Issues with Causality Assessment: A Personal Perspective

Abstract

Depending on the country of origin, causality assessment of a spontaneous report may or may not be performed. In the United States, causality assessment of a spontaneous report is not required. In the new European Community guidelines, causality assessment will be required. There are issues surrounding the use of causality assessment that have not been addressed. Some of these include: what type of report should be assessed, what action if any should be taken if causality is deemed possible, how will regulatory agencies handle assessed reports, and how an assessment affects the original benefit to risk analysis provided with a marketing dossier. These and other unanswered questions require close collaboration and discussion by pharmacoepidemiologists, the pharmaceutical industry, and regulatory agencies.