Food and Drug Law Commons^™

Enough Is As Good As A Feast, Noah C. Chauvin

Seattle University Law Review

Ipse Dixit, the podcast on legal scholarship, provides a valuable service to the legal community and particularly to the legal academy. The podcast’s hosts skillfully interview guests about their legal and law-related scholarship, helping those guests communicate their ideas clearly and concisely. In this review essay, I argue that Ipse Dixit has made a major contribution to legal scholarship by demonstrating in its interview episodes that law review articles are neither the only nor the best way of communicating scholarly ideas. This contribution should be considered “scholarship,” because one of the primary goals of scholarship is to communicate new ideas.

Washington Cannabusiness: Washington’S Durational Residency Requirement Should Be Eliminated On Economic, Social, And Constitutional Grounds, Alejandro Monarrez

Seattle University Law Review Online

No abstract provided.

Drug Policy Reform In The Americas: A Welcome Challenge To International Law, Alvaro Santos

Georgetown Law Faculty Publications and Other Works

Drug policy in the American hemisphere is in flux. After decades whereby a prohibitionist regime reigned supreme and proposing alternatives was taboo, several countries have begun to reconsider policy, particularly in the case of marijuana. International law has been instrumental in building the legal and institutional regime of prohibition, and it has remained largely impervious to critiques of its disastrous consequences. Indeed, when it comes to drug law and policy, international law has been part of the problem. Nevertheless, countries in the Americas have begun to adopt innovative strategies that also embrace international obligations. In this essay, I examine the …

Reputation And Authority: The Fda And The Fight Over U.S. Prescription Drug Importation, Thomas J. Bollyky, Aaron S. Kesselheim

Vanderbilt Law Review

There is popular and bipartisan support for legalizing the importation of lower-cost medicines from Canada to help reduce the high prescription drug costs that Americans pay. Despite the wide interest in this policy, attempts over the last sixteen years to create a formal system for large-scale prescription drug importation in the United States have failed. The Trump Administration recently issued a final rule to enable the legal importation of prescription drugs from Canada, but the rule has important design flaws and seems destined to suffer a similar fate as previous efforts.

In this Article, we argue that prescription drug importation …

Biosimilars: The Quest For A Rational Regulatory And Intellectual Property Approach In Canada, Elizabeth S. Dipchand

LLM Theses

Biologics and biosimilars represent the promise for more effective treatments of many diseases. International treaty obligations influenced heavily by the biopharmaceutical industry and advanced through the international trade agenda may lead to an imbalance between incentivizing innovation and the public interest. Canada’s implementation of its obligations into national patent and regulatory laws encourages aggressive biologic patent protection strategies that, coupled with linked regulatory assessments, may establish compounding layers of exclusion that disproportionately disincentivizes both the biologics innovation and biosimilar development. This comparative analysis addresses the progression of international obligations and the way in which they have been implemented into Canada’s …

Up In Smoke: Bankruptcy And Cannabis, Peter C. Alexander

University of Arkansas at Little Rock Law Review

No abstract provided.

Using One Dying Regime To Save Another, Robert A. Mikos

Vanderbilt Law School Faculty Publications

Cannabis reforms are proliferating. A handful of nations have already legalized the drug for recreational purposes, and several more may soon follow suit. These national cannabis reforms are generating bottom-up pressure to liberalize the transnational legal order (TLO) for cannabis prohibition, one that involves not only international law, but also domestic law and regulatory practice. Based on a trio of international conventions, this TLO currently requires member states to limit access to marijuana, especially for non-medical or non-scientific purposes. But even as it comes under attack from below, the existing cannabis prohibition TLO may be exerting its own downward pressure …

Distorted Drug Patents, Erika Lietzan

Faculty Publications

Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

21 In The 21st—An Evaluation Of The Tobacco Regulation Trend, Casey Kellum

St. Mary's Law Journal

Tobacco regulation persists as a controversial issue both legally and politically in the United States. Throughout American history, states rely on local legislation to provide adequate protection to consumers of tobacco products, as “Big Tobacco” targets consumers for its addictive product. One of the most recent amendments in this arena is the state by state decision to raise the minimum legal sales age for tobacco to twenty-one.

Despite rigorous regulation of tobacco products in the United States, however, tobacco remains the leading cause of preventable deaths in the country. These “Tobacco 21” ordinances come at a critical time when the …

Impossible Attempts And The Punishment Of Intent: Han Fang Guan V Public Prosecutor, Wing Cheong Chan

Research Collection Yong Pung How School Of Law

This comment reviews the new “two-stage framework” developed by the Singapore Court of Appeal in the case of Han Fang Guan v Public Prosecutor for impossible attempts under the Misuse of Drugs Act. The new framework clarifies the law and it is suggested that the approach should be adopted for all other criminal laws as well.

Competing Free Speech Rights: Evaluating Compelled Disclosures On Food Packaging In A Way That Reflects Scientific Realities - Or A Lack Thereof, Rakelle Shapiro

Cardozo Law Review

No abstract provided.

Resolving Disputes Before They Decant: An Alternative Dispute Resolution System For Growers And Wine Producers, Savannah Billingham-Hemminger

Pepperdine Dispute Resolution Law Journal

No abstract provided.

The Heavy Hand Of Amazon: A Seller Not A Neutral Platform, Edward J. Janger, Aaron D. Twerski

Brooklyn Journal of Corporate, Financial & Commercial Law

Since the adoption of Section 402A of the Second Restatement of Torts, every party in a product’s distribution chain has been potentially liable for injuries caused by product defects. Consumers who buy from reputable sellers are almost always guaranteed to have a solvent defendant if injured by a product defect. Amazon, though responsible for a vast number of retail sales, has sought to avoid liability by claiming that it is not a seller but a neutral platform that merely facilitates third-party sales to consumers. With two significant exceptions, most courts have sided with Amazon and concluded that Amazon is not …

Medical Marijuana, Taxation, And Internal Revenue Code Section 280e, Douglas A. Kahn, Howard J. Bromberg

Articles

Congress enacted § 280E of the Internal Revenue Code in 1982 to punish businesses engaged in illegal drug trafficking, including marijuana. Section 280E denies all credits and deductions, including ordinary business expenses, from gross income of businesses illegally trafficking in a Schedule I or II controlled substance. This provision violates the principle that the tax code should foster a consistent treatment of income, regardless of source; and that the income tax is ill-used for punitive measures. Now that marijuana has been legalized in some form in at least 46 states for therapeutic purposes, this federal tax penalty transgresses principles of …

Patent Eligibility And Investment, David O. Taylor

Cardozo Law Review

Have the Supreme Court's recent patent eligibility cases changed the behavior of venture capital and private equity investment firms, and if so how? This Article provides empirical data about investors' answers to those important questions. Analyzing responses to a survey of475 investors at firms investing in various industries and at various stages of funding, this Article explores how the Court's recent cases have influenced these firms' decisions to invest in companies developing technology. The survey results reveal investors' overwhelming belief that patent eligibility is an important consideration in investment decision making, and that reduced patent eligibility makes it less likely …

False Foods: Harmonizing The Eu And Us Organics Programs, Elizabeth G. Fudge

Brooklyn Journal of International Law

The growth of the importation and exportation of organic foods in recent years has led governments around the globe to take more aggressive approaches in overseeing and certifying such products. Currently, there is a discrepancy in how states certify and respond to non-compliance issues for imported organic products. This creates a strong need to harmonize organics programs, specifically between the EU and US programs, as they are the two largest consumers of organic products. Through auditing both the EU and US organic import programs, significant issues of non-compliance became exceedingly clear. This Note argues that the best solution for addressing …

The California Cannabis Industry: The Complexities Since Recreational Legalization, Talia Lux

The Journal of Business, Entrepreneurship & the Law

This comment will first provide a look into the history and legality of cannabis in the United States, followed by a look into California’s cannabis industry. There will be a discussion on both medical and recreational legality in California and the provisions surrounding both types of legality. Next, the complexities of the cannabis industries will be discussed in terms of opening and operating a cannabis business, the different cannabis business types and the requirements for starting them, and state and local limitations. Immediately following, there will be a federal illegality discussion and how federal illegality conflicts with California law in …

The Incredible Edible: Protecting Businesses And Consumers In A Society Of Legalized Cannabis, Brandon M. Thompson

Nevada Law Journal Forum

This Article briefly discusses the history and origin of marijuana, or more precisely the cannabis plant, before branching into an examination of its chemical properties, forms, and uses. Including a concise survey of the various effects—including adverse side effects—of cannabis use. Additionally, it provides an introduction to products liability as it relates to drugs, in general, and then more specifically to the production and distribution of edibles. It will discuss some of the dangers that edibles pose to children. The focus will be primarily on issues with the marketing and presentation of edibles that have led to unintended cannabis consumption …

Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley

Articles

As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.