Law Commons^™

A Modest Proposal: Leveraging Private Enforcement Mechanisms And The Bayh-Dole Act To Reduce Drug Prices In The U.S. Healthcare Industry, Brittany Day

Duke Journal of Constitutional Law & Public Policy Sidebar

The United States healthcare system is one of the most expensive in the world. Unlike other products, when drug prices skyrocket, people may die. While advocating for various solutions, both the Biden and Trump administrations have recognized the importance of halting the rise of prescription drug prices. Most of the solutions advanced are focused on government-side initiatives, such as allowing Medicare to directly negotiate with pharmaceutical companies. Yet, the "march-in rights" built into the Bayh-Dole Act create an opportunity to set up a mechanism that would invite private actors to sue pharmaceutical companies for unconscionable drug pricing. The Bayh-Dole Act …

Out Of Reach: The Mdlea’S Impermissible Extraterritorial Reach On Maritime Drug–Traffickers, Andres Chinchilla

University of Miami Inter-American Law Review

46 U.S.C. § 70503, known as the Maritime Drug Law Enforcement Act (MDLEA), prohibits individuals on board covered vessels from manufacturing, distributing, or possessing with an intent to distribute or manufacture, a controlled substance. The statute, as enacted, permits the prosecution of individuals arrested beyond U.S. jurisdiction and even within the territorial seas of other States. This provision is argued to be an impermissible extraterritorial reach absent a nexus requirement—showing a connection between the drug smuggling activity and the U.S. Recently, the Eleventh Circuit Court of Appeals held the statute’s extraterritorial reach and lack of nexus requirement as unconstitutional under …

Blood In The Water: Why The First Step Act Of 2018 Fails Those Sentenced Under The Maritime Drug Law Enforcement Act, Lauren R. Robertson

Washington and Lee Law Review

For some, the open ocean is prison. The Maritime Drug Law Enforcement Act (MDLEA) prohibits individuals from knowingly or intentionally distributing a controlled substance or possessing it with the intent to distribute. Empowered by the MDLEA, the United States Coast Guard arrests and detains foreign nationals hundreds of miles outside of U.S. territorial waters. After months shackled to Coast Guard ships, these individuals face the harsh reality of American mandatory minimum drug sentencing, judged by the kilograms of drugs on their vessels. But the MDLEA conflates kilograms with culpability. More often than not, those sentenced are fishermen-turned-smugglers due to financial …

Fair Lending For Cannabis Banking Justice, Benjamin T. Seymour

University of Michigan Journal of Law Reform Caveat

This Comment offers a fair lending solution to promote racial equity in cannabis banking reform: amend the Equal Credit Opportunity Act to ensure individuals previously arrested, charged, or convicted for selling, cultivating, or possessing marijuana will not therefore be precluded from loans to start legal cannabis businesses. Given disparities in the criminal enforcement of marijuana laws, this amendment would provide racial justice benefits, while also encouraging entrepreneurship. As a market-based social justice effort, this amendment offers a bipartisan approach to one of the most vexing and contentious issues in marijuana banking reform.

Part II of this Comment briefly surveys the …

Researching Marijuana Law, Seth Quidachay-Swan

Law Librarian Scholarship

This article provides a brief overview of the current legal framework governing the regulation of marijuana at the federal and state levels in the United States. It also provides an overview of the state of Michigan’s current regulatory framework and resources for attorneys interested in learning more about marijuana regulation.

Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous

Saint Louis University Journal of Health Law & Policy

Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome …

A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll

Faculty Publications

Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …

Marijuana Taxation: Theory And Practice, Benjamin Leff

Articles in Law Reviews & Other Academic Journals

Marijuana legalization creates a host of complex legal problems, not the least of which is how to best tax the emerging legal market. This Essay attempts to bridge the gap between tax theory and marijuana policy to make some modest claims. First, it roots the discussion of state-level marijuana taxation in the theoretical distinction between ordinary revenue-raising taxes and "Pigouvian" or regulatory taxes. It makes the somewhat controversial claim that the best taxing strategy for states is to attempt to capture as much of the marijuana legalization premium as possible without driving consumers into the illegal market and that other …

Save A Friend's Life Or Risk Your Freedom: The Dilemma Too Many People Face When Witnessing An Overdose, Jennie M. Miller

Journal of Civil Rights and Economic Development

(Excerpt)

You are a Chicago, Illinois resident, walking your dog when you trip over a crack in the pavement and break your arm. You need surgery. After surgery, your doctor gives you a one-month prescription of opioids. Just one little pill has the ability to make all of your pain magically disappear and allow you to function as though you had never even fallen. Near the end of your limited prescription, the pain fails to disappear as easily, and the high does not last quite as long as it once did. There are zero refills remaining. Suddenly, you find yourself …

Mistakes Were Made: Applying Lessons Learned From The Tobacco Master Settlement Agreement To The Opioid Settlement Agreement, Elizabeth Orrick

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

The Harmful Addiction To The War On Drugs, Walter E. Block, Alan G. Futerman

Touro Law Review

Most modern societies prohibit the use of addictive drugs such as cocaine and heroin. We contend this is a mistake. They should all be legalized, forthwith, since their usage constitutes a victimless crime. But more, we also maintain that these jurisdictions are actually addicted to these unjust and harmful laws since, no matter what the logic or the evidence about the perniciousness of this legislation, it still remains on the books

Analyzing Wrongful Convictions Beyond The Traditional Canonical List Of Errors, For Enduring Structural And Sociological Attributes, (Juveniles, Racism, Adversary System, Policing Policies), Leona D. Jochnowitz, Tonya Kendall

Touro Law Review

Researchers identify possible structural causes for wrongful convictions: racism, justice system culture, adversary system, plea bargaining, media, juvenile and mentally impaired accused, and wars on drugs and crime. They indicate that unless the root causes of conviction error are identified, the routine explanations of error (e.g., eyewitness identifications; false confessions) will continue to re-occur. Identifying structural problems may help to prevent future wrongful convictions. The research involves the coding of archival data from the Innocence Project for seventeen cases, including the one for the Central Park Five exonerees. The data were coded by Hartwick College and Northern Vermont University students …

Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina

Scholarship@WashULaw

State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on …

Pricing Drugs Fairly, Govind C. Persad

Sturm College of Law: Faculty Scholarship

Dissatisfaction with drug prices has prompted a flurry of recent legislation and academic research. But while pharmaceutical policy often regards fair pricing as a goal, the concept of fairness itself frequently goes undefined. Legal scholarship—even work ostensibly focused on fairness—has not defined and defended an account of fair pricing. Recent legislative proposals passed by the House and proposed by Sens. Ron Wyden and Chuck Grassley have similarly avoided a determinate position on fairness. This Article explains and defends an account of what makes a price for a drug fair that identifies fair price with social value, argues for implementing fair …