Food and Drug Law Commons^™

Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler

Pepperdine Dispute Resolution Law Journal

The article presents information on the Vaccine Injury Compensation Program. It discusses the U.S. Federal circuit case Hazlehurst v. Sec'y of Health & Human Servs., in which lawsuit against the defendant was filed by the plaintiff who sought claims against the liability of product to recover damages for alleged injuries which his son had received from vaccines. It also provides information on the structural moral hazard of the program which devolves it into a litigious adjudicatory process.

Mandatory Drug Testing Of College Athletes: Are Athletes Being Denied Their Constitutional Rights? , Allison Rose

Pepperdine Law Review

No abstract provided.

Public-Private Regime Interactions In Global Food Safety Governance, Ching-Fu Lin

Transnational Business Governance Interactions Working Papers

In response to an apparent decline in global food safety, numerous public and private regulatory initiatives have emerged to restore public confidence. This trend has been particularly marked by the growing influence of private regulators such as multinational food companies, supermarket chains and non-governmental organizations (NGOs), who employ private standards, certification protocols, third-party auditing, and transnational contracting practices. This paper explores how the structure and processes of private food safety governance interact with traditional public governance regimes, focusing on Global Good Agricultural Practices (GlobalGAP) as a primary example of the former. Due to the inefficiency and ineffectiveness of public regulation …

Implications Of The Supreme Court's Decision In Pliva, Inc. V. Mensing: Why Generic And Brand-Name Pharmaceuticals Must Be Treated Equally Under The Federal Food, Drug, And Cosmetic Act

Marquette Elder's Advisor

No abstract provided.

Christopher V. Smithkline Beecham Corporation: An Unsurprising Loss For Pharmaceutical Sales Representatives And An Erosion Of Power For Administrative Agencies, Anna Johnston

Proxy

No abstract provided.

Rights And Roles: Alaska Natives And Ocean And Coastal Subsistence Resources, Jordan Diamond, Greta Swanson, Kathryn Mengerink

Florida A & M University Law Review

This article explores the strengths and weaknesses of the two pillars of the framework for managing marine subsistence resources in Alaska: the pillar that protects Alaska Native rights to marine subsistence resources, and the pillar that protects the resources themselves. It focuses on how well the pillars support subsistence practices and Alaska Native leadership in the management framework. Part I summarizes the management challenge posed by the effects rapid climate change is causing in the Arctic, including impacts to the marine subsistence resources upon which Alaska Natives depend. Part II explores the laws and doctrines related to Alaska Native subsistence …

The Unconstitutional Prosecution Of Controlled Substance Metabolites Under Utah Code § 41-6a-517, Joshua C. Snow

Utah OnLaw: The Utah Law Review Online Supplement

This Article achieves three main goals. First, it explains and explores Utah’s per se metabolite laws against the backdrop of the national landscape of metabolite laws. Second, this Article provides a concise explanation regarding the science of drug metabolites. Finally, this Article presents two constitutional challenges to Utah Code section 41-6a-517. The first challenge argues that the statute creates an impermissible status offense in violation of the Eighth Amendment to the U.S. Constitution. The second challenge argues that the statute violates Utah’s Uniform Operation of Laws Clause found in the Utah Constitution. This Article concludes by asking Utah state courts …

Chapter 415: Big Help For Small Businesses, Matthew Read

McGeorge Law Review

No abstract provided.

Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork

Michigan Telecommunications & Technology Law Review

Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …

State Medical Marijuana Implementation And Federal Policy, Karen O'Keefe

Journal of Health Care Law and Policy

No abstract provided.

No Duty To Warn Of Drug Interactions: A Dangerous Prescription, 46 J. Marshall L. Rev. 533 (2013), Ryanne Bush Dent

UIC Law Review

No abstract provided.

Do You Know What's On Your Plate?: The Importance Of Regulating The Processes Of Food Production, Martha Dragich

Faculty Publications

This article argues that the current regulatory approach-focusing on the supposed equivalence of new foods to traditional ones-is unduly narrow, particularly given the characteristics of the modem food system. To achieve the broad objectives of the FDCA in the context of the industrialized, highly processed, and global food supply of the twenty-first century requires adopting a broader understanding of consumer protection needs with respect to food. The FDCA itself is written in very broad terms and provides much of the authority needed today. The FDA's enforcement capacity, however, already is severely strained.52 Moreover, the scientific basis for some process- oriented …

Pharmageddon: A Statutory Solution To Curb Ohio's Prescription Abuse Problem, Ed Woodworth

Journal of Law and Health

Prescription abuse in Ohio continues to be a serious and complex issue that should be addressed. Accordingly, Part II of this Note examines the background of prescription drug abuse generally. It identifies the dangers of prescription drug abuse, the cost drug abuse places on society, some reasons for prescription drug abuse, sources of prescription drugs, and discusses the current state and federal laws regarding prescription drug abuse and prescription reporting. Part III discusses the positive and negative aspects of H.B. 93 and Medical Rule 4731-11-11 and then offers proposals to more effectively prevent prescription drug abuse. Part IV discusses various …

Finding A Cure: Incentivizing Partnerships Between Disease Advocacy Groups And Academic Commercial Researchers , Anne M. Readel

Journal of Law and Health

Collaborations between for-profit drug companies and not-for-profit disease advocacy groups have risen in recent years in an effort to find cures for orphan diseases. These unique and beneficial collaborations are a result of disease advocacy groups assuming a more active role in drug development through the use of “venture philanthropy,” which employs concepts and techniques from venture capitalism and applies them to achieving philanthropic goals. While these collaborations have found remarkable success, such as the discovery of the first known cure for cystic fibrosis in 2012, venture philanthropy for drug discovery presents numerous legal and social challenges. This Article examines …

Investing In Cannabis: Inconsistent Government Regulation And Constraints On Capital, Adrian A. Ohmer

Michigan Business & Entrepreneurial Law Review

This note’s focus is on the future of investing in the growing legalized cannabis industry. In Part II, it will provide a brief history of federal and state regulation of cannabis. Part III will discuss the current role of the federal government in regulating the cannabis industry. Part IV will explore the current avenues of access to capital for the cannabis industry. Lastly, Part V will provide suggestions for the federal government and state governments to reduce investment risk that exists in the cannabis industry.

Winter 2013 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Faculty Publications

The past several decades have seen the creation of transformative new technologies that are being used to design innovative consumer product ingredients never seen before in nature. Examples include the use of nanotechnology and genetic modification, and, right around the corner, cloning and lab grown meat. These innovative technologies are harbingers of more pioneering consumer product ingredients to come. The remarkable pace of the development of ground-breaking new technologies means that the population is being steadily exposed to novel ingredients with unknown health risks.

Optimally, the Food & Drug Administration ("FDA") should be regulating these innovative, novel ingredients in consumer …

In Re K-Dur Antitrust Litigation: The Third Circuit's Controversial Pay-For-Delay Antitrust Decision Splits With Other Circuit Courts, Carl W. Hittinger, Lesli C. Esposito

Villanova Law Review (1956 - )

No abstract provided.

California's Proposition 37: Will Its Failure Forecast The Fate Of The Gm Food Labeling Movement In The United States Once And For All?, Meredith K. Schuh

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

From “Food Miles” To “Moneyball”: How We Should Be Thinking About Food And Climate, Bret C. Birdsong

Scholarly Works

Since Michael Pollan popularized the push to eat local food in his bestseller, The Omnivore’s Dilemma, the concept of “food miles” has been something of a rallying cry and an organizing principle in the marketing of the local food movement. Among locavores and their sympathizers, the term seems to encapsulate all that is wrong with the food system. Fresh grapes from Chile make their way to supermarkets from Maine to Minnesota, and even California. Major food conglomerates process commodity ingredients like corn, soy, and wheat into packaged food that travels across the country and across oceans before landing on …

Insights In Enforcement, Litigation & Compliance For Pharmaceutical And Medical Device Manufacturers At Fdli's Enforcement, Litigation And Compliance Conference, December 12-13, 2012, Thomas Sullivan, Abraham Gitterman

Student Articles and Papers

No abstract provided.

Taxing The Platypygous, James J. White

Articles

This Article maintains that obesity in the United States is an enormous public health issue that causes the health care costs of the obese Americans greatly to exceed those of citizens of normal weight. Recognizing that that much of that cost will be born by publicly financed programs and that the taxes supporting those programs will constitute an externality that the fat impose on the thin, the Article proposes a tax on high calorie food-but only when that food is purchased by the obese. The Article addresses many of the administrative, moral and other objections to a tax aimed at …

The American Public’S Perception Of Illegal Steroid Use: A National Survey, 2013, Gary Siperstein, Neil Romano, Gizem Iskenderoglu, Anthony Roman, Floyd J. Fowler Jr., Max Drascher

Center for Social Development and Education Publications

Through the surge of news about doping scandals in the media, it is expected that the public is aware of the magnitude of the problem among professional athletes; however, it is uncertain whether the public is aware that the problem often starts when athletes are younger. To this end, the National Baseball Hall of Fame and Museum, the Taylor Hooton Foundation, and the Professional Baseball Athletic Trainers Society partnered with the Center for Social Development and Education and the Center for Survey Research at the University of Massachusetts Boston to conduct the most comprehensive national opinion survey to date to …

Regulating Prescription Drugs For Patient Safety: Does Bill C-17 Go Far Enough?, Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, Barbara Mintzes

Articles, Book Chapters, & Popular Press

Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962. However, most of the drug’s distribution was in the form of free samples to medical professionals, which the directorate had no legal authority to control. Therefore, to avoid similar situations in the future and to stop sales of thalidomide, on Dec. 4, 1962, the Parliament of Canada amended the Food and Drugs …

When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder

Articles, Book Chapters, & Popular Press

Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …

A National "Natural" Standard For Food Labeling, Nicole E. Negowetti

Law Faculty Publications

No abstract provided.

Reconciling American Marijuana Policy In A Federal System, Catherine Morton

Global Tides

The recent successful ballot initiatives in Colorado and Washington to legalize recreational marijuana despite restrictive federal law continue to demonstrate the disconnect between national and state marijuana policy. In order to understand how many of these national policies were enacted, an investigation will be presented of the discriminatory history of marijuana legislation, indicating the inconsistent nature of past regulation. Thus following will be an examination of relevant Supreme Court cases depicting the Supreme Court’s ultimate hesitation to prevent the states from circumventing federal marijuana law. Finally, a discussion will be held on the ramifications of inconsistent state and national policies, …

Global Environmental Law: Food Safety & China, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This article makes the case for food security law and policy as a component of global environmental law in recognition of the global economy, trade liberalization, and concerns for food safety and environmental harm. It further describes rule of law as a significant force in mitigating food safety concerns and pollution in China. Part II explores global food safety concerns in the context of United States-China relations, while Part III discusses the U.S. Food & Drug Administration's on-the-ground presence in China as an example of the emergence of cooperative agreements in global environmental governance. Part IV shows how increased rule …

Is Sugar The New Tobacco? How To Regulate Toxic Foods, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

This article explores the health risks associated with added sugar. It then examines how, if at all, sugar should be regulated, by considering tobacco regulation as a possible model. Part I identifies the health risks of sugar consumption. Part II examines the reasons why sugar is added to so much of our food supply. Part III provides an overview of tobacco regulation, including educational initiatives, warning labels, advertising restrictions, age limitations, and taxes. Finally, Part IV provides a framework for sugar regulation, suggesting that most of the foregoing laws designed to discourage tobacco use should, with the exception of age …

Up To Our Ears: Corn Overproduction, Its Environmental Toll, And Using The 2012 U.S. Farm Bill To Limit Corn Subsidies, Increase Environmental Protection Incentives, And Place Accountability On Crop Operations, Christopher Frump

Florida A & M University Law Review

No abstract provided.