Food and Drug Law Commons^™

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 …

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 …

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 …

Politically Correct Eugenics, Seema Mohapatra

Faculty Scholarship

No abstract provided.

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 …

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 …

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 …

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.

The Food And Drug Administration Versus The Federal Trade Commission: Reconciling Their Interests In Regulating Homeopathic Products, 49 J. Marshall L. Rev. 1193 (2016), Jordannah Bangi

UIC Law Review

This Comment suggests that the FDA should require homeopathic products to carry a disclaimer label similar to those used on prescription drugs or certain food or food products.

Towards A Human Right To Food: Implications For Urban Growing In Baltimore City, Maryland, Becky L. Witt

Fordham Urban Law Journal

No abstract provided.

The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi

Faculty Publications

The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the harm or the risk …

Public Policy Arguments For Enacting Kentucky's Cannabis Freedom Act, Amanda Goff Connors

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

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 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.

Foreword: The Food Law Era, Nathan Cortez

SMU Science and Technology Law Review

No abstract provided.