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Food and Drug Law

2015

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Scuttling Iuu Fishing And Rewarding Sustainable Fishing: Enhancing The Effectiveness Of The Port State Measures Agreement With Trade-Related Measures, Anastasia Telesetsky Jul 2015

Scuttling Iuu Fishing And Rewarding Sustainable Fishing: Enhancing The Effectiveness Of The Port State Measures Agreement With Trade-Related Measures, Anastasia Telesetsky

Seattle University Law Review

Illegal, unreported, and unregulated fishing (IUU fishing) is a substantial threat to global food security and a recurring problem for global fishery managers already facing difficult baseline situations exacerbated by climate change, including warming oceans and increasing acidification. There is nothing historically new about IUU fishing; there have always been poachers who take advantage of operating in the shadows of legal commercial fishing. What is new is the extent to which marine poaching has industrialized. It is estimated that 19% of the worldwide value of marine catches are unlawful. The problem is not limited to developing states. For example, even …


Opening The Barnyard Door: Transparency And The Resurgence Of Ag-Gag & Veggie Libel Laws, Nicole E. Negowetti Jul 2015

Opening The Barnyard Door: Transparency And The Resurgence Of Ag-Gag & Veggie Libel Laws, Nicole E. Negowetti

Seattle University Law Review

Over the past several decades, as the agricultural system became increasingly industrialized and the steps from farm to plate multiplied, consumers became farther removed from the sources of their food. Until recently, most consumers in America were content to eat their processed, cheap, and filling foods without giving a second thought to how these foods were produced. The tides are changing. Increasingly, consumers are calling for more transparency in the food system. Repulsed by images of animal cruelty and shocked by unsavory food production practices, consumers want the food industry’s veil lifted and are demanding changes in food production. The …


The Dangerous Right To Food Choice, Samuel R. Wiseman Jul 2015

The Dangerous Right To Food Choice, Samuel R. Wiseman

Seattle University Law Review

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. 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 …


Ag Gag Past, Present, And Future, Justin F. Marceau Jul 2015

Ag Gag Past, Present, And Future, Justin F. Marceau

Seattle University Law Review

While the animal rights and food justice movements are relatively young, their political unpopularity has generated a steady onslaught of legislation designed to curtail their effectiveness. At each stage of their nascent development, these movements have confronted a new wave of criminal or civil sanctions carefully tailored to combat the previous successes the movements had achieved.


Re-Tooling Marine Food Supply Resilience In A Climate Change Era: Some Needed Reforms, Robin Kundis Craig Jul 2015

Re-Tooling Marine Food Supply Resilience In A Climate Change Era: Some Needed Reforms, Robin Kundis Craig

Seattle University Law Review

Ocean fisheries and marine aquaculture are an important but often overlooked component of world food security. For example, of the seven billion (and counting) people on the planet, over one billion depend on fish as their primary source of protein, and fish is a primary source of protein (30 percent or more of protein consumed) in many countries around the world, including Japan, Greenland, Taiwan, Indonesia, several countries in Africa, and several South Pacific island nations. Marine fisheries and marine aquaculture have been subject to a number of stressors that can undermine world food security, including overfishing, habitat destruction, and …


Pay No Attention To That Man Behind The Curtain: Concealment, Revelation, And The Question Of Food Safety, Denis W. Stearns Jul 2015

Pay No Attention To That Man Behind The Curtain: Concealment, Revelation, And The Question Of Food Safety, Denis W. Stearns

Seattle University Law Review

Despite knowledge that commerce in food is a profit-driven enterprise, the public has consistently put great faith in the wholesomeness and safety of the food being purchased. To some extent, such faith is necessary, even if not always justified. In making the decision to put a bite of food in one’s own mouth, or the mouth of a friend or family member, a form of faith or trust must accompany the act of eating. For who would knowingly eat food suspected to be unsafe? But that is precisely what millions of people do every year, with a great many of …


Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters Jul 2015

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …


The Medical Liability Exemption: A Path To Affordable Pharmaceuticals, Carrie E. Rosato Jul 2015

The Medical Liability Exemption: A Path To Affordable Pharmaceuticals, Carrie E. Rosato

Florida State University Law Review

Patent monopolies are tolerated because we believe they promote progress that benefits society. What should be done when these monopolies actually increase human suffering? Drug prices in America are fifty to eighty percent higher than the rest of the world, meaning many cannot afford drugs that will improve or even save their lives. When striking a balance between the interests of the patent holder and that of the public, it is important to bear in mind that the rewards granted to patentees are secondary to the public benefit derived from their labors. The ideal solution would come from Congress creating …


The Dangerous Right To Food Choice, Samuel R. Wiseman Jul 2015

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 …


Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled Jul 2015

Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled

Faculty Publications By Year

No abstract provided.


Keeping Up With New Legal Titles, Franklin L. Runge Jul 2015

Keeping Up With New Legal Titles, Franklin L. Runge

Law Faculty Scholarly Articles

In this book review, Franklin L. Runge discusses In Food We Trust: The Politics of Purity in American Food Regulation by Courtney I. P. Thomas.


The 2014 Farm Bill: Farm Subsidies And Food Oppression, Andrea Freeman Jun 2015

The 2014 Farm Bill: Farm Subsidies And Food Oppression, Andrea Freeman

Seattle University Law Review

The 2014 Farm Bill ushered in some significant and surprising changes. One of these was that it rendered the identity of all the recipients of farm subsidies secret. Representative Larry Combest, who is now a lobbyist for agribusiness, first introduced a secrecy provision into the bill in 2000. The provision, however, only applied to subsidies made in the form of crop insurance. Until 2014, the majority of subsidies were direct payments and the identity of the people who received them was public information. In fact, the Environmental Working Group’s release of the list of recipients led to a series of …


Closing The Door To Lost Earnings Under The National Childhood Vaccine Injury Act Of 1986, Aaron M. Levin Jun 2015

Closing The Door To Lost Earnings Under The National Childhood Vaccine Injury Act Of 1986, Aaron M. Levin

Aaron M Levin

After a wave of lawsuits against vaccine manufacturers hindered the profitability and production of life-saving vaccines, Congress enacted The National Childhood Vaccine Injury Act of 1986. The Act offers an incentive for individuals to get vaccinated in order to mitigate the population’s exposure to disease, while encouraging the continued production of these serums by pharmaceutical companies. Although imperfect, the Vaccine Act fosters promise in filtering out frivolous claims and provides a central route for due process to the individuals who suffer from a vaccine-related injury. By removing a potential state tort issue to the Federal Circuit, Congress created a reasonably …


Take Me To Your Liter: Politics, Power, And Public-Private Partnerships With The Sugar-Sweetened Beverage Industry In The Post-2015 Development Agenda, Craig W. Moscetti, Allyn L. Taylor Jun 2015

Take Me To Your Liter: Politics, Power, And Public-Private Partnerships With The Sugar-Sweetened Beverage Industry In The Post-2015 Development Agenda, Craig W. Moscetti, Allyn L. Taylor

Washington International Law Journal

Today, non-communicable diseases (“NCDs”) are widely recognized as a global public health crisis and a foreign policy priority. The international community was slow to identify and respond to the crisis of NCDs in the later part of the twentieth century. However, in 2011 the United Nations High Level Meeting on NCDs recognized NCDs as one of the greatest threats to health and development in the twenty-first century, and a major topic for the post-2015 development agenda. Notably, many experts, national governments, and global leaders have rallied for an inclusive, “whole-of-government” and “whole-of-society” approach, situating public-private partnerships (“PPPs”) with some of …


Battle Of The Streets: Food Cart Edition, Ninna Mendoza May 2015

Battle Of The Streets: Food Cart Edition, Ninna Mendoza

Tredway Library Prize for First-Year Research

Through this paper, I wanted to highlight the unique struggle of food carts in Chicago, IL. Unlike other major cities in America, in Chicago, it is illegal to sell freshly prepared food from a cart. However, given the unique characteristics of food carts, legalizing this practice could greatly benefit the city and its people.


Proving Personal Use: The Admissibility Of Evidence Negating Intent To Distribute Marijuana, Stephen Mayer May 2015

Proving Personal Use: The Admissibility Of Evidence Negating Intent To Distribute Marijuana, Stephen Mayer

Michigan Law Review

Against the backdrop of escalating state efforts to decriminalize marijuana, U.S. Attorneys’ Offices continue to bring drug-trafficking prosecutions against defendants carrying small amounts of marijuana that are permitted under state law. Federal district courts have repeatedly barred defendants from introducing evidence that they possessed this marijuana for their own personal use. This Note argues that district courts should not exclude three increasingly common kinds of “personal use evidence” under Federal Rules of Evidence 402 and 403 when that evidence is offered to negate intent to distribute marijuana. Three types of personal use evidence are discussed in this Note: (1) a …


Dissecting The Contents Of Law Of Indonesia On Halal Product Assurance, Aal Lukmanul Hakim Apr 2015

Dissecting The Contents Of Law Of Indonesia On Halal Product Assurance, Aal Lukmanul Hakim

Indonesia Law Review

Indonesia with its majority Moslem population and even the biggest Moslem nation in the world has obligations to its citizens to assurance the halal products (halal) for consumption and/or used as a constitutional obligation to be enforceable and applicable. The constitutional obligation is granted in the form of legal certainty covering the halalness of all products either to those useable, consumed and/or utilized by the society. Upon the legalization and enactment of Law of the Republic of Indonesia Number 33 year 2014 regarding Halal Product Assurance is the evidence of constitutionally protection commitment. Having this Halal Product Assurance Law, the …


Us Supreme Court To Weigh Future Of "No Harm" Class-Action Menace, David L. Wallace Apr 2015

Us Supreme Court To Weigh Future Of "No Harm" Class-Action Menace, David L. Wallace

David L Wallace

No abstract provided.


Requiem For A Remedy: The Law And Economics Of Mutual Pharmaceutical V. Bartlett’S Over-Preemption, Robert C. Baker Iii Apr 2015

Requiem For A Remedy: The Law And Economics Of Mutual Pharmaceutical V. Bartlett’S Over-Preemption, Robert C. Baker Iii

Maryland Law Review Online

No abstract provided.


The “Legal” Marijuana Industry’S Challenge For Business Entity Law, Luke Scheuer Apr 2015

The “Legal” Marijuana Industry’S Challenge For Business Entity Law, Luke Scheuer

William & Mary Business Law Review

In recent years, many states have legalized the use and sale of marijuana for medical or even recreational purposes. This has led to the booming growth of a “legal” marijuana industry. Businesses openly growing and selling marijuana products to the consuming public face some unusual legal hurdles. Significantly, although the sale of marijuana may be legal at the state level, it is still illegal under federal law. This Article explores the conflict between state and federal marijuana laws from a business entity law perspective. For example, managers owe a fiduciary duty of good faith to their businesses and equity holders. …


Scouting For Approval: Lessons On Medical Device Regulation In An Era Of Crowdfunding From Scanadu’S “Scout”, Colleen Smith Apr 2015

Scouting For Approval: Lessons On Medical Device Regulation In An Era Of Crowdfunding From Scanadu’S “Scout”, Colleen Smith

Student Award Winning Papers

This Article will argue that medical device companies should be able to utilize crowdfunding to raise the necessary capital to develop a product. However, because of the risks medical devices pose, any solution that allows medical device companies to employ crowdfunding should ensure the continuing commitment to consumer safety that is at the core of FDA regulation. This Article uses the Scanadu Scout as an example and a staring point for evaluating the use of crowdfunding in the medical device industry. This Article explains how and why Scanadu broke the law when it moved the Scout, an “adulterated or misbranded” …


Spring 2015 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law Apr 2015

Spring 2015 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.


Optimizing Reservoir Operations To Adapt To 21st Century Expectations Of Climate And Social Change In The Willamette River Basin, Oregon, Kathleen M. Moore Apr 2015

Optimizing Reservoir Operations To Adapt To 21st Century Expectations Of Climate And Social Change In The Willamette River Basin, Oregon, Kathleen M. Moore

Publications

Reservoir systems in the western US are managed to serve two main competing purposes: to reduce flooding during the winter and spring, and to provide water supply for multiple uses during the summer. Because the storage capacity of a reservoir cannot be used for both flood damage reduction and water storage at the same time, these two uses are traded off as the reservoir fills during the transition from the wet to the dry season. Climate change, population growth, and development in the western US may exacerbate dry season water scarcity and increase winter flood risk, creating a need to …


Man Made Organs: Technology Made It Possible But Can The Fda Keep Up?, Amanda Chatman Apr 2015

Man Made Organs: Technology Made It Possible But Can The Fda Keep Up?, Amanda Chatman

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.


No More Drugs! What Will North Carolina Do When Its Supplier Stops Supplying?, Cynthia D. Dixon Apr 2015

No More Drugs! What Will North Carolina Do When Its Supplier Stops Supplying?, Cynthia D. Dixon

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.


The Cost Of Evidence: Examining The Fda's Treatment Of Critically-Needed Drugs From An Ex Ante Perspective, Julie Dorais J.D., M.P.H. Apr 2015

The Cost Of Evidence: Examining The Fda's Treatment Of Critically-Needed Drugs From An Ex Ante Perspective, Julie Dorais J.D., M.P.H.

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.


Carrots And Sticks: Safer Fresh Produce In The United States Through British Style Supermarket Co-Regulation, Victoria Tokar Apr 2015

Carrots And Sticks: Safer Fresh Produce In The United States Through British Style Supermarket Co-Regulation, Victoria Tokar

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.


Orphan Drug Development: Incentives Under The Orphan Drug Act, Sara H D Smith Apr 2015

Orphan Drug Development: Incentives Under The Orphan Drug Act, Sara H D Smith

Senior Theses and Projects

After describing the intellectual property and regulatory environment for orphan drugs in the United States, this thesis compares the investment decisions in the orphan drug market with the larger pharmaceutical industry. A series of case studies trace the development paths of different orphan products using information collected through the Food and Drug Administration (FDA) Approved Drug Product and Orphan Drug Product Designation Databases. In addition to this analysis, difference-in-differences estimates calculated using annual revenues compare the relative success of different orphan products under the current incentive system. This study finds that partial orphan drugs are associated with larger revenue growth. …


Geographical Indications, Food Safety, And Sustainability Challenges And Opportunities, David A. Wirth Mar 2015

Geographical Indications, Food Safety, And Sustainability Challenges And Opportunities, David A. Wirth

David A. Wirth

This paper examines the legal and policy relationship reinforcement amongst international standards for GIs, food safety standards, and other claims of quality or safety. The paper addresses those relationships within the context of international trade agreements protecting GIs, such as the 1994 TRIPS Agreement, the EU-Canada Comprehensive Economic and Trade Agreement (CETA), and the chapter on intellectual property and geographical indications in the Transatlantic Trade and Investment Partnership (TTIP) currently under negotiation. Trade agreements also discipline food safety measures and non-GI indications of quality or safety such as “organic” and “GMO-free.” Accordingly, the paper also considers the extent to which …


Genetically Engineered Plant Pesticides: Recent Developments In The Epa's Regulation Of Biotechnology, Mary Jane Angelo Mar 2015

Genetically Engineered Plant Pesticides: Recent Developments In The Epa's Regulation Of Biotechnology, Mary Jane Angelo

Mary Jane Angelo

This paper examines the EPA's new policy regulating plant pesticides and presents the legal, scientific and policy issues surrounding the regulation of genetically engineered plants. Part I introduces the concepts covered in this paper. Part II.A. discusses products that have originated from biotechnology. Part II.B. describes the EPA's legal authority for regulating plant pesticides and other biotechnology products. Part II.C. presents the history of federal regulation of biological pesticides and biotechnology products. Part III examines the controversy surrounding the use of genetically engineered plants, including the potential risks and benefits of genetically engineered plants and the public's perception of these …