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Articles 121 - 142 of 142
Full-Text Articles in Food and Drug Law
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Michigan Telecommunications & Technology Law Review
The government, particularly the Food and Drug Administration ("FDA"), heavily regulates the life sciences industry. FDA actions can have an extraordinary influence on the fortunes of biotechnology companies. Timely FDA approval of a drug or medical device can permit a company to exploit an inviting market window. FDA product approval is, in turn, tied to clinical test results which demonstrate "efficacy" and safety. Delayed approval, unfavorable test results, or the denial of an FDA application may ruin a company. Beyond the FDA product approval process and related testing lie FDA inspections and the possibility that the government will investigate charges …
The Battle Over Life-Saving Pharmaceuticals: Are Developing Countries Being Tripped By Developed Countries, Michelle M. Nerozzi
The Battle Over Life-Saving Pharmaceuticals: Are Developing Countries Being Tripped By Developed Countries, Michelle M. Nerozzi
Villanova Law Review
No abstract provided.
Extraditing Mexican Nationals In The Fight Against International Narcotics Crimes, Joshua S. Spector
Extraditing Mexican Nationals In The Fight Against International Narcotics Crimes, Joshua S. Spector
University of Michigan Journal of Law Reform
In recent years, Mexican narcotics trafficking has become a major threat to the security of the Americas. Mexican narco-traffickers have used their wealth and violence to corrupt political and judicial systems and avoid effective prosecution or penalty in Mexican courts. Historically, Mexico has refused to extradite its nationals in reliance on Mexican law prohibiting the extradition of nationals in all but "exceptional" cases. This Note argues that Mexico should take a step toward controlling the cross-border narcotics trade and recognize international drug trafficking as an "exceptional" crime. Upon recognizing narcotics crimes as "exceptional," Mexico should then begin extraditing Mexican narco-traffickers …
In Memoriam: Ralph Seeley Obscured By Smoke: Medicinal Marijuana And The Need For Representation Reinforcement Review, Aryeh Y. Brown
In Memoriam: Ralph Seeley Obscured By Smoke: Medicinal Marijuana And The Need For Representation Reinforcement Review, Aryeh Y. Brown
Seattle University Law Review
This Comment contends that because of the continuing legislative inability to deal adequately with this issue the courts must apply strict judicial scrutiny by way of a representational reinforcement theory to cases concerning the medicinal use of marijuana. Failure to do so perpetuates the dysfunction of the judicial and legislative process. It additionally detracts from the legitimacy of that process by fostering cynicism and contempt toward the legislature that promulgates such oppressive laws and toward the judiciary that allows their enforcement.
Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green
Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green
University of Michigan Journal of Law Reform
Professor Green addresses the matter of the proper balance between the tort system and regulation in the context of prescription drugs and the FDA's vigorous oversight of the industry. He articulates several reasons why a regulatory compliance defense, in which tort law would defer to FDA regulation, is quite attractive. Despite the superior expertise of the FDA in assessing the benefits and risks of a drug, a regulatory compliance defense is considerably more problematical than might appear at first glance. Ascertaining compliance with FDA requirements could be a lengthy and complicated inquiry that would either replace or supplement the issues …
When Discretion Leads To Distortion: Recognizing Pre-Arrest Sentence-Manipulation Claims Under The Federal Sentencing Guidelines, Jeffrey L. Fisher
When Discretion Leads To Distortion: Recognizing Pre-Arrest Sentence-Manipulation Claims Under The Federal Sentencing Guidelines, Jeffrey L. Fisher
Michigan Law Review
This Note argues that sentence manipulation should be a legally viable partial defense - a defense that does not warrant complete exoneration, but does warrant a reduced sentence when the government's investigative techniques place a quantity of drugs before the court that overrepresents the defendant's culpability, or individual blameworthiness. Part I describes the policies and objectives that underlie the Guidelines, but then demonstrates how the rigid application of quantity-based sentencing provisions can lead to sentence manipulation that thwarts these goals, particularly the goal of sentencing according to culpability. Part II describes how courts have responded to sentence manipulation claims. It …
Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale For The Fda Regulatory Compliance Defense, W. Kip Viscusi
Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale For The Fda Regulatory Compliance Defense, W. Kip Viscusi
Vanderbilt Law School Faculty Publications
This Article examines the interaction between direct regulation of pharmaceuticals under the Federal Food Drug and Cosmetic Act (FDCA) and the indirect regulation of pharmaceuticals provided by common law tort incentives. The Article concludes that tort liability is generally inappropriate in cases where manufacturers have complied with the FDCA. The Article begins with a description of the FDCA's operation, and provides an overview of the Food and Drug Administration's (FDA) role in the drug approval process and drug labeling. This overview will demonstrate the need for centralized control over drug labeling. Moreover, we will provide an explanation of the costs …
Prostitution: A Narrative By A Former "Call Girl", Anonymous
Prostitution: A Narrative By A Former "Call Girl", Anonymous
Michigan Journal of Gender & Law
Why do women get involved in prostitution? I believe there are two primary causes: money and drugs.
Beyond The War On Drugs: Overcoming A Failed Public Policy, Kenneth R. Hillier
Beyond The War On Drugs: Overcoming A Failed Public Policy, Kenneth R. Hillier
Michigan Law Review
A Review of Beyond the War on Drugs: Overcoming a Failed Public Policy by Steven Wisotsky
Narrowing The Scope Of Civil Drug Forfeiture: Section 881, Substantial Connection And The Eighth Amendment, James B. Speta
Narrowing The Scope Of Civil Drug Forfeiture: Section 881, Substantial Connection And The Eighth Amendment, James B. Speta
Michigan Law Review
This Note offers two justifications for narrowing the scope of section 881 forfeiture. Part I argues that courts should apply the substantial connection test to section 881 forfeitures. This Part analyzes the statute using the traditional tools of statutory interpretation. While the text of the statute seems to support the broadest possible interpretation, the legislative history and context of adoption suggest that the substantial connection test is consistent with Congressional intent. In amending section 881, subsequent Congresses have favored application of the substantial connection test. Consistent with this narrower reading, present strategy in the "war on drugs" focuses stiff penalties …
The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox
The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox
University of Michigan Journal of Law Reform
This Note argues that courts should impose a due diligence requirement on plaintiffs as a prerequisite to the use of market share theory. Part I examines traditional products liability theories along with alternative theories and explains the relationship of due diligence to market share theory. Part II argues that due diligence should be a prerequisite to market share liability. Part III discusses the nature of due diligence in this context. Finally, Part IV considers various objections to a due diligence requirement and argues that they are essentially without merit.
The Heroin Solution, Michigan Law Review
The Heroin Solution, Michigan Law Review
Michigan Law Review
A Review of The Heroin Solution by Arnold S. Trebach
The Hardest Drug: Heroin And Public Policy, Michigan Law Review
The Hardest Drug: Heroin And Public Policy, Michigan Law Review
Michigan Law Review
A Review of The Hardest Drug: Heroin and Public Policy by John Kaplan
Drugs And Criminal Responsibility, Edward H. Benton, Andrew Bor, William H. Leech, Joyce A. Levy, Samuel D. Lipshie, Thomas B. Mitchell, Gary M. Brown
Drugs And Criminal Responsibility, Edward H. Benton, Andrew Bor, William H. Leech, Joyce A. Levy, Samuel D. Lipshie, Thomas B. Mitchell, Gary M. Brown
Vanderbilt Law Review
This Special Project has carried out three broad purposes.First, it has synthesized and organized materials concerning drugs and criminal responsibility into a useful guide for legal practitioners and others interested in the problems of the drug dependent defendant. Second, it has identified serious analytical flaws in many of the defenses available to the criminal defendant. Finally,it has responded to these deficiencies with proposals intended to protect not only the legal rights of the drug dependent defendant but also the rights of society pertaining to criminal justice. While these societal interests include the swift imposition of criminal penalties when warranted, they …
Decriminalizing The Marijuana User: A Drafter's Guide, Richard J. Bonnie
Decriminalizing The Marijuana User: A Drafter's Guide, Richard J. Bonnie
University of Michigan Journal of Law Reform
The article does not discuss the arguments in favor of decriminalization, a matter which the author' and others have covered elsewhere. Nor does the article consider the even more difficult questions involved in a legislative decision to legalize the drug and authorize its distribution for nonmedical uses. International obligations, federal law, and current political realities preclude enactment of a regulatory approach toward the availability of marijuana, including any variant of the so-called alcohol model. Although a state conceivably could repeal its laws against cultivation and distribution of marijuana, including only the federal prohibitions in effect, such an overt departure from …
Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer
Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer
University of Michigan Journal of Law Reform
This article attempts to show that the OTC drug review has distinct advantages over traditional drug regulation. Part I outlines briefly the traditional case-by-case approach to drug licensing and describes FDA enforcement efforts prior to the OTC drug review. Part II sets forth the new rulemaking approach and considers the use of advisory panels. Part III examines several procedural questions associated with the review and concludes that the use of monographs as regulatory standards will afford the FDA an expeditious enforcement mechanism by resolving complex scientific issues at the administrative rather than the judicial level. Judicial review should be available, …
The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review
The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review
Michigan Law Review
Two judicial decisions in the early 1950s construing the FTC's section 13 (a) power produced a conflict that has not been resolved either by later courts or by the amendments to section 13 enacted in 1973. The dispute basically concerns the depth of the courts' inquiry into whether an advertisement violates- section 12 and the applicability of traditional equitable concepts in the context of the statutory injunction procedure. This Note contends that the legislative history of pertinent provisions of the Act suggests an appropriate resolution of the conflict through a two-step approach that would relax the scrutiny ordinarily accorded petitions …
Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof
Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof
University of Michigan Journal of Law Reform
This note will describe the conditions which existed prior to enactment of the Michigan drug substitution law, will discuss the history and provisions of that legislation, and will identify certain problems which the law fails to correct.
Toward An International System Of Drug Control, Louis Lessem
Toward An International System Of Drug Control, Louis Lessem
University of Michigan Journal of Law Reform
By any measure the ongoing explosion in the abuse and trafficking of illicit drugs must be viewed as alarming. The past few years have seen a dramatic upsurge in the use of heroin and other opiates, the re-emergence of cocaine as a popular drug, and expansion of the use and availability of synthetic and psychotropic substances, and, perhaps of greatest international concern, the penetration of illicit narcotics into markets hitherto relatively free from drug involvement. Western Europe, Canada, and most recently the Soviet Union1 have reported the growth of drug-consuming populations. At the same time, there has been an awakened …
The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig
The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig
University of Michigan Journal of Law Reform
This article explores the legal problems presented to the practicing pharmacist by drug substitution. It delineates the practical and economic realities bearing on substitution and the arguments both in favor of and against limited legal substitution. After describing the current status of the law on the subject and the various resultant liabilities of the pharmacist, the article then suggests means by which substitution might be made an acceptable practice in certain circumstances.
Governmental Regulation Of The Drug Industry, J. Mark Hiebert
Governmental Regulation Of The Drug Industry, J. Mark Hiebert
Cleveland State Law Review
In today's world of increased government participation in business, certain industries are frequently spotlighted for particular attention. The communications industry is one, the drug industry is another. In both cases the special attention is fitting, for the communications industry, like the drug industry, each in its own way, reaches the very fiber of American life. Each has the inherent capability of changing our political and social order. At any rate two points are basic: first, the drug industry directly affects the foundations of our society and therefore is a reasonable concern of government. Secondly, the drug industry has a legitimate …