AUTHOR=Martin Allison , DiBiaso Victoria , Bozic Mladen , May Alexander T. TITLE=Building on the successes of patient-focused drug development: a call for new policies to maintain momentum JOURNAL=Frontiers in Medicine VOLUME=11 YEAR=2024 URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1416123 DOI=10.3389/fmed.2024.1416123 ISSN=2296-858X ABSTRACT=

Since its commencement as part of the Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA) V in 2012, patient-focused drug development (PFDD) has become an integral part of the drug development paradigm. FDA encourages the development and use of Patient-Experience Data (PED) as it provides important information on the patients’ needs and perspectives and inform regulatory decision-making. While the FDA is required to fill out a table which includes a list of various types of Patient Experience Data (PED) and if such data was reviewed by FDA as part of a drug application, there is still a need to understand how FDA uses PED in its regulatory decision-making. This article examines whether new policies are needed to ensure the full potential of PFDD.