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Articles 31 - 36 of 36
Full-Text Articles in Food and Drug Law
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 …
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 …