How the Inflation Reduction Act Could Delay Pharmaceutical Launches, Reduce Indications, and Chill Evidence Generation

AUTHORS

John M. O’Brien, Julie Patterson, James Motyka
 

Overview

Clinical development programs for new drugs play a crucial role in expanding treatment options for patients. This analysis, published in Health Affairs Forefront, examines new drug launches and research after a drug’s initial FDA approval and presents case studies of three drugs - rivaroxaban, empagliflozin, and osimertinib. In the analysis, authors illustrate how the Inflation Reduction Act (IRA) will impact economic incentives surrounding clinical development in the United States and delay manufacturers' decisions to seek initial approvals, disincentivize research towards subsequent indications, and impact overall survival data.