The Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492), has been reintroduced. It’s a bipartisan bill that would address the harmful “pill penalty” created by the Inflation Reduction Act (IRA). Introduced by Representatives Greg Murphy (R-NC), Don Davis (D-NC) and Richard Hudson (R-NC), this legislation seeks to correct a provision of the law that disincentivizes the development of small molecule drugs and equalizes the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.  

Small molecule drugs make up well over 90% of all prescriptions and two-thirds of new drug approvals annually. Yet, under the IRA, they face stricter price-setting timelines - 9 years versus 13 years for biologics – before being subject to federal drug price setting. Numerous pharmaceutical companies have adjusted their R&D pipelines away from small molecule drugs due to the onerous IRA provision. 

Indeed, a new analysis by research firm Vital Transformation found that R&D spends on small molecules has dropped by 70% in the two years since 2021 when the IRA was first introduced. Further, biologics R&D funding was 10 times larger than small molecules in the first six months of 2024, despite the latter being the most common and convenient treatment option for patients. 



A just released report by the Center for Life Sciences Innovation at the Information Technology & Innovation Foundation (ITIF) underscores even more emphatically  the need to pass the EPIC Act and provide an incentive and resources to companies to reinvest in future small-molecule projects.