Pharmaceutical Economics and Policy

Stuart O. Schweitzer is Professor of Health Policy and Management at UCLA's Fielding School of Public Health. He has held other academic and research appointments at the Urban Institute and the White House Commission for a National Agenda for the Eighties. His research and consulting activities have dealt with pharmaceutical regulation and policy, health care financing, and technology assessment.Z. John Lu is an Assistant Professor of Economics at the MVS School of Business and Economics, California State University, Channel Islands. Prior to this academic position, Dr. Lu was a health economist in the biopharmaceutical industry for 2 decades, including nearly 17 years at Amgen, where he was a director of global health economics and policy. Professor Lu's research interests include industrial economics and policy on pharmaceuticals, particularly in the United States and China.

• IntroductionThe Big PictureThe Supply of PharmaceuticalsThe Demand for PharmaceuticalsPharmaceutical PricesInternational Price ComparisonsPharmaceutical MarketingPharmaceutical PatentsRegulatory Control of the Pharmaceutical SectorTiming of Pharmaceutical ApprovalsPart I. The IndustryChapter 1 The Pharmaceutical IndustryThe Competitive Structure of the Pharmaceutical IndustryPharmaceutical Research and DevelopmentPharmaceutical R&D and PricesThe Pharmaceutical Research and Approval ProcessProduct LiabilityIncreasing Private Sector Research ActivityDrugs for Low-Income CountriesThe Role of Pharmaceutical Marketing in Prescribing DecisionsConclusionsChapter 2 The Biotechnology IndustryBackgroundWhat is Biotechnology?A Brief History of Modern Biotechnology IndustryFactors Distinguishing the Biotechnology from the Pharmaceutical IndustryCase Studies of Biotechnology Firm Growth and FailureConclusionChapter 3 Generics and BiosimilarsIntroductionA Brief History of Modern Generic Pharmaceutical Industry in the USThe Structure of the Generic Pharmaceutical IndustryGeneric Entry and Price Competition in the Pharmaceutical MarketplaceGeneric Entry and Strategic BehaviorDrug ShortageEconomic Analysis of Drug ShortageThe Emergence of BiosimilarsConclusionChapter 4 The Global Pharmaceutical IndustryGeographic Patterns of Pharmaceutical Production and SalesInternational Trade in Pharmaceutical ProductsPharmaceutical Research and Development: An International ViewDoes Government Drug Price Setting Influence R&D?Global Mergers and AcquisitionsThe Pharmaceutical Industry in Selected Countries and RegionsThe Chinese Pharmaceutical IndustryAccess to Appropriate Drugs in Developing CountriesPart II. The ConsumerChapter 5 The Demand for PharmaceuticalsThe Problem of Drug ExpendituresHow is Demand Determined?Pharmaceuticals and Other Health Services: Substitutes or Complements?The Changing Structure of the Pharmaceutical MarketConclusionChapter 6 The Demand for Pharmaceuticals in Major International MarketsComparison of Pharmaceutical Spending across Global MarketsComparison of Pharmaceutical Consumption across Global MarketsDemand for Pharmaceuticals in JapanDemand for Pharmaceuticals in ChinaDemand for Pharmaceuticals in France and GermanyDemand for Pharmaceuticals in the United KingdomDemand for Pharmaceuticals in CanadaDemand for Pharmaceuticals in BrazilConclusionPart III. Pricing and Marketing of Pharmaceutical ProductsChapter 7 Pharmaceutical PricesThe Problem of Pharmaceutical PricesPharmaceutical Prices Over TimeMeasuring Drug Prices: What Prices?Measuring Drug Prices: Rate of ChangeHow Are Drug Prices Determined?Economic Models from Industrial Organization LiteratureMarket Power, Generic Entry and PricingChapter 8 Economic Evaluation of New DrugsOptimizing Production of HealthCost-Benefit AnalysisCost-Effectiveness AnalysisCost-Utility AnalysisCost-Effectiveness League TablePolicy ApplicationsConclusionsChapter 9 Pricing Pharmaceuticals in a World EnvironmentWhy Do Drug Prices Vary Across Country?Comprehensive Comparison of International Drug PricesPolicy ImplicationsConclusionChapter 10 Pharmaceutical MarketingSize of the Pharmaceutical Promotion EffortPharmaceutical Promotion Directed at Healthcare ProvidersPharmaceutical Promotion Aimed at Patients: Direct-to-Consumer Advertising (DTCA)Pharmaceutical Promotion to Third-Party PayersRegulation of Prescription Pharmaceutical PromotionFalse and Misleading ClaimsOff-Label PromotionConclusionPart IV. Public Policies in the Pharmaceutical Market Chapter 11 Patent Protection IntroductionPatent LawPatentabilityPatent CategoriesHow Patents Are Obtained?What Protection Does a Patent Confer?Duration of Patent ProtectionInfringement of PatentsStrategic Responses by Pharmaceutical FirmsInternational Patent TreatiesPatent Procedures under International ConventionsCriticisms of the Patent SystemPatent and Societal ChoiceChapter 12 Drug Approval Process in the United StatesThe Drug Approval Process in the United StatesThe Rising Cost of Pharmaceutical R&DMajor Drug Legislations in the United StatesAnnual NME Approvals by FDA since 2000Regulatory Approval of Generic Drugs in the USRegulatory Approval of Biosimilars in the USChapter 13 Pharmaceutical Regulation in the European UnionThe European UnionMove Toward a Single MarketHistory of Drug Regulation in EuropeStructure and Role of the European Medicines AgencyDrug Review under the European Medicines AgencyEU Rules on Labeling of Medicinal ProductsRegulations of Drug AdvertisingPharmacovigilanceApproval of Generic Drugs in the European UnionApproval of Biosimilars in the European UnionComparison of International Drug Approval LagsChapter 14 Pharmaceuticals and Public Policy: A Look AheadIndustry StructureThe Nascent Biosimilar SectorPersonalized Medicine and Digital Healthcare InformationArtificial Intelligence and MedicineOutpatient Bundled Payment Program and PharmaceuticalsPharmaceutical PricesThe FDAConclusion

Schweitzer and Lu's new edition provides a broad and timely overview of pharmaceutical economics and policy issues. Topics of particular current interest include biotechnology and biosimilars, international differences in drug prices and regulations, and the contribution and affordability of new medical advances.