E-catalog        

Bibliogr.: p. 292-316

Index: p. 317-321

Machine generated contents note: Introduction -- Innovation, Therapeutic Progress and Regulation -- The Regulatory Culture of Accelerated Drug Development and Review -- Regulatory and Scientific Standards -- Reshaping the Evidence-Base -- Risk Management Versus Market Withdrawal -- Rapid Regulatory Review, Pharmaceutical Innovation and Public Health -- Transparency, Public Accountability and Meeting Patients' Needs -- Conclusion -- References/Bibliography -- Index.

"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. "--