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Series

Articles

Regulation

Food and Drug Law

2005

Articles 1 - 4 of 4

Full-Text Articles in Law

A Government Of Limited Powers, Carl E. Schneider Jul 2005

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 Jan 2005

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 Jan 2005

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 Jan 2005

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 …