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Trading Pain For Gain: Addressing Misaligned Interests In Prescription Drug Benefit Administration, Sheva J. Sanders, Jessica C. Wheeler 2022 Northwestern University School of Law

Trading Pain For Gain: Addressing Misaligned Interests In Prescription Drug Benefit Administration, Sheva J. Sanders, Jessica C. Wheeler

University of Michigan Journal of Law Reform

Over the last two decades, Pharmacy Benefit Managers (PBMs), organizations that act as middlemen between health plans and drug manufacturers, have become increasingly powerful players in the healthcare industry. PBMs promise to leverage their expertise and ability to aggregate buying power to negotiate lower drug prices and administer prescription drug benefit plans. In practice, however, PBMs are widely criticized for benefitting from, and contributing to, inefficiencies in the prescription drug market, particularly by imposing restrictions on beneficiary access to drugs in exchange for rebates paid to PBMs by manufacturers. To the extent that the rebates are retained by PBMs, or ...


High Time For Change: The Legalization Of Marijuana And Its Impact On Warrantless Roadside Motor Vehicle Searches, Molly E. O'Connell 2022 Washington and Lee University School of Law

High Time For Change: The Legalization Of Marijuana And Its Impact On Warrantless Roadside Motor Vehicle Searches, Molly E. O'Connell

Washington and Lee Law Review Online

The proliferation of marijuana legalization has changed the relationship between driving and marijuana use. While impaired driving remains illegal, marijuana use that does not result in impairment is not a bar to operating a motor vehicle. Scientists have yet to find a reliable way for law enforcement officers to make this distinction. In the marijuana impairment context, there is not a scientifically proven equivalent to the Blood Alcohol Content standard nor are there reliable roadside assessments. This scientific and technological void has problematic consequences for marijuana users that get behind the wheel and find themselves suspected of impaired driving. Without ...


The Arkansas Ll.M. Program: Forty Years Of Leadership, Susan A. Schneider 2022 University of Arkansas School of Law

The Arkansas Ll.M. Program: Forty Years Of Leadership, Susan A. Schneider

Journal of Food Law & Policy

The University of Arkansas School of Law has been a leader in agricultural law education for over forty years through its innovative LL.M. Program in Agricultural and Food Law. This essay memorializes the history of this signature Program and charts its progress through the decades as agricultural law issues evolved and the discipline expanded.


"Serving Time And It's No Longer A Crime: An Analysis Of The Proposed Cannabis Administration And Opportunity Act, Its Potential Effects At The Federal And State Level, And A Guide For Practical Application By Local Government", R. Allyce Bailey 2022 University of the District of Columbia School of Law

"Serving Time And It's No Longer A Crime: An Analysis Of The Proposed Cannabis Administration And Opportunity Act, Its Potential Effects At The Federal And State Level, And A Guide For Practical Application By Local Government", R. Allyce Bailey

University of the District of Columbia Law Review

There has been much recent discussion surrounding cannabis use with some researchers supporting the use of medical marijuana, some investors relishing in the recently booming cannabis and CBD industry, and some states decriminalizing marijuana and even harsh controlled substances. As it appears, at least some public opinion is changing regarding marijuana, but the law has not effectively caught up to that change. Bias in the criminal justice system has led to the over-policing of, higher conviction rates, and harsher sentences for minorities. Thus, the decriminalization of marijuana alone does not remedy the grave disproportionate negative effects on populations of color ...


Using Insurance To Regulate Food Safety: Field Notes From The Food Produce Sector, Timothy D. Lytton 2022 Georgia State University

Using Insurance To Regulate Food Safety: Field Notes From The Food Produce Sector, Timothy D. Lytton

New Mexico Law Review

Foodborne illness is a public health problem of pandemic proportions. In the United States alone, contaminated food sickens an estimated 48 million consumers annually, causing 128,000 hospitalizations and 3,000 deaths. Nowhere is this crisis more acute than in the fresh produce sector, where microbial contamination in growing fields and packing houses has been responsible for many of the nation’s largest and deadliest outbreaks.

This Article examines emerging efforts by private insurance companies to regulate food safety on farms that grow fresh produce.

Previous studies of using insurance to regulate food safety rely on economic theories that yield ...


A Helper For Patenting The “Unpredictable”: Artificial Intelligence, Shuang Liu 2022 University of Minnesota Law School

A Helper For Patenting The “Unpredictable”: Artificial Intelligence, Shuang Liu

Minnesota Journal of Law, Science & Technology

No abstract provided.


The President’S Remedy–What The Hydroxychloroquine Story Teaches Us About The Need To Limit Off-Lable Prescribing Powers, Jennifer Bard 2022 The Catholic University of America, Columbus School of Law

The President’S Remedy–What The Hydroxychloroquine Story Teaches Us About The Need To Limit Off-Lable Prescribing Powers, Jennifer Bard

Catholic University Law Review

When the history of the first year of the United States Government’s response to the COVID-19 virus is written, there is likely to be mention of the still unexplained vehemence with which then president Donald J. Trump made use of his access to social media to promote seldom used anti-malaria drug, hydroxychloroquine, for both the prevention and treatment of COVID-19 despite the active growing opposition of most of the world’s scientists, including his own government scientists. While the use of drugs developed and approved by the FDA for different purposes to combat new diseases, off-label prescribing, is legal ...


Legalization Without Disruption: Why Congress Should Let States Restrict Interstate Commerce In Marijuana, Scott Bloomberg, Robert A. Mikos 2022 Pepperdine University

Legalization Without Disruption: Why Congress Should Let States Restrict Interstate Commerce In Marijuana, Scott Bloomberg, Robert A. Mikos

Pepperdine Law Review

Over the past twenty-five years, states have developed elaborate regulatory systems to govern lawful marijuana markets. In designing these systems, states have assumed that the Dormant Commerce Clause (“DCC”) does not apply; Congress, after all, has banned all commerce in marijuana. However, the states’ reprieve from the doctrine may soon come to an end. Congress is on the verge of legalizing marijuana federally, and once it does, it will unleash the DCC, with dire consequences for the states and the markets they now regulate. This Article serves as a wake-up call. It provides the most extensive analysis to date of ...


Making Your Robotic Surgery Systems General Purpose: A Possible Preventive Measure For Induced And Contributory Infringement Liability Arising In Medical Procedures, Mengmeng Du 2022 University of Minnesota Law School

Making Your Robotic Surgery Systems General Purpose: A Possible Preventive Measure For Induced And Contributory Infringement Liability Arising In Medical Procedures, Mengmeng Du

Minnesota Journal of Law, Science & Technology

No abstract provided.


Biotechnology Patent Law Top Ten Of 2020: Valeant Victorious, Falling Eagle, And Successful Slayback, Kevin E. Noonan, Andrew W. Torrance 2022 University of Kansas School of Law

Biotechnology Patent Law Top Ten Of 2020: Valeant Victorious, Falling Eagle, And Successful Slayback, Kevin E. Noonan, Andrew W. Torrance

Texas A&M Journal of Property Law

This Article discusses the Top 10 BioTechnology Patent Cases of 2020. Suffice it to say that biotechnology patent law will continue to vigorously evolve, and we plan to continue our coverage of its evolution beyond the current trilogy of Biotechnology Patent Law Top Tens. As in previous years, we admit it was difficult to choose precisely ten top biotechnology patent law decisions. There are certainly others we did not include that warrant close attention for their reasonings, rules, and future implications. Nevertheless, both we and our readers can count, so we have done our best to select what we consider ...


Beefing Up Skinny Labels: Induced Infringement As A Question Of Law, Garrett T. Potter 2022 Candidate for J.D., Notre Dame Law School, 2023

Beefing Up Skinny Labels: Induced Infringement As A Question Of Law, Garrett T. Potter

Notre Dame Law Review

This Note proposes a novel argument for improving the application of induced infringement by splitting its elements into separate questions of fact and law, incorporating the relevant perception and reasoning of both judge and jury. Part I provides a primer of the Hatch-Waxman Act and interactions (and lack thereof) between the USPTO and FDA in regulating pharmaceutical compositions. Part II assesses the historical landscape that led to the codification of induced infringement. Part III concludes by proposing an alternate approach by treating an element of induced infringement as a question of law, rather than a question of fact, and sets ...


Patent Prophylaxis: Expanding Access To Prep Through 28 U.S.C. § 1498, Jonathan A. Bell 2022 William & Mary Law School

Patent Prophylaxis: Expanding Access To Prep Through 28 U.S.C. § 1498, Jonathan A. Bell

William & Mary Law Review

Part I of this Note details the discovery of Truvada for PrEP [pre-exposure prophylaxis] and the ongoing patent infringement litigation brought by HHS [United States Department of Health and Human Services], discusses the patents currently held by CDC and Gilead, and examines the shortcomings of infringement litigation as a means to expand access to the drug. Part II analyzes the mechanism of march-in rights under the Bayh-Dole Act and discusses two previously attempted applications for the HIV-management drug ritonavir to demonstrate why march-in rights will always fail to expand access to life-saving medications or reduce costs to consumers. Part III ...


China's Food Pagodas: Looking Forward By Looking Back?, Yifei Li, Dale Jamieson 2022 New York University

China's Food Pagodas: Looking Forward By Looking Back?, Yifei Li, Dale Jamieson

Journal of Food Law & Policy

In this Article we provide a close analysis of the Chinese Dietary Guidelines – the Food Pagoda. Our focus on the dietary guidelines is motivated by two main considerations. First, the guidelines represent the most comprehensive, nationwide, state sponsored effort to educate the people of China about food. Like citizens in most countries, Chinese people are presented with numerous, often competing, messages from scientists, food gurus and online influencers. The dietary guidelines are different in that they are backed by an entire suite of governmental resources for nationwide dissemination through hospitals, schools, public billboards, TV and radio ads, among others. Among ...


I Want You To Panic: Leveraging The Rhetoric Of Fear And Rage For The Future Of Food, Iselin Gambert 2022 George Washington University

I Want You To Panic: Leveraging The Rhetoric Of Fear And Rage For The Future Of Food, Iselin Gambert

Journal of Food Law & Policy

"Humanity Is About to Kill 1 Million Species in a Globe-Spanning Murder-Suicide. Only 11 Years Left to Prevent Irreversible Damage from Climate Change." Doomsday headlines like these are terrifying. But are they enough to make us act? The causes of the current climate crisis are many, but the science is clear that the meat and dairy industry shoulders much of the blame. Given the role the animal agriculture industry plays in perpetuating the climate crisis, combined with the harms the industry imposes on the animals and workers within it, politicians and governments—given their degree of power and influence—should ...


The Right To Food Comes To America, Wendy Heipt 2022 WhyHunger

The Right To Food Comes To America, Wendy Heipt

Journal of Food Law & Policy

The people of Maine recently exercised an opportunity no citizen of this country has ever had before: the ability to vote on whether to enshrine a right to food in their state constitution. This Essay provides an overview of Maine’s experience with food rights in order to explain how the state came to occupy this unique position.


France's Organisme De Défense Et De Gestion: A Model For Farmer Collective Action Through Standard Development And Brand Management, Christopher J. Bardenhagen, Philip H. Howard, Marie-Odile Noziéres-Petit 2022 Michican State University

France's Organisme De Défense Et De Gestion: A Model For Farmer Collective Action Through Standard Development And Brand Management, Christopher J. Bardenhagen, Philip H. Howard, Marie-Odile Noziéres-Petit

Journal of Food Law & Policy

Quality-based food production, often with a regional dimension, can provide farmers with new, value added markets. It can also provide consumers with access to place based high-quality products, and may benefit local economies through increased commerce. French Organismes de Défense et de Gestion (ODGs) illustrate a mode of quality-based agri-food business organization. ODGs focus on the development of production standards, as well as management of the intellectual property related to those standards. This mode, which is commonly used in Europe, has not often been used in the United States, despite its potential for regional food system development. The ODG mode ...


Safe Injection Facilities: Reconsidering American Drug Policy, Evelyn L.A. Jackson 2022 Boston College Law School

Safe Injection Facilities: Reconsidering American Drug Policy, Evelyn L.A. Jackson

Boston College Law Review

On January 12, 2021, in United States v. Safehouse, the U.S. Court of Appeals for the Third Circuit held that supervised injection facilities—sites where medical professionals monitor injection drug use—violate the Crack House Statute. The legality of supervised injection facilities was a matter of first impression at the circuit level. Research shows that supervised injection facilities reduce overdose deaths and the spread of infection and are important harm reduction measures for combatting the opioid epidemic. The Third Circuit held that these programs violate the Crack House Statute, 21 U.S.C. § 856(a)(2), because they act ...


The Tin Man Needs A Heart: A Proposed Framework For The Regulation Of Bioprinted Organs, Linda Foit 2022 Fordham University School of Law

The Tin Man Needs A Heart: A Proposed Framework For The Regulation Of Bioprinted Organs, Linda Foit

Fordham Law Review

Each day, seventeen people die in the United States while waiting for an organ transplant. At least part of this need could be met by bioprinting, a technology that allows the on-demand production of custom-sized organs from a patient’s own cells. The field of bioprinting is progressing rapidly: the first bioprinted organs have already entered the clinic. Yet, developers of bioprinted organs face significant uncertainty as to how their potentially lifesaving products will be regulated—and by which government agency. Such regulatory uncertainty has the potential to decrease investment and stifle innovation in this promising technological field. This Note ...


Slowing Down Accelerated Approval: Examining The Role Of Industry Influence, Patient Advocacy Organizations, And Political Pressure On Fda Drug Approval, Stephanie Diu 2022 Fordham University School of Law

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 ...


The Rise Of Concentrated Animal Feeding Operations, Their Effects, And How We Can Stop Their Growth, Andrea Prisco 2022 Penn State Dickinson Law

The Rise Of Concentrated Animal Feeding Operations, Their Effects, And How We Can Stop Their Growth, Andrea Prisco

Dickinson Law Review

Dramatic changes in the agricultural industry over the last century have led to the rise of concentrated animal feeding operations– industrial facilities that raise a large number of animals in confined spaces. Animals raised in these facilities suffer from poor quality of life and abuse. For humans, these facilities have had adverse effects on the environment and public health, but they are also associated with high productivity and low food costs. This Comment analyzes the effects of concentrated animal feeding operations on animal well-being, the environment, and public health. This Comment also analyzes current federal legislation that helps combat the ...


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