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Articles 2491 - 2520 of 2834

Full-Text Articles in Food and Drug Law

Merits Of Ratifying And Implementing The Cartagena Protocol On Biosafety, Jonathan A. Glass Jan 2001

Merits Of Ratifying And Implementing The Cartagena Protocol On Biosafety, Jonathan A. Glass

Northwestern Journal of International Law & Business

In a meeting in Cartagena, Colombia in February 1999, parties to the CBD, known as the Conference of the Parties ("COP"), could not agree on the proposed biosafety protocol drafted in prior meetings.3 However, in January 2000, in a meeting in Montreal, the parties to the CBD finally adopted the draft protocol, naming it the Cartagena Protocol on Biosafety ("Cartagena Protocol or Protocol"). 4 When the Cartagena Protocol opened for signature at the CBD's COP meeting in Nairobi in May 2000, sixty-four governments and the European Union signed the Protocol . Presently, eighty-one parties have signed the Protocol, while only …

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The Affordable Prescription Drugs Act: A Solution For Today's High Prescription Drug Prices , John D. Pinzone Jan 2001

The Affordable Prescription Drugs Act: A Solution For Today's High Prescription Drug Prices , John D. Pinzone

Journal of Law and Health

This article will discuss a recently proposed bill, The Affordable Prescription Drugs Act (APDA), and how it will attempt to strike a balance between reducing prices to make essential drugs more available and affordable, and working with pharmaceutical companies to make sure they profit and invest their money into research and development of new essential drugs. It argues that the APDA increases competition in the market place, thus reducing the price of prescription drugs, while still allowing pharmaceutical companies to profit from their inventions. In reaching this conclusion this article examines the bill itself, how to define an essential drug, …

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Lindsey V. Tacoma-Pierce County Health Department: Cipollone Revisited, Billboards, State Law Tort Damages Actions, Federal Preemption And The Federal Cigarette Labeling And Advertising Act, Harold C. Reeder Jan 2001

Lindsey V. Tacoma-Pierce County Health Department: Cipollone Revisited, Billboards, State Law Tort Damages Actions, Federal Preemption And The Federal Cigarette Labeling And Advertising Act, Harold C. Reeder

Seattle University Law Review

The Article evaluates Lindsey and other recent cases dealing with local regulations restricting tobacco advertising; it also examines their respective preemption analyses, suggesting that the use of the FCLAA's preemption provision against such regulations is unwarranted. The article argues that in Lindsey, the Ninth Circuit misconstrued the Supreme Court's discussion of the preemptive scope of the FCLAA by failing to read it in the proper contex and that the FCLAA's preemption provision was not intended to prevent the particular types of regulations involved in Lindsey and these other cases. It argues that the preemption provision was only meant to …

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Why Don't We Enforce Existing Drug Price Controls? The Unrecognized And Unenforced Reasonable Pricing Requirements Imposed Upon Patents Deriving In Whole Or In Part From Federally-Funded Research, Michael Henry Davis, Peter S. Arno Jan 2001

Why Don't We Enforce Existing Drug Price Controls? The Unrecognized And Unenforced Reasonable Pricing Requirements Imposed Upon Patents Deriving In Whole Or In Part From Federally-Funded Research, Michael Henry Davis, Peter S. Arno

Law Faculty Articles and Essays

This Article discusses drug pricing in the context of federally funded inventions. It examines the “march-in” provision of the Bayh-Dole Act, a federal statute that governs inventions supported in whole or in part by federal funding. It discusses technology-transfer activity as a whole and the often-conflicting roles of the government, academia, and industry. The Article discusses the mechanisms of the Bayh-Dole Act and examines its legislative history. It notes that the Act has had a powerful price-control clause since its enactment in 1980 that mandates that inventions resulting from federally funded research must be sold at reasonable prices. The Article …

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Web Of Manipulation: The Learned Intermediary Doctrine And Direct-To-Consumer Advertising On The World Wide Web, 35 J. Marshall L. Rev. 97 (2001), April L. Foreman Jan 2001

Web Of Manipulation: The Learned Intermediary Doctrine And Direct-To-Consumer Advertising On The World Wide Web, 35 J. Marshall L. Rev. 97 (2001), April L. Foreman

UIC Law Review

No abstract provided.

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A New Strategy For Human Rights Protection: Learning From Narcotics Trafficking In Mexico, Jeremiah E. Goulka Jan 2001

A New Strategy For Human Rights Protection: Learning From Narcotics Trafficking In Mexico, Jeremiah E. Goulka

Cardozo Journal of International and Comparative Law

The article explores the challenges in human rights protection by examining Mexico's struggle with narcotics trafficking. It highlights how corruption and ineffective law enforcement lead to both underpolicing and overpolicing, undermining the Rule of Law and human rights. The author advocates for a two-tiered strategy to develop the Rule of Law internationally and locally to address these issues effectively.

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Internet Pharmacies: Cyberspace Versus The Regulatory State , Ty Clevenger Jan 2001

Internet Pharmacies: Cyberspace Versus The Regulatory State , Ty Clevenger

Journal of Law and Health

The unique qualities of e-commerce make it difficult to regulate under any circumstances, but the growth of online pharmacies in particular is far outpacing the ability of government officials to investigate and enforce existing drug laws. In 1999, Americans spent an estimated $44 million purchasing prescription drugs from online pharmacies, a figure that is projected to reach $1 billion per year by 2003. In December of 1999, President Clinton proposed $10 million in new funding for the FDA to regulate Internet pharmacies and hire 100 new employees, but the FDA has yet to explain whether this would be enough to …

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Making Clinical Trials Safer For Human Subjects, Michael S. Baram Jan 2001

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …

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Implications Of Fda Approval Of Ru-486: Regulating Mifepristone Within The Bounds Of The Constitution, Bradley E. Cunningham Jan 2001

Implications Of Fda Approval Of Ru-486: Regulating Mifepristone Within The Bounds Of The Constitution, Bradley E. Cunningham

Kentucky Law Journal

No abstract provided.

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Pharmaceutical Patent Protection: More Generic Favored Legislation May Cause Pioneer Drug Companies To Pull The Plug On Innovation, Mandy Wilson Jan 2001

Pharmaceutical Patent Protection: More Generic Favored Legislation May Cause Pioneer Drug Companies To Pull The Plug On Innovation, Mandy Wilson

Kentucky Law Journal

No abstract provided.

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Democracy, Science, And Free Trade: Risk Regulation On Trial At The World Trade Organization, Robert Howse Jun 2000

Democracy, Science, And Free Trade: Risk Regulation On Trial At The World Trade Organization, Robert Howse

Michigan Law Review

Among the most common critiques of globalization is that it increasingly constrains the ability of democratic communities to make unfettered choices about policies that affect the fundamental welfare of their citizens, including those of health and safety, the environment, and consumer protection. Traditionally, free trade rules were about constraining border measures such as tariffs and quantitative restrictions on imports. Increasingly, however, such rules include requirements and constraints addressed directly to domestic regulation. For example, a country's policies with respect to intellectual property rights or its regulatory approach to network industries, such as telecommunications, may now be fundamentally shaped by rules …

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The Fda Knows Best . . Or Does It? First Amendment Protection Of Health Claims On Dietary Supplements: Pearson V. Shalala, Amber K. Spencer May 2000

The Fda Knows Best . . Or Does It? First Amendment Protection Of Health Claims On Dietary Supplements: Pearson V. Shalala, Amber K. Spencer

Brigham Young University Journal of Public Law

No abstract provided.

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Trends. On Drugs? Response To The Peruvian Elections, Ibpp Editor Apr 2000

Trends. On Drugs? Response To The Peruvian Elections, Ibpp Editor

International Bulletin of Political Psychology

This article discusses electoral "dirty tricks" in the Peruvian election between President Alberto Fuimori and Mr. Alejandro Toledo. The article also discusses comments made by the head of the United States (US) Office of National Drug Policy and Control, General Barry R. McCaffrey.

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Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel Apr 2000

Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel

Vanderbilt Law Review

Despite the continuing "war on drugs," the last decade has witnessed the creation and nationwide spread of a remarkable set of institutions, drug treatment courts. In drug treatment court, a criminal defendant pleads guilty or otherwise accepts responsibility for a charged offense and accepts placement in a court-mandated program of drug treatment. The judge and court personnel closely monitor the defendant's performance in the program and the program's capacity to serve the mandated client. The federal government and national associations in turn monitor the local drug treatment courts and disseminate successful practices. The ensemble of institutions, monitoring, and pooling exemplifies …

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Pediatric Testing Of Prescription Drugs: The Food And Drug Administration's Carrot And Stick For The Pharmaceutical Industry , Kurt R. Karst Feb 2000

Pediatric Testing Of Prescription Drugs: The Food And Drug Administration's Carrot And Stick For The Pharmaceutical Industry , Kurt R. Karst

American University Law Review

No abstract provided.

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Cigar Warnings: Proceed With Caution, 33 J. Marshall L. Rev. 521 (2000), Patricia A. Davidson Jan 2000

Cigar Warnings: Proceed With Caution, 33 J. Marshall L. Rev. 521 (2000), Patricia A. Davidson

UIC Law Review

No abstract provided.

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Rx For Liability: Advocating The Elimination Of The Pharmacist's No Duty To Warn Rule, 33 J. Marshall L. Rev. 425 (2000), Edward Casmere Jan 2000

Rx For Liability: Advocating The Elimination Of The Pharmacist's No Duty To Warn Rule, 33 J. Marshall L. Rev. 425 (2000), Edward Casmere

UIC Law Review

No abstract provided.

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Direct-To-Consumer Advertising Of Prescription Drugs: After A Decade Of Speculation, Courts Consider Another Exception To The Learned Intermediary Rule, Mae Joanne Rosok Jan 2000

Direct-To-Consumer Advertising Of Prescription Drugs: After A Decade Of Speculation, Courts Consider Another Exception To The Learned Intermediary Rule, Mae Joanne Rosok

Seattle University Law Review

This Comment will explore whether Washington courts should recognize direct-to-consumer advertising as an exception to the learned intermediary rule. With the ultimate goal of advocating the best protection for the consumer, the discussion will suggest that Washington courts should not create an exception. A review of other exceptions to the learned intermediary rule does not support abandoning the doctrine when a drug company advertises its product directly to consumers. Nevertheless, advertising does affect consumer purchases and does influence consumer choices, and drug companies should accept the responsibility to present balanced information. This responsibility should encompass more than meeting the minimum …

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Measuring Culpability By Measuring Drugs? Three Reasons To Re-Evaluate The Rockefeller Drug Laws, Susan Herman Jan 2000

Measuring Culpability By Measuring Drugs? Three Reasons To Re-Evaluate The Rockefeller Drug Laws, Susan Herman

Faculty Scholarship

No abstract provided.

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Whose Team Am I On Anyway - Musings Of A Public Defender About Drug Treatment Court Practice, Mae C. Quinn Jan 2000

Whose Team Am I On Anyway - Musings Of A Public Defender About Drug Treatment Court Practice, Mae C. Quinn

Journal Articles

No abstract provided.

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Thinking About Drug Law Reform: Some Political Dynamics Of Medicalization, Fredrick Polak Jan 2000

Thinking About Drug Law Reform: Some Political Dynamics Of Medicalization, Fredrick Polak

Fordham Urban Law Journal

The article begins by stating that many people believe that medicalization offers the most reasonable approach to drug policy because it offers a dignified approach to treatment of addicts. However, it risks being a form of repression itself because it may define abstinence as the only acceptable treatment outcome. The article then explores the position of the medical profession in drug policy. It then looks at the negative political and social aspects and consequences of an abstinence-directed medicalization policy. The article concludes by stating that if abstinence is always the treatment goal then medicalization will be even less voluntary and …

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Drug Policy Alternatives- A Response From The Bench, John Curtin Jan 2000

Drug Policy Alternatives- A Response From The Bench, John Curtin

Fordham Urban Law Journal

The article begins by discussing the tremendous financial and social cost incurred by drug use and regulation. It then discusses some positive efforts to deal with the problem such as legalization and decriminalization. The article then states that it will take time to figure out the extent of legalization needed, and until that is figured out we need to focus efforts on harm reduction. The article then addresses whether the constitution bans drugs at all. Finally, the article concludes by stating that we can never hope to fully eliminate drug use, we can only hope to contain it, and gives …

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Institutionalizing Innovation: The New York Drug Court Story, John Feinblatt, Greg Berman, Aubrey Foxx Jan 2000

Institutionalizing Innovation: The New York Drug Court Story, John Feinblatt, Greg Berman, Aubrey Foxx

Fordham Urban Law Journal

The article begins by discussing the problems that drug use is causing in the American Criminal Justice System. The article then discusses the use of "drug courts," which have proven effective in reducing drug use and recidivism. It then looks at the potential benefit of drug courts to the criminal justice system and states some of the questions pertaining to drug courts, such as limits and the requirement of specialized judges. The article concludes by looking at what critics have said about the use of drug courts, and by stating that the drug court idea is worth trying.

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Our Drug Laws Have Failed - So Where Is The Desperately Needed Meaningful Reform?, David C. Leven Jan 2000

Our Drug Laws Have Failed - So Where Is The Desperately Needed Meaningful Reform?, David C. Leven

Fordham Urban Law Journal

The article begins by stating that the harsh drug laws of New York have failed to have an effect on the amount of drug dealers and instead have led to overcrowding of prisons with non-addict drug users. It states that the laws must be modified to give greater sentencing to judges, increasing diversion of non-violent offenders to rehabilitation. The article then delineates the problems resulting from current drug law and the criticism thereof. It then states the attempted reforms of drug laws that have been insufficient. The article concludes by suggesting proposals to solve the problems delineated, including proportionate sentences, …

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From Free Trade To Prohibition: A Critical History Of The Modern Asian Opium Trade, Alfred W. Mccoy Jan 2000

From Free Trade To Prohibition: A Critical History Of The Modern Asian Opium Trade, Alfred W. Mccoy

Fordham Urban Law Journal

The article begins by exploring America's current war on drugs and how it represents a misuse of its power and misperception of the global narcotics trade. It continues and puts forth that Asia's opium production may soon increase to levels that will defeat the war on drugs now being waged by the United State and United Nations and goes into the the extent of Opium production in Asia. It then looks at a history of Opium trade, including the era which began prohibition and then the cold war, which began the expansion of the Asian opium trade. The article then …

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Is Our Drug Policy Effective, Jefferson M. Fish Jan 2000

Is Our Drug Policy Effective, Jefferson M. Fish

Fordham Urban Law Journal

The article begins by stating that the time has come for a reexamination of our drug policy. It continues by discussing the two day conference "Is Our Drug Policy Effective?" "Are There Alternatives?" organized by several committee's. Because of space constraints, the article mainly delves into two topics, certain substances both licit and illicit with regard to both their physiological effects and the policies governing them, and also the disproportionate emphasis placed by the war on drugs on combating marijuana. The article then gives summaries of the speakers at the conference. These include: Objectives of our drug policy, overviews of …

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Two Degrees Of Speech Protection: Free Speech Through The Prism Of Agricultural Disparagement Laws, Howard M. Wasserman Jan 2000

Two Degrees Of Speech Protection: Free Speech Through The Prism Of Agricultural Disparagement Laws, Howard M. Wasserman

Faculty Publications

In the wake of a 1989 national television broadcast reporting the alleged cancer risk of a chemical applied to apples on trees, many states passed agricultural product disparagement (APD) statutes. These statutes grant civil causes of action to the growers and sellers of perishable food products, against anyone who speaks negatively or disparagingly, without basis in scientific evidence, about the product's safety. In this Article, Howard M Wasserman explores the interplay between the APD statutes and the First Amendment. First, Mr. Wasserman discusses the three categories of restrictions on the freedom of speech, focusing primarily on private civil tort actions …

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Adverse Drug Reactions: Harnessing Experiential Data To Promote Patient Welfare, Barbara A. Noah Jan 2000

Adverse Drug Reactions: Harnessing Experiential Data To Promote Patient Welfare, Barbara A. Noah

Faculty Scholarship

Part I of this Article evaluates the pre-approval and post-approval regulatory framework governing prescription drugs, and the FDA's spontaneous reporting system for adverse events, as it contrasts that system with the regulatory mechanisms used to monitor risks associated with other products. Part II summarizes the recent series of prescription drug marketing withdrawals prompted by reports of unexpected adverse reactions. Finally, Part III offers some possible solutions designed to improve the efficiency of postapproval surveillance so that fewer patients will suffer the consequences of unexpected adverse drug reactions and interactions. This Article concludes that the existing regulatory system requires fundamental reprioritization …

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Breaking The Federal/State Impasse Over Medical Marijuana: A Proposal, Marsha N. Cohen Jan 2000

Breaking The Federal/State Impasse Over Medical Marijuana: A Proposal, Marsha N. Cohen

Faculty Scholarship

No abstract provided.

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Increasing Access To Emergency Contraceptive Pills Through State Law Enabled Dependent Pharmacist Prescribers, Heather M. Field Jan 2000

Increasing Access To Emergency Contraceptive Pills Through State Law Enabled Dependent Pharmacist Prescribers, Heather M. Field

Faculty Scholarship

No abstract provided.

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