Food and Drug Law Commons^™

The Right To 'Trip:' Navigating Psilocybin-Assisted Psychotherapy Under The Right To Try Pathway, Caitlyn S. Greenspun

Loyola University Chicago Law Journal

This Comment explores the legal, ethical, and regulatory challenges surrounding the use of psilocybin-assisted psychotherapy for terminally ill patients under the federal Right to Try (RTT) Act. While psychedelics like psilocybin are demonstrating extraordinary therapeutic potential, particularly in easing end-of-life psychological distress, patients remain barred from access due to the Controlled Substances Act (CSA) and the Drug Enforcement Administration's (DEA) narrow interpretation of its authority. Through a comprehensive analysis of legislative history, regulatory frameworks, and administrative law principles, this Comment argues that the DEA's position not only misinterprets the statutory relationship between the RTT Act and the CSA, but also …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

National Pork Producers Council V. Ross: Reining In The Dormant Commerce Clause, Pushing The Limits Of State Sovereignty, Jessica Kowalski

Loyola University Chicago Law Journal

The dormant Commerce Clause is one of the oldest constitutional doctrines in the United States and is essential in maintaining equal sovereignty among the states. While the doctrine has been substantially refined since it was first recognized, it had gone largely unchanged in recent years, until a controversial California law required further clarification of its scope.

In National Pork Producers Council v. Ross, the Supreme Court considered whether a California law prohibiting the in-state sale of pork produced in cruel conditions was constitutional under the dormant Commerce Clause. The Court ultimately upheld the California law, holding that a regulation …

Beyond Traditional Ip: Addressing Regulatory Barriers, Cynthia M. Ho

Faculty Publications & Other Works

The chapter begins with the genesis of relevant regulatory protections and their general parameters before discussing their prevalence among countries. It then turns to discussion of proposed and actual modification of TRIPS requirements for COVID and how that intersects with these regulatory barriers. The chapter concludes with recommendations.

The Status Of California's Pay-For-Delay Legislation And Litigation, Jordan Paradise

Faculty Publications & Other Works

Pay-for-delay settlements arise when the brand drug company compensates the generic in some form to delay entry to market, thereby effectively eliminating the 180-day exclusivity on the market the generic is entitled to under law. At the federal level, the Supreme Court has established factors to determine whether such agreements violate antitrust law, policymakers have introduced legislation to curb the practice, and the Federal Trade Commission continues to actively police such deals. At the state level, California Attorney General Xavier Becerra made headlines for securing legal settlements in July 2019 with several pharmaceutical companies accused of participating in pay-for-delay agreements. …

Insulin Federalism, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Pandemic Politics, Public Health, And The Fda, Jordan Paradise, Becky Bavlsik

Faculty Publications & Other Works

No abstract provided.

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Avoiding The Trips Trap: A Path To Domestic Disclosure Of Clinical Drug Data Consistent With International Norms, Cynthia M. Ho

Faculty Publications & Other Works

No abstract provided.

Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise

Faculty Publications & Other Works

In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug …

Fda Publicity And Enforcement In The Covid-19 Era, Jordan Paradise, Elise Fester

Faculty Publications & Other Works

No abstract provided.

Regulatory Silence At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Exploring Precision Fda, An Online Platform For Crowdsourcing Genomics, Jordan Paradise

Faculty Publications & Other Works

The U.S. Food and Drug Administration has created an online platform for the next generation sequencing community, enabling users to evaluate biomarker information and share resources. This article examines this online platform and offers several observations about potential legal and regulatory implications.

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

The Lanham Act's Wonderful Complement To The Fdca: Pom Wonderful V.Coca-Cola Enhances Protection Against Misleading Labeling Through Integrated Regulation, Jennifer Thurswell Radis

Loyola University Chicago Law Journal

POM Wonderful sued Coca-Cola under the Lanham Act claiming that it suffered losses due to the misleading label on Coca-Cola’s Minute Maid brand’s Pomegranate Blueberry juice blend. Reversing the Ninth Circuit’s decision in June 2014, the Supreme Court found that POM’s claim was not precluded even though the label was regulated by the FDCA. In fact, the Court acknowledged the complementary nature of private enforcement with FDA regulation, as it did in Wyeth v. Levine in 2009. This Article submits that POM exemplifies the Court’s willingness to strengthen the Lanham Act’s protections against misleading labeling, as it did the same …

Whipping A Game On Fellons: The Atf "Stash House" Cases, Tom Mcgettrick

Public Interest Law Reporter

No abstract provided.

Drug Tests For Welfare: Saving Taxpayer Money Or Flushing It Down The Drain?, Michelle Yoder

Public Interest Law Reporter

No abstract provided.

Combating Hunger Home And Away: Tracing America's $600 Million Price Tag For Safeguarding The Right To Food In The Horn Of Africa, Natnael Moges

Public Interest Law Reporter

No abstract provided.

Obama Administration Withholds Funds For Drug War In Mexico Pending Human Rights Reform, Christina Mcmahon

Public Interest Law Reporter

No abstract provided.

Re-Stocking The Shelves: Policies And Programs Growing In Food Deserts, Tess Feldman

Public Interest Law Reporter

No abstract provided.

Lawsuits Over Tainted Heparin Manufactured In China: Is The Fda Becoming The Global Healthcare Authority? , Christina Laga

Public Interest Law Reporter

No abstract provided.

House Passage Of Cheeseburger Bill Cheered On By Food Industry, Andrea Binion

Public Interest Law Reporter

No abstract provided.

Bioshield 2: A Shot In The Right Direction?, Lindsay Frank

Public Interest Law Reporter

No abstract provided.

The End Of Azt Patent: A New Beginning Or Too Little Too Late?, Lindsay Frank

Public Interest Law Reporter

No abstract provided.

To Prosecute Or Not To Prosecute: The Dilemma Posed By Pregnancy And Substance Abuse, Eileen D. Collins

Public Interest Law Reporter

No abstract provided.

Let The Testing Begin, Alexis Reed

Public Interest Law Reporter

No abstract provided.

Drug Price Quintuples, Does Not Invoke Federal "March-In" Protections, Zachary Ziliak

Public Interest Law Reporter

No abstract provided.

Striking The Balance: Pharmaceutical Patent Values And Consumer Availability, Valerie Sarigumba

Public Interest Law Reporter

No abstract provided.

Congress, Illinois Think Canada Is Answer To Prescription Drug Woes, Katherine Licup

Public Interest Law Reporter

No abstract provided.