Law Commons^™

A Place At The Table: What Food Litigation Tells Us About The Function Of Tort Law, Melissa Mortazavi

Melissa Mortazavi

No abstract provided.

The Regulation Of Genetic Aspects Of Donated Reproductive Tissue - The Need For Federal Regulation, Yaniv Heled

Yaniv Heled

It is estimated that egg and sperm donations account for more than 60,000 births every year in the United States. However, surprisingly, and despite common misconceptions, there are no federal requirements and barely any state requirements to screen and test sperm and egg donors for genetic diseases. The only nationwide standards for genetic screening and testing of donated reproductive tissue are guidelines created by professional organizations, but compliance with those guidelines is voluntary so they cannot be enforced effectively. Furthermore, the few reported cases involving children born from genetically-compromised reproductive tissue illustrate the court system’s failure to afford such children …

Private Voluntary Standards And New U.S. Food Safety Legislation: The Food Safety Modernization Act And Imported Food, David Wirth

David A. Wirth

No abstract provided.

The Limits Of Regulatory Science In Transnational Governance Of Transgenic Plant Agriculture And Food Systems, Taiwo Oriola

Taiwo Oriola

The current national and transnational regulatory and policy framework for transgenic plant agriculture and food is arguably largely defined by science. Notably, transgenic plant agriculture policy deference to science is ostensibly premised on the general perception that science is neutral, objective, reliable, and agnostic. This is exemplified by cases ranging from Alliance for Bio-integrity v Donna Shalala, European Communities: Measures Affecting the Approval and Marketing of Biotech Products, to European Commission v Republic of Poland, in which conscientious, ethical, religious, and cultural oppositional grounds to transgenic plant agriculture and food were trumped by scientific imperatives. However, the lack of unanimity …

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud

Jonathan R. K. Stroud

On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care. Traditionally, inventors of medical …

Enhancing Food Safety: The Role Of The Food And Drug Administration, Lewis Grossman

Lewis A. Grossman

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. …

Confidentiality Of Alcohol And Other Drug Abuse Treatment Information For Emergency Department And Trauma Center Patients, Richard Boldt

Richard C. Boldt

he diagnosis and treatment of alcohol and other drug (AOD) use disorders has for the most part been confined to a narrow band of the U.S. heath-care system. Recently, some hospital emergency departments and, especially, trauma centers have taken the lead in seeking to integrate AOD diagnosis and treatment through the adoption of screening and brief intervention protocols. The available data suggest that the practice of providing screening and either brief interventions or referrals for more intensive AOD treatment can significantly reduce re-injury rates. Despite these encouraging statistics, many trauma centers and emergency departments still do not provide these services …

A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

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.

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

Michael J. Malinowski

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

Biomedical Research And The Law:--Embryonic Stem Cells, Clones And Genes: Science, Law, Politics, And Values, Michael J. Malinowski

Michael J. Malinowski

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

Tort Reform By Regulation: Fda Prescription Drug Labeling Rules And Preemption Of State Tort Claims, Michael Moreland

Michael P. Moreland

No abstract provided.

Hastening Death: The Seven Deadly Sins Of The Status Quo, Charles Baron

Charles H. Baron

The seven deadly sins of the status quo -- inhumanity, paternalism, Utilitarianism, hypocrisy, lawlessness, injustice, and the deadly risk of error and abuse -- are seven arguments against maintaining the artificial bright-line distinction between the prohibition against assisted suicide and the allowance of patients’ right to refuse life-prolonging treatment. This article calls on courts and legislatures to follow the successful example of the Oregon Death with Dignity statute.