Food and Drug Law Commons^™

Fireproofing The Fda: Power, Politics, And Public Health, Daniel G. Aaron

Utah Law Review

On September 26, 2025, the S.J. Quinney College of Law hosted the Lee E. Teitelbaum Utah Law Review Symposium — Fireproofing the FDA: Power, Politics, and Public Health. The symposium is available on YouTube. Participants discussed problems longstanding and new in an attempt to chart a path for this vital agency. Topics included (1) What is the purpose of FDA?; (2) In what ways are the current Administration’s actions precedented or unprecedented?; (3) What is the current and ideal relationship between law and politics?; (4) How can law serve as an agent of public health?; and (5) How do we …

Fda Policymaking In The Trump Deregulation Era, Jordan Paradise

Utah Law Review

This Article endeavors to contribute to and continue the conversation about how the Trump deregulatory agenda is impacting a vital national public health agency, the FDA, and our national collective public health in ways that deviate from longstanding agency policy and practice. Various other FDA policy actions deserve concerted attention by legal scholars, including the agency’s recent moves in the direct-to-consumer marketing (DTC) drug space through targeted warning letters and publicity about reforming the “adequate provision” standards, food additives and generally recognized as safe (GRAS) listing processes and directives to industry, adjustments to the biosimilar interchangeability requirements through guidance document, …

The Fda’S New Clinical Decision Support Software Guidance And Its Implications For Artificial Intelligence, Sara Gerke

Utah Law Review

Artificial Intelligence (AI) is transforming healthcare. While the U.S. Food and Drug Administration (FDA) has authorized the marketing of more than 1,400 AI-based products classified as devices under Section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act, many other AIbased products, including certain clinical decision support (CDS) software tools that provide recommendations to health care professionals about diagnosis, treatment, or prevention of a disease or condition, have been placed on the U.S. market without FDA premarket review. On January 6, 2026, the FDA issued a revised CDS Guidance, which superseded the September 28, 2022 CDS Guidance. Shortly after, the …

Fda In 2050: Best- And Worst-Case Scenarios, Michael Sinha M.D., J.D., M.P.H.

Utah Law Review

In 2025, the Trump administration disrupted many critical aspects of the biomedical research infrastructure in the United States. The Food and Drug Administration (FDA) was not spared. Robert F. Kennedy, Jr., a known vaccine denier with no health care experience, was confirmed as Secretary of the U.S. Department of Health and Human Services (HHS) in February 2025, followed by the confirmation of Dr. Martin Makary as Commissioner of the FDA in April. Departures of long-time FDA scientists, coupled with appointments of key personnel, seemingly because of their public stances on COVID-19 mRNA vaccines, have resulted in a tumultuous year for …

Post-Approval Problems, Anjali Deshmukh

Utah Law Review

Sitting across from 4-year-old Jessica’s parents, I whispered the truth: the most promising drug to fight their daughter’s disease was a therapy approved for adults, not for children her age. We could estimate the dose, monitor her organs, and hope the toxicity would not outpace the benefits, but there was no high-quality clinical trial data proving it was safe for kids like her yet, despite congressional mandates. Unexpected safety issues are often identified after drugs are approved and used outside of a closely controlled clinical trial, especially in understudied populations like children, the elderly, and pregnant women. When I asked …

Evaluating The Case Against Fda Independence, Patricia J. Zettler, Rachel Sachs

Utah Law Review

Many former FDA officials, both politically-appointed leaders and those from the career ranks, as well as numerous FDA scholars have advocated for increased FDA independence in varied forms, and for good reason. At the same time, there are advantages to FDA’s current structure, and there may be ways to insulate career scientific experts’ decisions from political influence and to address other problems by generating independence, without overhauling the agency’s design. Policymakers should consider all options, as particular independence features may, or may not, be the best way, to address concerns about FDA’s capacity to carry out its vital public health …

A Primer Of Medical Device Regulation: How To Go From Reactive To Proactive To Better Protect Patient Safety, Sneha Dave, Rita Redberg

Utah Law Review

FDA oversight of medical devices has too often been reactive, following preventable disasters rather than based on a proactive commitment to patient safety. The history of the device framework, the expansion of expedited pathways, weak postmarket surveillance, broad preemption, and conflicted patient advocacy together create a perfect storm of a regulatory environment that tolerates uncertainty and externalizes costs onto patients. Reforms such as time‑limited breakthrough status, mandatory and enforceable postmarket studies, requirements for more robust safety and efficacy data, and strengthened reporting duty for clinicians would move device regulation closer to FDA’s statutory mandate to protect public health. It would …

Masthead

Seattle University Law Review

No abstract provided.

Table Of Contents

Seattle University Law Review

No abstract provided.

Converting Buildings Is Hard: Why Seattle’S Municipal Government Should Streamline Commercial-To-Residential Conversions, Tyler M. King

Seattle University Law Review

The conversion of commercial buildings into housing is a promising solution to the growing housing crisis in many urban areas. However, despite its potential benefits, the process of repurposing commercial spaces is often stymied by complex zoning codes, high conversion costs, and bureaucratic hurdles. This Article argues that the local and state governments in Seattle should adopt more streamlined policies and offer greater incentives to developers to facilitate these conversions. By reforming zoning regulations and providing targeted financial support, municipalities can reduce the barriers to conversion and unlock the potential of underutilized commercial properties. This article examines the legal and …

Legal Malpractice In Washington: Use Of The Rules Of Professional Conduct, Angelo Tadrous

Seattle University Law Review

Legal malpractice claims are difficult to prove. They are difficult to prove because many jurisdictions require that a plaintiff prove that, but for the lawyer’s misconduct, the client would have fared better. Thus, in a malpractice suit, a plaintiff must try a case within a case. Despite this difficulty, many jurisdictions prohibit the use of the Rules of Professional Conduct when litigating a malpractice case. Washington State is one of these jurisdictions. The Washington Supreme Court held in Hizey v. Carpenter that the Rules of Professional Conduct may not be referred to during trial. This Note argues that this prohibition …

Who Decides The Dead? Interpreting Washington’S Disposition Of Remains Statute, Wyatt Young

Seattle University Law Review

Washington’s disposition-of-remains statute, RCW 68.50.160, is designed to honor a decedent’s expressed wishes regarding the control and disposition of their body after death. Yet recent litigation reveals a critical gap between the statute’s intent-centered design and its practical enforceability. In Larotonda v. Blackburn, a trial court acknowledged that irreparable harm would occur if a decedent’s burial wishes were ignored but nonetheless denied relief on the grounds that the individual designated to carry out those wishes lacked standing. The result was a legal paradox: a statute that recognizes decedent autonomy in theory but withholds any meaningful mechanism for its enforcement …

Getting Money Out Of Politics By Putting Money Into Politics: A Few Modest Proposals To Reform Seattle’S Democracy Voucher Program, Decker O’Donnell

Seattle University Law Review

Seattle’s Democracy Voucher Program offers an unconventional response to the growing influence of money in American elections: rather than restricting political spending, it seeks to amplify the participation of ordinary voters by providing publicly funded vouchers that residents may assign to participating candidates. This Article examines the program’s development, operation, and constitutional foundation within the modern campaign-finance framework established by Buckley v. Valeo and subsequent Supreme Court decisions. It argues that democracy vouchers provide a constitutionally viable means of broadening participation in campaign financing while mitigating the influence of wealthy donors. The Article identifies two weaknesses in the current system: …

Brief Of Public Health And Health Law Scholars As Amici Curiae Urging Affirmance In Support Of Plaintiffs-Appellees, Rachel L. Zacharias, Zeinab Bakhet, Kevin Costello, Maya Manian

Amicus Briefs & Court Filings

INTRODUCTION: Physicians’ use of their judgment and expertise to prescribe drugs and devices for purposes other than those approved by the Food and Drug Administration (“FDA”)—colloquially known as off-label use—is an indispensable feature of modern medicine. The FDA approves drugs as “safe and effective for specific indications.” Christopher M. Wittich, Christopher M. Burkle & William L. Lanier, Ten Common Questions (and Their Answers) About OffLabel Drug Use, 87 Mayo Clinic Procs. 982, 982 (2012). Federal law then generally leaves prescribing decisions, including off-label use of FDA-approved drugs and devices for a patient’s particular indication, to physicians acting under state law …

Pragmatic Conceptualism, Public Nuisance, And The American Opioid Litigation, Benjamin C. Zipursky

Washington and Lee Law Review

Public nuisance as a part of American tort law has been as high profile in the first decades of this century as products liability law was in the last several decades of the twentieth century. The American opioid litigation over the past decades is a spectacular example, filling headlines and generating billions of dollars of settlements. There is a plausible argument, however, that the doctrinal core of the opioid litigation is meritless because there simply is no “interference with public right” as required by public nuisance law. The first aim of this Article is to articulate and assess that argument. …

A Bone To Pick: Back To The Basics In Food Product Liability With A Necessary Reformation Of The "Hybrid" Negligence Standard, Clay Cutteridge

Cleveland State Law Review

Ohio does not use the traditional negligence standard in determining negligence in food product liability cases. Instead, Ohio uses what is called the hybrid test. The hybrid test analyzes what a consumer would reasonably expect to find in their food, and Ohio courts consider the naturalness of an object to the food it is in to be the determinative factor: natural objects should be reasonably expected and cannot give rise to successful claims of negligence. This hybrid test fails to consider that food is complex, and consumers often cannot know what to reasonably expect in the food they buy. The …

Breaking Down Barriers To Giving: Policy Reform Needed To Protect Donors, Volunteers, And Food Charities, Ally Depriest

Journal of Food Law & Policy

Charitable organizations often depend on public support to fulfill their missions. This is especially true in the charitable food system, a network of nonprofit organizations, including food banks, pantries, and meal programs, which provide no-cost food to those in need. Within this system, volunteers, donors, and food charities each play an important role, such as donating surplus food, directing traffic at food drives, stocking local pantries, and preparing and serving meals at soup kitchens. Together, they provide both hope and nutrition to those in need. Without this public support, many food charities would be unable to operate. Encouraging public participation …

Closing The Gaps: Reforming Maryland Controls On Veterinary Antimicrobial Distribution, Samantha Capaldo, Kerry Mcclaughry

Journal of Food Law & Policy

Antimicrobials have been used in livestock and other food animals in the United States (“U.S.”) since the late 1940s. An antimicrobial is “[a]ny natural, synthetic, or semisynthetic substance that can eradicate or prevent the growth of microbes,” including “[a]ntibacterial, antifungal, antiparasitic, and antiviral medications.” Antimicrobial use in food animals is subject to a complex statutory and regulatory framework at both the state and federal levels. Antimicrobial use in food animals has been widely criticized for contributing to antimicrobial-resistant bacterial infections in humans. In response to this criticism, the U.S. Food and Drug Administration (“FDA”) and several states, including Maryland, have …

A Model For Food Safety Regulation And Effective Enforcement: A California Case Study, Ninveh Mansour

Loyola of Los Angeles Law Review

This Note examines California’s emerging leadership in food additive regulation amid perceived federal shortcomings, particularly within the FDA’s “generally recognized as safe” (“GRAS”) framework. Using recent legislation, the California Food Safety Act (“CFSA”) and the California School Food Safety Act (“CSFSA”), as case studies, this Note explores how California has acted to ban additives still permitted under federal law, citing gaps in federal oversight and consumer protection. This Note places these laws in the broader context of California’s regulatory legacy, including Proposition 65 and the artificial trans-fat ban. It also compares enforcement mechanisms, highlighting the effectiveness of Proposition 65’s private …

2025, Richard Delgado

Seattle University Law Review

"In a cutting and provocative social critique in one of the more extended Rodrigo Chronicles, Richard Delgado in 2025 employs skillful narrative—one of CRT’s many contributions to legal scholarship —to tell a gripping story of just how far the nation has descended into darkness with President Trump’s re-election. In Delgado’s vision, law professors—along with other political opponents of the President: immigrants, people of color, LGBTQ+ people, women, the underserved—have targets on their backs."

-excerpt from Kevin Johnson's review of 2025