To better understand how patients interpret and use written prescription drug information, the Reagan-Udall Foundation for the FDA (Foundation), in collaboration with the FDA’s Office of Clinical Pharmacology (OCP) Strategic Plan Working Group, conducted a qualitative patient engagement initiative. This work supports broader efforts within the Center for Drug Evaluation and Research (CDER) and Office of Translational Sciences (OTS) to advance patient-centered engagement and better understand the pharmacotherapeutic needs of patients, caregivers, and healthcare providers.
Through listening sessions and focus groups with patients and healthcare providers, along with a national poll, the Foundation explored how individuals with chronic illnesses engage with medication information and how written materials are experienced in real-world settings. This work identified areas where presentation, clarity, and usability may be improved. The findings are intended to inform FDA consideration of potential enhancements to patient labeling to support clearer communication about safe and effective medication use.
