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The FDA’s Role in Regulating Access to Gender-Affirming Care Medications
Get PDFOver the last decade, many states have passed laws seeking to restrict or ban certain medications approved by the United States Food and Drug Administration (FDA). One of the most recent examples: gender-affirming care medications for transgender youth and young adults. As of January 2025, twenty-six states have passed laws banning or restricting the provision of genderaffirming care to minors. Proponents of these laws challenge the procedures and prescription drugs as “experimental,” while critics of these laws characterize both as best-practice medical care. In either case, these laws demonstrate a second-guessing of the FDA’s long-established authority in determining the safety of prescription drugs. Although the FDA does not regulate the practice of medicine, the effect of these healthcare regulations is to limit or prohibit access to FDA-approved medications. This inconsistency raises the question of what the FDA’s role is— and should be—in protecting access to medicines.
This Article considers the FDA’s role in securing access to medications, focusing on the case of gender-affirming care medications. In doing so, this Article makes three key contributions. First, this Article provides a comprehensive account of the state laws restricting access to genderaffirming care. Second, this Article analyzes how these state laws interact with federal prescription drug regulation and demonstrates the limitations of FDA authority in preempting state laws on gender-affirming care medications. Third, this Article argues that federal prescription drug regulation must be strengthened in order to protect patients’ equitable access to medicines, including, but not limited to, gender-affirming care medications. Noting the historical role of the FDA in medical care and drug regulations, as well as the federalist implications of expanding this authority, this Article frames the FDA as not only a consumer protection agency, but also as an access to medicines agency. This framework will support the development of reforms centered at the FDA aiming to secure and expand the availability of prescription drugs for patients across the country
Beyond Human Oversight: Corporate Law and the Case for AI Directors
Get PDFCorporate laws in the United States require corporations to be governed by a board of directors consisting of humans—otherwise known as the natural person requirement. Mandating governance by individual persons stands in contrast to typical American business ideals and the freedom of contract. There are various reasons for corporate law’s imposition of the natural person requirement—many of them historical. But the justification for the natural person requirement has not been sufficiently critiqued, particularly in the context of AI. This Note argues this corporate law requirement should be amended to give corporations the option to permit AI directors in addition to other human and organizational entity directors. After reviewing the current corporate law landscape, this Note shows that the changes advocated for are quite simple to implement from a purely legal standpoint. Next, the Note presents three reasons for amending the requirement: (1) AI directors can be beneficial in ways that human directors cannot; (2) the justifications normally put forth in support of the natural person requirement fail; and (3) doing so would promote American ideals. Lastly, this Note discusses additional caveats and considerations to its proposal and compares approaches to organizational entity directors to the proposal made in this Note. The natural person requirement is outdated when considered in the context of modern artificial intelligence technology, and it should be amended to provide corporations with flexibility in designing their boards of directors
Secretive Sheriffs: Opacity and Variation in California\u27s Jail Responses to COVID-19
No full textAgnotology is the study of culturally induced ignorance or doubt, particularly the publication of inaccurate or misleading scientific data. In this Article, we draw attention to a disturbing site of agnotology: healthcare in California jails. Often obscured because of the attention to state prisons, jails were sites of opacity and misinformation, largely because of sheriffs’ refusal to collaborate with data collection efforts—both coordinated by the state and solicited through non-profits.
Building on the data collection effort of the Covid In-Custody Project and on public advocacy efforts of the #StopSanQuentinOutbreak coalition and its off-shoots, we show the chasm between data on infections, hospitalizations, and vaccinations in prison and in jail. We draw attention to the harms of decentralized data collection and argue that systemic paucity of data can harbor abysmal health outcomes and prevent collaboration when it is most needed. We also provide recommendations for improving transparency and collaboration among correctional facilities, and between them and neighboring communities, during public health crises and beyond
Navigating the Growing Prospects and Growing Pains of Managed Aquifer Recharge
No full textIncreasing water demands and declining groundwater levels have led to rising interest in managed aquifer recharge. That interest is growing in the United States—the focus of this article—and elsewhere. Increasing interest makes sense; managed aquifer recharge can reduce water-supply challenges and provide environmental benefits, sometimes with lower costs than alternative water-management approaches. But managed aquifer recharge also faces growing pains, which will make it difficult for projects to scale up and may limit the benefits provided by those projects that do go forward. Some of the problems arise from the challenges of finding physically suitable locations for managed aquifer recharge; many derive from economics, public policy, and law; and some derive from ways in which managed aquifer recharge could exacerbate traditional equity challenges of water management. But as we explain, there also are potential solutions to these challenges, and the future success of managed aquifer recharge will likely depend on the extent to which these solutions are adopted
Citizenship and Civic Engagement Among New Americans: Arab, Asian, and Latino Americans During a Shifting Political Landscape
No full textThis policy paper examines civic engagement among new Americans, focusing on factors that influence the sense of belonging and political participation, particularly among recently naturalized Asian Americans, Latinos, and Arab Americans. The study, conducted by the Center for Race, Immigration, Citizenship, and Equality (RICE) at University of California College of the Law, San Francisco (UC Law SF) in collaboration with the New Americans Campaign (NAC) at Immigrant Legal Resource Center
In Search of the Best Policies for Translational Geroscience
Get PDFThough it once seemed like an inevitable fact of life, geroscience can now credibly promise to slow and even reverse aging. New geroscience treatments offer the prospect of large increases in human welfare and will attract huge demand. How can governments best support research, development, and commercialization of the field? The answer will depend on many factors, including public policies, supply-side resources, and market size. This paper focuses on the first factor, seeking the best public policies for translating geroscience from bench to bedside. It begins with a review of current geroscience policy, identifying the rules and institutions that help or hinder innovation in anti-aging healthcare. The paper then combines facts with theory to suggest ways to improve geroscience policy. It starts with a model policy that reverses the usual precautionary prohibition on unapproved medical treatments and instead opens access to them, subject to a variety of conditions including risk disclosures, strict liability for defective manufacture, design, or documentation, and other common law protections. Something close to that model policy recently became law in two jurisdictions. Most jurisdictions remain far from that ideal, however, so the paper also describes seven pragmatic near-term reforms to promote anti-aging medicines. If limited to fixing one immediate problem, reformers should convince regulators to accept biomarkers as standards for evaluating anti-aging treatments. The paper concludes by describing a near possible future where geroscience can fulfill its potential to cure human aging safely and effectively
