Strengthening the Food and Drug Administration Office of Clinical Pharmacology's Labeling Authority

Abstract

Optimal prescribing of drug products requires accurate informative drug labels. One critical aspect of a label is the recommended dosage. We suggest that the final authority for this portion of the label should reside in FDA's Office of Clinical Pharmacology (OCP), rather than in the Office of New Drugs, given that most FDA clinicians do not have sufficient expertise to interpret pharmacometric analyses of dose-exposure, and dose/exposure-efficacy/safety relationships.