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Food and Drug Law

2014

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The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson Dec 2014

The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson

Georgia Journal of International & Comparative Law

No abstract provided.


Patents, Genetically Modified Foods, And Ip Overreaching, Elizabeth A. Rowe Dec 2014

Patents, Genetically Modified Foods, And Ip Overreaching, Elizabeth A. Rowe

Elizabeth A Rowe

Genetically engineered plants and animals have become and will continue to constitute a large part of the food we consume. The United States is the world's largest producer of genetically modified foods, making American consumers the most exposed population to these products. Agricultural biotechnology patents spur and support innovation. Accordingly, patent law is one of the main contributors to this phenomenon that has changed not only the kinds of food we eat, but the nature of the agri-business industry that produces these foods. This Article takes on an area of concern involving the patenting of food that has remained unexplored: …


Who's Swallowing The "Bitter Pill"?: Reforming Write-Offs In The State Of Washington, Lauren M. Martin Nov 2014

Who's Swallowing The "Bitter Pill"?: Reforming Write-Offs In The State Of Washington, Lauren M. Martin

Seattle University Law Review

Washington’s application of the collateral source rule permits recovery for medical expenses that were never incurred and have no relationship to their market value. This application is set forth in Hayes v. Wieber Enterprises, Inc., where the plaintiff sued a restaurant for injuries she sustained from falling down the restaurant’s basement stairs. Why should the collateral source rule compel the defendant in Hayes to pay the original amount billed, $5,800, when the physician accepted $3,300 as payment in full? Is not $3,300 the reasonable or market value of the medical services provided to the plaintiff? This Comment discusses whether Washington …


The Opioid-Dependent Criminal: Improving The Criminal Justice System To Account For Their Needs, Courtney Priolo Nov 2014

The Opioid-Dependent Criminal: Improving The Criminal Justice System To Account For Their Needs, Courtney Priolo

Courtney E Priolo

Over the past twenty-five years national concern over the drug-crime relationship has been increasing. This increase has led to growth of criminal justice penalties as opposed to therapeutic approaches such as medication-assisted treatment, resulting in an expansion of the drug-involved criminal justice population. Individuals who are opioid-dependent are vulnerable at the time of arrest, and at the time of their initial detention due to their chemical dependence and impairment of their neurocognitive functioning. The denial of medication to inmates in order to alleviate withdrawal symptoms is stigmatizing, punishing, and potentially life-threatening. This article argues that medication-assisted treatment for the criminal …


Mutual Pharmaceutical Co. V. Bartlett: A Need For “Explicit” Congressional Action And State Tort Law Reform, Kara A. Ritter Nov 2014

Mutual Pharmaceutical Co. V. Bartlett: A Need For “Explicit” Congressional Action And State Tort Law Reform, Kara A. Ritter

Kara A Ritter

No abstract provided.


Veggiecation: A Novel Approach To Improve Vegetable Consumption Among School-Aged Children, Yeon Bai, Lisa Suriano, Shahla M. Wunderlich Nov 2014

Veggiecation: A Novel Approach To Improve Vegetable Consumption Among School-Aged Children, Yeon Bai, Lisa Suriano, Shahla M. Wunderlich

Department of Nutrition and Food Studies Scholarship and Creative Works

Children's general preference for sweeter foods and aversion to bitter vegetables is explained partly by fear of new food and social and cultural influences. Reluctance to eat new foods is related to unfavorable facial expressions and is often learned from the child's family, social circle, and culture.1 Researchers report that the fruit and vegetable consumption of children 6–12 years of age is associated with the accessibility and availability.2 School-based interventions that combine classroom curricula, parental, and nutrition service components show the greatest promise for fruit and vegetable promotion among children.


A Place At The Table: What Food Litigation Tells Us About The Function Of Tort Law, Melissa Mortazavi Oct 2014

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

Melissa Mortazavi

No abstract provided.


International Trade - Possible Undermining Of U.S. Pesticide And Food Safety Laws By The Draft Text Of The Uruguay Round Of Gatt Negotiations, Beth Sanders Oct 2014

International Trade - Possible Undermining Of U.S. Pesticide And Food Safety Laws By The Draft Text Of The Uruguay Round Of Gatt Negotiations, Beth Sanders

Georgia Journal of International & Comparative Law

No abstract provided.


Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled Oct 2014

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

Yaniv Heled

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 Regulation Of Genetic Aspects Of Donated Reproductive Tissue - The Need For Federal Regulation, Yaniv Heled Oct 2014

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 …


Expedited Partner Therapies For Sexually Transmitted Diseases: Legal And Policy Approaches, James G. Hodge, Erin C. Fuse Brown Oct 2014

Expedited Partner Therapies For Sexually Transmitted Diseases: Legal And Policy Approaches, James G. Hodge, Erin C. Fuse Brown

Erin C. Fuse Brown

No abstract provided.


Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled Oct 2014

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

Yaniv Heled

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 …


Why Deny Parents New Technology?, Yaniv Heled Oct 2014

Why Deny Parents New Technology?, Yaniv Heled

Yaniv Heled

No abstract provided.


The Jurisprudence Of Nature: The Importance Of Defining What Is "Natural", Jill M. Fraley Oct 2014

The Jurisprudence Of Nature: The Importance Of Defining What Is "Natural", Jill M. Fraley

Catholic University Law Review

Informal regulations defining nature, natural, and organic have proliferated across diverse fields of law from patents to agriculture, from taxation to gemstones. The unwritten jurisprudence of defining nature is primarily a story of the struggle to isolate mankind’s manipulations and interventions, creating a man-nature dichotomy that frustrates more than it explicates. This failure to define nature continues with the Supreme Court’s recent Myriad decision, which struggles to define the law of nature exception to patentability, highlighting the challenge of measuring levels of human intervention and manipulation. Our dichotomous definitions do not generate neat, binary answers, but rather complicated scales of …


African Aids Crisis: Implications From The Rise Of Managed Care In South Africa, J. Christopher Driver Oct 2014

African Aids Crisis: Implications From The Rise Of Managed Care In South Africa, J. Christopher Driver

Georgia Journal of International & Comparative Law

No abstract provided.


Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget Oct 2014

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …


World Trade Organization Adjudication Of The European Union-United States Dispute Over The Moratorium On The Introduction Of New Genetically Modified Foods To The European Common Market: A Hypothetical Opinion Of The Dispute Panel, Charles W. Smitherman Iii Oct 2014

World Trade Organization Adjudication Of The European Union-United States Dispute Over The Moratorium On The Introduction Of New Genetically Modified Foods To The European Common Market: A Hypothetical Opinion Of The Dispute Panel, Charles W. Smitherman Iii

Georgia Journal of International & Comparative Law

No abstract provided.


Raging Hormones: A Discussion Of The World Trade Organization's Decision In The European Union-United States Beef Dispute, George H. Rountree Oct 2014

Raging Hormones: A Discussion Of The World Trade Organization's Decision In The European Union-United States Beef Dispute, George H. Rountree

Georgia Journal of International & Comparative Law

No abstract provided.


International Trade Law And The U.S.-Eu Gmo Debate: Can Africa Weather This Storm?, Michelle K. Mcdonald Sep 2014

International Trade Law And The U.S.-Eu Gmo Debate: Can Africa Weather This Storm?, Michelle K. Mcdonald

Georgia Journal of International & Comparative Law

No abstract provided.


A Tale Of Two Appellations: A Comparative Study Of International Agreements And Prevailing Law Impacting The Availability Of Seasonal Employees For The Wine-Grape Harvest In California's Napa Valley And France's Bordeaux Appellation, Michael K. Edmonson Sep 2014

A Tale Of Two Appellations: A Comparative Study Of International Agreements And Prevailing Law Impacting The Availability Of Seasonal Employees For The Wine-Grape Harvest In California's Napa Valley And France's Bordeaux Appellation, Michael K. Edmonson

Georgia Journal of International & Comparative Law

No abstract provided.


"Where You Stand Depends On Where You Sit": Should The United States' Fda Have Followed The Lead Of Great Britain's Mhra In Banning Antidepressant Drug Use In Children And Adolescents?, Jennifer Dorminey Sep 2014

"Where You Stand Depends On Where You Sit": Should The United States' Fda Have Followed The Lead Of Great Britain's Mhra In Banning Antidepressant Drug Use In Children And Adolescents?, Jennifer Dorminey

Georgia Journal of International & Comparative Law

No abstract provided.


B.Y.O. Heroin: Will Canada Finally Recognize The Fundamental Rights Of Injection Drug Users By Providing Access To Safe Injection Facilities?, Robert Marston Sep 2014

B.Y.O. Heroin: Will Canada Finally Recognize The Fundamental Rights Of Injection Drug Users By Providing Access To Safe Injection Facilities?, Robert Marston

Georgia Journal of International & Comparative Law

No abstract provided.


Beer, Liquor, Or A Little Bit Of Both? Getting To The Bottom Of Properly Classifying Flavored Malt Beverages In The United States And Australia, Bryan A. Schivera Sep 2014

Beer, Liquor, Or A Little Bit Of Both? Getting To The Bottom Of Properly Classifying Flavored Malt Beverages In The United States And Australia, Bryan A. Schivera

Georgia Journal of International & Comparative Law

No abstract provided.


High Time For Medical Marijuana Or Buzz-Kill?: The Controlled Substances Act And The Sherman Antitrust Act May Cause Florida's Compassionate Medical Cannabis Act To Go Up In Smoke, Thu Pham Sep 2014

High Time For Medical Marijuana Or Buzz-Kill?: The Controlled Substances Act And The Sherman Antitrust Act May Cause Florida's Compassionate Medical Cannabis Act To Go Up In Smoke, Thu Pham

Florida A & M University Law Review

Florida is the latest state to jump into the arena of medical marijuana with the passage of SBI030 on June 16, 2014. The law, named The Compassionate Medical Cannabis Act of 2014,' allows low-THC cannabis to be prescribed to patients suffering from cancer or physical medical conditions that chronically produce symptoms of seizures or severe and persistent muscle spasms.


A Proposed Reconciliation Of Stakeholder Interests In The Ge Soybean Industry And Role Of Earth Jurisprudence Principles, Kristen N. King Jaiven Sep 2014

A Proposed Reconciliation Of Stakeholder Interests In The Ge Soybean Industry And Role Of Earth Jurisprudence Principles, Kristen N. King Jaiven

Florida A & M University Law Review

The historical art of seed saving ensured farmers would have enough quality seeds for the following season. Traditional and indigenous farmers mastered seed saving techniques, saving the healthiest and strongest seeds to ensure preservation of seed diversity and adequate crop yields. To provide adequate protection and meet maximum sustainability for all interested parties, it is essential that laws governing the soybean industry consider the soybean as a stakeholder.


Prosser's Bait-And-Switch: How Food Safety Was Sacrificed In The Battle For Tort's Empire, Denis W. Stearns Sep 2014

Prosser's Bait-And-Switch: How Food Safety Was Sacrificed In The Battle For Tort's Empire, Denis W. Stearns

Nevada Law Journal

No abstract provided.


The Prohibition Of Moonshine: A Consumer Protection Analysis Of Raw Milk In Interstate Commerce, Whitney R. Morgan Sep 2014

The Prohibition Of Moonshine: A Consumer Protection Analysis Of Raw Milk In Interstate Commerce, Whitney R. Morgan

West Virginia Law Review

No abstract provided.


America's Political Prisoners, Ruben B. Botello Jd Aug 2014

America's Political Prisoners, Ruben B. Botello Jd

Ruben B Botello JD

America's political prisoners most often die behind bars because the U.S. government and its several states and territories have no intention of ever releasing them. These prisoners are usually the boldest and brightest adults from Minority communities, natural-born leaders with the greatest potential, to organize and inspire their people, to rise up en masse against the institutionalized racism that keeps their communities poor, exploited and oppressed.


Sacred Cows, Holy Wars: Exploring The Limits Of Law In The Regulation Of Raw Milk And Kosher Meat, Kenneth Lasson Aug 2014

Sacred Cows, Holy Wars: Exploring The Limits Of Law In The Regulation Of Raw Milk And Kosher Meat, Kenneth Lasson

Kenneth Lasson

SACRED COWS, HOLY WARS Exploring the Limits of Law in the Regulation of Raw Milk and Kosher Meat By Kenneth Lasson Abstract In a free society law and religion seldom coincide comfortably, tending instead to reflect the inherent tension that often resides between the two. This is nowhere more apparent than in America, where the underlying principle upon which the first freedom enunciated by the Constitution’s Bill of Rights is based ‒ the separation of church and state – is conceptually at odds with the pragmatic compromises that may be reached. But our adherence to the primacy of individual rights …


New York: Public Health Implications Of The 'Soda Ban' Ruling, Andrew Geltman Aug 2014

New York: Public Health Implications Of The 'Soda Ban' Ruling, Andrew Geltman

Homeland Security Publications

No abstract provided.