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The Effects of Product Liability Exemption in the Presence of the FDA

Author: Tomas J. Philipson

Publisher:

Published: 2009

Total Pages: 31

ISBN-13:

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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.

Book Synopsis The Effects of Product Liability Exemption in the Presence of the FDA by : Tomas J. Philipson

Download or read book The Effects of Product Liability Exemption in the Presence of the FDA written by Tomas J. Philipson and published by . This book was released on 2009 with total page 31 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Regulation Versus Litigation

Author: Daniel P. Kessler

Publisher: University of Chicago Press

Published: 2011-02

Total Pages: 344

ISBN-13: 0226432181

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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.

Book Synopsis Regulation Versus Litigation by : Daniel P. Kessler

Download or read book Regulation Versus Litigation written by Daniel P. Kessler and published by University of Chicago Press. This book was released on 2011-02 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Oxford Handbook of the Economics of the Biopharmaceutical Industry

Author: Patricia M. Danzon

Publisher: OUP USA

Published: 2012-04-24

Total Pages: 618

ISBN-13: 0199742995

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This volume examines the economics of the biopharmaceutical industry, with eighteen chapters by health economists.

Book Synopsis The Oxford Handbook of the Economics of the Biopharmaceutical Industry by : Patricia M. Danzon

Download or read book The Oxford Handbook of the Economics of the Biopharmaceutical Industry written by Patricia M. Danzon and published by OUP USA. This book was released on 2012-04-24 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume examines the economics of the biopharmaceutical industry, with eighteen chapters by health economists.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

Author: The Law The Law Library

Publisher: Createspace Independent Publishing Platform

Published: 2018-09-23

Total Pages: 412

ISBN-13: 9781727572667

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Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce. This book contains: - The complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

Book Synopsis Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) by : The Law The Law Library

Download or read book Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) written by The Law The Law Library and published by Createspace Independent Publishing Platform. This book was released on 2018-09-23 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce. This book contains: - The complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

Handbook of the Economics of Risk and Uncertainty

Author: Mark Machina

Publisher: Newnes

Published: 2013-11-14

Total Pages: 897

ISBN-13: 0444536868

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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

Book Synopsis Handbook of the Economics of Risk and Uncertainty by : Mark Machina

Download or read book Handbook of the Economics of Risk and Uncertainty written by Mark Machina and published by Newnes. This book was released on 2013-11-14 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Dietary Supplements

Author: United States. Federal Trade Commission. Bureau of Consumer Protection

Publisher:

Published: 1998

Total Pages: 32

ISBN-13:

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Book Synopsis Dietary Supplements by : United States. Federal Trade Commission. Bureau of Consumer Protection

Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Vending of Food and Beverages

Author: United States. Public Health Service. Division of Environmental Engineering and Food Protection

Publisher:

Published: 1965

Total Pages: 32

ISBN-13:

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Recommendations developed by the Public Health Service in cooperation with state and communities, interested federal agencies and the vending machine industry, 1965.

Book Synopsis The Vending of Food and Beverages by : United States. Public Health Service. Division of Environmental Engineering and Food Protection

Download or read book The Vending of Food and Beverages written by United States. Public Health Service. Division of Environmental Engineering and Food Protection and published by . This book was released on 1965 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recommendations developed by the Public Health Service in cooperation with state and communities, interested federal agencies and the vending machine industry, 1965.

NBER Reporter

Author: National Bureau of Economic Research

Publisher:

Published: 2008

Total Pages: 340

ISBN-13:

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Book Synopsis NBER Reporter by : National Bureau of Economic Research

Download or read book NBER Reporter written by National Bureau of Economic Research and published by . This book was released on 2008 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Devices and the Public's Health

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-10-25

Total Pages: 318

ISBN-13: 0309212456

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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.

Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Asbestos Bankruptcy Trusts

Author: Lloyd S. Dixon

Publisher: RAND Corporation

Published: 2010

Total Pages: 220

ISBN-13:

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This report describes the creation, organization, and operation of asbestos personal-injury trusts and compiles publicly available information on the assets, outlays, and governing boards of the 26 largest trusts. The authors find that the publicly available information provides a rich source of information on trust activity but that more detailed information is needed to determine their impact on important compensation outcomes.

Book Synopsis Asbestos Bankruptcy Trusts by : Lloyd S. Dixon

Download or read book Asbestos Bankruptcy Trusts written by Lloyd S. Dixon and published by RAND Corporation. This book was released on 2010 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report describes the creation, organization, and operation of asbestos personal-injury trusts and compiles publicly available information on the assets, outlays, and governing boards of the 26 largest trusts. The authors find that the publicly available information provides a rich source of information on trust activity but that more detailed information is needed to determine their impact on important compensation outcomes.