February 25, 2025 (Washington, D.C.) – The Partnership to Fight Chronic Disease (PFCD) released the following statement in response to today’s reintroduction of the bipartisan Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492) in Congress. The EPIC ACT will address a flaw in the Inflation Reduction Act (IRA) that undermines access to affordable and innovative treatments particularly important to people living with heart disease, cancers, and a host of other chronic conditions. The IRA sets a shorter Medicare pricing timeline for small molecule medicines – pills, patches, syrups, and tablets. That creates a significant disincentive for ongoing research on FDA-approved small molecule medicines and the development of new ones.
“Every day, patients and families across the country face the complex and often overwhelming challenges of managing one or more chronic diseases. Conditions such as diabetes, heart disease, and asthma are not just medical issues, they affect nearly every aspect of a patient’s life, from their ability to work, to their mental health, and to their financial stability.
“Small molecule medicines are a cornerstone of treatment for chronic diseases. They are the oral medications many people depend on for chronic disease management. Their ability to be taken at home, without the need for office visits or infusions, offers critical independence to patients. Because of their ability to cross the blood-brain barrier and penetrate cell walls, these medicines are critically important in the treatment of cancers, cardiovascular disease, and neurological conditions, including epilepsy and mental illnesses.
While the IRA has made strides in improving medication affordability, such as capping out-of-pocket costs for insulin and allowing beneficiaries to spread out their prescription drug payments, it includes provisions that unintentionally disadvantage small molecule drugs. Under the IRA, small molecule medicines are eligible for government pricing just 9 years after FDA approval, while biologics have a 13-year exemption period. This disparity creates a disincentive for investment in these crucial medications. By setting a four-year shorter pricing timeline for these medicines compared to biologics, the IRA threatens access to vital treatments for older adults, rural communities, and individuals with disabilities, who often face additional barriers to in-office care.
"The EPIC Act is a straightforward solution to prevent this negative, unintended consequence of the IRA and ensure that patients can continue to benefit from the full range of treatments they need to live healthier, more independent lives. The EPIC Act would ensure that both biologics and small molecule medications are eligible for government pricing 13 years after a first FDA approval. Not only would this equalize the selection timeline for both drug types, but it would also safeguard continued access to innovative therapies for the millions of Americans living with chronic conditions.
“The Partnership to Fight Chronic Disease, along with many others in the chronic disease community, urge members of Congress to co-sponsor and swiftly advance the EPIC Act, ensuring that both small molecule and biologic medicines remain accessible to patients who rely on them. This legislation is vital to preserving access to innovative treatments, improving health outcomes, and reducing health disparities across the country. We thank Representatives Greg Murphy, Don Davis, and Richard Hudson for their leadership on this important issue.”
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