Crisis management: The medical director's response

This paper discusses the incidence and type of adverse drug reactions in relationship to their impact on a pharmaceutical company. It emphasizes that managing such a crisis requires skills in organizational processes that are not normally needed in the daily operation of a commercial enterprise. The role of the medical director is defined as it relates to the management of such a crisis. The key processes of managing complex interdisciplinary groups, and the problem of re‐evaluating the risk/benefit profile of the drug in question, within a constrained time frame and with an inadequate database are described. The principles of crisis communication skills are outlined. A case is made for giving a higher priority to crisis prevention by adopting certain straightforward precautions.