Pharmaceutical Economics and Policy
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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The Pharmaceutical Industry
Pharmaceutical Research and Development
The Competitive Structure of the Pharmaceutical Industry
Pharmaceutical Research and Development and Prices
The Pharmaceutical Research Process
The Timing of Drug Approvals in the United States and Abroad
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 US Drug Lag?
Intervention in the Pharmaceutical Market Public and Private
Pharmaceutical Regulation and Cost Containment by the Public Sector
Evolution of the US Food and Drug Administration
The Biotechnology Industry
Product Development in the Biotechnology Industry
The Natural History of Biotech Firms
Case Studies of Alliances
Case Studies of Biotechnology Firm Growth
Other Firms in the Pharmaceutical Industry
Size of the Marketing Effort
Types of Promotion
Disguising Marketing as Research
Marketing in an Era of Managed Care
Pharmacy Benefit Managers
Roles of the US Food and Drug Administration in Marketing
False and Misleading Claims
The Demand for Pharmaceuticals
How Is Demand Determined?
The Changing Structure of the Pharmaceutical Market
The Problem of Pharmaceutical Prices
Pharmaceutical Prices over Time
Measuring Drug Prices
How Are Drug Prices Determined?
Cost Structure of Pharmaceutical Firms
Is the Pharmaceutical Industry Monopolistic?
How Drug Quality Influences Price
The Worldwide Market for Pharmaceuticals
Geographic Patterns of Pharmaceutical Production and Sales
An International View
Does Government Drug Price Setting Influence RD?
Worldwide Manufacturing and Sales
Access to Appropriate Drugs in Developing Countries
Effect of the World Trade Organization Treaty
Pricing Pharmaceuticals in a World Environment
Why Do Drug Prices Vary across Country?
Comparisons of International Drug Prices
How Do We Measure Drug Prices across Countries?
Why Drug Price Differences Persist
State CostContainment Efforts
Regulation by the Private Sector
Cost Containment in Managed Care
Pharmaceutical Regulation in Europe
History of Regulation in Europe
Move Toward a Single Market
Drug Review under the European Medicines Evaluation Agency
Current Regulatory Structure
The Centralized Procedure for Marketing Authorization
The MutualRecognition Procedure
Performance of Europes Centralized Drug Approval
Rules on Labeling of Medicinal Products
Patentability and Patent Categories
How Are Patents Obtained?
What Protection Does a Patent Confer?
Infringement of Patents
Patent Procedures under International Conventions
Patents and Societal Choice
Evaluating New Drugs
Interpretation and Misinterpretation of CostEffectiveness Studies
Complementary and Alternative Medicines
Who Uses Complementary and Alternative Medicines?
Concluding Remarks on Complementary and Alternative Medicine
Pharmaceuticals and Health Policy A Look Ahead
Health System Reform
Managed Care and Restricted Access to Pharmaceuticals
The US Food and Drug Administration
Genetically Targeted Drugs
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