ITIF-《通胀削减法案》正在谈判美国退出药物创新（英）

itif.org The Inflation Reduction Act Is Negotiating the United States Out of Drug Innovation STEPHEN J. EZELL, LEAH E. KANN, AND SANDRA BARBOSU | FEBRUARY 2025 The Inflation Reduction Act (IRA) undermines innovation in small-molecule drugs by subjecting them to price controls after 9 years, whereas large-molecule drugs (biologics) are allowed 13 years of market pricing. Congress should pass the bipartisan EPIC Act to remedy this issue. KEY TAKEAWAYS  The IRA grants the Centers for Medicare & Medicaid Services (CMS) the authority to set drug prices. These price controls reduce the incentives for biopharmaceutical innovation and thus reduce U.S. biopharmaceutical production.  The IRA distinguishes between two types of drugs: small molecules and large molecules. It allows small molecules to be sold at market price for 9 years before CMS begins price setting, compared with 13 years for large molecules.  Small-molecule drugs can cross the blood-brain barrier and penetrate cellular walls, enabling them to treat a wide range of diseases that are especially prevalent among underserved and elderly populations, from cancers to neurodegenerative conditions.  Neither category of drugs is more important than the other; both are needed to continue improving human health. Scientists should follow the science to determine which works best in treating a particular medical condition.  Yet the IRA discourages small-molecule development by shifting R&D incentives toward large molecules. This reduces funding for many smaller biotech companies that are developing effective small-molecule treatments for serious diseases.  Small-molecule drug funding has dropped 70 percent since legislation that would become the IRA’s drug pricing provisions was first drafted in September 2021.  Congress should pass the bipartisan EPIC Act, which aims to address the disproportionate impact of the IRA distinction on small-molecule drug development. INFORMATION TECHNOLOGY & INNOVATION FOUNDATION | FEBRUARY 2025 PAGE 2 CONTENTS Key Takeaways ................................................................................................................... 1 Introduction ....................................................................................................................... 3 Why the 9- vs. 13-Year Distinction? ..................................................................................... 4 The Economics of Biopharmaceutical Innovation ................................................................... 5 Small Molecules ................................................................................................................. 7 How They Work ............................................................................................................... 7 Diseases They Treat ........................................................................................................ 7 Production Cost ........................................................