Unhealthy Pharmaceutical Regulation: Innovation, Politics And Promissory Science (health, Technology

This is the first book to examine how effectively American and supranational EU governments have regulated innovative pharmaceuticals during the last 30 years regarding public health. It explains why pharmaceutical regulation has been misdirected by commercial interests and misconceived ideologies. European and American drug regulators govern a multi-billion-dollar pharmaceutical industry selling its products on the world's two largest medicines markets. This is the first book to investigate how effectively American and supranational EU governments have regulated innovative pharmaceuticals regarding public health during the neo-liberal era of the last 30 years. Drawing on years of fieldwork, the authors demonstrate that pharmaceutical regulation and innovation have been misdirected by commercial interests and misconceived ideologies, which induced a deregulatory political culture contrary to health interests. They dismantle the myth that pharmaceutical innovations necessarily equate with therapeutic advances and explain how it has been perpetuated in the interests of industry by corporate bias within the regulatory state, unwarranted expectations of promissory science, and the emergent patient-industry complex. Endemic across both continents, the misadventures of pharmaceutical deregulation are shown to span many therapeutic areas, including cancer, diabetes and irritable bowel syndrome. The authors propose political changes needed to redirect pharmaceutical regulation in the interests of health.--[Source inconnue] "European and American drug regulators govern a multi-billion-dollar pharmaceutical industry selling its products on the world's two largest medicines markets. This is the first book to investigate how effectively American and supranational EU governments have regulated innovative pharmaceuticals regarding public health during the neo-liberal era of the last 30 years. Drawing on years of fieldwork, the authors demonstrate that pharmaceutical regulation and innovation have been misdirected by commercial interests and misconceived ideologies, which induced a deregulatory political culture contrary to health interests. They dismantle the myth that pharmaceutical innovations necessarily equate with therapeutic advances and explain how it has been perpetuated in the interests of industry by corporate bias within the regulatory state, unwarranted expectations of promissory science, and the emergent patient-industry complex. Endemic across both continents, the misadventures of pharmaceutical deregulation are shown to span many therapeutic areas, including cancer, diabetes and irritable bowel syndrome. The authors propose political changes needed to redirect pharmaceutical regulation in the interests of health."-- Provided by publisher Front Matter....Pages i-xii Introduction: The Health of a Political System....Pages 1-4 Putting Pharmaceutical Regulation to the Test: From Historical Description to a Social Science for Public Health....Pages 5-35 The Political Economy of ‘Innovative’ Drug Regulation in the Neo-Liberal Era....Pages 36-115 Designs on Diabetes Drugs....Pages 116-154 Desperate Regulation for Desperate Cancer Patients: The Unmet Needs of Accelerated Drug Approval....Pages 155-200 The Making of a Harmful ‘Therapeutic Breakthrough’: Crossing Regulatory Boundaries for Drug Approval....Pages 201-234 The Regulatory Science and Politics of Risk Management: Who Is Being Protected?....Pages 235-258 Conclusions and Policy Implications....Pages 259-285 Back Matter....Pages 286-321