Food and Drug Law Commons^™

Regulating By Repute, David Zaring

Michigan Law Review

Is regulation a hopeless cause? Many thoughtful observers spend a lot of time enumerating all of the reasons why it is doomed to fail. The entire field of public choice, with impeccable logic, posits the likely corruption of every bureaucrat. And if corruption cannot explain the failure of regulation, the atrophy that comes from lack of competition-there is just one government, after all, and it does not have a profit motive-may be just as rich a vein to mine. It could also be that the legal system itself, with its myriad complexities, checks, and procedural requirements, may ossify to the …

Childhood Obesity: Balancing The Nation's Interest With A Parent's Constitutional Right To Privacy, Denise Cohen

Cardozo Public Law, Policy & Ethics Journal

The note argues that governmental intervention into parental rights regarding childhood obesity is constitutionally justifiable under strict scrutiny, as it serves the compelling interests of both the child's well-being and societal welfare. While the constitutional right to privacy in parenting is fundamental, it is not absolute, and the growing public health crisis of childhood obesity necessitates narrowly tailored measures to hold parents accountable. The analysis proposes that existing legal frameworks, such as neglect statutes, can be effectively applied to address severe cases of childhood obesity, balancing individual rights with public health needs.

Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System, Amy Murphy

Michigan Law Review

In Granholm v. Heald, the Supreme Court held that states must treat instate and out-of-state alcoholic beverages equally under the dormant Commerce Clause and established a heightened standard of review for state alcohol laws. Yet in dictum the Court acknowledged that the three-tier distribution system-a regime that imposes a physical presence requirement on alcoholic beverage wholesalers and retailers-was "unquestionably legitimate." Though the system's physical presence requirement should trigger strict scrutiny, lower courts have placed special emphasis on Granholm's dictum, refusing to subject the three-tier distribution system to Granholm's heightened standard of review. This Note argues that the dictum should be …

Playing By Market Rules: Anti-Doping Policy In The European Union, Kayla Mcculley

Claremont-UC Undergraduate Research Conference on the European Union

No abstract provided.

Doctors, Patients, And Pills - A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Cardozo Law Review

This Article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century; and regulatory necessity due to the limits of science and the innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based on genetic expression). Although both factors have changed immensely, the standard for drug approval …

The New England Food System In 2060: Envisioning Tomorrow's Policy Through Today's Assessments, Margaret Sova Mccabe, Joanne Burke

Law Faculty Scholarship

This Essay analyzes how the New England states' planning processes are envisioning revitalized local, state, and regional food systems. This Essay has five parts. First, it begins with examining compelling reasons for promoting more sustainable food systems based on national and global trends, and identifies strategies for promoting regional food systems approaches with a brief introduction to the major influences on the national and New England food system. Second, it describes the states' planning efforts and their enabling legislation or source of authority.

The Essay then introduces the New England Food Vision 2060 (the Vision) an emerging discussion of food …

Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson

University of Michigan Journal of Law Reform Caveat

Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.” The recent outbreak was caused …

Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer

UIC Law Review

No abstract provided.

The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety, Matthew Standeven

Journal of Health Care Law and Policy

No abstract provided.

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Michigan Telecommunications & Technology Law Review

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

Every High Has A Low: A Pragmatic Approach To The War On Drugs, Mark Garibyan

University of Michigan Journal of Law Reform Caveat

One of the lasting vestiges of Richard Nixon’s presidency is the infamous “War on Drugs,” a forty-year-old effort aimed at curtailing “illicit drug consumption and transactions in America.” Although the goal behind the policy—a reduction in the rate of substance abuse—may be altruistic, the War on Drugs has dismally failed to achieve its goals and has exacerbated existing problems. Specifically, laws dealing with crack cocaine result in a “heavily disproportionate impact on black defendants;” in 2008 “blacks comprised 79.8 percent of those convicted for crack cocaine-related offenses,” whereas “whites comprised only 10.4 percent.” More generally, these laws illustrate a fundamental …

Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled

Faculty Publications By Year

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products …

The Physician Payment Sunshine Act: An Important First Step In Mitigating Financial Conflicts Of Interest In Medical And Clinical Practice, 45 J. Marshall L. Rev. 963 (2012), Alexandros Stamatoglou

UIC Law Review

No abstract provided.

Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns

Villanova Law Review (1956 - )

The article presents information on the pharmaceutical companies manufacturing brand-name drugs and the issues related to pharmaceutical sales representative (PSR). The intensive sales training program, the exempt from overtime pay based on the U.S. Fair Labor Standards Act and the economic justice and security of low income group are discussed. The court decision of Smith v. Johnson & Johnson, white-collar exemptions and employee misclassification are also discussed.

Fighting Poison With Poison? The Chinese Experience With Pharmaceutical Patent Linkage, 11 J. Marshall Rev. Intell. Prop. L. 623 (2012), Benjamin Liu

UIC Review of Intellectual Property Law

Countries after countries are adopting a controversial regulatory system of linking the market approval for pharmaceuticals to the status of potentially blocking patents as part of their bilateral and multilateral trade agreement package with the United States. Surprisingly, China took up pharmaceutical patent linkage in the absence of any treaty obligations and became the first country to adopt this regulatory regime outside of North America, despite the presence of a flourishing generics pharmaceutical industry and its developing country status. In fact, the Chinese regulation promised more intellectual property ("IP") protection than what even the United States FDA is capable of …

Disease-Branding And Drug-Mongering: Could Pharmaceutical Industry Promotional Practices Result In Tort Liability?, Jason S. Cetel

Student Works

No abstract provided.

Superweeds And Suspect Seeds: Does The Genetically-Engineered Crop Deregulation Process Put American Agriculture At Risk, Margaret Sova Mccabe

Law Faculty Scholarship

The federal government’s regulatory approach to genetically engineered (GE) crops, known as “The Framework”, is now twenty-five years old. Despite two and half decades of a consistent regulatory regime, GE crop and food regulation remains controversial. This article suggests that regulatory science and its tenets of independence, transparency, and public science should guide reforms of The Framework so that it is an efficient and reliable regulatory system. The article has four parts: 1) it provides a brief overview of the history of GE crop regulation; 2)it describes the key attributes of The Framework and related regulatory documents, with particular focus …

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.

United States--Certain Measures Affecting Imports Of Poultry From China: The Fascinating Case That Wasn't, Donald H. Regan

Articles

US–Poultry (China) was the first Panel decision dealing with an origin-specific SPS measure, or with what the United States referred to as an ‘equivalence regime’. More specifically, it was the first instance in which the basis for the challenged measure was the claimed inability of the complainant country to enforce its own food-safety rules. Unfortunately, as the litigation developed, the very interesting novel issues raised by such a measure were not discussed. This essay discusses those novel issues – in particular, what sort of scientific justification or risk assessment should be required for a measure like this, and what SPS …

Hot, Crowded, And Legal: A Look At Industrial Agriculture In The United States And Brazil, David N. Cassuto

Elisabeth Haub School of Law Faculty Publications

Over the last sixty years, industrial agriculture has expanded in the United States and throughout the world, including in Brazil. Any benefit this expansion has brought comes at significant environmental and social costs. Industrial agriculture is a leading contributor to global climate change, air and water pollution, deforestation, and dangers in the workplace. This Article discusses the impact of industrial animal agriculture in the U.S. and Brazil. It also examines the laws pertaining to industrial agriculture in both countries and provides a comparative analysis of the two legal regimes. Finally, this Article concludes with the observation that although the price …

Food Choice And Fundamental Rights: A Piece Of Cake Or Pie In The Sky?, Kammi L. Rencher

Nevada Law Journal

No abstract provided.

Time To Cut The Fat: The Case For Government Anti-Obesity Legislation , Stephen A. Mcguinness

Journal of Law and Health

This Article examines—and ultimately rejects—this anti-paternalism argument against government anti-obesity policies. It argues that government intervention in the food industry for the purpose of stemming the American obesity epidemic is justified and survives paternalistic objections to the contrary. This Article begins by briefly outlining the nature, severity, and causes of the obesity epidemic. It considers what can be done about the problem, finding that only government intervention is capable of effectively combating the crisis. It also outlines several types of potentially successful government anti-obesity strategies. Finally, it considers the primary topic of this Article: whether government anti-obesity policies constitute unjustified …

Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman

Journal of Law and Health

This Article discusses the history of informed consent, critically analyzes this principle, and suggests an alternative approach to informed consent. Part II explores the concept of informed consent, including its philosophical bases, its implementation through FDA regulations, and current proposals on how to protect the principle in drug testing conducted abroad. Part III performs a critical analysis of the principle of informed consent; first providing an empirical examination of the realities of Third World human subject research, and then questioning both the coherence of an abstract “right” to informed consent, as well as the possibility of truly autonomous “consent” to …

The Biologics Price Competition And Innovation Act Of 2009: Legislative Imprudence, Patent Devaluation, And The False Start Of A Multi-Billion Dollar Industry, Brian F. Mcmahon

Kentucky Law Journal

No abstract provided.

Introduction, Justin Hughes

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Direct-To-Consumer Genetic Testing: Learning From The Past And Looking Toward The Future, Stephanie Bair

Faculty Scholarship

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. These tests have been subject to only minimal regulation, despite the fact that scientists and policymakers have serious concerns about both the clinical effectiveness of the tests and the safety of releasing certain types of health information to the public without the supervision of a health care professional. Proponents of minimal regulation argue that the tests allow for patient autonomy and privacy of genetic information, …

The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow

Other Publications

The good news for states is drug industry immunity only kicks in if the drugs in question are FDA-approved. And thanks to the first-rate influence-peddling and lobbying prowess of compounding pharmacists, the tainted steroid shots at issue today are free and clear of FDA regulation.

Reconsidering The U.S. Patent System: Lessons From Generics, Molly F.M. Chen

Vanderbilt Journal of Transnational Law

Scholars and pharmaceutical industry representatives consider the United States a worldwide leader in pharmaceutical innovation. However, the recent expansion of the international generics market has threatened the strength of the U.S. pharmaceutical industry. The pressure has led to the U.S. market's overreliance on a patentability standard that blocks generics competition without contributing substantially to the state of the art. This Note contrasts the U.S. nonobviousness standard and patent linkage regime with those of generics giants India and Israel and considers the effects of these policies on the relevant national and international generics industries. This Note proposes that the United States …

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai

Faculty Scholarship

The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms.

In contrast, this Perspective uses the lens …

One Size Does Not Fit All, David Spratt

Scholarly Articles in Law Reviews & Journals

No abstract provided.