Food and Drug Law Commons^™

Reclaiming The Right To Food As A Normative Response To The Global Food Crisis, Smita Narula

Elisabeth Haub School of Law Faculty Publications

In 2009, the number of hungry in the world crossed the one billion mark, a dubious milestone that has been attributed in large part to consecutive food and economic crises. Over ninety-eight percent of these individuals live in the developing world. Ironically, a great majority are involved in food production as small-scale independent food producers or agricultural laborers. These facts and figures signal a definitive blow to efforts to reduce global hunger and lift the world's poorest from abject and dehumanizing poverty. They also bring to light the deep imbalance of power in a fundamentally flawed food system. Responses to …

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 …

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, …

Making Changes: Generic Drug Labeling And The Case Against Federal Preemption, Lesley A. Stout

Kentucky Law Journal

No abstract provided.

Taking From Trailblazers: Learning From Those Who Have Gone Before When Approving Biosimilars, John A. Little, Jr.

Georgia Law Review

The creation of an approval pathway for biosimilar biologicalproducts holds tremendous promise for increased competition in the biopharmaceutical market and financial savings to the health care system. Yet, safely achieving these promised benefits depends heavily on the Food and Drug Administration's ability to evaluate and compare these complicated molecules to previously approved products. Because biosimilars are different than generic drugs, the FDA's current practice of considering only its prior finding of safety and efficacy of a reference product is ill-suited for approval of biosimilars. Unfortunately, the new pathway included in recently enacted health care reform legislation ignores this distinction and …

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, …

The Legal Ecology Of Resistance: The Role Of Antibiotic Resistance In Pharmaceutical Innovation, Kevin Outterson

Cardozo Law Review

Antibiotic effectiveness is a common pool resource that can be prematurely depleted through resistance. Some experts warn that we may face a global ecological collapse in antibiotic effectiveness.

Conventional wisdom argues for more intellectual property rights to speed the creation of new antibiotics. Recent theoretical literature suggests that conservation-based approaches may yield superior results. This Article describes a novel typology for organizing these emerging theories and provides an early empirical test of these models using proprietary data on the sales of vancomycin, an important hospital antibiotic for the last three decades.

The results challenge the assumptions in several models and …