Cover -- Contents -- Introduction -- The Supply of Pharmaceuticals -- The Demand for Pharmaceuticals -- Pharmaceutical Prices -- The Multinational Pharmaceutical Industry -- International Price Comparisons -- Timing of Pharmaceutical Approvals -- Government Intervention in the Pharmaceutical Sector -- Part I. The Industry -- 1 The Pharmaceutical Industry -- Pharmaceutical Research and Development -- The Competitive Structure of the Pharmaceutical Industry -- Pharmaceutical Research and Development and Prices -- The Pharmaceutical Research Process -- Product Liability -- Conclusions -- 2 The Biotechnology Industry -- Background -- Product Development in the Biotechnology Industry -- The Natural History of Biotechnology Firms -- Case Studies of Alliances -- Regulation -- Case Studies of Biotechnology Firm Growth -- Conclusions -- 3 Other Firms in the Pharmaceutical Industry -- Generic Drugs and Their Manufacturers -- Outsourcing Firms -- Conclusions -- 4 Marketing Pharmaceuticals -- Size of Marketing Effort -- Does It Work? -- Types of Promotion -- Disguising Marketing as Research -- Marketing in an Era of Managed Care -- Pharmacy Benefit Managers -- Direct-to-Consumer Advertising -- Over-the-Counter Drugs -- Joint Marketing -- Disease Management -- Roles of the U.S. Food and Drug Administration in Marketing -- False and Misleading Claims -- Part II. The Consumer -- 5 The Demand for Pharmaceuticals -- How Is Demand Determined? -- The Changing Structure of the Pharmaceutical Market -- Conclusions -- Part III. The Market -- 6 Pharmaceutical Prices -- 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 -- 7 The Worldwide Market for Pharmaceuticals.

Geographic Patterns of Pharmaceutical Production and Sales -- Pharmaceutical Research and Development: An International View -- Does Government Drug Price Setting Influence R&D? -- Worldwide Manufacturing and Sales -- Access to Appropriate Drugs in Developing Countries -- Effect of the World Trade Organization Treaty -- 8 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 -- Policy Implications -- 9 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 U.S. Drug Lag? -- Part IV. Intervention in the Pharmaceutical Market: Public and Private -- 10 Pharmaceutical Regulation and Cost Containment by the Public Sector -- Evolution of the U.S. Food and Drug Administration -- Medicaid -- State Cost-Containment Efforts -- Medicare -- 11 Regulation by the Private Sector -- Cost-Containment Mechanisms -- Cost Containment in Managed Care -- 12 Pharmaceutical Regulation in Europe -- The Pharmaceutical Industry in Europe -- History of Regulation in Europe -- Move Toward a Single Market -- Structure and Role of the European Medicines Evaluation Agency -- Drug Review under the European Medicines Evaluation Agency -- Current Regulatory Structure -- The Centralized Procedure for Marketing Authorization -- The Mutual-Recognition Procedure -- Performance of Europe's Centralized Drug Approval -- Rules on Labeling of Medicinal Products -- Advertising Regulations -- Pharmacovigilance -- Generic Drugs -- 13 Patent Protection -- Patent Law -- Patentability and Patent Categories -- How Are Patents Obtained?.

What Protection Does a Patent Confer? -- Duration of Patent Protection -- Infringement of Patents -- International Patent Treaties -- Patent Procedures under International Conventions -- Shortcomings of the Patent System -- Patents and Societal Choice -- Social Benefits 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 Studies -- 15 Complementary and Alternative Medicines -- Who Uses Complementary and Alternative Medicines? -- Manufacturers and Distributors of Complementary and Alternative Medicines -- Dietary Supplements -- Food Additives -- Medical Foods -- Concluding Remarks on Complementary and Alternative Medicines -- 16 Pharmaceuticals and Health Policy: A Look Ahead -- Structure of the Pharmaceutical Industry -- Health System Reform -- Drug Prices -- Drug Imports -- Patent Protection -- Drug Approvals -- Managed Care and Restricted Access to Pharmaceuticals -- The U.S. Food and Drug Administration -- Genetically Targeted Drugs -- Conclusions -- Index -- A -- B -- C -- D -- E -- F -- G -- H -- I -- J -- K -- L -- M -- N -- O -- P -- Q -- R -- S -- T -- U -- V -- W -- X -- Y -- Z.