Formulating an Ethics Agenda for Drug Development, Regulation, and Utilization.

Abstract

An Invitation: The time has come to examine the ethical dimensions of our pharmaceutical and device enterprise more broadly. In this inaugural edition of Therapeutic Innovation & Regulatory Science (TIRS), Lipworth et al have provided a useful introduction to ethical analysis, a framework to guide ethical discussions, and a possible research agenda around the ethical aspects of drug and device development and policy. It may seem strange to be proposing that TIRS become the vehicle for the discussion of the ethical dimensions of policies on drug, device, and companion diagnostics development. But for too long our "industry" has neglected this dimension of our work, to the detriment of all stakeholders, most notably the patient/consumer. All of us are aware that our standing as an industry has suffered, and most of us would dearly love to be recognized as part of a vital enterprise dedicated to improving human health, not only unsullied by scandals fuelling the perception of overriding self-interest but also free to explore new ways to contribute to society. We are excited that TIRS might become the forum in which new thinking will emerge through systematic ethical analyses of pharmaceutical and device policy and practice. As Acting Executive Editor and Editorial Board members we hope that you, as a regulator, pre-clinical scientist, project manager, patient, clinician, health economist, or other stakeholder, will accept this invitation to become involved, and contribute to a stimulating and productive discussion about aspects of drug and device development that have been relatively overlooked heretofore. Richard Day, Adil Shamoo, Wendy Lipworth.