Food and Drug Law Commons^™

The Experimental Purpose Doctrine And Biomedical Research, Tao Huang

Michigan Telecommunications & Technology Law Review

The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …

Breaking The Shield Of The Learned Intermediary Doctrine: Placing The Blame Where It Belongs, Sheryl Calabro

Cardozo Law Review

No abstract provided.

Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland

ExpressO

This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …

Mandatory Recall Authority: A Sensible And Minimalist Approach To Improving Food Safety, Michael T. Roberts

ExpressO

No abstract provided.

Securing Truth For Power: Informational Strategy And Regulatory Policy Making, Cary Coglianese

ExpressO

No abstract provided.

The Cocaine Vaccine, Dru Stevenson

ExpressO

The controversial new cocaine vaccine (TA-CD) has the potential to be an extremely effective treatment tool for recovering addicts, but it also presents opportunities for non-therapeutic uses, such as preventing cocaine use in the first place. It is foreseeable that the cocaine vaccine could become a condition of parole or probation, or receiving welfare payments, or for employment in certain occupations. Universal vaccination is also a possibility but less likely for political reasons. This article investigates each of these areas of potential use. Any setting where mandatory drug testing is currently in place could become a venue for the vaccination. …

Federalism And Drug Control, Michael M. O'Hear

Vanderbilt Law Review

Federalism issues have been neglected in the scholarship on drug control policy. This Article addresses both empirical and normative questions relating to federal-state-local relations in the "war on drugs." Contrary to common views of federal domination and national uniformity, drug control policy actually varies considerably from state to state. State diversity has increased since the mid- 1990s, when drug reformers began to use the ballot initiative to change state laws. While the federal government has contested these reforms, it has not sought to use its preemption powers to enforce federal preferences.

The Article employs public choice models to explain the …

Global Intellectual Property Protection As Viewed Through The European Community's Treatment Of Geographical Indications: What Lessons Can Trips Learn?, Jacqueline Nanci Land

Cardozo Journal of International and Comparative Law

The note examines the European Community's (EC) approach to geographical indications (GIs) and its implications for the TRIPS Agreement, highlighting the EC as a potential model for harmonizing intellectual property (IP) laws globally. It argues that while TRIPS has made significant strides in creating an international IP framework, challenges such as differing national priorities and the influence of industrialized nations hinder full harmonization. The EC's integrated system, particularly its handling of GIs, offers valuable lessons for addressing these challenges and achieving more effective global IP protection.

Will The European Union Prove To Be Lactose Intolerant? The European Union's Attempt To Strike A Delicate Balance Between Protecting Appellation Of Origin For Cheese And The Promotion Of Free Movement Of Goods Between Member States, Danielle B. Shalov

Cardozo Journal of International and Comparative Law

The note examines the tension within the European Union between protecting traditional cheese-making methods through designations of origin and ensuring the free movement of goods. It highlights how the EU has navigated this balance through regulations and judicial decisions, ultimately favoring free trade while attempting to preserve cultural and geographical heritage tied to food production.

Pesticides, Human Health, And The Food Quality Protection Act, Kristina Thayer, Jane Houlihan

William & Mary Environmental Law and Policy Review

No abstract provided.

State Law Tort Claims And The Fda: Proposing A Consumer-Oriented Prescription In Medical Device Cases, Sasha B. Rieders

Cardozo Law Review

No abstract provided.

Sources: Pharmaceutical Promotion And The Medical Profession: Appendix A , Joseph Rohan Lex Jr.

Journal of Law and Health

No abstract provided.

Medical Marijuana And Personal Autonomy, 37 J. Marshall L. Rev. 1253 (2004), Andrew J. Boyd

UIC Law Review

No abstract provided.

The Effectiveness Of International Enforcement Of Intellectual Property Rights, 37 J. Marshall L. Rev. 985 (2004), Allison Cychosz

UIC Law Review

No abstract provided.

Wto And Gmos: Analyzing The European Community's Recent Regulations Covering The Labeling Of Genetically Modified Organisms, Brian Schwartz

Michigan Journal of International Law

This Note explores the compatibility of the EC's GMO regulations within the framework of the Agreement on the Application of Sanitary and Phytosanitary Measures ("SPS Agreement"), the Agreement on Technical Barriers to Trade ("TBT Agreement"), and the General Agreement on Tariffs and Trade 1994 ("GATT 1994" or "GAT"), all integral parts of the WTO Agreement. Part II presents arguments for or against the use of GM-products. Part III explores the concept of ecolabeling by analyzing the general goals of such programs, including the economic theory behind green consumerism and the characteristics necessary for effective schemes. Part IV describes the core …

Mad Cow Disease: An Approach To Its Containment, Michael B. Abramson

Journal of Health Care Law and Policy

No abstract provided.

No Pain No Gain?! Who Will Make The Greatest Sacrifices In Curbing Opioid Analgesic Diversion And Abuse?, Kent Durning

Kentucky Law Journal

No abstract provided.

2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan

Faculty Publications

This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.

A Brief History Of 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan

Faculty Publications

This article summarizes the history of the 180-day exclusivity provision in the Hatch- Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). Part II presents the statutory language, as amended in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and summarizes the law that applies to new abbreviated new drug applications (ANDAs) (those filed after December 8, 2003, provided there was no paragraph IV certification to the listed drug prior to December 8), as well as the law that applies to all other ("old") ANDAs. Part III describes the legislative history of the original 1984 …

The New Codex Alimentarius Commission Standards For Food Created With Modern Biotechnology: Implications For The Ec Gmo Framework's Compliance With The Sps Agreement, Aaron A. Ostrovsky

Michigan Journal of International Law

This Note makes two assertions. First, despite the fact that the Codex guidelines do not specifically invoke the Precautionary Principle in name, it can indeed be read into the guidelines in the amount of deference given to states in how they assess risk. This in turn means that the E.C.'s Deliberate Release Directive should be enjoy a presumption of compliance with both the SPS Agreement and the GATT. The second assertion is that even if the adjudicating body of the WTO finds that the Deliberate Release Directive, in relying on the Precautionary Principle, prescribes a higher level of protection than …

Pharmaceutical Overpromotion Liability: The Legal Battle Over Rural Prescription Drug Abuse, Phillip J. Wininger

Kentucky Law Journal

No abstract provided.

How A Drug Becomes ‘Ethnic’: Law, Commerce, And The Production Of Racial Categories In Medicine, Jonathan Kahn

Faculty Scholarship

A drug called BiDil is poised to become the first drug ever approved by the Food and Drug Administration (FDA) to treat heart failure in African Americans - and only African Americans. This article explores the story of BiDil and considers some of its broader implications for the use of racial categories in law, medicine, and science. It argues that BiDil is an ethnic drug today as much, if not more because of the interventions of law and commerce as because of any biomedical considerations. The article is, first, a retrospective analysis of how law, commerce, science, and medicine interacted …

To Prosecute Or Not To Prosecute: The Dilemma Posed By Pregnancy And Substance Abuse, Eileen D. Collins

Public Interest Law Reporter

No abstract provided.

Let The Testing Begin, Alexis Reed

Public Interest Law Reporter

No abstract provided.

Drug Price Quintuples, Does Not Invoke Federal "March-In" Protections, Zachary Ziliak

Public Interest Law Reporter

No abstract provided.

Dr. Joseph Rohan Lex, Jr., M.D. Faaem - The Physician-Pharmaceutical Industry Relationship, Joseph Rohan Lex Jr.

Journal of Law and Health

My premise is that physician interactions with marketing representatives result in inevitable and irreconcilable conflicts of interest or the appearance of conflicts of interest. Our patients in medicine are the ultimate losers from such interactions.

Reply To Judge Easterbrook: Judicial Discretion And Statutory Interpretation, Steven J. Cleveland

Oklahoma Law Review

No abstract provided.

Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Jonathan H. Adler

Faculty Publications

What I want to talk about are some legal issues relating to labeling and, in particular, constitutional issues relating to mandatory labeling for genetically modified foods or food products that may contain genetically modified components. This is a separate issue from whether or not the FDA, or some other agency, has sufficient statutory authority at present to mandate labeling, and that is something worth discussing. Even if they do have such authority, or even if Congress tomorrow were to give the FDA such authority or were to require the FDA to impose labels on genetically modified foods, or if a …

Don't Bite The Hand That Provides Life-Saving Drugs: Application Of The Hatch-Waxman And Sherman Acts To The Pharmaceutical Industry And The Detrimental Effects To Future Innovation In Order To Achieve Current Savings For Consumers, Edward J. King

Villanova Law Review (1956 - )

No abstract provided.

The Implementation Of Fda Determinations In Litigation - Why Do We Defer To The Pto But Not To The Fda?, William G. Childs

Faculty Scholarship

This Article examines the possible inequity of the treatment of licensees' rights in tort litigation in comparison to patent rights in patent litigation. In particular, this Article presents the presumptions afforded from issued patents as a valid model for the proper treatment of FDA approval in litigation. Presently, most academic discussion proposes either preclusion of tort claims or leaving the system more or less as it stands. This Article, on the other hand, proposes a middle ground.

This Article begins by examining the differences between the USPTO and the FDA. In particular, the quantity and quality of the review provided …