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Articles 31 - 60 of 61
Full-Text Articles in Food and Drug Law
Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie
Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie
Journal of Law and Health
The prospective review and approval of drugs is central to the public health mission of the United States Food and Drug Administration (FDA). Requiring pharmaceutical manufacturers to generate information about their products' safety and efficacy enables the agency to evaluate the risks and benefits associated with their use, thereby preventing overly harmful products from reaching the market. The majority of consumers benefit from this intervention by gaining access to an array of drugs that are proven to be safe and effective. Thus, governmental regulation in this area is arguably justified because the aggregate social welfare is substantially improved. However, this …
The First Amendment And Diet Industry Advertising: How Puffery In Weight-Loss Advertisements Has Gone Too Far, Jennifer E. Gross
The First Amendment And Diet Industry Advertising: How Puffery In Weight-Loss Advertisements Has Gone Too Far, Jennifer E. Gross
Journal of Law and Health
Stricter government regulations regarding commercial speech that promotes weight-loss or diet products should be considered for three reasons. First, studies have shown that diet industry advertising often makes weight loss claims that are scientifically impossible. Second, consumers have suffered adverse health effects as a result of trying weight-loss programs or diet products. Third, current FTC regulations are not curbing the problem. Part II of this note outlines the history of commercial speech and its protections under the First Amendment, along with the history of the rapidly expanding diet industry and its regulatory framework. Part II examines the three arguments in …
Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann
Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann
Law Faculty Articles and Essays
Reprocessing single-use medical devices is a growing but controversial industry subject to an increasingly complex and fast-developing set of regulations and a wide range of unresolved legal issues.
Sources: Pharmaceutical Promotion And The Medical Profession: Appendix A , Joseph Rohan Lex Jr.
Sources: Pharmaceutical Promotion And The Medical Profession: Appendix A , Joseph Rohan Lex Jr.
Journal of Law and Health
No abstract provided.
Dr. Joseph Rohan Lex, Jr., M.D. Faaem - The Physician-Pharmaceutical Industry Relationship, Joseph Rohan Lex Jr.
Dr. Joseph Rohan Lex, Jr., M.D. Faaem - The Physician-Pharmaceutical Industry Relationship, Joseph Rohan Lex Jr.
Journal of Law and Health
My premise is that physician interactions with marketing representatives result in inevitable and irreconcilable conflicts of interest or the appearance of conflicts of interest. Our patients in medicine are the ultimate losers from such interactions.
The Affordable Prescription Drugs Act: A Solution For Today's High Prescription Drug Prices , John D. Pinzone
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, …
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
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 …
Internet Pharmacies: Cyberspace Versus The Regulatory State , Ty Clevenger
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 …
Misconceptions And Misleading Information Prevail - Less Regulation Does Not Mean Less Danger To Consumers: Dangerous Herbal Weight Loss Products, Jennifer Sardina
Misconceptions And Misleading Information Prevail - Less Regulation Does Not Mean Less Danger To Consumers: Dangerous Herbal Weight Loss Products, Jennifer Sardina
Journal of Law and Health
This Note will examine the dangers associated with current dietary supplement regulation under the DSHEA and the problem of ill-informed consumers. As reflected in the title of this Note, misconceptions about dietary supplement regulation are abundant; consequently, section II of this Note will further discuss and offer illustrations in support of this position. Part III gives an overview of current regulation under the Dietary Supplement Health and Education Act of 1994. Also a brief discussion of the legislation that preceded the DSHEA is offered in section VI. Part V of this Note analyzes and defines the dietary ingredients that are …
Food For Sport Or Faustian Bargain: Regulating Performance Enhancing Dietary Supplements, Jennifer Kay Braman
Food For Sport Or Faustian Bargain: Regulating Performance Enhancing Dietary Supplements, Jennifer Kay Braman
Cleveland State Law Review
The defining line between legal and illegal substance-between dietary supplement and drug is horribly skewed. Accordingly, Part I of this Note will investigate the complexities that exist with regard to the classification and regulation of dietary supplements, looking at the history leading to the passage of the governing Dietary Health and Supplement Act of 1994. Part II will focus on supplements that consumers may use for performance enhancement purposes, and the regulation of sports products. Part III will look at the regulatory debate over dietary supplements, the andro product example and the interrelationship between drugs and sport. Part IV will …
Current Legal Intervention Regarding Experimental Treatments Must Be Changed: An Analysis Of High Doses Of Chemotherapy With Autologous Bone Marrow Transplantation For Breast Cancer Patients, Emily Smayda
Journal of Law and Health
The specific analysis of HDC-ABMT will help the reader to realize that the medical procedures being dealt with by litigation are not necessarily wildly innovative. Insurance companies are hiding behind the guise of words such as "experimental" to avoid paying for treatments that are both feasible and needed. Further, HDC-ABMT being used for breast cancer patients, suggests a possible discriminatory aspect that cannot be reached with current legal intervention. This Note suggests ways of dealing with insurance coverage denial on a more direct level. Instead of being bogged down by contract language and ERISA preemption, proposals for national standards and …
Race For Perfection: Children's Rights And Enhancement Drugs, Therese Powers
Race For Perfection: Children's Rights And Enhancement Drugs, Therese Powers
Journal of Law and Health
This Note will address the question of what are a child's rights when the child's views differ from his or her parents regarding the child's use or refusal of enhancement drugs such as Ritalin and Human Growth Hormone. This Note will begin with a description of Ritalin and Human Growth Hormone along with the uses and abuses of each drug. It will then discuss the evolution of children's rights dealing with situations such as civil commitment, abortion, and medical treatment over religious objection. Furthermore, it will draw comparisons from the case law in these situations to a child's right to …
Pharmaceuticals: The Battle For Control In The 21st Century, Rachel F. Ochs
Pharmaceuticals: The Battle For Control In The 21st Century, Rachel F. Ochs
Journal of Law and Health
To explore these concepts, this paper focuses on the Japanese motivation for taking control in the pharmaceutical industry and efforts that the US can take to ensure its role as a leader in the pharmaceutical industry. First, the paper discusses how Japan is poised to invade the US pharmaceutical market, reasons for Japanese entry into the market, the Japanese focus on research, recent examples of Japanese expansion and how US policy may affect Japanese expansion into the pharmaceutical market. The next section describes the need for the FDA to protect consumer interests in the US since market forces and / …
The Politics Of Reducing Tobacco Use Among Children And Adolescents: Why The Food And Drug Administration Cannot Regulate Tobacco And A Proposed Policy For States And Local Communities, Timothy J. Degeeter
The Politics Of Reducing Tobacco Use Among Children And Adolescents: Why The Food And Drug Administration Cannot Regulate Tobacco And A Proposed Policy For States And Local Communities, Timothy J. Degeeter
Journal of Law and Health
This paper will reveal that although the FDA has a compelling argument from a public health point of view to regulate tobacco products, the proposed federal rule is beyond the scope of the FDA's authority. The FDA cannot unilaterally assert jurisdiction over tobacco products in order to implement restrictions for children and adolescents without specific Congressional action. Instead, Congress has specifically delegated such regulatory authority to the states. Moreover, the proposed rule lacks necessary enforcement mechanisms to adequately keep tobacco products out of the hands of children and adolescents.
Meeting The Objectives Of The Mda: Implied Preemption Of State Tort Claims By The Medical Device Amendments, Theresa J. Pulley Radwan
Meeting The Objectives Of The Mda: Implied Preemption Of State Tort Claims By The Medical Device Amendments, Theresa J. Pulley Radwan
Journal of Law and Health
This article attempts to reconcile the competing purposes of the MDA, and to offer one alternative to effectuate Congress' purposes without preempting some claims and permitting others. First, this article will describe the arrangement of the MDA, including the classification provisions for medical devices and the preemption provision of the MDA. Next, this article will interpret the caselaw regarding preemption in general, and specifically preemption of state tort claims by the MDA. Finally, this article seeks to reconcile two competing purposes of Congress in enacting the MDA through implied preemption of state tort claims, with exceptions for devices which have …
Is Law The Prescription That Can Cure Medicine?, Samuel Gorovitz
Is Law The Prescription That Can Cure Medicine?, Samuel Gorovitz
Journal of Law and Health
Now medical care has been transformed. We recognize that the human organism is a complex interaction of many different systems-respiratory, circulatory, neurological, digestive, and so on. Some of them can fail and create both problems and opportunities we did not formerly have. One of the opportunities we now have is that we can keep people alive who in an earlier era would not have survived. And one of the problems we now have is also that we can keep people alive who in an earlier era would not have survived. Some of them are kept alive with such diminished capacity …
Rare Diseases, Drug Development And Aids: The Impact Of The Orphan Drug Act, Michael Henry Davis, Peter S. Arno, Karen Bonuck
Rare Diseases, Drug Development And Aids: The Impact Of The Orphan Drug Act, Michael Henry Davis, Peter S. Arno, Karen Bonuck
Law Faculty Articles and Essays
In this article, we examine the Orphan Drug Act with an eye toward its contribution to the public interest, using AIDS drugs to illustrate many of the central points. The major policy question is, How, if at all, can the act be used to meet the legislative goal of stimulating drug development for small patient populations without resulting in prices that make drugs inaccessible?
The Patentability And Patent Term Extension Of Lifesaving Drugs: A Deadly Mistake, Jonathan L. Mezrich
The Patentability And Patent Term Extension Of Lifesaving Drugs: A Deadly Mistake, Jonathan L. Mezrich
Journal of Law and Health
The pharmaceutical business is dominated largely by two types of entities: large, research-intensive corporations, and the smaller "generic" drug "knock-off" artists. because the former organizations have to put so much of their budget into research and development (R&D), a form of investment which is often akin to pouring money into a hole, the 17-year exclusive monopoly of a patient is often the only way such a company can remain profitable. However, because of a concern for public safety, all substances prepared for human consumption must be put through extensive testing by the FDA. This testing could take a long period …
Prescription Drugs And The Duty To Warn: An Argument For Patient Package Inserts, Alan R. Styles
Prescription Drugs And The Duty To Warn: An Argument For Patient Package Inserts, Alan R. Styles
Cleveland State Law Review
It has been more than ten years since the Food and Drug Administration proposed regulations which would have required detailed patient information for all prescription drugs. The proposed regulations, intended to promote the safe and effective use of prescription drugs, would have required a manufacturer to supply non-technical, non-promotional information, referred to as patient package inserts, directly to the patient. This note will analyze the need for patient information in satisfying the tort objectives of informed consent and public safety. The note will then analyze the practical effect of the learned intermediary and informed consent doctrines upon the manufacturer's and …
Accutane: Has Drug Regulation In The United States Reached Its Limits, Joan H. Krause
Accutane: Has Drug Regulation In The United States Reached Its Limits, Joan H. Krause
Journal of Law and Health
By a careful examination of the Accutane experience, both here and abroad, I will illustrate some of the shortcomings of the current American system of drug regulation. There are a number of ways in which this system fails to live up to the strict regulatory philosophy that it purports to follow; in particular, there are systematic inadequacies in the design of clinical trials, the official labeling received by drugs, and the manner in which adverse reaction reports are collected and assessed. Additionally, although the system often works well, there are natural limitations to a system of pre-approval testing; for some …
Mental Hospital Drugging - Atomistic And Structural Remedies, Sheldon Gelman
Mental Hospital Drugging - Atomistic And Structural Remedies, Sheldon Gelman
Law Faculty Articles and Essays
Thirty years have passed since the discovery of Thorazine, a neuroleptic drug, and the drugging of American state mental patients has become commonplace. Part I distinguishes between two approaches to remedy--"structural" and "atomistic"--and, as a basis for testing the two, describes a state hospital's handling of the most serious drug side effect. This account also provides a sense of the dimensions of the drugging problems in state hospitals. Part II explores a family of atomistic remedies. These would address drugging problems by seeking to ensure that state doctors are knowledgeable about drugs and/or reasonably careful in administering them. I reject …
Regulation Of Pharmaceutical Advertising, Anthony S. Zito Jr.
Regulation Of Pharmaceutical Advertising, Anthony S. Zito Jr.
Cleveland State Law Review
Federal trade commission regulation of pharmaceutical advertising is a subject of considerable current interest. The criteria for determining the acceptability of these advertisements are still evolving, and a definitive set of rules has not yet been fully articulated. Nevertheless certain trends are developing.' One of the major objectives of this paper is to predict the ultimate form of these rules.
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 …
Legal Aspects Of Drug Abuse, C. William O'Neill
Legal Aspects Of Drug Abuse, C. William O'Neill
Cleveland State Law Review
In discussing the existing drug laws in this country, it is useful to break them down into two categories: First, the Federal and state laws directed at marijuana and narcotics and, second, the Federal and state laws governing hallucinogenic drugs, such as LSD. Laws regulating and prohibiting the use of and traffic in the various drugs arose in response to public concern over their abuse. Federal regulation began with the Harrison Narcotic Drug Act of 1914, which was aimed at opium and other "hard" narcotics. In 1937 Congress enacted the Marijuana Tax Act, modeling it largely after the Harrison Act, …
The Doctor, The Patient, And The Fda, Herbert L. Ley Jr.
The Doctor, The Patient, And The Fda, Herbert L. Ley Jr.
Cleveland State Law Review
There have been considerable charges and counter-charges the United States Food and Drug Administration's role in protecting the consumer, at least as far as the medical profession is concerned. The FDA has absolutely no intention nor desire to assume the role of the physician or to interfere with the bona fide practice of medicine. Why the complaints by some the FDA's actions on drugs, including drug labelling, drug recall and the withdrawal of certain drugs from the market, constitute attempts to interfere with the practice of medicine? It is possible that one of the reasons, and perhaps the principal one, …
Investigational Drugs And The Law, George F. Archambault
Investigational Drugs And The Law, George F. Archambault
Cleveland State Law Review
Moving directly to the subject "Investigational Drugs and the Law" and being concerned primarily with preventative law, a topic not unlike preventative medicine, what is it that must be known as a lawyer in this specialty field in order to aid physicians and pharmacists involved in clinical research, in clinical pharmacology research, in hospital administration, and in nursing and pharmacy practices to keep them from legal pitfalls? It is necessary to tackle the subject in a two-pronged manner: (1) the federal and state statutes, and (2) case law.
Retail Druggist's Warranty Of Drugs, Thomas M. Schmitz
Retail Druggist's Warranty Of Drugs, Thomas M. Schmitz
Cleveland State Law Review
Jurisdictions retaining a contractual warranty theory hold that a retail druggist warrants the wholesomeness, fitness, and merchantability of his products. This warranty applies to all drugs whether they are prescription drugs, proprietary drugs ,brand name drugs, or drugs sold in the original sealed containers. Liability for the sale of a prescription drug may be exempted if the patient relies on the physician's judgment, and liability for the sale of a brand name drug may be relieved if there is reliance on the manufacturer's reputation. Jurisdictions construing product warranty as a strict liability in tort will invariably hold a retail druggist …
Due Care By Physicians In Use Of New Drugs, Edward T. Haggins
Due Care By Physicians In Use Of New Drugs, Edward T. Haggins
Cleveland State Law Review
How careful must a physician be in using new drugs on his patients? Before discussing these questions, we must look at three problems: (1) What role does the physician play in the new drug picture? (2) What are some of the new drugs and their side effects, and (3) What steps must a new drug go through before it is placed on the market for public consumption?
Food Additives: Legal Recognition Of A Scientific Problem, Robert E. S. Post
Food Additives: Legal Recognition Of A Scientific Problem, Robert E. S. Post
Cleveland State Law Review
Food additives could create one of the nicest legal problems that courts have ever had to face. We are not concerned with theories of negligence, warranty, privity, or statutory interpretation as it applies to any of these three concepts. The real problem is twofold: establishment of harm arising from the presence of an additive or additives; and establishment of a judicial policy to contemplate the fact that, if and when such harm does befall someone, it will happen in spite of the utmost good faith on the part of the manufacturer, and in the face of legislative and administrative authorization …
Food Additives Law And Practice, Milton Oppenheim
Food Additives Law And Practice, Milton Oppenheim
Cleveland State Law Review
A decision of the United States Supreme Court on Dec. 15, 1958, interpreting the Federal Food Drug & Cosmetic Act, has focused attention on the use of coloring and other materials in foods, drugs and cosmetics. This requires a complex study of the effects of the various food additives, contaminants and chemicals upon the individual, whether intentionally added or accidently produced, in foods, drugs and cosmetics. Evaluation of the tremendous group of food additives can best be approached in the light of the benefits intended by the manufacturer or grower using them.