Food and Drug Law Commons^™

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 …

Wine Wars: How We Have Painted Ourselves Into A Regulatory Corner, Rachel M. Perkins

Vanderbilt Journal of Entertainment & Technology Law

A private citizen can violate the Constitution in two ways. The first is by enslaving another person, an atrocious act that should be proscribed by the highest law in the land. The second is by transporting alcohol across a state line in violation of the laws of that state. The two actions are hardly of the same magnitude.

The history of alcohol regulation has been a litany of failed attempts--on both the state and federal levels. Each new layer of legislation created additional problems. Most are familiar with the infamy of Prohibition, the federal ban on the manufacture or sale …

Allocating Liability For Deficient Warnings On Generic Drugs: A Prescription For Change, Sarah C. Duncan

Vanderbilt Journal of Entertainment & Technology Law

Brand-name pharmaceutical companies create pioneer drugs that cure diseases around the world. However, because research and development costs are very high, brand-name drugs are expensive. In response to escalating costs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act") to promote generic competition. As generics become more prominent in the pharmaceutical marketplace, individuals injured by generic drugs are suing the manufacturers with more frequency. The cases often turn on which company should bear the liability for failing to warn--the brand-name manufacturer or the generic drug maker. Although the injured person took the generic drug, …

State Taxation Of Marijuana Distribution And Other Federal Crimes, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The financial crisis has breathed new life into proposals to reform marijuana law. Commentators suggest that legalizing and taxing marijuana could generate substantial revenues for beleaguered state governments-as much as $1.4 billion for California alone. This Article, however, suggests that commentators have grossly underestimated the difficulty of collecting a tax on a drug that remains illegal under federal law. The federal ban on marijuana will impair state tax collections for two reasons. First, by giving marijuana distributors powerful incentives to stay small and operate underground, the federal ban will make it difficult for states to monitor marijuana distribution and, consequently, …

On The Limits Of Supremacy: Medical Marijuana And The States' Overlooked Power To Legalize Federal Crime, Robert A. Mikos

Vanderbilt Law School Faculty Publications

Using the conflict over medical marijuana as a timely case study, this Article explores the overlooked and underappreciated power of states to legalize conduct Congress bans. Though Congress has banned marijuana outright, and though that ban has survived constitutional scrutiny, state laws legalizing medical use of marijuana constitute the de facto governing law in thirteen states. This Article argues that these state laws and (most) related regulations have not been, and, more interestingly, cannot be preempted by Congress, given constraints imposed on Congress's preemption power by the anti-commandeering rule, properly understood. Just as importantly, these state laws matter, in a …

Over The Counter But Under The Radar: Direct-To-Consumer Genetics Tests And Fda Regulation Of Medical Devices, Lauren B. Solberg

Vanderbilt Journal of Entertainment & Technology Law

Direct-to-consumer genetic tests are laboratory-developed tests that are marketed and sold directly to consumers. They typically do not require a prescription or any other involvement from a consumer's health care provider. Consumers order these tests online and return a specimen, usually a saliva sample, directly to the laboratory. The results are mailed directly to the consumer, and no health care provider or insurance company need ever learn the contents of these results. The FDA does not currently regulate direct-to-consumer genetic tests, though tests for hundreds of different diseases are readily available to the public.

The FDA's approach to regulating genetic …

Giving The Terminally Ill Their Due (Process): A Case For Expanded Access To Experimental Drugs Through The Political Process, Linda K. Leibfarth

Vanderbilt Law Review

The stated purpose of the Food and Drug Administration ("FDA" or "Agency") is "to promote and protect the public health." In furtherance of this end, the FDA has created a regulatory framework to ensure that drugs marketed to the general public are both safe and effective. However, critics insist that the FDA's paternalistic drug approval process does little to achieve its goal. At the onset of the AIDS epidemic in the 1980s, criticism of the FDA intensified, as the FDA's lengthy and expensive drug approval process hindered terminally ill AIDS patients' access to potentially lifesaving treatment. Advocates for these patients …

An Intellectual Property Food Fight: Why Copyright Law Should Embrace Culinary Innovation, J. Austin Broussard

Vanderbilt Journal of Entertainment & Technology Law

In the United States, dining has become an increasingly popular form of leisure and entertainment, generating an estimated $537 billion in 2007. However, dining represents only one aspect of the modern food economy; cooking and dining are regularly featured in newspapers and magazines, while celebrity chefs tout their own brands on television. Eating has been transformed from a mere perfunctory activity into big business. Increasing competition for the attention and money of restaurant patrons has prompted chefs of grande cuisine to differentiate their menus by creating unique dishes. The time and labor that chefs sink into this form of innovation …

A Healthy Solution For Patients And Patents: How India's Legal Victory Against A Pharmaceutical Giant Reconciles Human Rights With Intellectual Property Rights, Sara B. Myers

Vanderbilt Journal of Entertainment & Technology Law

The Swiss drug company Novartis challenged India's status as the "Pharmacy of the Developing World" when it initiated a lawsuit against the Indian government on February 15, 2007. In 2005, India updated its Patents Act to comply with the World Trade Organization's (WTO) intellectual property requirements. Before 2005, India only granted patents to processes, not products, which facilitated the development of the country's booming generic drug industry. On January 25, 2006, India's Office of the Controller General of Patents, Designs and Trademarks denied Novartis's patent application for its cancer-fighting drug Glivec on the grounds that it was not substantially different …

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 …

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 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 …

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 …

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 …

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. …

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 …

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 …

Just What The Doctor Ordered: The Admissibility Of Differential Diagnosis In Pharmaceutical Product Litigation, Wendy Michelle Ertmer

Vanderbilt Law Review

In the decade since Daubert v. Merrell Dow Pharmaceuticals Inc., federal judges have exercised their role as gatekeepers of expert witness testimony to evaluate many different categories of scientific evidence. They have not done so without controversy, however. Because the element of causation in pharmaceutical product litigation is frequently dispositive, the application of Daubert to scientific evidence of causation has been particularly contentious. Plaintiffs in such cases must prove both general causation-that the product is capable of causing an injury of the type from which the plaintiff suffers-and specific causation-that the product was the actual cause of the plaintiffs injury. …

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 …

Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel

Vanderbilt Law Review

Despite the continuing "war on drugs," the last decade has witnessed the creation and nationwide spread of a remarkable set of institutions, drug treatment courts. In drug treatment court, a criminal defendant pleads guilty or otherwise accepts responsibility for a charged offense and accepts placement in a court-mandated program of drug treatment. The judge and court personnel closely monitor the defendant's performance in the program and the program's capacity to serve the mandated client. The federal government and national associations in turn monitor the local drug treatment courts and disseminate successful practices. The ensemble of institutions, monitoring, and pooling exemplifies …

Teen Smoking Behavior And The Regulatory Environment, Joni Hersch

Vanderbilt Law School Faculty Publications

Professor Hersch argues that most state regulations aimed at fighting teen smoking have had little or no effect. She provides evidence that despite widespread age restrictions on purchasing tobacco, most teens do not consider it difficult for minors to purchase tobacco products within their community. She also presents evidence demonstrating a strong correlation between smoking rates and perceptions about the addictive nature of smoking. These findings suggest that facilitating greater awareness of the addictive power of cigarettes could be effective in curbing teen smoking. She explores the potential for parental restrictions on limiting teen smoking, but provides indications that parents …

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 …

Liquor And Lemon: The Establishment Clause And State Regulation Of Alcohol Sales, Steven L. Lane

Vanderbilt Law Review

Approximately half of the fifty states and numerous municipalities maintain and enforce legislation that prohibits the sale of alcohol close to churches. A number of other states allow their liquor- licensing authorities to consider proposed vendors' proximity to churches. Likewise, states and municipalities in all regions of the country have laws that restrict the sale of alcohol on Sunday. Notwithstanding the secular justifications offered by the proponents of such legislation, analysis reveals that it is religiously motivated. Although the Bible contains no clear mandate against the sale, purchase, or consumption of alcohol, history illustrates that prohibitions on the sale of …

Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale For The Fda Regulatory Compliance Defense, W. Kip Viscusi, Steven R. Rowland, Howard L. Dorfman, Charles J. Walsh

Vanderbilt Law School Faculty Publications

This Article examines the interaction between direct regulation of pharmaceuticals under the Federal Food Drug and Cosmetic Act (FDCA) and the indirect regulation of pharmaceuticals provided by common law tort incentives. The Article concludes that tort liability is generally inappropriate in cases where manufacturers have complied with the FDCA. The Article begins with a description of the FDCA's operation, and provides an overview of the Food and Drug Administration's (FDA) role in the drug approval process and drug labeling. This overview will demonstrate the need for centralized control over drug labeling. Moreover, we will provide an explanation of the costs …

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 …

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 …

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 …

Drug Diplomacy And The Supply-Side Strategy: A Survey Of United States Practice, Sandi R. Murphy

Vanderbilt Law Review

The illicit drug trade is gigantic. The United Nations reports that the annual value of the illegal drug trade worldwide is 250 to 300 billion dollars.' The United States leads the world in illicit drug consumption and suffers a myriad of drug-related problems. The majority of marijuana, cocaine, and heroin consumed in the United States through out the 1980s was supplied by six Latin American and Caribbean countries. These countries, like the United States, are plagued by drug-related problems. The governments and citizens of both drug producing and drug transit countries are increasingly victims of crime, violence,and corruption.

Attendant to …

Special Project: Current Issues In Drug Enforcement Law, S. Douglas Williams, Jr.

Vanderbilt Law Review

The illegal drug trade and its costs to society have grown exponentially in the past several years. Drug traffickers, both within the United States and abroad, have amassed incredible wealth trafficking illicit drugs while the United States, the world's leading consumer of those drugs,' has suffered drug related increases in lost productivity, insurance costs, and health care expenditures. As the impact of these problems has reached more Americans, popular support for increased enforcement efforts has grown. Politicians have successfully used the drug war as a get-tough-on-crime campaign message. Local communities have organized themselves to confront drug dealers and to attempt …