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Full-Text Articles in Law
The Stifling Of Competition By The Antitrust Laws: The Irony Of The Health Care Industry, John A. Powers
The Stifling Of Competition By The Antitrust Laws: The Irony Of The Health Care Industry, John A. Powers
Journal of Law and Health
The text to follow is intended to provide an overview of the legal basis for the imbalance of power currently inherent to the health care industry, suggesting several reasons for its development. It also provides an outline of the current basis for antitrust liability in this country and describes some possible solutions. The most practical and effective means through which to rectify this imbalance would be to enact new federal legislation that would amend the antitrust laws to allow for limited "unionization" of independently practicing physicians for collective bargaining purposes.
Lessons Taught By Miss Evers' Boys: The Inadequacy Of Benevolence And The Need For Legal Protection Of Human Subjects In Medical Research , Donald H.J. Hermann
Lessons Taught By Miss Evers' Boys: The Inadequacy Of Benevolence And The Need For Legal Protection Of Human Subjects In Medical Research , Donald H.J. Hermann
Journal of Law and Health
The Tuskegee study is perhaps the most notorious example of abuse in medical research in the United States. It is significant that the project was not ended until twenty-five years after the adoption of the Nuremberg Code of 1948, the first article of which establishes its principle that human subjects should not be experimented on without their consent. Continuing concern about the ethics of medical and scientific research have been fueled by finding about other research abuse such as the radiation experiments in the 1940's and 1950's that involved subjects being injected with plutonium without their knowledge and feeding radioactive …
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 …
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 …
Consumer-Directed Prescription Drug Advertising: Effects On Public Health , William E. Holtz
Consumer-Directed Prescription Drug Advertising: Effects On Public Health , William E. Holtz
Journal of Law and Health
This Paper will evaluate the effectiveness of the current FDA regulatory scheme regarding consumer-directed prescription drug advertising. Part II discusses the relevant history of consumer-directed prescription drug advertising of prescription drugs which is a relatively new practice in the United States. Possible explanations are reviewed for why the change in focus from physicians to consumers as the targets of such advertising has occurred. Part III explains the major classifications of consumer-directed advertising that the FDA has categorized and examines the differences existing among them. Part IV focuses on the current FDA regulatory scheme and begins to expose some of the …
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 …
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.
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 …
Medical Device Technology: Does Federal Regulation Of This New Frontier Preempt The Consumer's State Common Law Claims Arising From Injuries Related To Defective Medical Devices?, Susan M. Mesner
Journal of Law and Health
The purpose of this paper is to explore the relationship between federal medical device regulation and state common law tort actions. Specifically, the issue to be addressed is whether the Medical Devices Act and regulations promulgated thereunder preempt state law damage actions brought by injured consumers against device manufacturers. An analysis of the preemptive provision of the Medical Devices Act and case law construing this provision is set forth below. The United States Supreme Court's recent preemption analysis in Cipollone v. Liggett Group, Inc. will be used as a guide in establishing a useful method for determining whether state tort …
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 …
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 …
Assessment Of Carcinogenic Risk And The Delaney Clause: The Search For A Better Standard, Mark A. Cleaves
Assessment Of Carcinogenic Risk And The Delaney Clause: The Search For A Better Standard, Mark A. Cleaves
Journal of Law and Health
This article will focus upon the legislative history and subsequent case law dealing with the Delaney Clause and it will include the rationale and limitations of the provision. In order to regulate carcinogens one must have a clear understanding of the cancer processes. Therefore a brief discussion of the biological parameters involved is warranted. The purpose of this discussion is to find a more rational alternative to the Delaney Clause. The use of quantitative risk assessment as an approach to regulate carcinogens found in food is also discussed. By combining the purposes of the original (and current statutory provisions with …