Food and Drug Law Commons^™

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Current Navigation Points In Drug Diversion Law: Hidden Rocks In Shallow, Murky, Drug-Infested Waters, John J. Mulrooney Ii, Katherine E. Legel

Marquette Law Review

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Sickeningly Sweet: Analysis And Solutions For The Adverse Dietary Consequences Of European Agricultural Law, Emile K. Aguirre

Journal of Food Law & Policy

Sixty-nine percent of adults in the United States, sixty-four percent in the United Kingdom, and over one-third worldwide are overweight or obese. These staggering figures continue to grow, with accompanying emotional, physical, and economic consequences, both for individuals and society as a whole. The role law plays in facilitating this global trend is significant, and yet puzzlingly, little recognized or understood The current food system is profoundly structurally flawed: it establishes unhealthy dietary behaviors as the default option for consumers. This Article is the first to examine how agricultural law has facilitated these unhealthier diets for the past fifty years, …

The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan

Michigan Telecommunications & Technology Law Review

The United States spends nearly $1,000 per person annually on drugs—forty percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, intellectual property law plays a crucial and well-documented role in inhibiting access to cheaper, generic medications. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different avenue of exclusivity—trademark law. New studies suggest that pharmaceutical …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Scholarly Publications

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right.1 The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan

Faculty Publications

On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other …

Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan

Faculty Publications

Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are multiple options available to …

New York City Rules! Regulatory Models For Environmental And Public Health, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Scholars have become increasingly interested in facilitating improvement in environmental and public health at the local level. Over the last few years, former New York City Mayor Michael Bloomberg and the New York City Council have proposed and adopted numerous environmental and public health initiatives, providing a useful case study for analyzing the development and success (or failure) of various regulatory tools, and offering larger lessons about regulation that can be extrapolated to other substantive areas. This Article, first, seeks to categorize and evaluate these “New York Rules,” creating a new taxonomy to understand different types of regulation. These “New …

Sickeningly Sweet: Analysis And Solutions For Adverse Dietary Consequences Of European Agricultural Law, Emilie K. Aguirre

Faculty Scholarship

Sixty-nine percent of adults in the United States, sixty-four percent in the United Kingdom, and over one-third worldwide are overweight or obese. These staggering figures continue to grow, with accompanying emotional, physical, and economic consequences, both for individuals and society as a whole. The role law plays in facilitating this global trend is significant, and yet puzzlingly, little recognized or understood. The current food system is profoundly structurally flawed: it establishes unhealthy dietary behaviors as the default option for consumers. This Article is the first to examine how agricultural law has facilitated these unhealthier diets for the past fifty years, …

Paradise Found? Food Transportation Regulation: A Detour Through Regulatory Purgatory, William Nash

Journal of Food Law & Policy

On January 31, 2014, the Food and Drug Administration ("FDA") issued a Notice of Proposed Rulemaking ("NPRM") that would set requirements for shippers, carriers and receivers of food transported in intrastate and interstate commerce. The NPRM marks a potentially important step in a long history of the (non-)regulation of food transportation. In Parts I and II, this paper will provide some context of the history of food transportation, as well as the major incidents that placed the food transportation industry on the regulatory map. In Parts III and IV, the paper will consider the history of food transportation regulation from …

A Cost-Benefit Analysis Of Sugary Drink Regulation In New York City, Shi-Ling Hsu

Journal of Food Law & Policy

New York City Mayor Bill de Blasio spent much of his time during his successful 2013 campaign positioning himself as the populist candidate, pointedly contrasting himself with the outgoing mayor, billionaire Michael Bloomberg. There is one Bloomberg initiative, however, that de Blasio has committed to carry forward: the city-wide size restriction on sales of "sugary drinks," most commonly, carbonated sodas. On city public health issues such as the sugary drink policy, the populist de Blasio and the billionaire Bloomberg would appear to have much in common. "People are dying every day, this is not a joke," remarked Bloomberg in striking …

Health And Welfare Preempted: How National Meat Association V. Harris Undermines Federalism, Food Safety, And Animal Protection, Marya Torrez

Journal of Food Law & Policy

In 2008, the Humane Society of the United States (HSUS) released an undercover video filmed at the Hallmark Meat Packing Company and Westland Meat Company (Hallmark/Westland) in Chino, California. "The footage depicted nonambulatory cows being kicked, dragged, electrocuted, jammed with forklifts and sprayed in the nostrils with water to simulate drowning - in an effort to get them to stand up and walk to their slaughter." At least five inspectors from the U.S. Department of Agriculture (USDA) - the federal agency tasked with ensuring that food safety and animal welfare guidelines are followed - were present at the time. The …

Taxing Food And Beverage Products: A Public Health Perspective And A New Strategy For Prevention, Jennifer L. Pomeranz

University of Michigan Journal of Law Reform

The power to tax and spend is considered a primary government power, and the use thereof is associated with great public health achievements. The greatest public health challenge at present stems from the increase in obesity and chronic diseases due to poor nutrition. Several taxation strategies have emerged in the health and economic literature to raise revenue, deter consumption, and address food prices and obesity directly. These proposals include taxing obese individuals, taxing problematic food products, and instituting a tax based on certain food components. This article weighs each proposal's value and disadvantages and concludes by proposing a new tax …

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

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 Real Toy Story: The San Francisco Board Of Supervisors Healthy Food Incentives Ordinance, Cortney Price

Journal of Food Law & Policy

Obesity among children in the United States has tripled over the last thirty years. Incidentally, the world's largest fast food restaurant, McDonald's, first introduced its children's Happy Meal thirty-two years ago. Shortly thereafter, the first Disney inspired toy found its way into Happy Meals and the hearts of the "billions and billions served." Although the iconic Happy Meal and accompanying toy have become "a staple of Americana akin to baseball and apple pie," the continued existence of the practice is being threatened in light of the powerful influence toys have on children's food choices, thus contributing to the current obesity …

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang

University of Michigan Journal of Law Reform

Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …

Cheaters Shouldn't Prosper And Consumers Shouldn't Suffer: The Need For Government Enforcement Against Economic Adulteration Of 100% Pomegranate Juice And Other Imported Food Products, Michael T. Roberts

Journal of Food Law & Policy

In the modern global food system - marked by the trade flow of a variety of food products and ingredients from multiple locations in the world - economically motivated adulteration has emerged as a growing menace that threatens the health and wellbeing of consumers, the economic livelihoods of honest purveyors of food in the global marketplace, and the integrity and viability of national food regulatory systems. Economic adulteration is a form of cheating that includes the padding, diluting, and substituting of food product. Although this cheating is rooted in past food systems, the new paradigm for economic adulteration - a …

Reconsidering Federalism And The Farm: Toward Including Local, State And Regional Voices In America's Food System, Margaret Sova Mccabe

Journal of Food Law & Policy

Why is the relationship between our food system and federalism important to American law and health? It is important simply because federal law controls the American food system. This essay considers how federal law came to structure our food system, and suggests that though food is an essential part of our national economy, the dominating role of the federal government alienates citizens from their food system. It does so by characterizing food as a primarily economic issue, rather than one that has ethical, health, and cultural components. However, state and local governments have much to offer in terms of broadening …

Food Justice As Crime Prevention, Avi Brisman

Journal of Food Law & Policy

In December 2008, Governor David Paterson (D-NY) proposed an 18 percent tax on nondiet sodas and fruit drinks containing less than 70 percent natural fruit juice. While the tax was part of a broader budget proposal designed to address New York State's fiscal crisis - a plan that that included new taxes and tax hikes on 137 items and services' - state officials promoted the "obesity tax," as the soft drink levy came to be called, as a public health measure.

Regulatory Dysfunction: How Insufficient Resources, Outdated Laws, And Political Interference Cripple The 'Protector Agencies', Sidney A. Shapiro, Rena I. Steinzor, Matthew Shudtz

Faculty Scholarship

In the last several years, dramatic failures of the nation’s food safety system have sickened or killed tens of thousands of Americans, and caused billions of dollars of damages for producers and distributors of everything from fresh vegetables to granola bars and hamburger meat. In each case, the outbreak of food-borne illness triggered what can only be described as a frantic scramble by health officials to discover its source. Inevitably, the wrong lead is followed or a recall is too late or too narrow to prevent further illnesses, and the government has to defend itself against withering criticism. Americans expect …

The Deregulatory State, Lawrence O. Gostin

O'Neill Institute Papers

Public health can be achieved only through collective action, not through individual endeavor. Collective goods are essential conditions for health, but can be secured only through a well-regulated society. Yet, successive governments have eroded health and safety protections, with serious consequences. Think about the death of miners, lead in children’s toys, industrial solvents in toothpaste, salmonella in peanut butter, e-coli in spinach, and unsafe or ineffective pharmaceuticals such as COX-2 inhibitors or non-statin cholesterol medications.

Conservatives have waged a campaign against the administrative state that has created and reinforced deep-seated concerns about over-bearing government, particularly at the national level. The …

The Battle Of The Bulge: Evaluating Law As A Weapon Against Obesity, Margaret Sova Mccabe

Journal of Food Law & Policy

"Silly rabbit, Trix are for kids." Since the 1970s, kids have gotten to know the silly rabbit created to promote sugary, fruit-flavored cereal in television ads. Today, "i'm lovin' it" is the McDonald's slogan, but to millions of children the more recognizable symbol is Ronald McDonald. Ronald McDonald is so recognizable that one study pegged recognition of Ronald among American children at 96% and another at 80% by children in nine other countries. Given the "obesity crisis," many question whether these ads should be permitted, with some questioning whether such products are even safe for children's consumption. The Trix Rabbit …

Safe But Not Wholesome: The Troubling State Of Trans Fat Regulation, Ross Williams

Journal of Food Law & Policy

On March 7, 2007, the New York Times reported that Starbucks, the retail coffee chain which sells millions of baked goods every day from its over 8,700 U.S. stores, had asked its suppliers to eliminate all trans fats from their products by the end of the year. The big story for New York readers, though, was not that Starbucks was requiring the elimination of trans fats from its baked goods. In fact, New York City had just passed an ordinance strictly limiting the use of artificial trans fats, the type present in partially hydrogenated vegetable oil (PHVO), by virtually all …

Defying Nature: The Ethical Implications Of Genetically Modified Plants, Debra M. Strauss

Journal of Food Law & Policy

Genetic engineering is changing the semantics, the meaning of life itself. We're trying to usurp the plant's choice. To force alien words into the plant's poem, but we [have] a problem. We barely know the root language. Genetic grammar's a mystery.... We've learned a lot about the letters-maybe our ability to read and spell words now sits halfway between accident and design - but our syntax is still haphazard. Scrambled. It's a semiotic nightmare.

Setting The Stage For Public Health: The Role Of Litigation In Controlling Obesity, Jason A. Smith

University of Arkansas at Little Rock Law Review

No abstract provided.

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Mandatory Recall Authority: A Sensible And Minimalist Approach To Improving Food Safety, Michael T. Roberts

ExpressO

No abstract provided.