Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals

Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals PDF

Author: Steven Garber

Publisher: Rand Corporation

Published: 2013

Total Pages: 117

ISBN-13: 0833079913

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Liability effects on the economic performance of the pharmaceutical industry play a prominent role in the debate about the economic effects of product liability in the United States. The author analyzes incentive effects on company decisions, implications for economic outcomes such as drug safety and effectiveness, and suggests how public policy changes could mitigate liability-based sources of inefficient decisions of pharmaceutical companies.

Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals

Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals PDF

Author: Steven Garber

Publisher: Rand Corporation

Published: 2013-02-15

Total Pages: 217

ISBN-13: 0833079891

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Liability effects on the economic performance of the pharmaceutical industry play a prominent role in the debate about the economic effects of product liability in the United States. The author analyzes incentive effects on company decisions, implications for economic outcomes such as drug safety and effectiveness, and suggests how public policy changes could mitigate liability-based sources of inefficient decisions of pharmaceutical companies.

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

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

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.

Product Liability Entering the Twenty-First Century

Product Liability Entering the Twenty-First Century PDF

Author: Michael J. Moore

Publisher: Brookings Institution Press

Published: 2004-05-13

Total Pages: 54

ISBN-13: 0815798792

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Are liability "crises" an inevitable part of the modern industrial landscape? Does the inherent nature of the insurance industry promote recurring liability crises? What have been the effects of the liability reforms of the 1990s? Should lawyers be given de facto regulatory authority? This report provides perspective on these and other key issues concerning the law and economics of products liability. The authors begins with a brief description of the evolution of products liability doctrine in the U.S., up to the point of the liability crisis of the late 1980s. They discuss the economic implications of product risk for both consumers and producers, offer economic hypothesis on the implications of the increased scope of liability and subsequent reforms, and provide an update of trends in litigation and liability law. The book ends with a discussion of pending legislation and prospects for further improvements. Moore and Viscusi make the point that effective liability policy calls for a balancing of the incentives for improved public safety on one hand, and the benefits of new and existing products on the other.

Regulation Versus Litigation

Regulation Versus Litigation PDF

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.

New Medical Devices

New Medical Devices PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1988-01-01

Total Pages: 203

ISBN-13: 0309038472

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In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.

Pharmaceutical R&D

Pharmaceutical R&D PDF

Author:

Publisher: DIANE Publishing

Published: 1993

Total Pages: 380

ISBN-13: 9780788104688

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Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.

Research and Development in the Pharmaceutical Industry (A CBO Study)

Research and Development in the Pharmaceutical Industry (A CBO Study) PDF

Author: Congressional Budget Office

Publisher: Lulu.com

Published: 2013-06-09

Total Pages: 65

ISBN-13: 1304121445

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Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...