JAMA Health Forum
October 17, 2025
Abstract
The Inflation Reduction Act (IRA) requires Medicare to negotiate prices for certain brand-name drugs with gross annual Medicare spending exceeding $200 million. Small-molecule drugs are exempt from negotiation for 9 years following US Food and Drug Administration approval and biologics for 13 years. The pharmaceutical industry, some members of Congress, and the Trump administration have argued that this difference prioritizes the development of biologics over small-molecule drugs and have proposed aligning the initial eligibility periods for both at 13 years.1,2 To inform these policy discussions, we compared the revenues earned by manufacturers after 9 vs 13 years on negotiation-eligible products from 2012 to 2022.
Citation
Vogel, Matthew, William B. Feldman, Zander Cowan, Benjamin N. Rome, Amitabh Chandra, Aaron S. Kesselheim, and Wouters, Olivier J. "Revenue Differences Between Top-Selling Small-Molecule Drugs and Biologics in Medicare." JAMA Health Forum (October 17, 2025).