Food and Drug Law Commons^™

The Legal Status Of Cannabidiol Oil And The Need For Congressional Action, Shelly B. Deadder J.D.

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Post Amarin: Drug Promotion Superhighway Or Speed Trap, Beth E. Wolfe

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Evan R. Youngstrom

Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …

The Challenge Of Adverse Selection To Domestic Seafood Markets In Vietnam: Assessing Consumer Demand And Supply-Side Policy Options, Eliot Martin

Independent Study Project (ISP) Collection

The Vietnamese seafood industry has grown rapidly over the past few decades, largely rallying behind huge foreign demand. Institutions surrounding the production and processing of seafood for export have supported efforts to implement reliable regulations and eco-label certifications in line with demand for safe, environmentally friendly, and otherwise high quality products. No comparable efforts exist in the domestic market. Adverse selection is identified as the core problem with the lack of higher end goods on the domestic market, resulting from asymmetric information between producers and consumers, as well as moral hazard between actors in the supply chain. This study finds …

Despite What You've Been Sold - Unwrapping The Falsities Surounding Food Labels, Camille Currey

West Virginia Law Review

No abstract provided.

Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier

Akron Intellectual Property Journal

Pharmaceutical product hopping is a relatively new phenomenon in which a brand-name pharmaceutical company tactically reformulates a drug and patents the reformulation in an attempt to avoid competition by a generic competitor. When viewed in the context of the HatchWaxman framework, product hopping can effectively eliminate generic competitors from the market, thereby implicating § 2 of the Sherman Act. In addressing antitrust liability, this Note advocates a per se legal approach to product hopping so long as the hop is supported by a valid patent. Although some have argued that deference to the United States Patent and Trademark Office and …

Congress Puts The Usda’S Cool Enforcement On Ice, Golden Gate University School Of Law

GGU Law Review Blog

It is more important that Americans have safer food than to know if their steak is “single‑origin”. Especially in the wake of major E. coli outbreaks at mega chains like Chipotle, food safety in the United States should take priority over pseudo‑protectionist policymaking and food transparency.

Corporate Agricultural Investment And The Right To Food: Addressing Disparate Protections And Promoting Rights-Consistent Outcomes, Kaitlin Y. Cordes, Anna Bulman

Columbia Center on Sustainable Investment Staff Publications

Over the past decade, the world has witnessed heightened corporate interest in large-scale land-based agricultural investment. While such investments can potentially have positive effects for local communities, they also can have wide-ranging negative impacts on human rights, including through forced displacement and the loss of livelihoods. This Article examines the impact of large-scale corporate agricultural investment on the right to food, as well as on human rights more generally. It considers the protections offered by the investment and human rights legal regimes to both corporations and individuals, including recent international developments relating to transnational corporate accountability and efforts to integrate …

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …

A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort

Articles

Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed …

Underbanked: Cooperative Banking As A Potential Solution To The Marijuana-Banking Problem, Patrick A. Tighe

Michigan Law Review

Numerous states have recently legalized recreational marijuana, which has created a burgeoning marijuana industry needing and demanding access to a variety of banking and financial services. Due, however, to the interplay between the federal criminalization of marijuana and federal anti-money laundering laws, U.S. financial institutions cannot handle legally the proceeds from marijuana activity. As a result, most financial institutions are unwilling to flout federal anti-money laundering laws, and so too few marijuana-related businesses can access banking services. This Note argues that the most viable policy option for resolving this “underbanking” problem is a financial cooperative approach such as a cannabis-only …

Immortal Invasive Initiatives? The Need For A Genetic "Right To Be Forgotten", Thomas Hale-Kupiec

Minnesota Journal of Law, Science & Technology

No abstract provided.

The Technical Barriers To Trade Agreement: A Reconciliation Of Divergent Values In The Global Trading System, Samantha Gaul

Chicago-Kent Law Review

In the context of multilateral trading, there is a historical tension between economically oriented, laissez-faire, pro-trade concerns as they are juxtaposed with social, environmental, and health concerns. These conflicting values are inextricable from one another in a world that encourages, and quite frankly mandates, a high level of economic interdependency. But what if institutional actors could reconcile these conflicting values—at least toward the more efficient and practical goals of alleviating (rather than eliminating) the underlying tension? This Note argues that Article 2.2 of the World Trade Organization’s Technical Barriers to Trade Agreement operates to reconcile these fundamental tensions to some …

Comment: Maryland State Bank: The Responsible Solution For Fostering The Growth Of Maryland's Medical Cannabis Program, David Bronfein

University of Baltimore Law Forum

In 2013, Maryland passed its initial medical cannabis law.1 Although seemingly a success in the medical cannabis reform movement, the law only allowed for “academic medical centers” to participate in the program.2 In essence, an academic medical center could dispense medical cannabis to patients who met the criteria for participation in their research program.3 The success of this type of program structure was a concern for medical cannabis advocates,4 and the concerns were validated when no academic medical centers decided to participate.5 As a result of this lackluster program, the General Assembly responded by passing a bill6 during the 2014 …

We Built It And They Did Not Come: Using Governance Theory In The Fight For Food Justice In Low-Income Communities Of Color, Deborah N. Archer, Tamara Belinfanti

Articles & Chapters

Food deserts and food insecurity have received considerable attention from various stakeholders, such as state and local governments, community organizations, and private sector institutions. These stakeholders have sought to overcome food insecurity by turning food deserts into oases by providing “access” to fresh, healthy food. However, many of their solutions—building supermarkets and sponsoring farmers markets—have missed the mark. Residents of food deserts did not flock to grocery stores to purchase fruits andvegetables. As a result, many stakeholders blame the residents of food deserts for their own predicament, lamenting, to paraphrase Field of Dreams, “we built it but they did not …

Perpetual Twilight: How The Usda's Change To The Sunset Process Violates The Organic Foods Production Act Of 1990, Valentina Lumaj

Brooklyn Law Review

In 1990, Congress enacted the Organic Foods Production Act of 1990 (OFPA) in response to consumer and industry demands for uniform standards in organic production. The drafters recognized that the basic tenet of the legislation was that organic foods would be produced without the use of synthetic materials, but they left room for minimal exceptions in the National List of Allowed and Prohibited Substances (the National List). The National List enumerates the exemptions for synthetic substances, as well as prohibitions of natural substances, such as arsenic, in organic production. In September 2013, the USDA amended the Sunset Process, which is …

Lessons From Washington And Colorado: The Potential Financial Gains Of Recreational Marijuana To Canada, Nachshon Goltz, Ekaterina Bogdanov

Osgoode Legal Studies Research Paper Series

While Colorado and Washington are among the jurisdictions spearheading the global trend towards legalization of recreational Cannabis (marijuana), Canada lags behind in the regulatory process - but not in Cannabis consumption. An empirical study conducted in downtown Toronto, as well as studies done by Statistics Canada, reveal that Cannabis use is widespread among Canadians, which indicates that the current regulatory regime is not effective as a deterrent.

This paper details the results of the above-mentioned empirical study, reviews the regulatory framework of recreational Cannabis use in Colorado, Washington and Canada, and uses taxation data from Colorado to estimate the potential …

Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd

Faculty Articles

This Article examines a relatively new business strategy in the pharmaceutical market -- "product hopping" or "product replacement" -- in which brand pharmaceutical companies shift their marketing efforts from a drug nearing the end of its patent period to a new, substitute drug with a longer patent life. In July 2015, the Second Circuit issued an opinion in the first appellate case addressing pharmaceutical product replacement, New York ex rel. Schneiderman v. Actavis PLC. This Article explains that product replacement is the predictable business response to the incentives created by patent law and state substitution laws, and withdrawing an …

The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan, Jr.

Faculty Articles and Papers

No abstract provided.

Enforcement Discretion Under Attack: Implications For Fda, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

Author's Note: On June 23, as this article was going to press, the Supreme Court deadlocked 4-4 in U.S. v. Texas, thus affirming a preliminary injunction against implementation of the Obama Administration’s deferred-action program for millions of undocumented immigrants. Because the Court’s terse per curiam decision established no precedent, the questions that the case raised regarding the permissible scope of administrative enforcement discretion remain unresolved on the national level. The Supreme Court will likely consider them again—after a decision on a permanent injunction in the same case, in a similar immigration dispute, or perhaps in another field of administrative law. …

Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens

Reports & Public Policy Documents

In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “F&D Act”]. Known as “Vanessa’s Law,” these amendments were intended to enhance the regulation of pharmaceutical drugs and thereby protect Canadians from harm by giving the regulator, Health Canada, new powers to, inter alia, recall drugs, require active post-market surveillance, and improve the transparency of information around pharmaceutical drugs. Vanessa’s Law explicitly recognized that “new measures are required to further protect Canadians from the risks related to drugs and medical devices.” (emphasis added) (Bill C-17, An Act to Amend the …

The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post

Faculty Publications

In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …

The Role Of States In Shaping The Legal Debate On Medical Marijuana, Florence Shu-Acquaye

Faculty Scholarship

The ongoing debate in the United States about the legality and use of medical marijuana (also known as medicinal cannabis) is intriguing.

Maryland's Medical Marijuana Law: Transactional And Ethical Perspectives For Real Estate Practitioners, Nicole M. Lacoste Folks, Lawrence F. Haislip, Matthew L. Kimball

University of Baltimore Journal of Land and Development

The congruence between Federal and state laws relating to marijuana, 2 which has existed for generations, is unraveling. In recent years a number of states have reduced or eliminated criminal penalties for the possession or use of small amounts of marijuana;3 twentythree states have established a state law exception for medical marijuana; 4 and Colorado, Washington, Alaska and Oregon now authorize the retail and personal growth, sale and possession of marijuana as a matter of state law.5 Maryland has lately joined the list of states purporting to create exceptions or safe harbors for those wishing to engage in the manufacture, …

"Zoning" In On Maryland's Nascent Marijuana Industry, Matthew Mccomas

University of Baltimore Journal of Land and Development

Is green the new gold?1 Last year, the marijuana industry pulled in a whopping $2.4 billion.2 To put it in perspective that’s about 74% more than it did the year before.3 As of today, four states (Alaska, Colorado, Oregon, and Washington) and the District of Columbia have legalized recreational marijuana.4 But, more so, 23 states have decriminalized medical marijuana, including the State of Maryland in 2013.5

One of the most frequent legal issues in states with medical or recreational marijuana industries concerns where to locate marijuana distribution and production facilities.6 In Maryland, new law states that local municipalities shall determine …

Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States, 15 J. Marshall Rev. Intell. Prop. L. 228 (2016), Daria Kim

UIC Review of Intellectual Property Law

The article addresses specifics of trade secret protection under international investment law. As a particular example, it analyzes protection of pharmaceutical regulatory data against the background of the growing public policy campaign for broader access to clinical trial data and the recent unprecedented practice of the European Medicines Agency of disclosing clinical dossiers submitted for drug marketing approval. Given the significant role of foreign direct investment in the global pharmaceutical industry and substantial, exponentially increasing costs incurred by drug originator companies in conducting clinical trials, the prospect of investor-state dispute over data disclosure does not appear purely hypothetical. The question …

The Art Of Food Placement: Will The U.S. Follow Germany's Lead In Copyrighting Artistic Food Placement?, 15 J. Marshall Rev. Intell. Prop. L. 565 (2016), Julianna Walo

UIC Review of Intellectual Property Law

Recently, German courts created groundbreaking precedent allowing copyright protection for the artistic placement of food on a plate. The rulings allow chefs to prohibit people from taking pictures of the copyrighted food placement. While Germany’s moral-based legal system allows for such copyright protections, this comment compares the U.S. legal system to that of Germany and examines if and how such copyright protection could extend to food placement in the U.S.

Mystery Date: Advocating For A Harmonized System Of Expiration Date Labeling Of Food, Akshat Tiwari

Vanderbilt Journal of Transnational Law

Americans throw out roughly 25 percent of the food they bring home. Negative perceptions associated with expiration dates are a leading cause for this waste. However, a complex patchwork of state-run regulatory regimes and varying terminology makes it difficult for consumers to determine whether a food product is unsafe to eat or simply past a peak quality level arbitrarily set by manufacturers. Regulatory trends in Europe, the United Kingdom, Canada, Australia, and New Zealand suggest a move towards binding expiration date labeling through guidelines for establishing a "best before" or "use-by" date. This Note examines laws currently in place in …

The Effects Of Allergies And Anaphylaxis On The Body And Mind: A Survey Of Opinions And Knowledge On These Disorders, Kathryn E. O'Brien

Honors Program: Student Scholarship & Creative Works

Despite common knowledge, allergies and anaphylaxis are considered disabilities. As such, these disorders affect the daily lives of those who have them, including one's mental health. In this paper, all the nuances of allergies and anaphylaxis will be discussed as the etiology and scientific aspects of allergies, anaphylaxis, and hypersensitivity are distinguished from one another. Furthermore, the findings are reported from two surveys; an assessment of how well educated and prepared teachers are for students with allergies and whether other students with food allergies have had similar experiences to the author's and those described in research by other studies concerning …

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.