Food and Drug Law Commons^™

Pharming Out Data: A Proposal For Promoting Innovation And Public Health Through A Hybrid Clinical Data Protection Scheme, Lea M. Gulotta

Vanderbilt Journal of Transnational Law

The pharmaceutical industry, one of the largest industries in the world, is rapidly becoming globalized. Clinical trials, which are required for drugs to be approved for human use, are increasingly performed outside of the pharmaceutical company's home country in an attempt to save money. This is mainly due to drug development's steep costs, and the high risks involved in an industry where only 12 percent of products that begin development ever make it to market. In order to help offset these risks and encourage innovation, many countries offer clinical trial data certain protections through patents, market exclusivity, or trade secret …

Constructing A "Creative Reading": Will Us State Cannabis Legislation Threaten The Fate Of The International Drug Control Treaties?, Michael Tackeff

Vanderbilt Journal of Transnational Law

While marijuana remains illegal at the federal level in the United States, state-level efforts to legalize cannabis have gained enormous momentum in recent years. The federal government, which possesses only limited power to stop this trend, has responded by grudgingly allowing such efforts to proceed, maintaining that its inaction on the issue comports with the international drug control regime. This presents a particularly complex problem for international policymakers and legal scholars, who worry that this state-federal conflict may render international drug treaties meaningless. This Note argues that the federal government's strategy is a productive lens through which to view an …

Mystery Date: Advocating For A Harmonized System Of Expiration Date Labeling Of Food, Akshat Tiwari

Vanderbilt Journal of Transnational Law

Americans throw out roughly 25 percent of the food they bring home. Negative perceptions associated with expiration dates are a leading cause for this waste. However, a complex patchwork of state-run regulatory regimes and varying terminology makes it difficult for consumers to determine whether a food product is unsafe to eat or simply past a peak quality level arbitrarily set by manufacturers. Regulatory trends in Europe, the United Kingdom, Canada, Australia, and New Zealand suggest a move towards binding expiration date labeling through guidelines for establishing a "best before" or "use-by" date. This Note examines laws currently in place in …

The International War Against Doping: Limiting The Collateral Damage From Strict Liability, Thomas W. Cox

Vanderbilt Journal of Transnational Law

The World Anti-Doping Agency (WADA) and the World Anti-Doping Code are largely considered the model for an effective and well-coordinated antidoping regime. This model has allowed numerous sports and various countries to secure the same rules for domestic and international athletes. Within this regime, strict liability for prohibited substances stands as the "cornerstone." Strict liability has allowed antidoping officials to prosecute doping violations through an effective testing regime. However, this principle occasionally implicates innocent athletes with no intention of performance enhancement. This Note proposes that WADA modify its criteria for including substances on the Prohibited List and suspend strict liability …

Reconsidering The U.S. Patent System: Lessons From Generics, Molly F.M. Chen

Vanderbilt Journal of Transnational Law

Scholars and pharmaceutical industry representatives consider the United States a worldwide leader in pharmaceutical innovation. However, the recent expansion of the international generics market has threatened the strength of the U.S. pharmaceutical industry. The pressure has led to the U.S. market's overreliance on a patentability standard that blocks generics competition without contributing substantially to the state of the art. This Note contrasts the U.S. nonobviousness standard and patent linkage regime with those of generics giants India and Israel and considers the effects of these policies on the relevant national and international generics industries. This Note proposes that the United States …

Food Safety And Security: What Tragedy Teaches Us About Our 100-Year-Old Food Laws, Caroline S. Dewaal

Vanderbilt Journal of Transnational Law

The United States food safety system is antiquated and failing. The laws that form the foundation of our food protection and govern the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) were enacted over 100 years ago. While some new powers were given to FDA with the Bioterrorism Act of 2002, funding has not kept pace. Safe Food International (SF), a coalition of consumer organizations from around the world, created a set of guidelines outlining an ideal national food safety program. The current system in the United States falls short of that goal. The outbreaks …

The Role Of International Agreements In Achieving Food Security, Jack A. Bobo

Vanderbilt Journal of Transnational Law

This Article discusses how international agreements impact the ability of science and technology to enhance food security. International agreements, domestic laws, and regulations have the power to promote scientific research and the adoption of new technology through effective, efficient, and predictable science-based regulatory systems, or to impede development and adoption of new technology by miring it in burdensome or unnecessary regulations. This Article examines the disparate impacts of international agreements on food security through a case study of agricultural biotechnology. In particular, the Article looks at the principles and guidelines for risk assessment developed by the Codex Alimentarius Commission and …

Legislative Implementation Of The Food Chain Approach, Jessica Vapnek

Vanderbilt Journal of Transnational Law

Food safety is an essential element of food security, since "adequate" food means food that is not only available, but also safe. Food safety systems have traditionally focused on end-product testing, which is an unsatisfactory means of ensuring safe food. An increasing focus on prevention has spurred interest in a food chain approach, which aims to control all steps in the food chain from production to consumption. Although the approach has drawn international attention in recent years, national lawmakers have lacked guidance on its implementation. This Article serves that need. Part II of the Article describes the international backdrop to …

Attack Of The Balloon People, Keith E. Sealing

Vanderbilt Journal of Transnational Law

Any discussion of food security would, at first blush, seem to focus primarily on world hunger and other threats to the safety of the food supply, whether intentionally man-made (e.g., terrorism), inadvertently man-made (e.g., global warming), made-for-profit by industrial agriculture (referred to as "industrial food" throughout this Article), or "natural" although arguably man-abetted (such as bovine spongiform encephalopathy, or mad cow disease). And hunger is indeed a problem and likely to become more of a problem. However, this Article focuses on the long term threat to world health and world food security caused by the American way of eating; the …

Food Safety, South-North Asymmetries, And The Clash Of Regulatory Regimes, Obijiofor Aginam

Vanderbilt Journal of Transnational Law

This Article explores the globalization of food safety concerns driven by the phenomenon of economic globalization, and the "legalization" of food safety disputes within the rules-based architecture of the World Trade Organization (WTO). Focusing on the interaction between WTO norms and the treaties of other multilateral organizations, the Article discusses the implications of the "clash of food safety regulatory regimes" for South-North asymmetrical relations between the rich and poor countries. The Article also discusses global economic diplomacy and the emerging WTO jurisprudence on the Agreement on Sanitary and Phyto-Sanitary Measures (SPS) disputes. This Article explores both the perceived and actual …

The Roles Of Precaution And Political Accountability In The Regulation Of Polybrominated Diphenyl Ethers, Danielle Brim

Vanderbilt Journal of Transnational Law

The differing approaches used in the United States and the European Union to regulate toxic chemicals have been highlighted by debates about a group of chemicals called polybrominated diphenyl ethers, or PBDEs. PBDEs act as flame-retardants and are added to consumer products to increase their safety. Questions about the continued use of PBDEs have been raised, however, because of concerns that PBDEs may be dangerous to human health and the environment. The European Union has decided to ban two types of PBDEs, while the United States has not issued similar restrictions. In this Note, the Author argues that neither decision …

Free Trade And Illegal Drugs: Will Nafta Transform The United States Into The Netherlands?, Taylor W. French

Vanderbilt Journal of Transnational Law

In the postwar era, the United States typically has taken an approach to dealing with illegal drugs different from Europe. Americans have favored prohibitionist measures to combat drug use, while Europeans have gradually relaxed many of their illicit substance laws. Recently, however, there has been a growing movement within the United States to decriminalize and legalize marijuana. Numerous states have already reformed their laws to allow doctors to prescribe marijuana to patients. Moreover, many states are dramatically decriminalizing personal use of cannabis.

A review of postwar Europe's experience with drugs provides a useful paradigm to explain the U.S.'s shifting attitude. …

New Drug Research, The Extraterritorial Application Of Fda Regulations, And The Need For International Cooperation, William Dubois

Vanderbilt Journal of Transnational Law

In recent years, U.S. pharmaceutical companies have expanded their new drug trials beyond the borders of the United States. While the companies have a variety of reasons for making this move, among them may be a desire to avoid Food and Drug Administration (FDA) regulation and monitoring. Lack of adequate supervision of drug trials conducted in the developing world endangers both the subjects of the tests and the consumers in the United States. It is unclear whether the FDA can execute regulatory and supervisory authority abroad. The FDA statute does not clearly authorize the agency to regulate extraterritorially. Applying the …

Bolivia And Coca: Law, Policy, And Drug Control, Melanie R. Hallums

Vanderbilt Journal of Transnational Law

International drug trafficking looms large in the future of international relations. Although drug production and consumption can no longer be labeled as problems belonging to a few discrete nations, some countries' identities in the international arena are still shaped by their perception as drug-producing nations. Bolivia is one such country. Coca and cocaine have dominated its modern history and will continue to dominate its future. Bolivia's experience, however, is representative of not only other Andean nations' struggles with the drug epidemic, but of the international community's struggle with drug trafficking.

This Note sheds light on the legal tools to address …

The Changing Game: The United States Evolving Supply-Side Approach To Narcotics Trafficking, Gregory Wilson

Vanderbilt Journal of Transnational Law

Despite over two decades of focused government efforts, drug use and related problems persist in the United States. Moreover, combatting narcotics trafficking now may be more difficult than ever as the sophisticated Cali Cartel has replaced the Medellin Cartel as the world's preeminent supplier of cocaine. Cali's advanced methods of operation have rendered traditional approaches to battling drugs even less effective than they were previously. Clearly, the United States must establish a new direction in drug law enforcement. This Note traces the development of Colombia's drug cartels from the rise of the Medellin Cartel to the emergence of Cali as …

International Regulatory Harmonization: A New Era In Prescription Drug Approval, David W. Jordan

Vanderbilt Journal of Transnational Law

Critics of the Food and Drug Administration (FDA) have asserted that the agency's process of reviewing new drugs has long been laden with inefficiency and waste and, as a result, new drugs are not made available to consumers on a timely basis. This Note considers the veracity of this claim by examining the history of prescription drug regulation in the United States and the current procedure by which new drugs are reviewed. This Note also addresses the limited extent to which the FDA has interacted with its foreign counterparts in assessing the safety and efficacy of new drugs and the …

Fighting The War On Drugs In The "New World Order": The Ker-Frisbie Doctrine As A Product Of Its Time, Kirk J. Henderson

Vanderbilt Journal of Transnational Law

This Note analyzes the United States policy of abducting fugitives from abroad to stand trial when an asylum nation refuses an extradition request. The United States has justified this so-called "snatch" authority under the century-old Ker-Frisbie Doctrine. Pursuant to this doctrine, the Supreme Court has refused to examine the means by which a person has been brought before a court. In 1974, however, the United States Court of Appeals for the Second Circuit created a narrow exception that would bar jurisdiction if an accused proved acts of torture, but no defendant has ever met this standard.

Since Ker and Frisbie …

Transfer Of Penal Sanctions Treaties: An Endangered Species?, Abraham Abramovsky

Vanderbilt Journal of Transnational Law

This Article discusses the viability of United States Transfer of Penal Sanctions Treaties, focusing primarily on the Mexican-United States Treaty. The author argues that these treaties are effective and enforceable, but have been undermined by resort to unilateral abductions by the United States.

Part I of the Article examines the history and rationales leading to the promulgation of various penal sanctions treaties. The United States has entered these treaties largely because of the rising number of United States citizens incarcerated abroad, because of the substandard treatment afforded such prisoners, and because of the idea that offenders' rehabilitation will be eased …

Case Digest, Law Review Staff

Vanderbilt Journal of Transnational Law

Maritime Drug Law Enforcement Act is Applicable to Aliens on Foreign Vessels Outside the Territory of the United States--Fourth Amendment Held Inapplicable to Searches and Seizures on the High Seas, United States v. Davis, 905 F.2d 245 (9th Cir. 1990)

Executive Order Authorizing Naturalization for Aliens Serving in Designated Geographical Areas During Grenada Campaign Struck Down--President Reagan Held to Have Exceeded His Authority--Severability of Order Impossible as President Did Not Intend that All Aliens Serving in United States Forces at Time of Campaign Become Citizens--Reyes v. United States Dep't. of Immigration & Naturalization, No. 89-55403 (9th Cir. 1990).

Provision of …

The Impact Of The Drug Export Amendments Act Of 1986 On Foreign Tort Victims, James C. Grant

Vanderbilt Journal of Transnational Law

In response to domestic pharmaceutical producers' demands, Congress amended the Federal Food, Drug, and Cosmetic Act (FFDCA) on November 14, 1986. The advantages of foreign drug producers over United States drug producers prompted Congress to enact the Drug Export Amendments Act of 1986 (DEAA) which was designed to help United States drug producers compete effectively in the world market. The DEAA now puts domestic producers on more of an equal basis with the rest of the market by allowing them to export unapproved drugs.

The first section of this Note will examine the new amendment and outline its requirements. Then, …

Recent Treaties And Statutes, Donald C. Van Pelt, Jr., George H. Carnall Ii

Vanderbilt Journal of Transnational Law

The Single Convention on Narcotic Drugs, 1961, constituted a major step toward international acceptance of responsibility for the control of licit and illicit drug traffic. The Single Convention achieved a unified codification4 of existing multilateral treaties in the field' and created the International Narcotics Control Board (INCB), center of illicit traffic...In an effort to carry out the principle of limiting the use of narcotic drugs to medical and scientific purposes, the Narcotics Convention of 1931 required noncontracting parties as well as parties to the Convention to furnish annual advance estimates of narcotics needed for these purposes. These estimates were examined …