Pharmaceutical Economics and Policy

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