Food and Drug Law Commons^™

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, …

Two Masters, Carl E. Schneider

Articles

American government rests on the principle of distrust of government. Not only is power within the federal government checked and balanced. Power is divided between the federal government and the state governments. So what if a state law conflicts with a federal law? The Constitution says that the "Constitution, and the Laws of the United States ... shall be the supreme Law of the Land; ... any Thing in the ... Laws of any State to the Contrary notwithstanding." Sometimes the conflict between federal and state law is obvious and the Supremacy Clause is easily applied. But sometimes ...

We Can Work It Out: Co-Op Compulsory Licensing As The Way Forward In Improving Access To Anti-Retroviral Drugs, Horace E. Anderson

Elisabeth Haub School of Law Faculty Publications

This Article explores the social and developmental underpinnings of the access problem and describes the legal framework that provides the backdrop for the Waiver's licensing scheme. Part III examines the various lenses, humanitarian, economic, and political, through which the underutilization problem may be viewed and explained. Part IV sets out the structural heart of the Waiver scheme's deficiencies: the notion of the “compulsory” license itself. Part V posits a co-op scheme of licensing that aligns the concerns, goals, and incentives of IP owners, importers, exporters, and consumers. Finally, the Article relates the proposed scheme to more general trends in thinking …

Bundling Public And Private Goods: The Market For Sustainable Organics, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

Modern agriculture has vast environmental externalities. The pesticides, fertilizers, and sediments in irrigation runoff pollute surface and groundwater; single-crop farms destroy biodiversity; and massive amounts of fossil fuels are burned in agricultural production, post-harvest processing, and shipping. Nevertheless, farming operations have largely escaped the post-1970 expansion of federal environmental regulation. Compounding the problem, federal farm policy has encouraged the very farming practices that most cause this degradation.

In 1990, Congress passed the Organic Foods Production Act (OFPA), which created an organic food certification and labeling system. While OFPA's primary purposes are to facilitate the growth of the organic sector and …

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, …

Private Regulation And Foreign Conduct, Adam I. Muchmore

Faculty Scholarship

Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens of …