Food and Drug Law Commons^™

The End Of Azt Patent: A New Beginning Or Too Little Too Late?, Lindsay Frank

Public Interest Law Reporter

No abstract provided.

A Prescription For Drug Liability And Regulation, Victor E. Schwartz, Phil Goldberg

Oklahoma Law Review

No abstract provided.

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 …

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 …

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. …

Strictly Speaking About Ephedra: A Baseball Tragedy Helping To Define The Dynamic Between Warning Defect And Design Defect, Michael Kane

Jeffrey S. Moorad Sports Law Journal (1994 - )

No abstract provided.

Do Recent Studies Prove That Farmed Salmon Are Toxic - A Commentary On Whether The Current Fda Guidelines Adequately Protect Consumers From Potential Toxins In Farmed Salmon, Arthur Cutillo

Villanova Environmental Law Journal (1991 - )

No abstract provided.

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 …

Weight-Loss Advertising Too Good To Be True: Are Manufacturers Or The Media To Blame?, Jodie Sopher

Cardozo Arts & Entertainment Law Journal

No abstract provided.