Food and Drug Law Commons^™

Pharmaceutical Price Gouging: The Need For Direct Regulation On The Gray Market, Nicole Rende

Journal of Civil Rights and Economic Development

(Excerpt)

This Note proposes federal legislation that will ultimately shut down the Pharmaceuticals gray market. The federal government should directly regulate the gray market and the price gouging mechanisms used. Congress should pass the Fair Accountability and Innovative Research Drug Pricing Act of 2016, currently proposed. This Act will increase price transparency and provide a civil penalty for wrong doers. In addition to the passage of this Act, there needs to be a direct attack on the gray market by creating an act that does not allow companies to participate in these distributions and ultimately form monopolies. This act needs …

A Primer On Opioid-Epidemic Litigation, Roger Michalski

Other Faculty Publications

No abstract provided.

Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman

Articles

A majority of Americans now live in states that purport to authorize medical use of cannabis, although federal law continues to prohibit both recreational and medical use. The current legal regime for cannabis is unstable and may be more effective at deterring research than it is at deterring medical use. Lack of data on medical cannabis products poses public health risks as well as policy and legal challenges. Modified regulatory approaches for other kinds of products provide alternative models for encouraging safety and effectiveness research and providing better information about cannabis products already in clinical use.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Weed Whacking Through The Tenth Amendment: Navigating A Trump Administration Threat To Withhold Funding From Marijuana-Friendly States, Arlen Gharibian

Loyola of Los Angeles Law Review

The Trump administration has taken a firm stance against marijuana legalization at the state level. While an official federal policy is still pending, this Article focuses on whether the Trump administration’s threats to preventCalifornia from pursuing its duly enacted marijuana legalization law violates the Tenth Amendment. This Article then addresses how the federal government could achieve its goal while remaining within the bounds of the Constitution.

The Surprising Reach Of Fda Regulation Of Cannabis, Even After Descheduling, Erika Lietzan, Sean M. O'Connor

Faculty Publications

As more states legalize cannabis, the push to "deschedule" it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis - cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA's focus on precise analytical characterization and on individual active and inactive ingredients may be …

Comparative Analysis Of State Regulation Of Direct-To-Market Sales Of Finfish, Marine Affairs Institute, Roger Williams University School Of Law, James Philopena Jr.

Sea Grant Law Fellow Publications

No abstract provided.

Advancing The Aquaculture Industry Through The Federal Crop Insurance Program, Matthew H. Bowen

Ocean and Coastal Law Journal

In recent times, the aquaculture industry has experienced dramatic growth. The growth of the industry is a direct result of an increase in demand for seafood, and a decrease in supply from wild fisheries. The industry, however, is also experiencing growing pains. Aquaculture species, compared to their wild counterparts, are at a higher risk of catastrophic loss from a variety of different perils. These perils make investment in the aquaculture industry significantly risky. The federal crop insurance program could be a tool that mitigates these risks, but the program was designed around terrestrial agriculture, and while aquaculture may be covered …

Pacta Sunt Servanda State Legalization Of Marijuana And Subnational Violations Of International Treaties: A Historical Perspective, Brian M. Blumenfeld

Pepperdine Law Review

In November 2012, voters in the states of Colorado and Washington passed ballot initiatives to legalize recreational marijuana industries. Since then, eight additional states and the District of Columbia have followed suit, and many more have seen legalization debates in their legislative halls and among their electorates. Over twenty bills recently introduced in Congress have sought to break federal marijuana laws away from prohibition. Although the national debate is indeed a vibrant one, it has neglected to address how legalization may be jeopardizing the compliance status of the United States under international drug treaties, and what the consequences may be …

From A Culture Of Food Waste To A Culture Of Food Security: A Comparison Of Food Waste Law And Policy In France And In The United States, Lindsay Bunting Eubanks

William & Mary Environmental Law and Policy Review

Fighting food waste fights hunger. It also cleans the planet. Currently, one third of all the food produced in the world—1.3 billion tons of edible food—goes to waste every year. Each ton of food wasted produces 3.8 tons of the world’s greenhouse gas emissions. In America, wasted food produces over 20% of methane gas emissions annually. Recovering all this wasted food could feed the food insecure, could clean the environment, and could even create new market opportunities within the food industry. If food industry businesses find ways to resell or recover the cost of what they currently throw away, this …

Interactions, Iteration And Early Institutionalization: Competing Lessons Of Globalgap’S Legitimation, Donal Casey

Transnational Business Governance Interactions Working Papers

Since its inception, GLOBALGAP has transformed from an informal grouping of retailers into a highly elaborate regulatory organisation. This chapter critically examines GLOBALGAP’s development. I argue that, through an iterative process of legitimation, actual and anticipated interactions with state, market and civil society actors led GLOBALGAP to develop structures, practices and processes that sought to enhance representation and participation of structurally weaker parties such as smallholders, whilst also addressing concerns relating to the exclusionary effect of its standards. I tease out how, as non-state regulatory organisations emerge and develop, they respond to actual and anticipated governance interactions in order to …

Seeking Insurance Parity During The Opioid Crisis, Valarie K. Blake

Scholarly Works

Too many privately insured face substantial barriers and delays to getting timely and affordable substance use disorder (SUD) care when they need it, sometimes with terrible and irreversible consequences. Historically, private insurers have been reluctant to cover such services and have been glad to leave this responsibility to public systems like Medicaid. Laws like the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and the Affordable Care Act (ACA) were meant to make private insurance more generous, but these laws are underenforced and too weak to fully address the challenges of the opioid epidemic. When patients and the …

What Are We Really Eating?: An Analysis Of Food Labeling Transparency, Lily Van Petten

Fordham Undergraduate Law Review

Understanding a nutrition label can often be like deciphering ancient hieroglyphics. This Note examines the ethical and legal constraints of food nutrition labeling with specific key words such as “all-natural” and “superfood” in the United States. The subject of nutrition in the law is first explored through the 2018 lawsuit Rice v. National Beverage Corp. Many educated, nutritionally informed citizens still do not have a clear grasp of what chemicals and other synthetic ingredients they are consuming when buying popular brands. Large food companies use persuasive marketing to attract consumers, especially through misrepresenting nutritional data. In this case specifically, Lenora …

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie

Marquette Intellectual Property Law Review

This paper will examine the challenges of international compulsory licensing by examining the issue historically and legally as well as offer possible solutions. Thus, this paper will explore the challenge of balancing corporate interests against the affordability and availability of pharmaceuticals by focusing on discrete situations in developing countries, the history of compulsory licensing, and how the World Health Organization (the “WHO”) and the WTO have attempted to tackle these challenges through compulsory licensing, and it will suggest a possible framework for use in arbitration, which balances equities through a Georgia-Pacific analysis.

Protecting Wisconsinites From Trolls: The Federal Circuit's "Bad Faith" Preemption And Its Restrictive Effect, Andrew Salomone

Marquette Intellectual Property Law Review

In this comment, I use Wis. Stat. Ann. § 100.197 (“Wisconsin’s anti-PAE statute”) to demonstrate the significant degree to which the Federal Circuit’s current preemption regime restricts states’ abilities to regulate the behavior of PAEs. In Part II, I summarize Wisconsin’s legislative response to PAEs. In Part III, I contrast the Federal Circuit’s preemption doctrine and the Supreme Court’s doctrine as it relates to state laws similar to anti-PAE statutes. Paying particular attention to Wisconsin’s patent notification statute, I provide a brief preemption analysis in Part IV. Finally, in Part V, I conclude by arguing that the severe consequences of …

The Role Of Pressure Groups And Problem Definition In Crafting Legislative Solutions To The Opioid Crisis, Taleed El-Sabawi

Faculty Publications

Organized interest groups and federal administrative agencies have historically been influential in defining problem drug use during nationwide crisis. As such, the manner in which these pressure groups defined the problem may have influenced or, at least, provided support for legislators’ decisions to shy away from a criminal justice approach and towards acceptance of a more “health-oriented” — one that did not comprehensively address demand factors or demonstrate a commitment to reforming U.S. drug policy to meet international standards of best practice. In an effort to provide a snapshot of what such involvement may look like, this article explores the …

Patents And The Pharmaceutical Industry: Curbing The Abusive Practices Employed By Blockbuster Drug Companies To Prolong Market Exclusivity, Kelley Chandler

Cornell Journal of Law and Public Policy

Patent law in the pharmaceutical space presents unique challenges. Interactions between patent terms, the FDA, the drug development process, and the need for quality medical solutions create a complex dynamic which leads to uncertainty. This uncertainty makes it difficult to discern between solutions which might be effective, and solutions which will spawn new challenges where they so intently sought to eliminate old ones. Although Hatch-Waxman was a success in many ways, in other ways it has proven to frustrate the purposes behind its enactment. The suggestions presented here are a sound starting point for alleviating some of the burden plaguing …

Rohrabacher-Blumenauer Amendment, Case Law And The Department Of Justice: Who Prevails In The Medical Marijuana Legalization Debate?, Florence Shu-Acquaye

Faculty Scholarship

No abstract provided.

Legal Discrimination Against Organ Transplant Candidates: Medicinal Marijuana And The Double-Edged Sword, 52 Uic J. Marshall L. Rev. 859 (2019), Kyle Jorgensen

UIC Law Review

No abstract provided.

"Hash"Ing Out Inequality In The Legal Recreational Cannabis Industry, Maya Rahwanji

Northwestern Journal of International Law & Business

No abstract provided.

Ships In The Night: Resolving Administrative Conflict Between Fda- And Patent-Related Legislation, Carlos Garcia, Jonathan Stroud

American University Law Review

No abstract provided.

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

Exploring Legal And Policy Responses To Opioids: America's Worst Public Health Emergency, James G. Hodge Jr., Chelsea Gulinson, Leila F. S. Barraza, Walter G. Johnson, Drew Hensley, Haley R. Augur

South Carolina Law Review

No abstract provided.

A Higher Authority: Canada’S Cannabis Legalization In The Context Of International Law, Antonia Eliason, Robert Howse

Michigan Journal of International Law

Part I of this Article provides an overview of some of the key terms and provisions of Canada’s Cannabis Act. Part II looks at the Cannabis Act in the context of the International Drug Conventions, examining how the various convention provisions might apply, looking first at the Single Convention and then at the 1988 Convention and how that convention fits with Canadian constitutional provisions. Part III focuses on the international human rights framework and how the Cannabis Act might be viewed as compatible with international human rights law even where incompatible with the International Drug Conventions. This Part also offers …

The Surprising Reach Of Fda Regulation Of Cannabis Even After Descheduling, Sean M. O'Connor, Erika Lietzan

American University Law Review

No abstract provided.

Marijuana Legalization, Racial Disparity, And The Hope For Reform, Michael Vitiello

Lewis & Clark Law Review

The criminalization of marijuana is rooted in a deeply racist history and has devastated minority communities. Studies show that usage of the drug is consistent across racial groups, but arrests of minorities are nevertheless higher than arrests of white offenders. Indeed, those kinds of disparities have persuaded some voters and policy makers to support legalization of marijuana.

California’s initiative, Proposition 64, passed in November 2016 and is now being implemented statewide. Drafters of Proposition 64 were aware of the racial disparity in enforcement of marijuana laws and attempted to offer a remedy. This Article asks whether Proposition 64 can achieve …

Zoning, Race, And Marijuana: The Unintended Consequences Of Proposition 64, Alexis Holmes

Lewis & Clark Law Review

This Article revisits the campaign to legalize cannabis in California with Proposition 64. It then dissects the localism within the new California regulations and how it conflicts with the social justice goals central to the spirit of Proposition 64’s passage. With local governments retaining control over marijuana in their jurisdictions, land use takes on new importance with respect to how marijuana will be controlled. The problem is that the land use system, like the criminal law apparatus, has yet to overcome systemic racism that is inherently part of its design. Proposition 64 wrongly relied on local control to regulate marijuana …