Health Law and Policy Commons^™

Bison, Tribes, And Brucellosis In The Interagency Bison Management Plan, Bailey Nickoloff

Sustainable Development Law & Policy

Introduction

It would be in the best interest of the Interagency Bison Management Plan (“IBMP”) and its affiliated agencies to allow Tribal governments and Tribal members to hunt bison within Yellowstone National Park (“YNP”). This would help to reduce the spread of brucellosis, reduce the environmental impacts from bison in YNP, and honor the treaties signed between the United States and Tribal governments. These agencies can accomplish this by implementing treaty hunting rights in a new Environmental Impact Statement (“EIS”) and within an existing legal framework.

Paving A Path To Independent Tiny Living: An Introduction To Roadblocks, Jaclyn Troutner

Sustainable Development Law & Policy

“Tiny living” is a growing trend in which small-scale, ecoconscious housing is used as an alternative means for homeownership. Tiny homes are smaller than the average detached home with the appearance and character of a traditional freestanding residential home. They are one-story, single-occupant dwellings and usually constructed on a trailer base for towing. State-of-the-art building techniques provide a lower environmental burden and utility cost per square foot. Due to their smaller size, tiny homes are cheaper with an average price of $52,000, opening a wider door to home ownership. The typical design is to include all the standard amenities and …

Rulemaking Doubletake: An Opportunity To Repair And Strengthen The National Environmental Policy Act, Rachel Keylon

Sustainable Development Law & Policy

Introduction

In the middle of the twentieth century, there was a turning point in the United States and around the world in the understanding of the human relationship with the natural environment and natural resources. It was a shift from a perspective of natural resources endlessly available for exploitation to a perspective that natural resources are finite, and conservation and preservation are necessary to ensure that these resources are available for future generations. The accumulation of chronic environmental degradation, such as the unchecked proliferation of pesticides and other toxic chemicals, pollution to the nation’s waters, loss of land to erosion, …

About Sdlp

Sustainable Development Law & Policy

The Sustainable Development Law & Policy Brief (ISSN 1552-3721) is a student-run initiative at American University Washington College of Law that is published twice each academic year. The Brief embraces an interdisciplinary focus to provide a broad view of current legal, political, and social developments. It was founded to provide a forum for those interested in promoting sustainable economic development, conservation, environmental justice, and biodiversity throughout the world.

Because our publication focuses on reconciling the tensions found within our ecosystem, it spans a broad range of environmental issues such as sustainable development; trade; renewable energy; environmental justice; air, water, and …

Editor's Note, Juliette Jackson, Bailey Nickoloff

Sustainable Development Law & Policy

Dear Readers,

For more than two decades, the Sustainable Development Law and Policy Brief (SDLP) remains true to its mission of providing innovative solutions to some of the most important legal issues related to environmental law, energy law, and natural resources law. We are honored to be the Editors-in-Chief during these unprecedented times in our history, as we witnessed a historical presidential election and now enter the third year of the COVID-19 global pandemic. Despite these unparalleled times, the SDLP staff brought our readership another great issue.

In this issue, our authors provide an in-depth analysis into current regulations and …

Costly Gadgets: Barriers To Market Entry And Price Competition For Generic Drug-Device Combinations In The United States, Michael S. Sinha

Minnesota Journal of Law, Science & Technology

No abstract provided.

How Public Health Informed Lawmaking Would Address The Rising Synthetic Opioid Death Toll, Jennifer S. Bard

Brooklyn Law Review

The sharply rising deaths associated with use of synthetic opioids in the United States highlight the failure of a legislative strategy focused on reducing the availability of prescription opioids. However, since synthetic opioids prescribed for pain relief have never been a major contributor to either developing opioid dependence or dying from opioid use, it is not surprising that these measures have not only failed to reduce deaths, but have also caused considerable harm to people in need of pain relief. Yet reversing them and taking a public health approach focused on preventing the most serious harms associated with synthetic opioids …

It’S About Lyme: Why Congress Must Enact Medical Insurance Coverage Laws For Lyme Disease Patients Now, Jennifer Barrett

Seattle University Law Review Online

The Centers for Disease Control and Prevention (CDC) estimates approximately 476,000 people are diagnosed with Lyme disease in the United States each year. While many will recover with a short course of antibiotics, up to 35% will suffer from persistent symptoms after initial treatment. Despite scientific evidence showing the infection can persist long after initial treatment, most insurance companies restrict access to treatment beyond twenty-eight days, leaving patients to bear much of the financial burden. To limit crippling out-of-pocket expenses, Congress must enact legislation mandating coverage for the treatment of clinically diagnosed Lyme disease and co-infections based on the International …

Learning From South Korea’S Covid-19 Response: Why Centralizing The United States Public Health System Is Essential For Future Pandemic Responses, Meghan Ricci

Seattle Journal of Technology, Environmental, & Innovation Law

The COVID-19 pandemic revealed stark differences in governmental preparedness across the globe. The United States, once thought of as a global leader in public health, had the theoretical skill and efficiency to handle the pandemic but failed to utilize those skills and resources during an actual health crisis. In the spring of 2020, everyone watched the U.S.’s reaction to the unfolding of the COVID-19 pandemic due to its historic placeholder as a global leader and innovator. However, the performance of the U.S. in response to the global pandemic disappointed both global commentators and U.S. citizens. This paper will compare the …

A Hot Topic: Is The Fda’S Approach To Sunscreen Regulation Failing Consumers?, Haley Westman

Seattle University Law Review

This Note suggests a better balance between allowing sunscreen innovation and protecting the public from unsafe products. Part I of this Note will review the factual background of the public’s attention to sunscreen, explain the current sunscreen issues in the news, and highlight the different actors involved in the growing discourse surrounding sunscreen. Part I will also show that the actors involved in the sunscreen industry—scientific researchers, social media influencers, and the public at large—have considerable influence on consumers’ trust in sunscreen, their buying habits, and the FDA’s approach to sunscreen regulation. Part II of this Note will outline the …

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

Journal of Health Care Law and Policy

No abstract provided.

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 …

Table Of Contents

Seattle University Law Review

Table of Contents

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 …

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.

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 …

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 …

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 …

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 …

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 …

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 …

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

Mitchell Hamline 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 …

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 …