Pharmaceutical innovation and public policy: The case for a new strategy for drug discovery and development

The major research-intensive pharmaceutical companies (big pharma), are facing a profound crisis. Their R&D expenditures have grown at a staggering rate, while the creation of drugs that represent truly novel advances in therapy, so-called new molecular entities (NMEs), has stagnated. Here I present a comprehensive analysis of the NME crisis and discuss possible solutions. This includes proposals to fix the problem by increasing the efficiency of corporate R&D, as well as several alternative strategies for pharmaceutical research, including academic drug discovery centers and the public--private partnerships that have been so successful in attacking neglected diseases. Finally, a new policy initiative, the creation of non-profit drug development corporations (NPDDCs) designed to bring key aspects of early-stage drug development into the pre-competitive public arena is proposed. The creation of effective NPDDCs will be challenging, but promises to provide the health care system with less costly and more effective medicines. Copyright The Author 2013. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com, Oxford University Press.