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Full-Text Articles in Law
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Articles
This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …
United States--Certain Measures Affecting Imports Of Poultry From China: The Fascinating Case That Wasn't, Donald H. Regan
United States--Certain Measures Affecting Imports Of Poultry From China: The Fascinating Case That Wasn't, Donald H. Regan
Articles
US–Poultry (China) was the first Panel decision dealing with an origin-specific SPS measure, or with what the United States referred to as an ‘equivalence regime’. More specifically, it was the first instance in which the basis for the challenged measure was the claimed inability of the complainant country to enforce its own food-safety rules. Unfortunately, as the litigation developed, the very interesting novel issues raised by such a measure were not discussed. This essay discusses those novel issues – in particular, what sort of scientific justification or risk assessment should be required for a measure like this, and what SPS …
Two Masters, Carl E. Schneider
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 ...
Drugged, Carl E. Schneider
Drugged, Carl E. Schneider
Articles
The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …
A Government Of Limited Powers, Carl E. Schneider
A Government Of Limited Powers, Carl E. Schneider
Articles
Roscoe C. Filburn owned a small farm in Ohio where he raised poultry, dairy cows, and a modest acreage of winter wheat. Some wheat he fed his animals, some he sold, and some he kept for his family's daily bread. The Agricultural Adjustment Act of 1938 limited the wheat Mr. Filburn could grow without incurring penalties, but his 1941 crop exceeded those limits. Mr. Filburn sued. He said Claude Wickard, the Secretary of Agriculture, could not enforce the AAI's limits because Congress lacked authority to regulate wheat grown for one's own use. He reasoned: In our federal system, the states …
Dimensions Of Equality In Regulating Assisted Reproductive Technologies, Mary Crossley
Dimensions Of Equality In Regulating Assisted Reproductive Technologies, Mary Crossley
Articles
Although concerns about individual liberty and the nature and extent of reproductive freedom have tended to dominate discussions regarding the proliferation of and access to reproductive technologies, questions about the implications of assisted reproductive technologies (ARTs) for equality have also arisen. Despite the high number of invocations of equality in the literature regarding ARTs, to date little effort has been made to comprehensively examine the implications of ARTs for equality. This short Article seeks to highlight the variety of equality issues that ARTs present and to develop a framework for classifying different types of equality issues. Specifically, I suggest that …
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Articles
Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …
The Problem Of New Uses, Rebecca S. Eisenberg
The Problem Of New Uses, Rebecca S. Eisenberg
Articles
Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …