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Lions and Tigers and Bears, Oh My or Redskins and Braves and Indians, Oh Why?: Ruminations on McBride v. Utah State Tax Commission, Political Correctness, and the Reasonable Person
Get PDFMy Brother\u27s Keeper? The Criminalization of Nonfeasance: A Constitutional Analysis of Duty to Report Statutes
Get PDFA Tale of Two Proteins
No full textIn this article we examine the Orphan Drug Act and one of the most important incentives it provides for the development of new drugs for rare diseases, a seven-year period of market exclusivity for new orphan drugs. The FDA has had difficulty interpreting the market exclusivity provisions of the Orphan Drug Act since its enactment. The continuing uncertainties about the scope of protection that the Act provides for innovative products threaten the basic purposes of the Act. The FDA\u27s recent interpretation of the Act raises numerous questions: Should market protection from the Orphan Drug Act depend on the physical and functional properties of the drug, or should the protection depend on the design of the clinical trial? Should there be a nexus between biochemical similarity and clinical superiority, or should a competing drug be brought to the market if its application to the FDA is based on a differently designed clinical trial? Should the market protection afforded by the Orphan Drug Act be commensurate with the effort required to bring the drug to the market? Should the market protection afforded by the Orphan Drug Act be analogous to the scope of patent protection? Finally, should the FDA provide clear rules, analogous to the FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, to assist orphan drug sponsors in their efforts to determine the non-comparability of two orphan drugs?
The article provides a brief overview of the Orphan Drug Act and its incentives for pharmaceutical research in general and the biotechnology industry in particular. The article also provides an introduction to the general scientific context of the problem of determining when two drugs are the same or different and the history of such Orphan Drug Act controversies. The article then uses the most recent major controversy under the Act, the approval of two variant forms of interferon-alpha (and the rejection of a third form) to examine several approaches to the problem of distinguishing similar biotechnology drugs. In particular, we suggest that rules similar to the FDA\u27s policies concerning generic drugs and the comparability of biological molecules from different manufacturing sources should be used to provide guidance under the Act. We also conclude that guidelines for non-comparability testing, particularly focused on bioavailability and bioequivalence, could significantly reduce the uncertainties which have continually plagued the FDA\u27s administration of the Orphan Drug Act and would bolster the Act\u27s incentives for innovative medical treatments for rare diseases
Human Rights: The Universalist Controversy. A Response to Are the Principles of Human Rights Western Ideas? An Analysis of the Claim of the Asian Concept of Human Rights From the Perspectives of Hinduism, by Dr. Surya P. Subedi.
Get PDFSocial and Legal Repercussions of Latinos\u27 Colonized Mentality
Get PDFThis essay begins by defining internalized oppression and racism and exposing the harms they cause. It dissects the reasons we engage in internalized racism and explains how once exposed, it will be easier to engage in a conscious effort to eradicate internalized racism. It will then describe how the intersectionality of internalized oppression and racism is expressed in the Latino community. The essay will then re-imagine Latino identity without internalized oppression and racism. It will include ideas on how to overcome internalized oppression and racism generally, both at the corporate and individual levels. The essay concludes that exposing internalized oppression and racism is the first step to alleviating the harm that results from a negative self-perception, which must be followed by the active construction of positive self-images. This, in turn, will lead not only to less support for racist and discriminatory legislation but to a more active and united denouncement of racist lawmaking. The final step is to engage in pro-active agenda setting and campaigns to capitalize on a newly-forged, positive identity
Not Quite Grown Up: The Difficulty of Applying an Adult Education Model to Legal Externs
Get PDFUsing andragogical theory developed by Malcolm Knowles as a foundation as well as a counterpoint, this article presents a new framework for teaching clinic students. Frustrated by tensions they encountered in teaching students whom they expected to have all the qualities of “adult learners,” the authors developed a new theory that blends humanistic as well as developmental theory. The article describes this new theory and evaluates why it works in clinical teaching
