U.S. Representative Richard Hudson, along with Representatives Greg Murphy and Don Davis, has introduced the Ensuring Pathways to Innovative Cures (EPIC) Act. This bipartisan legislation seeks to address what is referred to as the “pill penalty” in the Inflation Reduction Act (IRA). The goal is to encourage research and development investments in small molecule medicines. Senator Thom Tillis is presenting a companion bill in the Senate.
Representative Hudson emphasized the importance of developing new drugs to ensure access to life-saving treatments for patients. He stated, “By creating incentives to develop new drugs, we can help ensure greater access to life-saving cures for patients.”
Representative Murphy highlighted the critical role of small molecule drugs in treating serious illnesses like cancer and neurological disorders. He criticized the IRA’s approach by saying, “Unfortunately, the Inflation Reduction Act’s price-fixing scheme destroys research and development, reducing treatment options for patients.”
The act aims to support innovation and investment in medicine development, particularly for underserved communities. Representative Davis remarked on this necessity: “We must encourage innovation, investment, and the development of new medicines to treat unmet medical needs.”
The current structure under the IRA allows small molecule drugs into Medicare’s Drug Price Negotiation program seven years after FDA approval. Biologics enter this program four years later than small molecules. This disparity could lead pharmaceutical companies away from investing in small molecule medicines due to reduced potential returns.
A University of Chicago policy brief suggests that 188 fewer small molecule medicines will reach the market because of these regulations, resulting in significant life-years lost. Since September 2021 when the IRA was introduced, funding for small molecule drug research has dropped by 70%.
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