Food and Drug Law Commons^™

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 …

Fda As Food System Stewards, Margot J. Pollans, Matthew F. Watson

Elisabeth Haub School of Law Faculty Publications

The Food and Drug Administration (“FDA”) is one of the primary regulators of the U.S. food system, yet it all but ignores the food system's vast environmental footprint. Although the agency is not technically an environmental agency, it could and should view redressing the food system's significant environmental footprint as part of its health and safety mission. In this Article, we review FDA's history of National Environmental Policy Act (“NEPA”) compliance. This history affirms our hypothesis that FDA does not view its own work as environmental. The review, along with assessment of some of FDA's core food programs, reveals that …

The Role Of State Attorneys General In Improving Prescription Drug Affordability, Michelle M. Mello, Trish Riley, Rachel Sachs

Scholarship@WashULaw

Impact litigation initiated by state attorneys general has played an important role in advancing public health goals in contexts as diverse as tobacco control, opioids, and healthcare antitrust. State attorneys general also play a critical role in helping governors and legislatures advance health policies by giving input into their drafting and defending them against legal challenges. State attorneys general have entered the prescription drug affordability arena in both these ways—for example, by initiating lawsuits relating to price fixing by generic drug manufacturers and defending state laws requiring disclosures of pharmaceutical prices. Yet the scope of their collective efforts is not …

New Innovation Models In Medical Ai, W. Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg

Scholarship@WashULaw

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

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 …

Cannabis Receiverships: The Alternative For State Legal Cannabis Businesses Seeking Financial Rehabilitation Locked Out Of Bankruptcy Court By The Controlled Substances Act, Ryan C. Griffith

Seattle University Law Review

This article explores how cannabis businesses suffer by being unable to utilize federal bankruptcy and explore state law receiverships as an alternative remedy to help cannabis businesses weather financial storms.

Part I explores the limitations and differences between a receivership and a bankruptcy. Part II discusses how state legal cannabis companies cannot seek financial rehabilitation in bankruptcy court due to cannabis being listed as a schedule I drug federally. Part III explores how receivership be used to help cannabis companies that cannot seek bankruptcy protection to financially rehabilitate themselves. Part IV details how a receiver can help a cannabis company …

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 …

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 …

Essential But Ignored: Covid-19 Litigation And The Meatpacking Industry, Alexia Brunet Marks

Publications

The spread of the novel coronavirus SARS-CoV-2 (COVID-19) among meatpacking employees forced closures and slowdowns at many plants across the United States. As the meatpacking giants JBS, Smithfield, and Tyson became hotbeds for COVID-19, national meat production plummeted. To forestall further supply chain disruptions, former President Trump passed an Executive Order compelling plants to continue operating as “essential businesses.” As work continued, employees reported that social distancing and mask-wearing were not being enforced, managers were pressuring sick employees to work and not revealing co-worker’s infections, and an overall lack of Personal Protective Equipment (PPE) or training to reduce the risk …

Trick Or Treat? How A U.S. Patent Over A Method For Processing Sugarcane Wrongly Alarmed The Colombian Panela Industry, Carter Ostrowski

University of Cincinnati Law Review

No abstract provided.

Legal And Ethical Implications Of U.S. And Canadian Vaccine Contracts: The Impact Of Vaccine Nationalism On The Global Pandemic Response, Ryan S. Tahiri

University of Miami Inter-American Law Review

This note explores the COVID-19 vaccine contracts between the U.S. and Canada and the impact of these types of agreements on the global pandemic response. These “pre-purchases,” many of which were executed before the development of a vaccine, have afforded a select few nations the opportunity to stockpile vaccines, while other nations with fewer resources are unable to secure any doses. An effective method to counter the effects of the pandemic is the creation of a global vaccine network that provides equitable access to vaccine doses for nations in need. COVAX was launched to ensure that lower and middle-income nations …