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![Pharmaceutical Economics and Policy](http://img.images-bn.com/static/redesign/srcs/images/grey-box.png?v11.9.4)
Pharmaceutical Economics and Policy
by Stuart O. Schweitzer
Stuart O. Schweitzer
![Pharmaceutical Economics and Policy](http://img.images-bn.com/static/redesign/srcs/images/grey-box.png?v11.9.4)
Pharmaceutical Economics and Policy
by Stuart O. Schweitzer
Stuart O. Schweitzer
eBook2 (2)
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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.
Product Details
ISBN-13: | 9780190293796 |
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Publisher: | Oxford University Press |
Publication date: | 11/02/2006 |
Sold by: | Barnes & Noble |
Format: | eBook |
File size: | 3 MB |
About 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.
Table of Contents
Introduction 3
The Supply of Pharmaceuticals 5
The Demand for Pharmaceuticals 7
Pharmaceutical Prices 8
The Multinational Pharmaceutical Industry 11
International Price Comparisons 12
Timing of Pharmaceutical Approvals 12
Government Intervention in the Pharmaceutical Sector 13
The Industry
The Pharmaceutical Industry 21
Pharmaceutical Research and Development 22
The Competitive Structure of the Pharmaceutical Industry 23
Pharmaceutical Research and Development and Prices 27
The Pharmaceutical Research Process 29
Product Liability 38
Conclusions 40
The Biotechnology Industry 44
Background 44
Product Development in the Biotechnology Industry 47
The Natural History of Biotechnology Firms 48
Case Studies of Alliances 53
Regulation 55
Case Studies of Biotechnology Firm Growth 57
Conclusions 60
Other Firms in the Pharmaceutical Industry 63
Generic Drugs and Their Manufacturers 63
Outsourcing Firms 68
Conclusions 78
Marketing Pharmaceuticals 82
Size of Marketing Effort 85
Does It Work? 85
Types of Promotion 87
Disguising Marketing as Research 93
Marketing in an Era of Managed Care 94
Pharmacy Benefit Managers 95
Direct-to-Consumer Advertising 97
Over-the-Counter Drugs 100
Joint Marketing 103
Disease Management 103
Roles of the U.S. Food and Drug Administration in Marketing 104
False and Misleading Claims 105
The Consumer
The Demand for Pharmaceuticals 115
How Is Demand Determined? 116
The Changing Structure of the Pharmaceutical Market 117
Conclusions 131
The Market
Pharmaceutical Prices 137
The Problem of Pharmaceutical Prices 138
Pharmaceutical Prices over Time 139
Measuring Drug Prices 141
How Are Drug Prices Determined? 143
Cost Structure of Pharmaceutical Firms 144
Is the Pharmaceutical Industry Monopolistic? 149
How Drug Quality Influences Price 153
The Worldwide Market for Pharmaceuticals 157
Geographic Patterns of Pharmaceutical Production and Sales 158
Pharmaceutical Research and Development: An International View 159
Does Government Drug Price Setting Influence R&D? 166
Worldwide Manufacturing and Sales 167
Access to Appropriate Drugs in Developing Countries 170
Effect of the World Trade Organization Treaty 173
Pricing Pharmaceuticals in a World Environment 177
Why Do Drug Prices Vary Across Country? 178
Comparisons of International Drug Prices 180
How Do We Measure Drug Prices across Countries? 184
Why Drug Price Differences Persist 186
Policy Implications 186
The Timing of Drug Approvals in the United States and Abroad 191
The Timing of Pharmaceutical Approvals and Health Policy 192
The Drug Approval Process in the United States 193
Recent Initiatives to Expedite Drug Approvals 198
Is There a U.S. Drug Lag? 199
Intervention in the Pharmaceutical Market: Public and Private
Pharmaceutical Regulation and Cost Containment by the Public Sector 209
Evolution of the U.S. Food and Drug Administration 2110
Medicaid 211
State Cost-Containment Efforts 213
Medicare 214
Regulation by the Private Sector 222
Cost-Containment Mechanisms 222
Cost Containment in Managed Care 230
Pharmaceutical Regulation in Europe 238
The Pharmaceutical Industry in Europe 238
History of Regulation in Europe 239
Move Toward a Single Market 240
Structure and Role of the European Medicines Evaluation Agency 240
Drug Review under the European Medicines Evaluation Agency 241
Current Regulatory Structure 242
The Centralized Procedure for Marketing Authorization 243
The Mutual-Recognition Procedure 245
Performance of Europe's Centralized Drug Approval 246
Rules on Labeling of Medicinal Products 247
Advertising Regulations 248
Pharmacovigilance 248
Generic Drugs 249
Patent Protection 252
Patent Law 253
Patentability and Patent Categories 254
How Are Patents Obtained? 255
What Protection Does a Patent Confer? 256
Duration of Patent Protection 256
Infringement of Patents 258
International Patent Treaties 258
Patent Procedures under International Conventions 260
Shortcomings of the Patent System 260
Patents and Societal Choice 261
Social Benefits of the Patent System 261
Evaluating New Drugs 263
Optimizing Production of Health 263
Cost-Benefit Analysis 266
Cost-Effectiveness Analysis 270
Cost-Utility Analysis 272
Policy Applications 274
Interpretation and Misinterpretation of Cost-Effectiveness Studies 277
Complementary and Alternative Medicines 280
Who Uses Complementary and Alternative Medicines? 282
Manufacturers and Distributors of Complementary and Alternative Medicines 282
Dietary Supplements 283
Food Additives 293
Medical Foods 296
Concluding Remarks on Complementary and Alternative Medicines 300
Pharmaceuticals and Health Policy: A Look Ahead 304
Structure of the Pharmaceutical Industry 304
Health System Reform 306
Drug Prices 308
Drug Imports 308
Patent Protection 309
Drug Approvals 310
Managed Care and Restricted Access to Pharmaceuticals 311
The U.S. Food and Drug Administration 313
Genetically Targeted Drugs 314
Conclusions 315
Index 317
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