Food and Drug Law Commons^™

Cannabis Derivatives And Trademark Registration: The Case Of Delta-8-Thc, W. Michael Schuster

Indiana Law Journal

The legal environment surrounding the cannabis industry is ambiguous and constantly changing. While cannabis is prohibited under federal law, a 2018 statute legalized a variant of the cannabis plant (“hemp”) that is low in its most common intoxicating agents. Recognizing this, entrepreneurs began to process hemp to extract and sell chemicals contained therein. Included in this trend is the extraction of Delta-8 Tetrahydrocannabinol (Δ8-THC)—a psychoactive drug with an increasing market presence in states where most cannabis (e.g., “marijuana”) is illegal.

As competition in the Δ8-THC field emerged, firms sought to distinguish their wares through brand recognition and federal trademark registration. …

Permissive Regulation: A Critical Review Of The Regulatory History Of Buprenorphine Formulations In Canada, Abhimanyu Sud, Meghan Mcgee, Barbara Mintzes, Matthew Herder

Articles, Book Chapters, & Popular Press

Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal …

On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder

Articles, Book Chapters, & Popular Press

The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of legal and policy attention due to the drug’s central role in the ongoing overdose crisis. However, little is known about the basis for OxyContin’s approval by regulators, such as Health Canada in 1996. Taking advantage of a recently created online database containing information pertaining to the safety and effectiveness of drugs, we conducted a retrospective analysis of Purdue Pharma’s submission to Health Canada, including both published and unpublished clinical trials. None of the trials sponsored by Purdue Pharma sought to meaningfully assess the risks …

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore

Faculty Scholarship

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.

The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …

Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu

Faculty Articles

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines …

The Lawyer's Role In Improving "Humane" Meat Labeling, Ryne P. Smith

Mitchell Hamline Law Review

No abstract provided.

A Prescription For Crisis: Opioids, Patients, And The Controlled Substances Act, Dennis Davis

Mitchell Hamline Law Review

No abstract provided.

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. …

Comment: On Patents And Appropriations—And Tragedies, David O. Taylor

Washington and Lee Law Review

I write to provide a few remarks concerning Sasha Hoyt’s illuminating work published in the pages of this journal. In it, Hoyt addresses the impact of the Supreme Court’s patent eligibility decisions on private investment in the development of medical diagnostic technologies. As an initial matter, I want to congratulate Hoyt for tackling an important topic. As Hoyt discusses, medical diagnostic technologies enable the diagnosis of diseases and other medical conditions such as genetic disorders, and early and accurate diagnosis may lead to early treatments and, ultimately, at least in some cases, saved lives. But the creation of medical diagnostic …

“Over-Stressed” Vines Produce No Wines, Whereas “Under-Stressed” Vines Mass Produce: Consolidation, Anti-Competition, And The Fall Of The Family Winery, Elyse Gottschalk

University of San Francisco Law Review

No abstract provided.

What’S The Beef? The Fda, Usda, And Cell-Cultured Meat, Tammi S. Etheridge

Washington and Lee Law Review

Over the past ten years, administrative law scholarship has increasingly focused on interactions between multiple agencies. As part of this trend, most scholars have called for policymakers to combine multiple agencies, rather than rely on a single agency, to solve policy problems. The literature in this area espouses the benefits of shared regulatory space. But very little of this scholarship addresses when shared jurisdiction is problematic. This is particularly concerning when an agency opts into or cedes oversight authority to another agency at will, with little regard for whether the second agency is an appropriate regulator. The case of cell-cultured …

Patent Eligibility And Cancer Therapy, Christopher B. Seaman

Washington and Lee Law Review

As an empirical legal scholar, I am pleased to report that Sasha Hoyt has done what very few law students—and even many law professors—could achieve. She successfully conducted a novel empirical study to assess the real-world impact of a U.S. Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., on venture capital (VC) investment in startups and other companies that develop medical diagnostic technology.

As Ms. Hoyt notes, patent protection is particularly important for startup companies, as it can help protect their innovations from unauthorized use, attract funding and other investments, and foster collaboration with third parties. In …

Congressional Myopia In Biomedical Innovation Policy, W. Nicholson Price Ii

Reviews

Innovation policy is hard. Getting it right requires balancing incentives for developers, consumer access, rewards for later innovators, safety concerns, and other factors. This balance is vitally important and wickedly difficult—even when it’s the focus of concerted, careful, informed effort. How well should we expect it to go when innovation policy is made by accident? Enter The Accidental Innovation Policymakers, an illuminating new project by Professor Rachel Sachs. Sachs persuasively shows how Congress has repeatedly made substantial changes to innovation policy, seemingly without talking about, seriously considering, or even recognizing that it is doing so. There’s an asymmetry to this …

Antibody Claims And The Evolution Of The Written Description/Enablement Requirement, S Sean Tu, Christopher M. Holman

Faculty Works

No abstract provided.

Take It With A Grain (Or More) Of Salt: Why Industry-Backed Dietary Guidelines Fail Americans And How To Fix Them, Caroline Farrington

University of Michigan Journal of Law Reform

The U.S. Dietary Guidelines lack oversight and accountability. The result: Guidelines that reflect food industry interests instead of modern science. This deleterious guidance goes on to govern federally-subsidized food assistance programs and to influence dietary choices throughout the private sector and private life. Ultimately, the Guidelines significantly contribute to the endemic chronic disease they seek to address.

The Guidelines Advisory Committee is notoriously rife with conflicts of interest, and thus most Guidelines scholarship has focused on reforming the Committee. But the 2015 and 2020 Guidelines show that these reforms are insufficient and agency-level change is necessary. In 2015, the Committee …

What Should Ethical And Strategic Employers Do About Covid-19 Vaccines?, Dale B. Thompson, Susan A. Suspina, Katherina G. Pattit, Dawn R. Swink

University of San Francisco Law Review

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina

Scholarship@WashULaw

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers.

Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications …

Post-Grant Adjudication Of Drug Patents: Agency And/Or Court?, Arti K. Rai, Saurabh Vishnubhakat, Jorge Lemus, Erik Hovenkamp

Articles

The America Invents Act of 2011 (AIA) created a robust administrative system-the Patent Trial and Appeal Board (PTAB)-that provides a route for challenging the validity of granted patents outside of district courts. Congress determined that administrative adjudication of the validity of initial patent grants could be cheaper and more scientifically accurate than district court adjudication of such validity.

For private economic value per patent, few areas of technology can match the biopharmaceutical industry. This is particularly true for small-molecule drugs. A billion-dollar drug monopoly may be protected from competition by a relatively small number of patents. Accordingly, the social cost …

Smoke Without Fire: Employing Mediation To Create Workplace Accommodations For Medical Cannabis Use By Disabled Armed Forces Veterans, Brendan William Potocki

Cardozo Journal of Conflict Resolution

Over the course of a nearly twelve-year career in the Air Force, which included multiple tours of duty in Afghanistan and Iraq, Stephen Otero experienced unspeakable trauma. He has the scars-both visible and invisible-to prove it. Despite being diagnosed with post-traumatic stress disorder ("PTSD") in 2008, Otero once again placed country before self and reaffirmed his commitment to serving the United States by agreeing to complete another tour of duty. During this final deployment, Otero sustained extensive abdominal injuries as a result of a suicide bombing attack.