The Effects of Product Liability Exemption in the Presence of the FDA PDF Download
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Author: Tomas J. Philipson
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 31
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Book Description
The NBER Bulletin on Aging and Health provides summaries of publications like this. You can sign up to receive the NBER Bulletin on Aging and Health by email. In the United States, drugs are jointly regulated by the US Food and Drug Administration, which oversees premarket clinical trials designed to ensure drug safety and efficacy, and the liability system, which allows patients to sue manufacturers for unsafe drugs. In this paper, we examine the potential welfare effects of this dual system to ensure the safety of medical products, and conclude that product liability exemptions for FDA regulated activities could raise economic efficiency. When the safety level mandated by the FDA is binding-in the sense that manufacturers will not conduct additional clinical testing beyond what is mandated by FDA-then product liability may reduce efficiency by raising prices without pushing firms, who are already bound by the FDA's requirements, to invest further in product safety. We consider as a case study the National Vaccine Injury Compensation Program, which sharply reduced vaccine manufacturer's liability in 1988. We find evidence that the program reduced prices without affecting vaccine safety, suggest that liability limits can enhance economic efficiency in the presence of the FDA.
Author: Tomas J. Philipson
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 31
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Book Description
The NBER Bulletin on Aging and Health provides summaries of publications like this. You can sign up to receive the NBER Bulletin on Aging and Health by email. In the United States, drugs are jointly regulated by the US Food and Drug Administration, which oversees premarket clinical trials designed to ensure drug safety and efficacy, and the liability system, which allows patients to sue manufacturers for unsafe drugs. In this paper, we examine the potential welfare effects of this dual system to ensure the safety of medical products, and conclude that product liability exemptions for FDA regulated activities could raise economic efficiency. When the safety level mandated by the FDA is binding-in the sense that manufacturers will not conduct additional clinical testing beyond what is mandated by FDA-then product liability may reduce efficiency by raising prices without pushing firms, who are already bound by the FDA's requirements, to invest further in product safety. We consider as a case study the National Vaccine Injury Compensation Program, which sharply reduced vaccine manufacturer's liability in 1988. We find evidence that the program reduced prices without affecting vaccine safety, suggest that liability limits can enhance economic efficiency in the presence of the FDA.
Author: Thomas J. Philipson
Publisher:
ISBN:
Category :
Languages : en
Pages : 31
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Book Description
Author: Daniel P. Kessler
Publisher: University of Chicago Press
ISBN: 0226432181
Category : Business & Economics
Languages : en
Pages : 344
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Book Description
The efficacy of various political institutions is the subject of intense debate between proponents of broad legislative standards enforced through litigation and those who prefer regulation by administrative agencies. This book explores the trade-offs between litigation and regulation, the circumstances in which one approach may outperform the other, and the principles that affect the choice between addressing particular economic activities with one system or the other. Combining theoretical analysis with empirical investigation in a range of industries, including public health, financial markets, medical care, and workplace safety, Regulation versus Litigation sheds light on the costs and benefits of two important instruments of economic policy.
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
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Book Description
Author: Patricia M. Danzon
Publisher: OUP USA
ISBN: 0199742995
Category : Business & Economics
Languages : en
Pages : 618
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Book Description
This volume examines the economics of the biopharmaceutical industry, with eighteen chapters by health economists.
Author: Mark Machina
Publisher: Newnes
ISBN: 0444536868
Category : Business & Economics
Languages : en
Pages : 897
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Book Description
The need to understand the theories and applications of economic and finance risk has been clear to everyone since the financial crisis, and this collection of original essays proffers broad, high-level explanations of risk and uncertainty. The economics of risk and uncertainty is unlike most branches of economics in spanning from the individual decision-maker to the market (and indeed, social decisions), and ranging from purely theoretical analysis through individual experimentation, empirical analysis, and applied and policy decisions. It also has close and sometimes conflicting relationships with theoretical and applied statistics, and psychology. The aim of this volume is to provide an overview of diverse aspects of this field, ranging from classical and foundational work through current developments. Presents coherent summaries of risk and uncertainty that inform major areas in economics and finance Divides coverage between theoretical, empirical, and experimental findings Makes the economics of risk and uncertainty accessible to scholars in fields outside economics
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309184134
Category : Medical
Languages : en
Pages : 158
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Book Description
The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Author:
Publisher:
ISBN:
Category : Food
Languages : en
Pages : 72
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Book Description
Author: Ajay Agrawal
Publisher: University of Chicago Press
ISBN: 0226833127
Category : Business & Economics
Languages : en
Pages : 172
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Book Description
A timely investigation of the potential economic effects, both realized and unrealized, of artificial intelligence within the United States healthcare system. In sweeping conversations about the impact of artificial intelligence on many sectors of the economy, healthcare has received relatively little attention. Yet it seems unlikely that an industry that represents nearly one-fifth of the economy could escape the efficiency and cost-driven disruptions of AI. The Economics of Artificial Intelligence: Health Care Challenges brings together contributions from health economists, physicians, philosophers, and scholars in law, public health, and machine learning to identify the primary barriers to entry of AI in the healthcare sector. Across original papers and in wide-ranging responses, the contributors analyze barriers of four types: incentives, management, data availability, and regulation. They also suggest that AI has the potential to improve outcomes and lower costs. Understanding both the benefits of and barriers to AI adoption is essential for designing policies that will affect the evolution of the healthcare system.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318
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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
