Uses of Drug-Event Assessment

Abstract

The spectrum of parties making judgments about the relationship of a drug to an event is broad. In addition to the clinician who must make an immediate judgment, drug manufacturers and regulators must address the need to deal with data suggesting an adverse event is connected to a drug product. If a particular event or group of events gains broader attention, judgments are made by the media and the public, often using varying and arbitrary methods. The reasons for varying approaches relate to both need, setting, and use of the decision. A description of the evolution of the FDA's approach to a method and use of the decisions is provided as an example. It is important to note that individual case-related decisions should be put in context with a wide array of information to provide a better basis for judgment.