Food and Drug Law Commons^™

From Petri Dish To Main Dish: The Legal Pathway For Cell-Based Meat, Brian P. Sylvester, Nathan A. Beaver, Kara Schoonover, Jonathan I. Tietz

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

Meat grown outside an animal is no longer simply science fiction, and the market is poised for introduction of a variety of so-called cell-based meat products. Commercializing these products will require a clear regulatory path forward. In this Article, we explore that legal pathway. We introduce the concepts of cellular agriculture and cell-based meat, including the science, the state and history of the industry, and the general regulatory background, in which the USDA and FDA are the major players. Further, we explore in particular regulatory aspects of food safety and labeling in the context of cell-based meat. Overall, we contend …

Planting The Seed: A Proposal For A Farm Operation Test Under The Fsma Produce Safety Rule, Sophia Kruszewski, Samuel Ingraham

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The “Free Market” For Marijuana: A Sober, Clear-Eyed Analysis Of Marijuana Policy, H. Justin Pace

Lewis & Clark Law Review

Federal law prohibits the possession and sale of marijuana. At the same time, states are not only decriminalizing marijuana but also attempting to provide a regulatory apparatus for its sale. This has created a unique business environ- ment. In some ways, there is a true “free market” for marijuana in states that have legalized it—free, that is, of the legal and financial infrastructure avail- able to fully licit businesses in America.

Contracts may not be enforceable because they lack a legal purpose. Relief in bankruptcy court may not be available, either as a debtor or as a creditor. Use of …

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Faculty Scholarship

No abstract provided.

Deadly Delay: The Fda's Role In America's Covid-Testing Debacle, Barbara J. Evans, Ellen Wright Clayton

UF Law Faculty Publications

In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) published a series of 2020 guidance documents on how to seek Emergency Use Authorizations (EUAs) for new SARS-CoV-2 tests. These guidance documents suggest EUAs are needed for laboratory-developed tests (LDTs), a type of test created and used in-house by high-complexity clinical laboratories that already are regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These CLIA-regulated laboratories traditionally have provided a rapid response to emerging epidemics. Many laboratories viewed the FDA’s 2020 guidance documents as having a practical binding effect even though the FDA lacked clear …

How Come Mary-Jane Is Not On Workers’ Comp?: Requiring Rhode Island Workers’ Compensation Insurers To Reimburse Employees For Medical Marijuana, Devon Q. Toro

Roger Williams University Law Review

No abstract provided.

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise

Faculty Publications & Other Works

In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug …

Fda Publicity And Enforcement In The Covid-19 Era, Jordan Paradise, Elise Fester

Faculty Publications & Other Works

No abstract provided.

Minor Advances, Major Consequences: Hatch-Waxman Administers Exclusivity For Drug Delivery Devices, Taylor Stemler

Mitchell Hamline Law Review

No abstract provided.

The Burden On Society From Eleventh-Hour "Citizen Petitions" Filed To Slow Generic Drugs, Feldman Robin

Maryland Law Review Online

No abstract provided.

(Carbon) Farming Our Way Out Of Climate Change, Alexia Brunet Marks

Publications

Numerous climate-related emergencies highlight the challenges and urgency posed by climate change: the 2018 Intergovernmental Panel on Climate Change (IPCC) Report, the Global Climate Action Summit in California and international student walkouts, to name a few. While the IPCC Report sent an urgent cry to reduce total emissions and to achieve specific results—45% reduction by 2030 and net-zero emissions by 2050—reductions need to be combined with capturing and storing atmospheric carbon dioxide. Scientific studies have shown that an annual increase of 0.4% of carbon stored in soils would make it possible to stop the present increase in atmospheric CO2.

This …

Taming America's Sugar Rush: A Traffic-Light Label Approach, Alexia Brunet Marks

Publications

Excess added sugar negatively impacts health and can lead to a litany of problems, such as diet-related chronic diseases, e.g., diabetes, cancer, heart disease, and obesity, costing Americans millions in rising medical bills each year. Even more, new studies reveal that individuals with these underlying chronic diseases are at a higher risk of complications from COVID-19 and other viruses compared to those who are deemed healthy. And yet added sugars are difficult to avoid because unlike naturally occurring sugars found in fruits, vegetables, and milk, these sweeteners are added during food processing and preparation.

The problem is that while consumers …

Cannabis Legalization In State Legislatures: Public Health Opportunity And Risk, Daniel G. Orenstein, Stanton A. Glantz

Marquette Law Review

Cannabis is widely used in the United States and internationally despite its illicit status, but that illicit status is changing. In the United States, thirty-three states and the District of Columbia have legalized medical cannabis, and eleven states and D.C. have legalized adult use cannabis. A majority of state medical cannabis laws and all but two state adult use laws are the result of citizen ballot initiatives, but state legislatures are beginning to seriously consider adult use legislation. From a public health perspective, cannabis legalization presents a mix of potential risks and benefits, but a legislative approach offers an opportunity …

Innovating Federalism In The Life Sciences, Myrisha S. Lewis

Faculty Publications

This Article challenges the view that the US. Food and Drug Administration (FDA) has exclusive Jurisdiction over life sciences innovations. Many current and forthcoming life sciences innovations are "innovative therapies" such as gene editing, gene therapy, and regenerative stem cell treatments, which are actually "hybrids" of state and federal Jurisdiction. Thus, both state and federal Jurisdiction coexist: federal Jurisdiction exists to the extent that these medical innovations use drugs or biologics, but state Jurisdiction exists to the extent that these innovations are procedures regulated by states as the practice of medicine.

This Article argues that the regulation of numerous current …

Puff, Puff, Patent: Identifying And Addressing The Tensions Between The Medical Marijuana Industry, Patent Law, And The Controlled Substances Act, Dustin Boone

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Ensuring Access To Emerging Covid-19 Treatments Through Medicare Reimbursement Policy, Rachel Sachs, Adam Sacarny

Scholarship@WashULaw

Effective pharmaceutical treatments for coronavirus disease 2019 (COVID-19) are urgently needed, and there has been an explosion of research into compounds with potential efficacy against the disease. The highest-profile success to date is Gilead Sciences’ antiviral remdesivir, which received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) after preliminary data showed that it may speed patients’ time to recovery.¹ Gilead is just beginning to sell remdesivir commercially. However, Medicare reimbursement policy is likely to pose challenges for hospitals seeking to administer remdesivir and other COVID-19 drugs to patients. Policy makers ought to think critically …

The Current Application Of The Myriad And Mayo/Alice Rulings On Patent Eligibility: Inconsistent Results And Contradistinguishing Biotechnology Products, Skye Cho

Cardozo Arts & Entertainment Law Journal

The note examines the inconsistent application of the patent eligibility framework under Section 101 of the Patent Act, particularly in biotechnology. It argues that despite efforts by the USPTO to clarify the framework through memos and examples, courts have applied it inconsistently, leading to discrimination against biotechnology products. The analysis focuses on key Supreme Court decisions, such as Myriad Genetics and Mayo, and their impact on the patent eligibility of biotechnological innovations. The note highlights the need for clearer guidance to ensure consistent outcomes and fair treatment of biotechnological inventions.

Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli

Faculty Scholarship

In this article, I propose that geographical indications (GIs) carry important economic benefits. First, GIs are essential instruments to facilitate investments in high-quality products and niche markets, and promote local trade and development. Second, GIs offer an additional layer of information for consumers about the geographical origin and quality of the products they identify, in turn reducing the information asymmetries between producers and consumers. Third, because of this information function, GIs can assist in rewarding or holding producers accountable for their products based on the additional information they convey to the market. Yet, GIs can also protect culture-related interests and …

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …