Fordham Law Review最新文献

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 Despite these possible consequences, CRISPR remains largely unregulated due to the United States's outdated regulatory scheme for biotechnology.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.

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.

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.

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.

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.