DRUGS-REWIND: drugs regulation

DRUGS-Regulation: WIthdrawal Impact and Determinants

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Why do we take drugs off the market? Who leads to these decisions? And for what consequences?

Throughout most of the world, drugs are legally prescribed and sold only once they have received a Market Authortization (MA) from a regulatory body such as the European Medicines Agency (EMA). Criteria of ‘quality’, ‘safety’ and ‘efficiency’ ostensibly guide MA decision-makers. Until recently, this process invariably increased the number of drugs on the market. However, under pressure to both improve safety and cut costs, many regulators have begun to remove MAs. This trend, the decision-making it entails and its health and financial impacts, has yet to be systematically studied. REWIND seeks to begin filling this knowledge gap through its team of pharmacologists, economists and political scientists. This interdisciplinary initiative will first produce data about the arguments and alliances developed by a variety of actors which, together, have given rise in each regulatory space to what we label Market Removal (MR). Who have been the advocates of this change in policy and regulatory tools? Who have been its adversaries and how has each ‘side’ worked politically in order to modify or reproduce the deeply institutionalized practices of MA? This line of questioning will then be deepened and specified by focusing initially upon three concrete examples of MRs in France: pioglitazone (used to treat diabetes), tétrazépam ( ?) and Acomplia® (obesity). Finally, REWIND will also generate systematic data about the health and financial consequences of MRs. What are their knock-on effects? More generally, how does the spread of MRs affect the very principles and practices of ‘Evidence-based medicine’?