Pharmaceutical Economics and Policy / Edition 2

Pharmaceutical Economics and Policy / Edition 2

by Stuart O. Schweitzer
     
 

The pharmaceutical industry is praised as a world leader in high technology innovation and the creator of products that increase both longevity and quality of life for people throughout the world. At the same time, the industry is also criticized for its marketing and pricing practices and for its apparent anticompetitive responses to generic competition. Even its

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Overview

The pharmaceutical industry is praised as a world leader in high technology innovation and the creator of products that increase both longevity and quality of life for people throughout the world. At the same time, the industry is also criticized for its marketing and pricing practices and for its apparent anticompetitive responses to generic competition. Even its research and development priorities are criticized as being too closely driven by the goal of maximizing shareholder value, rather than the health of the public. Unfortunately, many of the critics of the industry fail to understand the complexities of the industry and its role in the nations healthcare system. This book uses the tools of economic analysis to explore the conflicting priorities and aims of the pharmaceutical industry, from both an American and worldwide perspective. This is the second edition of a uniquely comprehensive and balanced discussion of pharmaceutical policy issues. All the chapters of the former edition have been fully re-written and extensively updated. In addition, the book includes six new chapters on emerging topics such as the broadened role of FDA regulations and the increasing diversity of the industry. An entire chapter is devoted to the biotechnology industry and one to alternative medicines, often called "nutraceuticals." Another new chapter discusses segments of the industry that specialize in particular activities including generic drugs and drug delivery systems. The recent controversial expansion of Medicare to cover outpatient drugs is discussed in depth. The introduction is also updated to address the volatile pace of pharmaceutical innovation and how the pharmaceutical industry has responded to the emergence of managed care.

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Product Details

ISBN-13:
9780195300956
Publisher:
Oxford University Press
Publication date:
11/02/2006
Edition description:
REV
Pages:
352
Sales rank:
955,539
Product dimensions:
9.30(w) x 6.20(h) x 0.50(d)

Table of Contents

Introduction
The Volatile Pace of Pharmaceutical Innovation
The Pharmaceutical Industry Responds to the Health Care Revolution of Managed Care
Increased Role for Consumers in Decision-making
II. The Industry
1. Pharmaceutical Industry Research and Development
Concentration Among Pharmaceutical Manufacturers
Recent Mergers. Are There Economies of Scale?
Pharmaceutical R&D and Prices
Preclinical Pharmaceutical Development
Clinical Pharmaceutical Development
Product Liability
Strategic Decisions on Research Programs: Blockbuster, Me-too, or Market Segmentation?
The Supply Chain and Drug Safety
2. The Biotechnology Industry
How Does the Biotechnology Industry Differ from the Pharmaceutical Industry?
How Does a Biotech Firm Differ from a Traditional Pharmaceutical Firm?
The Life-cycle of a Biotechnology Firm
3. Other Firms in the Pharmaceutical Industry
Drug Delivery Firms
Processing Firms Isomer Filtering
Generic Firms
4. Marketing Pharmaceuticals
Types of Promotion
Does it Work?
False and Misleading Claims
Marketing in an Era of Managed Care
Direct-to-Consumer Advertising: Challenges to Society
Over-the-Counter Drugs
Joint Marketing
Pharmacy Benefit Managers (PBMs)
Disease Management
New Roles for the FDA in Marketing
III. The Consumer
5. The Demand For Pharmaceuticals
How is Demand Determined?
The Changing Structure of the Pharmaceutical Market
Quality of Life drugs Viagra, Propecia, Obesity
IV. The Market
6. Pharmaceutical Prices
The Problem of Pharmaceutical Prices
Pharmaceutical Prices Over Time
Measuring Drug Prices
How are Drug Prices Determined?
The Cost Structure of Pharmaceutical Firms
Is the Pharmaceutical Industry Monopolistic?
How Drug Quality Influences Prices
7. The Worldwide Market for Pharmaceuticals
Geographic Patterns of Pharmaceutical Production and Sales
Pharmaceutical Research and Development: An International View
Worldwide Manufacturing and Sales
Improving Access to Appropriate Drugs in Developing Countries
The Effect of the World Trade Organization Treaty
8. Pricing Pharmaceuticals in a World Environment
Geographic Patterns of Pharmaceutical Production and Sales
Pharmaceutical Research and Development: An International View
Worldwide Manufacturing and Sales
Improving Access to Appropriate Drugs in Developing countries
The Effect of the World Trade Organization Treaty
9. The Timing of Drug Approvals in the United States and Aborad
The Timing of Pharmaceutical Approvals and Health Policy
The Drug Approval Process in the United States
Recent Initiatives to Expedite Drug Approvals
Is There a U.S. Drug Lag?
The Darker Side of Speedier Drug Approvals: Drug Recalls
V. Intervention in the Pharmaceutical Market: Public and Private
10. Pharmaceutical Regulation and Cost Containment-The Public Sector
The Broadening of the FDAs
The FDA Modernization Act
The FDA User Fee Act
Drug Cost Containment Programs in the Public Sector
Expanding Medicare to Cover Outpatient Drugs
11. Pharmaceutical Regulation and Cost Containment-The Private Sector
Bringing Market Incentives into Managed Care
12. Drug Regulation in Europe: The Birth of EMEA
13. Patent Protection
Patent Law
Patentability and Patent Categories
How Patents are Obtained
What Protection Does a Patent Confer?
Duration of Patent Protection
Infringement of Patents
International Patent Treaties
Patent Procedure Under International Conventions
Alternatives to Traditional Patent Policy
Patents and Societal Choice
Abuses of the Patent System
14. Evaluating New Drugs
Optimizing Production of Health
Cost-benefit Analysis
Cost-effectiveness Analysis
Cost-utility Analysis
Policy Applications
Interpretation and Misinterpretation of Cost-effectiveness Analysis
15. Alternative Drugs-Nutraceuticals
Regulation of Supplements, Food Additives, and Medicinal Foods
16. Pharmaceutical and Health Policy: A Look Ahead
The Structure of the Pharmaceutical Industry
Health System Reform
Drug Prices
Patent Protection
Drug Approvals
Managed Care and Restricted Access to Pharmaceuticals
The FDA
The New Paradigm of Genetically-targeted Drugs
Conclusion

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