Food and Drug Law Commons^™

An Opiate Of The Masses: Religious Gerrymandering Of Sacramental Intoxication, Mark A. Levine

North Carolina Central Law Review

No abstract provided.

Up In Smoke: Federal Preemption And Medicinal Marijuana Id Cards In County Of San Diego V. San Diego Norml, Douglas Farr

Brigham Young University Journal of Public Law

No abstract provided.

Revisiting The Regulation Debate: The Effect Of Food Marketing On Childhood Obesity, Nicole E. Negowetti

Law Faculty Publications

No abstract provided.

The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang

Michigan Telecommunications & Technology Law Review

China's pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the world by the year 2050. However, entry to the market remains difficult for many international pharmaceutical manufacturers due to the country's costly and complicated regulatory licensing requirements. This Article provides an overview of the regulatory licensing regime for pharmaceutical products in China. Then, the Article evaluates three key features of the regulatory licensing regime through a law and economics approach. These features include the use of licensing, as contrasted with alternative regulatory and non-regulatory mechanisms; the standards to be met …

Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray

Michigan Telecommunications & Technology Law Review

If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. …

Over The Counter But Under The Radar: Direct-To-Consumer Genetics Tests And Fda Regulation Of Medical Devices, Lauren B. Solberg

Vanderbilt Journal of Entertainment & Technology Law

Direct-to-consumer genetic tests are laboratory-developed tests that are marketed and sold directly to consumers. They typically do not require a prescription or any other involvement from a consumer's health care provider. Consumers order these tests online and return a specimen, usually a saliva sample, directly to the laboratory. The results are mailed directly to the consumer, and no health care provider or insurance company need ever learn the contents of these results. The FDA does not currently regulate direct-to-consumer genetic tests, though tests for hundreds of different diseases are readily available to the public.

The FDA's approach to regulating genetic …

Owning What You Eat: The Discourse Of Food, David N. Cassuto

Elisabeth Haub School of Law Faculty Publications

This essay examines the role of communication in the formation of law and social norms and the implications of that role for animal law and ethics. Part III contextualizes animal law within contemporary risk society. Part IV looks at how efficiency has transformed from an economic concept into a normative guideline and discusses how that transformation has affected animals and agriculture. It tracks the rise of industrial agriculture and ties it to this fundamental misunderstanding of the concept of efficiency. The essay concludes with some thoughts on how to reformulate contemporary notions of efficiency and ethics to account for the …

Marketing Mothers' Milk: The Commodification Of Breastfeeding And The New Markets For Breast Milk And Infant Formula, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This paper explores the commodification of women and biological processes, the confusion of scientific evidence with social agendas, and the conflict between marketing and public health. I assert that key actors in the healthcare marketplace - government, businesses, and doctors – have acted to enable weak medical and scientific evidence to be manipulated by ideological and profit-making partisans in a poorly regulated market. I focus on the unique role of the medical profession, which has acted with government and the private sector to shape the markets in human milk and infant formula. In a striking parallel to the pharmaceutical industry, …

Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel

Michigan Telecommunications & Technology Law Review

The possibility that small populations would see few medications developed for their conditions has [...] led the U.S. Congress to pass the 1983 Orphan Drug Act ("ODA"), giving firms special incentives to develop drugs for diseases afflicting fewer than 200,000 persons per year.[...][U]under the Act, drug makers receive seven years of exclusive marketing upon FDA approval of newly-developed drugs qualifying as "orphan drugs"--i.e., drugs for disorders affecting fewer than 200,000 persons.[...]Together, [the] provisions (a) increase the effective market size; and (b) reduce fixed (sunk) costs. In doing so, the Act provides a natural experiment for measuring the impact of increased …

Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah

Michigan Telecommunications & Technology Law Review

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation …

Pdufa And Initial U.S. Drug Launches, Mary K. Olson

Michigan Telecommunications & Technology Law Review

In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …

Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget

Michigan Telecommunications & Technology Law Review

Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …

When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller

Michigan Telecommunications & Technology Law Review

Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed. Nevertheless, it is possible to treat the FDA's approval as significant without eliminating the possibility of all state actions against drug makers by providing a litigation back-up through state attorneys general ("AGs"). This Note examines the question of FDA approval in state tort actions in Part I, discusses Michigan's answer to that question in Part II, and offers a …

Making Sense Of Drug Regulation: A Theory Of Law For Drug Control Policy , Kimani Paul-Emile

Faculty Scholarship

This article advances a new theory of drug regulation that addresses two previously unexamined questions: how law-makers are able to regulate drugs differently irrespective of the dangers the drugs may pose and independent of their health effects, and the process followed to achieve this phenomenon. For example, although tobacco products are the leading cause of preventable death in the U.S. they can be bought and sold legally by adults, while marijuana, a substantially safer drug, is subject to the highest level of drug control. This article posits a conceptual model for making sense of this dissonance and applies this model …

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 …

A New History And Discussion Of 180-Day Exclusivity, Erika Lietzan, David E. Korn, Shaw W. Scott

Faculty Publications

This is the third in a series of articles on 180-day exclusivity. The first article traced the history of 180-day exclusivity from 1984 through its amendment in 2003 and court cases in 2004. A second article, published by two of the authors in 2007, updated the earlier piece through the end of 2006 but was arranged by issue rather than in a chronology. This article, which includes a third author, provides a comprehensive resource on 180-day exclusivity for old abbreviated new drug applications (ANDAs) (but less detail in some places where the 2007 article may be referenced) and focuses more …

Eatin' Good? Not In This Neighborhood: A Legal Analysis Of Disparities In Food Availability And Quality At Chain Supermarkets In Poverty-Stricken Areas, Nareissa Smith

Michigan Journal of Race and Law

Many Americans-especially the poor-face severe hurdles in their attempts to secure the most basic of human needs-food. One reason for this struggle is the tendency of chain supermarkets to provide a limited selection of goods and a lower quality of goods to patrons in less affluent neighborhoods. Healthier items such as soy milks, fresh fish, and lean meats are not present in these stores, and the produce that is present is typically well past the peak of freshness. Yet, if the same patron were to go to another supermarket owned by the same chain--but located in a wealthier neighborhood-she would …

Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne

Faculty Scholarship

In December 2006, the Food and Drug Administration (FDA) announced that it had reviewed all the available evidence and was poised to approve meat and milk from cloned animals and their progeny. Such products, said the FDA, are virtually identical to meat or milk from a non-clone. Further, the FDA announced it would almost certainly not require food from clones to be labeled as such. Part I of this article identifies three functions that labels perform, outlines the types of information usually required, and introduces the rule that voluntary label information cannot be misleading. Part II focuses on process information …

Midwestern Juvenile Drug Courts: Analysis & Recommendations, Nicole A. Kozdron

Indiana Law Journal

No abstract provided.

The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

The 2009 Revision To The Phrma Code On Interactions With Healthcare Professionals: Challenges And Opportunities For The Pharmaceutical Industry In The Age Of Compliance, Howard L. Dorfman

Campbell Law Review

This Article will describe the basic tenets of the 2009 PhRMA Code, how the 2009 PhRMA Code has been relied upon by at least one state in crafting its own response to the industry-healthcare professional debate, and it will conclude with a brief overview of pending activity apart from the self-policing guidance of the 2009 PhRMA Code with an outlook on the future of the compliance debate.

The Role Of Litigation In Combating Obesity Among Poor Urban Minority Youth: A Critical Analysis Of Pelman V. Mcdonald's Corp., Ashley B. Antler

Cardozo Journal of Equal Rights & Social Justice

The note argues that litigation, particularly when focused on low-income urban minority youth, could serve as a strategic tool to address childhood obesity by reframing the issue and catalyzing policy and industry change. It critiques the Pelman v. McDonald's Corp. lawsuit for failing to address the socioeconomic and racial disparities underlying obesity rates, thereby missing an opportunity to advance meaningful solutions. The analysis suggests that public health litigation, when strategically framed, can complement broader advocacy efforts and push for environmental changes to combat the obesity epidemic.

Dying To Wait: How The Abigail Court Got It Wrong, Juan Joel Tovanche

Journal of Law and Health

At age twenty-one, Abigail Kathleen Burroughs met a fate usually reserved for aged men who have spent much of their lives drinking and smoking. Diagnosed with cancer at nineteen, Abigail battled the squamous cell carcinoma that invaded her body even as she struggled to maintain her characteristic optimism. Abigail struggled with more than her illness, however. In the last years of her life, Abigail and her family also wrestled with Food and Drug Administration (FDA) regulations that denied her access to medication that could have saved her life. The policy at issue was the FDA's practice of progressive testing, which …

Crises, Congress, And Cognitive Biases: A Critical Examination Of Food And Drug Legislation In The United States, Sharon B. Jacobs

Publications

No abstract provided.

Kidney Transplantation: Only For The Well-To-Do?, Jennifer M. Smith

Journal Publications

The world of organ transplantation remains a wealthy one, especially in the United States. This is especially true for kidney transplantations, which involve the solid organ most in demand. Increasingly, transplant professionals desperately push for more solutions to overcome the organ transplant shortage that exists in the United States. Congress has introduced legislation that addresses the additional problem of the high cost of post-transplant anti-rejection medications by providing that the government will pay eighty percent of the cost for the post-transplant medications for life. But unless this bill passes and other needed changes are made, kidney transplantation remains an option …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

Dying To Know: A Demand For Genuine Public Access To Clinical Trial Results Data, Christine Galbraith Davik

Faculty Publications

Four years ago at the age of 34, I heard the awful words "I'm sorry, but you have breast cancer" coming from my doctor. After the initial shock of the diagnosis wore off, I like many others who have faced life-threatening diseases began to work with a team of physicians to develop an appropriate treatment plan, which included contemplating enrollment in a clinical trial. Quite unexpectedly, my position as an intellectual property professor whose scholarship focuses primarily on information control, my role as a member of my university's Institutional Review Board that oversees studies involving human subjects, and my newly …

Steroid Regulation In Professional Sports: Sarbanes-Oxley As A Guide, Sarah R. Heisler

Cardozo Arts & Entertainment Law Journal

No abstract provided.

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Scholarly Articles in Law Reviews & Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …