Food and Drug Law Commons^™

Slowing Down Accelerated Approval: Examining The Role Of Industry Influence, Patient Advocacy Organizations, And Political Pressure On Fda Drug Approval, Stephanie Diu

Fordham Law Review

The U.S. Food and Drug Administration (FDA) has been revered as the gold standard in pharmaceutical safety and efficacy review since the 1960s. More recently, partly in response to the HIV/AIDS epidemic and the pressing need for new treatments, the FDA established an accelerated approval process to hasten the review of new drug applications so that drugs could be approved and brought to market as soon as possible. Although accelerated approval has led to the availability of new treatments for patients with few other options, this Note argues that, today, the FDA grants accelerated approval too hastily and may be …

Food And Drug Regulation: Statutory And Regulatory Supplement (2022 ), Adam I. Muchmore

Books

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than comprehensive.

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 …

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 …

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

Mitchell Hamline Law Review

No abstract provided.

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 …

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 …

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 …

A Solution To The Hard Problem Of Soft Law, Keagan Potts

Michigan Journal of Environmental & Administrative Law

Administrative Agencies often rely on guidance documents to carry out their statutory mandate. Over the past few decades, the Food and Drug Administration (FDA) has been criticized for using soft law guidance documents to exercise powers beyond those authorized by Congress. Since attacks on the use of guidance documents persist and agencies need soft law to respond quickly and flexibly to rapid technological growth, it is essential to develop a solution that preserves this crucial regulatory mechanism and prevents its abuse. The most likely alternative to soft law guidance is formal regulation, which must be developed through the notice-and-comment process. …

Agents Of Bioshield: The Fda, Emergency Use Authorizations, And Public Trust, Kirstiana Perryman

Georgia Law Review

The SARS-CoV-2 pandemic spurred the U.S. Food & Drug Administration (FDA) to utilize the Emergency Use Authorization (EUA) procedure more than ever before. The pandemic pushed the relatively obscure procedure into public consciousness, making it a frequent topic of discussion and debate. The EUA procedure permits the FDA Commissioner to authorize the introduction of drugs, devices, or biological products into interstate commerce for use in an actual or potential emergency. To issue an authorization, the FDA Commissioner must determine that it is “reasonable to believe,” based on the “totality of the evidence,” that the product “may be effective.” This standard …

Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino

Brooklyn Law Review

The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …

The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein

Brooklyn Law Review

In recent years, concern over the environmental, animal welfare, and human costs of animal agriculture has spurred an increased demand for nonanimal sourced protein. This has led to significant innovation in food technology. As part of this trend, food scientists have developed a process for in-vitro cultivation of meat cells to produce protein that is biologically and nutritionally identical to meat from traditionally raised and slaughtered animal sources, but that involves neither animal agriculture nor animal slaughter. This lab-grown “clean meat” represents a new era in food technology and is already having an effect on the existing meat industry. In …

"Not For Human Consumption": Prison Food's Absent Regulatory Regime, Amanda Chan, Anna Nathanson

William & Mary Bill of Rights Journal

Prison food is poor quality. The regulations which govern prison food are subpar and unenforceable by prisoners, due in large part to Sandin v. Conner and the Prison Litigation Reform Act. This Article aims to draw attention to the dire food conditions in prisons, explain the lax federal administrative law that permits these conditions, highlight the role of Sandin v. Conner and the Prison Litigation Reform Act in curtailing prisoners’ rights, and criticize the role of the private entity American Correctional Association in enabling mass neglect of prison food. The authors recommend that the Prison Litigation Reform Act be repealed, …

Making Executioners Out Of Pharmacists: Why South Carolina Should Not Adopt A Lethal Injection Secrecy Statute, Elizabeth T. French

South Carolina Law Review

No abstract provided.

When Claims About Lollipops Are Best Kept Under Wraps: Can The Fda Regulate Off-Label Speech?, Emily Moss

Minnesota Journal of Law, Science & Technology

No abstract provided.

Climate Change, Competition & Conflict Along The River Nile: The Great Ethiopian Renaissance Dam & Shifting Customary International Water Law, Salma Shitia

Fordham Environmental Law Review

Decade-long negotiations between the Arab Republic of Egypt and the Federal Democratic Republic of Ethiopia surround the decision to build the hydroelectric power plant along the River Nile. For much of Ethiopia, the Grand Ethiopian Renaissance Dam represents a beacon of prosperity. For countless Egyptians, the structure embodies a potential catastrophe. Grounded in threats of displacement for Egyptian agricultural communities, some have compared the Grand Ethiopian Renaissance Dam crisis to disasters culminating in mass migration.

This battle for natural resource access has intensified as climate change exacerbates the region’s dire conditions. Specifically, exhaustible resource allocation amid climate change indicates that …

A Paper Tiger? Prosecutorial Regulators In China’S Civil Environmental Public Interest Litigations, Chunyan Ding, Huina Xiao

Fordham Environmental Law Review

In July 2015, China’s national legislature brought in prosecutor-led civil environmental public interest litigation (“EPIL”) for thirteen selected provincial areas of the country. After a two-year legal experiment, this prosecutor-led civil EPIL system was then established nationwide in July 2017. Yet, can it be said that prosecutorial regulators in China are in fact a paper tiger? Drawing upon content analysis of the 655 prosecutor-led civil EPILs and in-depth interviews with twelve frontline prosecutors and judges, this article examines the dynamics of regulatory practice and the motivation of the Chinese prosecutorial organs to engage in environmental regulation through litigation. Based upon …

The Yoga Analogy: Scaling-Up The U.S.’S Renewable Energy Sector Mindfully With New Technologies, Evolving Standards, Public Buy-In, Data Sharing, And Innovation Clusters, Kimberly E. Diamond

Fordham Environmental Law Review

This paper focuses on innovative renewable energy devices, exploring how scientifically-based industry standards that continuously evolve with engineering design technology, the public’s buy-in and feeling of connectedness with groundbreaking devices, and innovation clusters that accelerate device development through data sharing and public-private partnerships can all help advance the U.S.’s domestic renewable energy industry.

Part I analyzes challenges inherent to scaling- up novel renewable energy technologies while simultaneously developing the industry standards regulating them. Part II uses the Block Island Wind Farm, an offshore wind demonstration project, and Pavegen’s globally-deployed arrays of piezoelectric smart flooring tiles as examples illustrating the importance …

Environmental Racism: Using Environmental Planning To Lift People Out Of Poverty, And Re-Shape The Effects Of Climate Change & Pollution In Communities Of Color,, William C.C. Kemp-Neal

Fordham Environmental Law Review

In the mid-1900s the United States began to see a rise in concern for environmental awareness issues. In the early days the movement focused on things like clean air, water and pollution but by the 1970s-1990s many prominent environmental awareness groups began to form focused on the idea that in order to avert climate change the principal goal needed to be to reduce global greenhouse gas emissions. In 1987 a report was released called Toxic Waste and Race, which outlined an intimate link between the placement of environmental hazardous waste sites in communities of color, and greater instances of polluted …

Beyond Equity: Shared Natural Resources And Human Rights, Criminal Law, And The Use Of Force, Eian Katz

Fordham Environmental Law Review

Transboundary resource disputes are often analyzed by reference to two nebulous and conflicting principles that have emerged in international environmental law: “equitable and reasonable utilization” and “no significant harm.” Frequently overlooked in this context is the potential value of other canons of international law—especially human rights law, criminal law, and the rules governing the use of force—in adding definition to the muddled contours of these foundational precepts. This Article therefore undertakes an assessment of sovereign rights and obligations regarding shared natural resources which arise from these other bodies of law. In doing so, it offers new lenses through which to …

Squaring The Cercla: Superfund And The Superfund Task Force, Manny Marcos

Fordham Environmental Law Review

The Superfund Task Force recently released its final report on the implementation of its recommendations for improving the Superfund program. The Task Force was given five goals for improving the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (“CERCLA’s”), implementation. These goals are to expedite cleanup and remediation, re-invigorate responsible party cleanup and reuse, encourage foreign investment, promote redevelopment and community revitalization, and engage with partners and stakeholders. While the Task Force’s recommendations have improved CERCLA’s implementation, many of CERCLA’s structural flaws remain intact. Specifically, CERCLA still has a severe shortage of funding, an unfair liability scheme, perverse incentives, …

Covid-19: A Crisis And An Opportunity To Improve The Emergency Use Authorization Process, Daniel Walsh

Minnesota Journal of Law, Science & Technology

No abstract provided.

Don't You Know That You're Toxic? Cercla Section 113(H) Challenges, Sovereign Immunity, And Perfluoroalkyl Substances In Pennsylvania Drinking Water In Giovanni V. Navy, Stephanie J. Oppenheim

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Out Of Sight, Out Of Mind: Analyzing Inhumane Practices In Mississippi’S Correctional Institutions Due To Overcrowding, Understaffing, And Diminished Funding, Ariel A. Williams

Honors Theses

The purpose of this research is to examine the political, social, and economic factors which have led to inhumane conditions in Mississippi’s correctional facilities. Several methods were employed, including a comparison of the historical and current methods of funding, staffing, and rehabilitating prisoners based on literature reviews. State-sponsored reports from various departments and the legislature were analyzed to provide insight into budgetary restrictions and political will to allocate funds. Statistical surveys and data were reviewed to determine how overcrowding and understaffing negatively affect administrative capacity and prisoners’ mental and physical well-being. Ultimately, it may be concluded that Mississippi has high …

The Pandemic, Climate Change And Farm Subsidies, Allen H. Olson, Edward J. Peterson

Journal of Food Law & Policy

Many people believe that once the COVID-19 pandemic has passed, life will return to the way it was. This belief is both unrealistic and dangerous. It is unrealistic because the virus will be around for years if not indefinitely. The timeframe for the worst of the pandemic will depend on our ability to administer effective vaccines worldwide and the public’s willingness to accept continued social distancing in the meantime. The damage done to public health, the economy and individuals is already substantial and will get worse. Recovery will be slow and incomplete. The belief that life will return to the …

Addressing Food Insecurity In The United States During And After The Covid-19 Pandemic: The Role Of The Federal Nutrition Safety Net, Sheila Fleischhacker, Sara N. Bleich

Journal of Food Law & Policy

Food insecurity has been a direct and almost immediate consequence of the coronavirus disease 2019 (COVID-19) pandemic and its associated ramifications on unemployment, poverty and food supply disruptions. As a social determinant of health, food insecurity is associated with poor health outcomes including diet related chronic diseases, which are associated with worst COVID-19 outcomes (e.g., COVID-19 patients of all ages with obesity face higher risk of complications, death). In the United States (US), the federal nutrition safety net is predominantly made up of the suite of 15 federal nutrition assistance programs that the US Department of Agriculture (USDA) administers and …

Where's The Meat? A Constitutional Analysis Of Arkansas's Law Prohibiting The Use Of "Meat" Terms On Plant-And Cell-Based Products, Christy Wyatt

University of Cincinnati Law Review

No abstract provided.