Considerations for Communicating DDI Findings from Various Sources in US Prescription Information

Prescription drug labeling (PDL) is the primary mechanism through which FDA and drug manufacturers communicate essential, science-based prescribing information to health care providers (HCP). How well information regarding the safe and effective use of a drug is ultimately communicated to the prescribing HCP is a key element of a drug development program. The Office of Clinical Pharmacology (OCP) at the Center for Drug Evaluation and Research (CDER), FDA plays a critical role in developing prescribing information (labeling) for drug products. This includes active participation in CDER’s labeling initiative that is designed to increase the number of drugs with labeling that comply with the Physician Labeling Rule (PLR) content and format requirements, establish guidances and best labeling practices, and develop and evaluate approaches to enhance clarity, utility, and comprehension of PDL within their respective review areas.

Patients frequently use more than one medication at a time. Unanticipated, unrecognized, or mismanaged DDIs are major causes of preventable morbidity and mortality, and have occasionally caused the withdrawal of approved drugs from the market. FDA’s goal is to effectively convey information about clinically important known and predicted DDIs in PDL to the HCP to help address this problem. Prescription drug labeling should include a summary of essential DDI information that is needed for the safe and effective use of the drug by the HCP. This information can include data and results from prospective clinical DDI studies (e.g., stand-alone DDI studies, nested DDI studies), population pharmacokinetic analyses, modeling and simulations, postmarketing reports, or data extrapolated from other information.

The objectives of this presentation will be to 1) Provide an overview of key labeling principles based upon regulation and information from recently published guidances, 2) Explore different labeling formats (e.g., tables, figures, structured text) to further enhance the presentation of DDI-related information in labeling; and 3) Discuss strategies for presenting DDI information based upon population analysis, modeling and simulation, or in vitro studies in PDL.