Pharmaceutical Economics and Policy / Edition 2

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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.

The book contains black-and-white illustrations.

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Editorial Reviews

Doody's Review Service
Reviewer: Albert I Wertheimer, BS, MBA, PhD (Temple University School of Pharmacy)
Description: This is a wonderfully comprehensive examination of the internal and external economic forces affecting the pharmaceutical industry. It includes the biotechnology, generic, and international sectors and provides thorough reviews on the impact of regulations, price controls, patents, and marketing policies. This second edition is up-to-date and complete.
Purpose: The pharmaceutical sector is essential in all healthcare systems and yet most studies or reports only deal with selected topics or questions. This book reviews the entire industry and its components. It is useful for students in pharmacy, medicine, public health, health administration, and economics as well as for health planners, regulators, and those working in health policy. The book is much needed as there are few places where one can find a thorough, organized, and integrated treatise on this topic. The book even has a section on complementary and alternative medicines and a look into the future for pharmaceuticals and health policy. The author has succeeded in providing a one-stop resource for information about the economic and regulatory environment facing the pharmaceutical industry.
Audience: The author suggests that the book should be useful for students in related fields as well as for persons working in these areas. The book is useful in pharmaceutical marketing, public relations, lobbying, for persons preparing lectures, and persons in the various regulatory agencies. The information is accurate, objective, and current and is presented with appropriate perspective. It is very useful for anyone involved in the pharmaceutical realm.
Features: One may find fine information on the approval of new drugs, their marketing, price controls, the use of patents, pricing, and most aspects of the conduct of the industry in these areas. What is best about the book is its comprehensiveness. It covers topics little written about, such as nongovernmental price regulations, timing information about government approvals, and detailed data about alternative medicines, and a superb interpretation of the conduct of the marketplace in the U.S. and abroad. A more detailed index would be the only thing I would suggest if there is to be a third edition.
Assessment: This is a welcome addition to the market. It is extremely well organized and written and has precise information. The listed citations are abundant enough to enable the serious student to locate further information.
Daniel E. Hilleman
This book is the first in-depth evaluation of the economics of the U.S. and world-wide pharmaceutical industry in more than 25 years. It evaluates the pharmaceutical industry, marketing strategies of the pharmaceutical industry, the demand for pharmaceuticals, the pharmaceutical market, and interventions in the pharmaceutical market, including regulation, patient protection, new drug evaluation, and future health policy. The purpose is to explore conflicting priorities and aims of the pharmaceutical industry. This text, using an economic framework, examines the supply and demand sides of the pharmaceutical market as well as policies that attempt to alter market performance. The audience for this book is broad and will include healthcare professionals and students interested in health economics, health administration, pharmacy administration, and public policy. In addition, individuals working for healthcare regulatory agencies, pharmaceutical industry, health delivery organizations and healthcare insurance providers will find this information valuable. Highlights of the text include an in-depth discussion of pharmaceutical industry research and development practices, pharmaceutical marketing strategies, pharmaceutical pricing strategies, and patient protection issues. This book represents a worthwhile effort in discussing the economics and market forces that shape the pharmaceutical industry in the U.S. and abroad. Although some of the chapters appear to be disjointed from others, each contains useful and relevant information. The discussion of foreign regulatory affairs, foreign drug development, and pharmacoeconomic evaluations of new drugs tend to be less in-depth than otherissues. The book may have faired better if the global perspective were eliminated. Given these relatively minor detractions, the text is a welcome addition to those readers who deal with the pharmaceutical industrial and public policy issues.

2 Stars from Doody
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Product Details

  • ISBN-13: 9780195300956
  • Publisher: Oxford University Press
  • Publication date: 11/2/2006
  • Edition description: REV
  • Edition number: 2
  • Pages: 352
  • Product dimensions: 9.30 (w) x 6.20 (h) x 0.50 (d)

Meet the Author

Stuart O. Schweitzer, Ph.D., is Professor of Health Services at the UCLA School of Public Health. His research in health economics deals primarily with the application of new technology to health care. Dr. Schweitzer is a frequent consultant to health organizations both in the U.S. and abroad.

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Table of Contents

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 New Paradigm of Genetically-targeted Drugs

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