uncover statistical relationships that defy intuition, relying on intuition is not a satisfying approach. This Article thus argues for other mechanisms for normative evaluation. To know why the rules are what they are, one must seek explanations of the process behind a model’s development, not just explanations of the model itself.","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2018-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2139/SSRN.3126971","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43901879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Deceptively Simple: Framing, Intuition and Judicial Gatekeeping of Forensic Feature-Comparison Methods Evidence","authors":"J. Moriarty","doi":"10.2139/SSRN.3157122","DOIUrl":"https://doi.org/10.2139/SSRN.3157122","url":null,"abstract":"For many decades, prosecutors have relied on feature-comparison methods (FCM) of forensic science evidence, including hair, fingerprints, toolmarks, handwriting, and bitemarks. Since the late 1980s, scholars and practitioners have raised serious questions about the reliability and error rates of such evidence. Two national bodies have published serious criticism of FCM evidence: the 2009 Committee of the National Research Council of the National Academy of Sciences; and the 2016 President’s Council of Advisors on Science and Technology. Despite these concerns and proof from the Innocence Project data that poor quality forensic science evidence has been a substantial component in wrongful convictions, courts continue to admit FCM evidence routinely and with little analysis, generally avoiding application of the Daubert factors related to reliability. This article questions why courts are unreceptive to challenges about the reliability of such evidence and suggests that judges perceive feature-comparison evidence as fairly straightforward and intuitively accurate. As such, courts often unknowingly rely upon heuristic approaches to the evidence — that is, cognitive shortcuts to manage complexity. By using these shortcuts, rather than rigorously evaluating reliability, decisions may inadvertently incorporate cognitive biases, including belief perseverance, confirmation bias, and assumptions of simplicity. If judges can appreciate that feature-comparison “matching” is a complex, multifaceted procedure, they might become more willing to engage in a deeper, science-based review of the evidence and better understand its shortcomings and limitations.","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68567542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Twenty-Fifth Amendment and the establishment of medical impairment panels: are the two safely compatible?","authors":"Robert E Gilbert","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2017-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35246345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}