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FSU Law Focus - 11/16/2022
Get PDFFrom the Dean: Judge T. Kent Wetherell II (\u2795) for Jurist in Residence Program; Students Participate in 2022 Moot Court Final Four Competition; Alum Profile: Benjamin C. DeStefano (\u2719); Student Profile: 3L Ella Bigginshttps://ir.law.fsu.edu/fsu-law-focus/1046/thumbnail.jp
FSU Law Focus - 12/16/2022
Get PDFFrom the Dean: Alumni connection to law school, Stoops Colabhttps://ir.law.fsu.edu/fsu-law-focus/1070/thumbnail.jp
FSU Law Focus - 08/16/2022
Get PDFFrom the Dean: Celebrating Summer 2022 Graduates; Students Gain Valuable Experience Through Summer Externships; Alum Profile: Russell S. Kent (\u2794); Student Profile: 3L Sofia Azpuruahttps://ir.law.fsu.edu/fsu-law-focus/1079/thumbnail.jp
FSU Law Focus - 06/03/2022
Get PDFFrom the Dean: New faculty members; Faculty Profile: Charquia Wright; Alum Profile: John M. Vernaglia (\u2718); Celebrating 2022 Grad Allaa Tayebhttps://ir.law.fsu.edu/fsu-law-focus/1150/thumbnail.jp
FSU Law Focus - 03/18/2022
Get PDFFrom the Dean: The Political Case for Carbon Pricing Panel hosted at FSU, moderated by Shi-Ling Hsu; Moot Court Team Wins National Competition; PILC Students Advocate for Children; Alum Profile: Sandra M. Upegui (\u2799); Student Profile: 3L Matthew Stronghttps://ir.law.fsu.edu/fsu-law-focus/1213/thumbnail.jp
Automating FDA Regulation
Get PDFIn the twentieth century, the Food and Drug Administration ( FDA ) rose to prominence as a respected scientific agency. By the middle of the century, it transformed the US. medical marketplace from an unregulated haven for dangerous products and false claims to a respected exemplar of public health. More recently, the FDA\u27s objectivity has increasingly been questioned. Critics argue the agency has become overly political and too accommodating to industry while lowering its standards for safety and efficacy. The FDA\u27s accelerated pathways for product testing and approval are partly to blame. They require lower-quality evidence, such as surrogate endpoints, and shift the FDA\u27s focus from premarket clinical trials toward postmarket surveillance, requiring less evidence up front while promising enhanced scrutiny on the back end. To further streamline product testing and approval, the FDA is adopting outputs from computer models, enhanced by artificial intelligence ( AI ), as surrogates for direct evidence of safety and efficacy. This Article analyzes how the FDA uses computer models and simulations to save resources, reduce costs, infer product safety and efficacy, and make regulatory decisions. To test medical products, the FDA assembles cohorts of virtual humans and conducts digital clinical trials. Using molecular modeling, it simulates how substances interact with cellular targets to predict adverse effects and determine how drugs should be regulated. Though legal scholars have commented on the role of AI as a medical product that is regulated by the FDA, they have largely overlooked the role of AI as a medical product regulator. Modeling and simulation could eventually reduce the exposure of volunteers to risks and help protect the public. However, these technologies lower safety and efficacy standards and may erode public trust in the FDA while undermining its transparency, accountability, objectivity, and legitimacy. Bias in computer models and simulations may prioritize efficiency and speed over other values such as maximizing safety, equity, and public health. By analyzing FDA guidance documents and industry and agency simulation standards, this Article offers recommendations for safer and more equitable automation of FDA regulation
Patents on Psychedelics: The Next Legal Battlefront of Drug Development
Get PDFIn the past two decades, pioneering research has rekindled interest in the therapeutic use of psychedelic substances such as psilocybin, ibogaine, and dimethyltryptamine (DMT). Indigenous communities have used them for centuries, and researchers studied them in the i9gos and \u276cs. However, most psychedelics were banned in the \u277os, when President Nixon launched the U.S. war on drugs. Fifty years later, rising rates of mental illness, substance use, and suicide are prompting researchers to revisit psychedelics, and some have gained permission to study them in limited quantities. Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. This Essay analyzes the ethical, legal, and social implications of patenting these controversial substances. Patents on psychedelics raise unique concerns associated with their unusual qualities, history, and regulation. Because they were criminalized for decades, the U.S. Patent and Trademark Office (PTO) lacks personnel with expertise in the field, rendering more questionable the quality of its evaluation of psychedelic patents. Moreover, because Indigenous communities pioneered many aspects of modern psychedelic therapies, their patenting by Western corporations may promote biopiracy, the exploitation of Indigenous knowledge without compensation. Importantly, control of psychedelics by a small number of companies may stifle innovation and reduce access to these therapies. The Essay presents proposals to reduce the risk of biopiracy and the issuance of unwarranted psychedelic patents. Potential solutions include the implementation of psychedelic patent pledges, the creation of psychedelic prior art repositories, and the tightening of patentability requirements for novel drug therapies. The Essay concludes that ultimately, due to their importance to the advancement of science and public health, it may be appropriate to view psychedelics as tools of scientific discovery, eligible only for limited patent protection
Previvors
Get PDFIndividuals who are not yet sick, but who have a genetic predisposition to disease, often identify as previvors\u27 a combination of the terms predisposition and survivor. The previvor experience challenges many of the traditional expectations related to the provision of medical care and individual decision making. This article is the first to define the term \u27`previvor for the legal literature and the first to examine the role of law in previvor decision making. In essence, this project uses previvorship as a case study to demonstrate how the practice of medicine and medical decision making is evolving to render current law and policy increasingly inapplicable to modern medical practice. It concludes that the legal doctrine of informed consent is inappropriate to ensure adequate medical decision making, as exemplified by the previvor experience. The doctrine\u27s overemphasis on risk-based disclosures and its failure to address medical uncertainty is representative of the hazards of relying on the biomedical model of disease. Rather, we should begin to envision a legal doctrine that supports a robust shared decision-making approach to truly address individual preferences and values, the increasing complexity of risk/benefit assessment, and inherent (and sometimes irreducible) uncertainty
Innovation in Adversity
Get PDFAdverse experiences, like long-term poverty, can inhibit innovation. But as much research and many real-world examples show, adversity can also stimulate innovation. Indeed, the COVID-19 pandemic provides a number of recent examples where adverse conditions have led individuals, firms, and governments to innovate in the hope of benefiting society. Despite the fact that some forms of adversity undermine innovation while others stimulate it, legal scholars have largely failed to distinguish between the two forms or even account for adversity\u27s relationship to innovation when assessing innovation law and policy, including intellectual property (IP) laws. Yet given adversity\u27s significant role in affecting the pace and direction of innovation, doing so is crucial. In this Article, we undertake that task. Our analysis shows that adversity is most likely to stimulate innovation when it satisfies what we call the Goldilocks principle: the adversity is neither too intense nor too mild, too fleeting nor too enduring, too all-encompassing nor too confined, too commonly experienced nor too isolated, too severe nor too insignificant, but instead is just right. Hence, for adversity to have the best chance of stimulating innovation, it should be (1) a relatively discrete experience; (2) of moderate intensity; (3) experienced collectively rather than in isolation; and (4) significant enough that, if left unaddressed, the adversity could result in severe consequences for large groups of people. To be clear, these conditions are not necessary for innovation- adversity, or some other trigger, might spur innovation even if each of these conditions is not met. Neither are they sufficient-innovation will not necessarily occur even if all of these conditions are present. Indeed, individual and organizational characteristics often play a role in determining whether a party will respond to adversity with innovation. But existing research suggests that these are some of the features of adversity most conducive to, and thus most likely to inspire, innovation. Conversely, adverse conditions falling outside of these parameters are more likely to inhibit innovation, or at least fail to stimulate it. We then assess what this means for IP laws and innovation policy more generally. Predominant theories suggest that IP laws are meant to incentivize parties to benefit society through innovation and creativity. Yet over the years, commentators have pointed out that IP rights are often unnecessary to inspire these activities and thus at times impose unnecessary costs on society by restricting access to those innovations. We contribute to this important discussion by highlighting the role that adverse conditions frequently play in affecting the pace and direction of innovation. First, we argue that the role of certain types of adversity in stimulating innovations provides another reason to doubt the efficacy of IP rights as applied to many of those innovations. Other policy levers, such as grants and prizes, may often be preferable in such cases. Second, we explore possible solutions to innovation-inhibiting adversity, including bolstering IP rights in certain situations and a greater societal commitment to basic research funding. Finally, we examine the role that adversity can play in creating innovation path dependencies, and we briefly explore some possible solutions to this dilemma