Changes in the approval process for contrast media.

Abstract

This paper discusses, from an academic perspective, the changes proposed by the Food and Drug Administration (FDA) regarding the approval process for contrast media. The proposed changes are extensive, covering indications, safety and efficacy assessments, and image acquisition and handling. The draft guidance unfortunately grouped together therapeutics and diagnostics. Indications were divided into the following categories: a) structure delineation, b) functional physiological, or biochemical assessment, c) disease or pathology detection/assessment, and d) diagnostic or therapeutic patient management. Such a division would greatly complicate the approval process, requiring multiple trials to gain approval. The draft guidance also disregarded that indications for imaging agents are often general and not disease specific. As issued, it implied that separate trials would be required for each clinical setting where lesions might be important. As the standard of truth, blinded reads with no clinical information were proposed as the primary endpoint. This ignores how diagnostic exams are interpreted and the value of medical history.