Food and Drug Law Commons^™

Pharmaceutical "Pay-For-Delay" Reexamined: A Dwindling Practice Or A Persistent Problem?, Laura Karas, Gerard F. Anderson, Robin Feldman

Articles

The Supreme Court ruled in FTC v. Actavis that a delay in generic entry may be anticompetitive when part of a patent settlement includes a large and otherwise unjustified value transfer to the generic company, termed a reverse payment patent settlement, or "pay-for-delay." Following Actavis, drug companies have limited the size of reverse payments and have fashioned settlement terms that include more discreet categories of compensation to generic companies. In light of the fact that such settlements retain the potential for anticompetitive effects, the apparent size of the reverse payment may no longer be a useful gauge of the …

States, Localities And Public Health, David Gartner

West Virginia Law Review

No abstract provided.

Room To Grow: A Comparative Analysis Of Cannabis Regulation Models In Europe, Amanda H. Cronin

Independent Study Project (ISP) Collection

Debilitated by years of economic instability, the Spanish economy has not fully rebounded to its once strong place in the European market. And now, in the aftermath of a devastating pandemic, the nation will be searching for new sources of wealth. The lucrative market potential of controlled cannabis in medicinal and recreational settings is an attractive industry gaining popularity across Europe. This paper explores the various policy models and legal systems in Portugal, Germany, and the Netherlands. Combining a variety of sources, I seek to ascertain the best plan for Spain. Ultimately, analysis shows that a multi-pronged approach is the …

Cannabis And Its Historical Role In America’S Intentional Segregation Of Race, William E. Kelley

Student Publications

One of the more dramatic shifts in attitudes towards a particular trend or culture we have seen during the turn of the century is none other than attitudes towards marijuana. The Cannabis plant, commonly known as marijuana, has been illegal in the United States for a while now. In the past ten years, we have seen an influx of states and countries relaxing their attitudes towards marijuana, and it's potential benefits. While this shift in attitude towards a relatively harmless drug is a step in the right direction, many are unaware of the sinister and racist history behind outlawing the …

How Can Pennsylvania Protect Itself From Its Own Measles Outbreak?, Megan M. Riesmeyer, Kristen Feemster

Faculty Scholarly Works

When a response to inaccurate information strives to be an informative exercise of its own, it is difficult to balance the desire to respond point by point to mischaracterized, misleading, or untrue information, with the need to simply offer a complete picture of facts. This article is a response to Abigail Wenger’s article regarding

vaccinations. To reply to each mischaracterization or inaccuracy in turn means this response loses its own informative intent and becomes simply a rebuttal. However, to ignore mischaracterizations and inaccuracies is to risk the reader’s acceptance of those points as true. Through illustrative examples in the United …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Dickinson Law Review (2017-Present)

No abstract provided.

Mhpaea & Marble Cake: Parity & The Forgotten Frame Of Federalism, Taleed El-Sabawi

Dickinson Law Review (2017-Present)

No abstract provided.

State Regulatory Responses To The Prescription Opioid Crisis: Too Much To Bear?, Lars Noah

Dickinson Law Review (2017-Present)

In order to prevent further overuse of prescription opioids, states have adopted a variety of strategies. This article summarizes the growing use of prescription drug monitoring programs, crackdowns on “pill mills,” prohibitions on the use of particularly hazardous opioids, limitations on the duration and dosage of prescribed opioids, excise taxes, physician education and patient disclosure requirements, public awareness campaigns, and drug take-back programs. Although occasionally challenged on constitutional grounds, including claims of federal preemption under the Supremacy Clause, discrimination against out-of-state businesses under the dormant Commerce Clause doctrine, and interference with rights of commercial free speech, this article evaluates the …

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Safe Consumption Sites And The Perverse Dynamics Of Federalism In The Aftermath Of The War On Drugs, Deborah Ahrens

Dickinson Law Review (2017-Present)

In this Article, I explore the complicated regulatory and federalism issues posed by creating safe consumption sites for drug users—an effort which would regulate drugs through use of a public health paradigm. This Article details the difficulties that localities pursuing such sites and other non-criminal-law responses have faced as a result of both federal and state interference. It contrasts those difficulties with the carte blanche local and state officials typically receive from federal regulators when creatively adopting new punitive policies to combat drugs. In so doing, this Article identifies systemic asymmetries of federalism that threaten drug policy reform. While traditional …

Food In Prison: An Eighth Amendment Violation Or Permissible Punishment?, Natasha M. Clark

Honors Thesis

This piece analyzes aspects such as; Eighth Amendment provisions, penology, case law, privatization and monopoly, and food law, that play into the constitutionality of privatized prisons using food as punishment. Prisoners have protection from excessive bail and fines and from cruel and unusual punishment, as per the 8^th Amendment; however, deprivations such as restricted diets and harm caused by them is only a valid violation if the prisoner can prove deliberate indifference. Privatization of the prison industry has led to reduced quality, choice, and diversity in areas such as food, which comes at a detrimental cost to prisoners. Serving …

Dirty Business: Accountability For Harmful Pesticide Use In Brazil, Anna Goldstein

Cardozo International & Comparative Law Review

The note argues that the alarming rise in pesticide use in Brazil, particularly under President Jair Bolsonaro, has severe human health and environmental consequences. It emphasizes the need for a binding international legal framework to hold multinational corporations accountable for human rights abuses and environmental harm in their supply chains. Current voluntary frameworks and domestic laws, such as Brazil's Law 7802, are insufficient due to weak enforcement and lack of binding standards. The proposed UN Draft Treaty on Business and Human Rights is presented as a critical solution to address these gaps and ensure corporate accountability.

The Evolving Federal Response To State Marijuana, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The states have launched a revolution in marijuana policy, creating a wide gap between state and federal marijuana law. While nearly every state has legalized marijuana in at least some circumstances, federal law continues to ban the substance outright. Nonetheless, the federal response to state reforms has been anything but static during this revolution. This Essay, based on my Distinguished Speaker Lecture at Delaware Law School, examines how the federal response to state marijuana reforms has evolved over time, from War, to Partial Truce, and, next (possibly) to Capitulation. It also illuminates the ways in which this shifting federal response …

Patents As Property: Oil States And Its Implications On The Takings Clause, Jordan T. Owens

Cardozo Law Review

No abstract provided.

Fertility Fraud And Proposal For Florida Legislation, Cheyenne Dunn

Child and Family Law Journal

No abstract provided.

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

Washington and Lee Law Review

This Article explores four beliefs about supposed pharma-benevolence that appear to be shared by more than the industry, reaching the level almost of conventional wisdom. These figurative pillars help support one-sided results in court. However, each of the pillars on examination turns out at least a bit shaky. This Article puts them forward for review to start a necessary discussion.

The locus of this Article is products liability, where a court concludes that a manufactured object is defective or could be called defective by a factfinder following a trial. Drug manufacturers enjoy near-immunity from this consequence. Modern products liability identifies …

How The Food And Drug Administration Could Use The Power Of Publicity To Minimize Harm And Maximize Safety Of Regulated Products, Katelen Walsh

Health Law and Policy Brief

No abstract provided.

End Notes, Sustainable Development Law & Policy

Sustainable Development Law & Policy

No abstract provided.

State Preemption And Single Use Plastics: Is National Intervention Necessary?, Ethan D. King

Sustainable Development Law & Policy

No abstract provided.

The Right To Legally Sourced Lumber? How The Effective Enforcement Of The Lacey Act Is A U.S. Human Rights Obligation And Critical To Preventing Abuse In The Illegal Logging Industry, Melanie Hess

Sustainable Development Law & Policy

No abstract provided.