The Information Technology and Innovation Foundation (ITIF) has released a report highlighting concerns that the Inflation Reduction Act (IRA), enacted during the Biden administration, may negatively impact innovation in small-molecule drugs. According to ITIF, these drugs are crucial for treating various conditions, including high blood pressure and Parkinson's disease.
Stephen Ezell, vice president for global innovation policy at ITIF, stated, "Partly because of their size, small-molecule drugs can target a tremendous range of medical conditions, so the reduced innovation incentive in the IRA will turn back the clock on medical progress if we don’t correct course." He emphasized that while price controls generally harm innovation, a more immediate solution would be to apply them consistently across drug types.
To address this issue, ITIF recommends Congress pass the bipartisan Ensuring Pathways to Innovative Cures (EPIC) Act. This legislation seeks to extend market exclusivity for small-molecule drugs from nine years to thirteen years, aligning it with the period currently granted to large-molecule biologics. The EPIC Act aims to restore balance in drug development incentives and support ongoing research and development in small-molecule innovations.
Sandra Barbosu, associate director of ITIF’s Center for Life Sciences Innovation, remarked on the challenges posed by current policies: “Drug development is already a high-risk, high-cost venture, and the IRA’s policies make it even harder to justify investing in small-molecule innovation.” She warned that shortening market exclusivity could lead to fewer breakthroughs and treatment options.
Ezell concluded by advocating for broader reforms beyond just passing the EPIC Act. He expressed concern that without such changes, America's leadership in life sciences might be jeopardized: “The EPIC Act rights a major wrong by leveling the playing field... Without broader reforms...the future of cutting-edge treatments—hangs in the balance.”
