Digital Commons Network^™

Prescriptions At A Price: America's Opioid Crisis And The Increasing Toll On Drug Record Privacy, Reem Blaik

Vanderbilt Journal of Entertainment & Technology Law

How should the US Constitution govern patient privacy in the face of a public health emergency? Declaring the United States' opioid crisis as a public health emergency may put the already-compromised integrity of drug record privacy at higher risk by virtue of emerging administrative responses, existing Supreme Court precedent, and acquiescent state laws. The White House convened a summit on opioids where the then-US attorney general discussed law enforcement responses to the crisis. Although the Fourth Amendment protects against unreasonable searches and seizures, the Supreme Court's third-party doctrine generally grants state and federal actors access to records released to third …

Reconciling The Lanham Act And The Fdca: A Comment On Chris Hurley’S Note, Christopher B. Seaman

Washington and Lee Law Review

No abstract provided.

The Formulary Fix Buries Fritz & Harvey: Drug Promotion Escapes Its Past Constraints, James T. O'Reilly

Washington and Lee Law Review

No abstract provided.

Guns N' Ganja: How Federalism Criminalizes The Lawful Use Of Marijuana, Ira P. Robbins

Articles in Law Reviews & Other Academic Journals

Federalism is a vital tenet of our Republic. Although federal law is the supreme law of the land, our Constitution recognizes the integral role that state law plays in the national scheme. Like any pharmaceutical drug that withstands rounds of clinical testing, state law functions as a laboratory in which Congress can evaluate and potentially adopt novel policies on a nation-wide basis. Most of the time, federal and state law exist harmoniously, complementing one another; other times, however, the two systems clash, striking a dissonant chord.

In the United States, state marijuana laws are currently on a crash course with …

Telemedicine Is The New Narcotics Candy Store: Teladoc Opens The Floodgates For The Unrestricted Sale Of Dangerous Drugs, Madeleine Rosuck

SMU Science and Technology Law Review

No abstract provided.

The Off-Label Use Of Pom Wonderful: Using Section 43(A) To Eliminate Misleading Off-Label Drug Promotion, Christopher A. Hurley

Washington and Lee Law Review

No abstract provided.

All Is Fair In Drugs And War: An Analysis Of "Pay-For-Delay" Agreements And Product Hopping, Sean Boyle

Valparaiso University Law Review

No abstract provided.

The “Deeming Rule”: The Fda’S Destruction Of The Vaping Industry, Lauren H. Greenberg

Brooklyn Law Review

The FDA has recently passed sweeping regulations, which classifies and then regulates electronic cigarettes as “tobacco products” in the same manner as traditional cigarettes. Though the agency reasons that unknowing adults and children may easily turn to e-cigarettes without fully understanding the potential health effects, there is a lack of conclusive evidence in this field to justify such a comprehensive regulatory scheme. Through the far-reaching “Deeming Rule,” e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market. The channels by which the FDA proposes manufacturers and retailers gain permission from …

Food Federalism: States, Local Governments, And The Fight For Food Sovereignty, Sarah B. Schindler

Faculty Publications

Recently, a number of states have sought to withdraw or restrain local power. In this Article, which is part of the “Re-Thinking State Relevance” symposium hosted by the Ohio State Law Journal, I write about a state taking the opposite approach, and attempting to affirmatively endow its local governments with additional powers. The state is Maine, and the context is control over local food production and sales. This Article begins by addressing the emergence of the sustainable local foods movement broadly, and reasons for the growth of this movement. It then focuses more pointedly on the food sovereignty movement, considering …

The Fda's Priority Review Voucher Program's Role In Bringing Benznidazle To Chagas Disease Patients In The United States, Lisa Cline

Cybaris®

No abstract provided.

What Is Useful And Novel? The Collision Between Intellectual Property Protection And Regulation Regarding Medical Devices, James Sutherland

Cybaris®

No abstract provided.

Crafting Next Generation Eco-Label Policy, Jason J. Czarnezki, Katrina F. Kuh

Elisabeth Haub School of Law Faculty Publications

Eco-labels present a promising policy tool in the effort to achieve sustainable consumption. Many questions remain, however, about the extent to which eco-labels can contribute to sustainability efforts and how to maximize their effectiveness. This Article deploys research from evolutionary psychology, behavioral law and economics, and norm theory to offer specific insights for the design and implementation of eco-labels to enhance their influence on sustainable consumer choice. Notably, this research suggests possibilities for eco-labels to shape or expand consumer preferences for green goods, and thereby enhance eco-label influence on consumer behavior by extending it beyond eco-minded consumers. We suggest that …

“High” Standards: How The Tide Of Marijuana Legalization Sweeping The Country Ignores The Hidden Risks Of Edibles, Steve Calandrillo, Katelyn Fulton

Articles

As a tide of marijuana legalization sweeps across the United States, there is a surprising lack of scrutiny as to whether the benefits of recreational marijuana outweigh the risks. Notably, marijuana edibles present special risks to the population that are not present in smoked marijuana. States that have legalized recreational marijuana are seeing an increase in edible-related calls to poison control centers and visits to emergency rooms. These negative reactions are especially prevalent in vulnerable populations such as children, persons with underlying preexisting conditions, and out-of-state marijuana novices. Unfortunately, research on edible marijuana is scant and state regulatory regimes are …

Dying For A Solution: The Regulation Of Medical Devices Falls Short In The 21st Century Cures Act, Marilyn Uzdavines

Nevada Law Journal

No abstract provided.

A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan

Faculty Publications

This short paper comments on Professor Carrier's new article, Biologics: The New Antitrust Frontier. His article makes a profound initial contribution to a new area of scholarship, based on a large body of prior work considering antitrust issues relating to small molecule drugs. But Professor Carrier’s article, like my own forthcoming piece on innovation and competition in the biologics marketplace, is inherently speculative. We are making our best judgments about the nature of a still emerging marketplace and likely conduct in that marketplace, based on our understandings of a new regulatory framework that is itself still emerging, the broader legal …

The History And Political Economy Of The Hatch-Waxman Amendments, Erika Lietzan

Faculty Publications

Reform of the Hatch–Waxman generic drug framework is in the air. Scholars, consumer advocacy groups, regulated industry, and policymakers are engaged in heated debate about perceived shortcomings in the scheme, flaws, and unexpected loopholes. Changes in how the U.S. Food and Drug Administration (FDA) implements the law, as well as changes to the law itself, are under serious consideration. These policymaking discussions take place against a backdrop of shared assumptions about the origins and nature of the original Hatch–Waxman legislation — assumptions that this Article claims are wrong. Convention wisdom holds that the Hatch–Waxman legislation was a delicate compromise privately …

The United States, Mexico, And The War On Drugs In The Trump Administration, James M. Cooper

Faculty Scholarship

This Article examines the war on drugs as persecuted by the United States and how it has been exported to Mexico. It also explores the increased efforts in the drugs war that the Trump administration, through the U.S. Department of Justice, is pursuing at a domestic level. Part I of this Article provides an outline of the dynamics in the quickly evolving and highly tense relationship between the United States and Mexico. Part II of this Article details the historical background of the U.S.-Mexico border region and demonstrates that the border has long been a contested site. Part III provides …

Administrative Guidance And Genetically Modified Food, Edward L. Rubin, Joanna K. Sax

Faculty Scholarship

One of the most controversial issues in administrative law, the use of guidance, is exemplified by the regulation of one of the most controversial areas in modern society: genetically modified (GM) food. The appropriate use of guidance versus notice and comment rulemaking is a much-debated issue in administrative law. While agency officials generally assert that they are using guidance to express an agency’s thoughts about how to comply with a specific statutory provision or agency rule, the practical consequence is that the regulated party will hesitate to disobey, even if it believes that the guidance goes beyond the requirements of …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …