Pharmaceutical Economics and Policy

Hardcover | January 5, 2007

byStuart O. Schweitzer

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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 forits 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 tounderstand 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 newchapter 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 ofpharmaceutical innovation and how the pharmaceutical industry has responded to the emergence of managed care.

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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 forits apparent anticompetitive responses to g...

Stuart O. Schweitzer is Professor of Health Economics, University of California, Los Angeles.
Format:HardcoverDimensions:352 pages, 6.18 × 9.29 × 0.51 inPublished:January 5, 2007Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0195300955

ISBN - 13:9780195300956

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Table of Contents

Introduction The Volatile Pace of Pharmaceutical InnovationThe Pharmaceutical Industry Responds to the Health Care Revolution of Managed CareIncreased Role for Consumers in Decision-makingII. The Industry1. Pharmaceutical Industry Research and DevelopmentConcentration Among Pharmaceutical ManufacturersRecent Mergers. Are There Economies of Scale?Pharmaceutical RandD and PricesPreclinical Pharmaceutical DevelopmentClinical Pharmaceutical DevelopmentProduct LiabilityStrategic Decisions on Research Programs: Blockbuster, Me-too, or Market Segmentation?The Supply Chain and Drug Safety2. The Biotechnology IndustryHow 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 Firm3. Other Firms in the Pharmaceutical IndustryDrug Delivery FirmsProcessing Firms Isomer FilteringGeneric Firms4. Marketing PharmaceuticalsTypes of PromotionDoes it Work?False and Misleading ClaimsMarketing in an Era of Managed CareDirect-to-Consumer Advertising: Challenges to SocietyOver-the-Counter DrugsJoint MarketingPharmacy Benefit Managers (PBMs)Disease ManagementNew Roles for the FDA in MarketingIII. The Consumer5. The Demand For PharmaceuticalsHow is Demand Determined?The Changing Structure of the Pharmaceutical MarketQuality of Life drugs Viagra, Propecia, ObesityIV. The Market6. Pharmaceutical PricesThe Problem of Pharmaceutical PricesPharmaceutical Prices Over TimeMeasuring Drug PricesHow are Drug Prices Determined?The Cost Structure of Pharmaceutical FirmsIs the Pharmaceutical Industry Monopolistic?How Drug Quality Influences Prices7. The Worldwide Market for PharmaceuticalsGeographic Patterns of Pharmaceutical Production and SalesPharmaceutical Research and Development: An International ViewWorldwide Manufacturing and SalesImproving Access to Appropriate Drugs in Developing CountriesThe Effect of the World Trade Organization Treaty8. Pricing Pharmaceuticals in a World EnvironmentGeographic Patterns of Pharmaceutical Production and SalesPharmaceutical Research and Development: An International ViewWorldwide Manufacturing and SalesImproving Access to Appropriate Drugs in Developing countriesThe Effect of the World Trade Organization Treaty9. The Timing of Drug Approvals in the United States and AboradThe Timing of Pharmaceutical Approvals and Health PolicyThe Drug Approval Process in the United StatesRecent Initiatives to Expedite Drug ApprovalsIs There a U.S. Drug Lag?The Darker Side of Speedier Drug Approvals: Drug RecallsV. Intervention in the Pharmaceutical Market: Public and Private10. Pharmaceutical Regulation and Cost Containment-The Public SectorThe Broadening of the FDAsThe FDA Modernization ActThe FDA User Fee ActDrug Cost Containment Programs in the Public SectorExpanding Medicare to Cover Outpatient Drugs11. Pharmaceutical Regulation and Cost Containment-The Private SectorBringing Market Incentives into Managed Care12. Drug Regulation in Europe: The Birth of EMEA13. Patent ProtectionPatent LawPatentability and Patent CategoriesHow Patents are ObtainedWhat Protection Does a Patent Confer?Duration of Patent ProtectionInfringement of PatentsInternational Patent TreatiesPatent Procedure Under International ConventionsAlternatives to Traditional Patent PolicyPatents and Societal ChoiceAbuses of the Patent System14. Evaluating New DrugsOptimizing Production of HealthCost-benefit AnalysisCost-effectiveness AnalysisCost-utility AnalysisPolicy ApplicationsInterpretation and Misinterpretation of Cost-effectiveness Analysis15. Alternative Drugs-NutraceuticalsRegulation of Supplements, Food Additives, and Medicinal Foods16. Pharmaceutical and Health Policy: A Look AheadThe Structure of the Pharmaceutical IndustryHealth System ReformDrug PricesPatent ProtectionDrug ApprovalsManaged Care and Restricted Access to PharmaceuticalsThe FDAThe New Paradigm of Genetically-targeted DrugsConclusion