Food and Drug Law Commons^™

The Regulation Of Lab-Grown Meat Under Existing Jurisdictional Authority, Kate Sollee

Journal of Health Care Law and Policy

No abstract provided.

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 …

Why Can't I Get Pliny The Elder? Beer Distribution Law In Michigan, Kincaid C. Brown

Law Librarian Scholarship

If you are a craft beer drinker, you have noticed that there are many beers brewed in the United States that you cannot buy in Michigan, like California-based Pliny the Elder. You will have also noticed that there are many craft beers brewed in Michigan that you cannot buy at your local grocery store or bottle shop. Why is that the case? The short answer is because Michigan law mandates that beer pass through what’s known as a three-tier distribution system. This article outlines what a three-tier distribution is, what it means for Michigan brewers and beer drinkers,

Let’S Get Crafty: The Evolution And Challenges Of Beer In The Southeast, Kennedy Weathers

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

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 Legal Role In Building Sustainable Public Health (Symposium Transcript), Joanna K. Sax

Faculty Scholarship

The article presents a discussion of food as a public health issue, beginning with why science matters and utilizing science to solve food as a public health issue, especially as it relates to sustainability and climate change. Consumer misperceptions of the risk created by new scientific technologies (e.g., GMOs), or even older scientific technologies, may thwart use of such technologies to solve sustainability problems. The talk addresses why consumers might inappropriately assign risk to certain scientific applications and ways that we might want to think about resolving that issue or closing the divide between consumer misperception of risk and evidence-based …

Off-Label Innovations, David A. Simon

Georgia Law Review

Modern medicine faces many significant problems. This Article is about two of them. The first is that approved drugs have many potential therapeutic uses that are never identified, investigated, or developed. The second is the routine practice of physicians prescribing approved drugs for unapproved uses—so-called “off-label” uses. These problems seem very different. Failure to invest in potential new uses is an innovation problem: firms lack incentives to research and develop new uses of old drugs. The problem of off-label uses, on the other hand, is one of safety and efficacy: off-label uses are risky because they are not supported by …

Where's The Beef? Meat Shortages, Farmer Needs, And Long-Term Recovery Policies In A Pandemic Era, Kim Vu-Dinh

Faculty Scholarship

COVID-19 not only affected every hospital bed in the nation--if not the world; it also affected nearly every dinner table in America and beyond. Supply chain disruptions caused by the pandemic highlighted deep-seated problems with how we get our meat, and how difficult we make it for American farmers to sell to the family next door. Within a few months of the first reported case in the US, hundreds of workers from just two meat-processing plants on American shores became infected with COVID-19, and imports from around the world came to a standstill as factories and shipping companies were forced …

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …

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 …

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. …

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 …

Misinformation About Marijuana: Commercialization, Consolidation, And The New First Amendment, David Angelatos

American University Law Review

From “Reefer Madness” to “This Is Your Brain on Drugs,” Americans have lived through decades of anti-cannabis propaganda. Legalization is poised to turn this information environment on its head, unleashing a torrent of corporate-funded, pro-cannabis misinformation that regulators cannot prevent or dispel. This appears to be a problem caused by the Supreme Court’s creation and expansion over the past fifty years of First Amendment protections for corporate and commercial speech. Although these doctrines contribute substantially to the problem, this Article shows how it originates in lax antitrust policy rather than expansive First Amendment jurisprudence.

If Congress follows current legalization trends …

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 …

Steering Loan Modifications Post-Pandemic, Pamela Foohey, Dalie Jimenez, Christopher K. Odinet

Articles

As part of federal and state relief programs created during the COVID-19 pandemic, many American households received pauses on their largest debts, particularly on mortgages and student loans. Others may have come to agreements with their lenders, likewise pausing or altering payment on other debts, such as auto loans and credit cards. This relief allowed households to allocate their savings and income to necessary expenses, like groceries, utilities, and medicine. But forbearance does not equal forgiveness. At the end of the various relief periods and moratoria, people will have to resume paying all their debts, the amounts of which may …

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.

“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.

Eviscerating Patent Scope, Shahrokh Falati

Articles & Chapters

The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Table Of Contents

Seattle University Law Review

Table of Contents

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 …

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.

Autumn Is Coming: A Novel Liability Theory That May Kill Pharmaceutical Evergreening, Uri Y. Hacohen

Cardozo Arts & Entertainment Law Journal

Pharmaceutical evergreening-attempts by brand-name manufacturers to leverage patent rights to artificially extend legal protection for drugs-is among the most pressing and unresolved public policy challenges of our time. On July 14, 2021, in Sanofi et al. vs. Unipharm Ltd., the Israeli Supreme Court adopted a novel and internationally unprecedented legal policy to combat the evergreening pandemic. By using its equitable powers, the Israeli court empowered a generic manufacturer, Unipharm, to claim on behalf of the public interest the wrongly obtained monopoly profits that a brand-name manufacturer, Sanofi, obtained by improperly leveraging its improvement patent to impair generic market entry. This …

Genetically Engineered Food, Food Security, And Climate Change, Joanna K. Sax

Faculty Scholarship

Malnutrition is the leading cause of death and disease worldwide. Climate change is an existential crisis. We need to feed people and address the role of agriculture in climate change – at the same time. This is problematic, as agriculture inherently creates issues that contributes to climate change. Utilizing science, through genetically engineered crops, is one way to close the harm gap between food security and climate change. This essay addresses the controversial issue of genetically engineered crops with the complicated issues of food security and climate change by analyzing three main issues: (1) how the science of genetically engineered …