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Articles 1 - 4 of 4
Full-Text Articles in Law
The Informational And Institutional Theories Of Off-Label Promotion, Miguel A. Lopez
The Informational And Institutional Theories Of Off-Label Promotion, Miguel A. Lopez
San Diego Law Review
This Article contends that there are two distinct theories of the offense of off-label promotion—the informational theory and the institutional theory. One is concerned with controlling the flow of medical knowledge and the other is concerned with protecting regulatory legitimacy. Different kinds of evidence are key under each theory. I argue that although the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its accompanying regulations emphasize the informational theory, federal prosecutors rely more heavily on the legal arguments that underpin the institutional theory of enforcement. A corollary to this contention is that the informational theory of off-label promotion does …
Pliva Shields Big Pharma From Billions, Cuts Consumers' Rights, Dana Taschner
Pliva Shields Big Pharma From Billions, Cuts Consumers' Rights, Dana Taschner
San Diego Law Review
This Article explores the emergence of the LRA test, as well as its dangers, and explains how an equivalent norm underlies recent monopolization cases. The Author concludes that the law should not require business practices to maximize social welfare to pass muster under the antitrust laws. As tools of public policy directed at unilateral market behavior, antitrust and regulation have long played distinct, though complementary, roles. Natural-monopoly regulation has as its immodest goal the maximization of consumer welfare by simultaneously imposing universal service obligations and spurring the efficiencies associated with competition through the imposition of various behavioral constraints. That such …
The Ftca, Veterans, And Future Medical Expenses, R. J. Pinto
The Ftca, Veterans, And Future Medical Expenses, R. J. Pinto
San Diego Law Review
In this comment the author aims to expose the jurisprudential flaws in a particular area of the law and advocate, as his prescription a refocused jurisprudence. Part II describes how courts have historically come to the conclusion that veterans suing under the FTCA should be awarded future medical expenses despite their entitlement to VA medical care. Part III address a threshold issue: the extent to which courts using this framework have overcompensated veterans. Part IV addresses why overcompensating veterans under the FTCA matters on a policy level. Part V exposes the problems with the court's jurisprudence and provides a solution …
Age Of An Information Revolution: The Direct-To-Consumer Genetic Testing Industry And The Need For A Holistic Regulatory Approach, Michelle D. Irick
Age Of An Information Revolution: The Direct-To-Consumer Genetic Testing Industry And The Need For A Holistic Regulatory Approach, Michelle D. Irick
San Diego Law Review
In order to safeguard consumers and ensure the continued progress of a fledgling industry, determining how to interpret results and communicate them with consumers poses one of the most challenging and important tasks. In discussing the challenges the law faces in this area, this Comment will discuss: (1) consumer interfacing issues, such as in advertising and results analysis, faced by the genetic testing industry; (2) the methods DTC companies use in arriving at results and corresponding problems; (3) who may interpret and communicate results; (4) how the DTC genetic testing industry's activities relate to the claims made regarding test results; …