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131.
Gilhooley M 《American journal of law & medicine》2011,37(2-3):258-277
This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures. Allergan, the maker of Botox, recently maintained in a lawsuit that the First Amendment permits drug companies to provide "truthful information" to doctors about "widely accepted" off-label uses of a drug. While the case was settled as part of a fraud and abuse case on other grounds, extending constitutional protections generally to "widely accepted" uses is not warranted, especially if it covers the use of a drug for a new purpose that needs more proof of efficacy, and that can involve substantial risks. A health law academic pointed out in an article examining a fraud and abuse case that off-label use of drugs is common, and that practitioners may lack adequate dosage information about the off-label uses. Drug companies may obtain approval of a drug for a narrow use, such as for a specific type of pain, but practitioners use the drug for similar uses based on their experience. The writer maintained that a controlled study may not be necessary to establish efficacy for an expanded use of a drug for pain. Even if this is the case, as discussed below in this paper, added safety risks may exist if the expansion covers a longer period of time and use by a wider number of patients. The protections for commercial speech should not be extended to allow manufacturers to distribute information about practitioner use with a disclosure about the lack of FDA approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies. The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important. 相似文献
132.
Margaret Stout 《Public administration review》2012,72(3):388-398
A growing number of public administration theorists are taking up the question of ontology—the nature of existence. This primer on the topic provides a basic explanation of ontology, describes the fundamental debates in the competing ontologies of Western philosophy, and discusses why ontology is important to social and political theory, as well as to public administration theory and practice. Using an ideal‐type approach, the author analyzes how different ontologies imply particular political forms that undergird public administration theories and practices. This ideal‐type model can be used to identify the ontological assumptions in these theories and practices. The article concludes with an invitation for personal reflection on the part of scholars and practitioners in regard to which ontology best fits their experience and beliefs and the alternatives that we might pursue for a better future. 相似文献
133.
Betsy Sinclair Margaret McConnell Donald P. Green 《American journal of political science》2012,56(4):1055-1069
Interpersonal communication presents a methodological challenge and a research opportunity for researchers involved in field experiments. The challenge is that communication among subjects blurs the line between treatment and control conditions. When treatment effects are transmitted from subject to subject, the stable unit treatment value assumption (SUTVA) is violated, and comparison of treatment and control outcomes may provide a biased assessment of the treatment’s causal influence. Social scientists are increasingly interested in the substantive phenomena that lead to SUTVA violations, such as communication in advance of an election. Experimental designs that gauge SUTVA violations provide useful insights into the extent and influence of interpersonal communication. This article illustrates the value of one such design, a multilevel experiment in which treatments are randomly assigned to individuals and varying proportions of their neighbors. After describing the theoretical and statistical underpinnings of this design, we apply it to a large‐scale voter‐mobilization experiment conducted in Chicago during a special election in 2009 using social‐pressure mailings that highlight individual electoral participation. We find some evidence of within‐household spillovers but no evidence of spillovers across households. We conclude by discussing how multilevel designs might be employed in other substantive domains, such as the study of deterrence and policy diffusion. 相似文献
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135.
Margaret E. Blume-Kohout 《The Journal of Technology Transfer》2016,41(6):1327-1353
Foreign-born workers have made significant and substantial contributions to economic productivity and new firm creation in the United States. This paper identifies predictors of entrepreneurial participation among foreign-born workers, combining nationally representative survey datasets covering the U.S. resident, college-educated workforce with country-of-origin macro statistics from the Global Entrepreneurship Monitor. Immigrants who come to the U.S. after earning university degrees abroad are more likely to own businesses than other college-educated, U.S. resident workers. However, much of their higher rate of business ownership can be attributed to differences in demographic characteristics, such as years of postgraduate work experience and marital status. By contrast, science and engineering-based business ownership is most common among immigrants who came to the U.S. to pursue higher education. Furthermore, after controlling for differences in human capital, U.S.-trained adult immigrants have higher propensity to own businesses than other foreign-born workers and native U.S. citizens, overall. U.S.-trained immigrants’ higher probability of business ownership is not explained by differences in human capital or other demographic characteristics, but does seem partly attributable to differences across foreign-born workers’ countries-of-origin. Specifically, adult immigrants and foreign temporary residents from countries that offer entrepreneurs lower levels of cultural support are more likely to start and own U.S. businesses. 相似文献
136.
137.
The business of bribery: Globalization, economic liberalization, and the “problem” of corruption 总被引:1,自引:0,他引:1
This paper is intended as a critical response to the emerging consensus within both academic and policy literatures that we are currently facing an epidemic of corruption which threatens to undermine the stability of economic and political development on both a national and global scale, and which requires both immediate and wide-ranging policy interventions. Based on a review of the publications and policy statements of the leading anti-corruption crusaders — namely the OECD, the IMF, and the World Bank — it will be argued that the recent concern with corruption is attributable, not to any substantive increase incorrupt practices, but rather, to the re-framing of corruption in light of broader shifts and transformations within the global economy. This revised version was published online in July 2006 with corrections to the Cover Date. 相似文献
138.
John Dewey has much to say to contemporary criminal justice educational strategies, particularly in respect to broadening
the curriculum to include exposure to the humanities, values exploration, and moral decision-making. The case study method,
coupled with Socratic teaching use of varied materials from the humanities, can approach an optimal learning experience within
the Dewayan model. This educational model is offered in response to the calls for sensitive, holistic criminal justice practitioners
in the modern age. 相似文献
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140.