Food and Drug Law Commons^™

The Transatlantic Clinical Trial Transparency Gap, Gabriela Lenarczyk

Georgia Journal of Law & Technology

Clinical trial data occupy a contested space between private commercial assets and public goods. While the United States Food and Drug Administration (FDA) has historically shielded these data through expansive trade-secret interpretations, the European Union (EU) has adopted a more open disclosure regime. This Article compares the two regimes and traces how the EU’s two-decade journey toward transparency has become a key reference for researchers and advocates of open data-sharing.

Focusing on EU practices—targeted redactions, time-bound access, granular disclosure guidelines—the paper shows that U.S. objections to broader transparency often rest on overstated concerns about competitive harm. A Filspari (sparsentan) case …

Drug Scheduling As Institutional Design, Matthew B. Lawrence, David E. Pozen

Faculty Scholarship

Controlled Substances Act (CSA), U.S. drug law has simultaneously fueled mass incarceration, inhibited needed access, and enabled an opioid crisis. To make better choices, this Article argues that the CSA’s institutional design must account for three distinctive features of psychoactive drugs: the prohibition problem (drug bans tend to backfire when demand is inelastic), the pharma problem (drug companies have supercharged incentives to manipulate markets and exploit consumers), and the pluralism problem (drug policy involves irreducibly political questions that no expert discipline can answer). On their own, each of these problems calls for reform to the CSA. Taken together, they call …

Medical Device Dangers: Choosing Ignorance In The Courts And At The Fda, George Horvath

William & Mary Law Review

Medical devices save lives and improve well-being but have caused as many as 83,000 deaths and 1.7 million injuries in a recent decade. Decisions of critical importance—patients’ decisions whether to have a device implanted, doctors’ decisions about which device to use, insurers’ decisions whether to reimburse for those devices—depend on information about risk that is provided by manufacturers. But producing this information is costly. Injured patients, through private lawsuits under state products liability theories, can incentivize device manufacturers to incur these costs and to produce and disclose information about device risk. Unfortunately, courts are making it increasingly unlikely that this …

Tracing The Truth: Strengthening U.S. Food Traceability With Lessons From The Eur. Union, Carolina Gomez

University of Miami Business Law Review

The United States (U.S.) has made significant progress in improving food traceability, with the FDA’s Final Food Traceability Rule set to take effect in 2026. This long-overdue regulation aims to improve outbreak response and better protect public health. However, major gaps in the U.S. traceability system remain, leaving consumers exposed to preventable foodborne illness outbreaks. Legislative challenges, including H.R. Bill 7563 and provisions in the Fiscal Year 2025 Agriculture Appropriations bill, threaten to delay or weaken these necessary reforms. Compounding these challenges, on August 7, 2025, the FDA proposed extending the compliance deadline for the rule by 30 months, to …

Fda Policy Shift On Clinical Efficacy Study Requirements For Monoclonal Antibody Biosimilars, Rileigh Rahrig, Madilyn Paphanchith, Allie Honigford, Daniella Egbujor, Haley Brown, Jenny Magana Figueroa, Connor Dains, Brenna Hissong, Kyle W. Parker

Pharmacy and Wellness Review

Biologic products are widely used in the treatment of various disease states, including rheumatoid arthritis, inflammatory bowel disease, cancers, and genetic diseases. These products are derived from proteins and genes produced by living organisms and are subsequently used to treat specific disease states. Due to the complexity of biological products, the costs of research and production are high. Currently, the United States approval pathway requires extensive testing for biologics to be designated as biosimilars, meaning there are no clinically meaningful differences in safety or purity of their active components. These required tests can be redundant, as biosimilars are developed using …

A New Framework For Drug Pricing Law And Policy, Rachel E. Sachs

Indiana Law Journal

Scholars and policymakers have expressed concern about the impact of high prescription drug costs on patients and healthcare budgets. This Article presents a new theoretical framework for evaluating both the problem to be addressed by drug pricing reforms as well as the efficacy of potential solutions. In seeking to solve “the drug pricing problem,” our legal system has given primacy to competition rather than regulation to drive down drug prices. This Article disaggregates the broader concept of drug competition into four steps, each of which must be addressed and each of which elevates different institutional actors to key roles. In …

The Law’S Failure To Protect Our Drinking Water From Pfas, Emily Levine

Indiana Law Journal

How did per- and polyfluoroalkyl substances (PFAS), the forever chemicals known to harm human health and appear in most Americans’ blood, spread so widely in drinking water? Why didn’t someone with the power and knowledge to stop this crisis step in sooner? Simply imposing limits on PFAS levels in public water systems is the bare minimum to protect American drinking water—a necessary step but only the starting point of a long path toward creating a regulatory framework that can withstand the whims of changing presidential administrations and political influences.

     It is too easy for the EPA Administrator, either out of …

Rebalancing The Milk Market: A Shared-Burden Framework For Dairy And Plant-Based Producers, Isabelle Ulrich

Mitchell Hamline Law Review

This Note examines the structural and regulatory differences between traditional dairy products and the rapidly expanding plant-based milk products in the United States. Through analysis of historical Federal Milk Marketing Order policies, mandatory checkoff programs, and contrasting labeling standards in the United States and European Union, this Note reveals how plant-based milk producers enjoy competitive advantages without sharing the financial or regulatory burden that traditional dairy producers face. This Note argues for a shared-burden policy requiring all entities marketing “milk,” whether dairy or plant-based, to contribute to promotional and regulatory funds. This framework will restore market fairness, preserve consumer choice, …

Hester’S Dubious Roots And Legacy: Open Fields Doctrine Under Scrutiny, Laura K. Donohue

Georgetown Law Faculty Publications and Other Works

For over a century, open fields doctrine has shaped Fourth Amendment law, denying people the right to be secure on their own property. Its application has steadily expanded, with the result that, by some estimates, the Government can now engage in warrantless surveillance of some ninety-six percent of private land and buildings regardless of fences, postings, the distance from public roads or byways, or the use to which the property is put. An originalist approach throws the doctrine into disarray: at the time of the Founding, common law protected the curtilage, which extended to the fields, barns, storehouses, and other …

Legalizing Magic Mushrooms: A Different Set Of Laws For A Different Kind Of Drug, Edward S. Adams

Articles

This Article explores the regulation of the cannabis industry, highlighting its origins, history, and shortcomings. The Article then compares the cannabis and psilocybin industries, arguing against the replication of the cannabis regulatory structure for psilocybin. Instead, this Article will propose tailored regulatory solutions designed to address the unique characteristics of psilocybin and foster a well-regulated, safe, and effective market.