The Evaluation of Postmarketing Adverse Drug Experience Reports at FDA: Part I

Abstract

This series of two papers provides an overview of the Food and Drug Administrations's (FDA) processing of postmarketing ADE reports. The first paper describes the spontaneous reporting system, computerized processing of Form FDA 1639, and the clinical review of individual ADE reports. The clinical review of ADE reports uses a medical model, very similar to one used in clinical practice when developing a patient's chart. This medical model also contributes to the identification of safety signals since it forms the basis of the clinical assessment of the report and the determination of how an ADE report, or group of reports, may be related to drug use. The signaling functions are discussed in the companion paper.

“Causality assessment,” “attribution,” and other related terms have various definitions. These papers will use these terms rather loosely in describing how FDA staff determine if there may be a preliminary signal of a meaningful association of a drug to an adverse event.