Open Access. Powered by Scholars. Published by Universities.®

Food and Drug Law Commons

Open Access. Powered by Scholars. Published by Universities.®

1284 Full-Text Articles 1214 Authors 541624 Downloads 111 Institutions

All Articles in Food and Drug Law

Faceted Search

1284 full-text articles. Page 32 of 38.

The New England Food System In 2060: Envisioning Tomorrow's Policy Through Today's Assessments, Margaret Sova McCabe, Joanne Burke 2012 University of New Hampshire School of Law

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 ...


Superweeds And Suspect Seeds: Does The Genetically-Engineered Crop Deregulation Process Put American Agriculture At Risk, Margaret Sova McCabe 2012 University of New Hampshire School of Law

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 ...


Hot, Crowded, And Legal: A Look At Industrial Agriculture In The United States And Brazil, David N. Cassuto 2012 Elisabeth Haub School of Law at Pace University

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

Pace 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 ...


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

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

The John Marshall Law Review

No abstract provided.


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 2012 John Marshall Law School

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

The John Marshall Law Review

No abstract provided.


Direct-To-Consumer Genetic Testing: Learning From The Past And Looking Toward The Future, Stephanie Bair 2012 BYU Law

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 ...


Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai 2012 Duke Law School

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 ...


Tavern Talk & The Origins Of The Assembly Clause: Tracing The First Amendment’S Assembly Clause Back To Its Roots In Colonial Taverns, Baylen Linnekin 2011 George Mason University Law School

Tavern Talk & The Origins Of The Assembly Clause: Tracing The First Amendment’S Assembly Clause Back To Its Roots In Colonial Taverns, Baylen Linnekin

Baylen J. Linnekin

This article traces the origins of the American freedom of assembly, as guaranteed by the First Amendment to the Constitution's Assembly Clause, to its rightful place in colonial American taverns. Taverns were the fundamental centers of colonial assembly, where colonists read and shared printed tracts, debated news and action, organized boycotts, and planned rebellion. The First Amendment’s protection of the freedom of assembly is the direct result of this tavern talk—a thoroughly constitutional mishmash of both mundane and vital discourse between and among Americans in taverns in the period immediately before, during, and after the Revolutionary War ...


Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin 2011 Rutgers - School of Law, Newark

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In ...


The Food-Safety Fallacy: More Regulation Doesn't Necessarily Make Food Safer, Baylen Linnekin 2011 George Mason University Law School

The Food-Safety Fallacy: More Regulation Doesn't Necessarily Make Food Safer, Baylen Linnekin

Baylen J. Linnekin

The Food Safety Modernization Act ("FSMA"), signed into law in 2011 by President Barack Obama, has been touted by its supporters as the most thorough update of FDA food safety authority in more than seventy-five years. But will the FSMA make our food safer? This article argues that we can and should look to the past to predict whether costly government efforts to make our food safer will succeed. In hindsight, the FDA’s own record—-and those of other federal agencies—-shows that food-safety regulations often rest on factually erroneous premises and, consequently, can sometimes be so counterproductive that ...


Food & Law, Baylen Linnekin, Emily Broad Leib 2011 Harvard Law School

Food & Law, Baylen Linnekin, Emily Broad Leib

Baylen J. Linnekin

This chapter discusses the field of Food Law & Policy.


Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns 2011 Selected Works

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

Brooke Burns

This Casebrief recognizes the current division developing among courts concerning whether PSRs have been wrongly misclassified as exempt from overtime pay since the World War II era. Despite the Second Circuit’s more recent decision in In re Novartis Wage and Hour Litigation, this Casebrief identifies the Third Circuit’s jurisprudence in Smith v. Johnson & Johnson as providing controlling guidance for practitioners navigating the current legal landscape.


Polar Law And Good Governance, Prof. Elizabeth Burleson 2011 Selected Works

Polar Law And Good Governance, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

This chapter will assess the Antarctic Treaty System, ask what polar lessons can be learned regarding common pool resources, and analyze law of the sea and related measures. It will consider such substantive areas as Arctic and Antarctic natural resource management and procedural opportunities as inclusive governance structures. Enhancing good governance can occur through trust building forums that bring together stakeholders, share information, and make environmentally sound decisions regarding sustainable development.


Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin 2011 Rutgers - School of Law, Newark

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In ...


Mergers, Market Dominance And The Lundbeck Case, Herbert J. Hovenkamp 2011 University of Pennsylvania Law School

Mergers, Market Dominance And The Lundbeck Case, Herbert J. Hovenkamp

Faculty Scholarship

In Lundbeck the Eighth Circuit affirmed a district court’s judgment that a merger involving the only two drugs approved for treating a serious heart condition in infants was lawful. Although the drugs treated the same condition they were not bioequivalents. The Eighth Circuit approved the district court’s conclusion that they had not been shown to be in the same relevant market.

Most mergers that are subject to challenge under the antitrust laws occur in markets that exhibit some degree of product differentiation. The Lundbeck case illustrates some of the problems that can arise when courts apply ideas derived ...


The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth 2011 Boston College Law School

The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth

David A. Wirth

Any day now, a World Trade Organization panel is expected to rule in a dispute between the U.S. and the EU concerning market access for genetically-engineered foods and crops. This piece, written before the release of the WTO panel's report, analyzes novel systemic issues concerning the impact of WTO law on regulatory design, at both the national and international levels, that are raised by this dispute. These include (1) the application of WTO disciplines to regulatory schemes that require prior governmental approval to protect the environment and public health from newly-introduced products and substances; (2) the role of ...


Restitution For Wrongs And The Restatement (Third) Of The Law Of Restitution, James S. Rogers 2011 Boston College Law School

Restitution For Wrongs And The Restatement (Third) Of The Law Of Restitution, James S. Rogers

James S. Rogers

The law of restitution has been the forgotten step-child of American private law for many decades. The American Law Institute’s current project to produce a new restatement of the law of restitution holds the promise of bringing the subject to the foreground and removing some of the confusion that many lawyers and judges feel in approaching the topic. One of the important issues that must be addressed in any comprehensive treatment of the law of restitution is how to treat those areas where the possibility of recovery based on the unjust enrichment principle overlaps with recovery based on the ...


Food Justice As Interracial Justice: Urban Farmers, Community Organizations And The Role Of Government In Oakland, California, Christopher J. Curran, Marc-Tizoc González 2011 University of Miami Law School

Food Justice As Interracial Justice: Urban Farmers, Community Organizations And The Role Of Government In Oakland, California, Christopher J. Curran, Marc-Tizoc González

University of Miami Inter-American Law Review

No abstract provided.


Unanswered Questions Of A Minority People In International Law: A Comparative Study Between Southern Cameroons & South Sudan, Bernard Sama Mr 2011 Auckland University

Unanswered Questions Of A Minority People In International Law: A Comparative Study Between Southern Cameroons & South Sudan, Bernard Sama Mr

Bernard Sama

The month July of 2011 marked the birth of another nation in the World. The distressful journey of a minority people under the watchful eyes of the international community finally paid off with a new nation called the South Sudan . As I watched the South Sudanese celebrate independence on 9 July 2011, I was filled with joy as though they have finally landed. On a promising note, I read the UN Secretary General Ban Ki-moon saying “[t]ogether, we welcome the Republic of South Sudan to the community of nations. Together, we affirm our commitment to helping it meet its ...


Unanswered Questions Of A Minority People In International Law: A Comparative Study Between Southern Cameroons & South Sudan, Bernard Sama Mr 2011 Auckland University

Unanswered Questions Of A Minority People In International Law: A Comparative Study Between Southern Cameroons & South Sudan, Bernard Sama Mr

Bernard Sama

The month July of 2011 marked the birth of another nation in the World. The distressful journey of a minority people under the watchful eyes of the international community finally paid off with a new nation called the South Sudan . As I watched the South Sudanese celebrate independence on 9 July 2011, I was filled with joy as though they have finally landed. On a promising note, I read the UN Secretary General Ban Ki-moon saying “[t]ogether, we welcome the Republic of South Sudan to the community of nations. Together, we affirm our commitment to helping it meet its ...


Digital Commons powered by bepress