WASHINGTON, D.C. – This week, Senators Thom Tillis (R-NC), Ted Budd (R-NC), Marsha Blackburn (R-TN), James Lankford (R-OK), and Steve Daines (R-MT) introduced the Ensuring Pathways to Innovative Cures (EPIC) Act, bipartisan, bicameral legislation that fixes the Inflation Reduction Act's small molecule “pill penalty” to ensure continued R&D investments into small molecule medicines.
“For patients battling cancer, rare diseases, and chronic conditions, timely access to innovative treatments can mean the difference between life and death,” said Senator Tillis. “Unfortunately, the Inflation Reduction Act disincentivizes research on small molecule treatments and undermines development of the most accessible and affordable medications. The EPIC Act of 2025 will ensure patients of today and tomorrow have uninterrupted access to life-saving and life-changing therapies.”
“President Biden’s Inflation Reduction Act ‘pill penalty’ has hindered important research and development for potentially life-saving cures,” said Senator Budd. “The EPIC Act will right this wrong by encouraging more investment in innovative medicines and treatments that are needed to help North Carolinians live long and healthy lives.”
“Montanans in need of life-saving medicine should not have to worry about government overreach that stifles critical research and development for much-needed cures,” said Senator Daines. “I’m proud to join my colleagues in introducing this bill to bolster innovation so that Montanans and patients across the country can get the care they deserve.”
“Incubate Coalition appreciates Senator Tillis’ leadership in addressing the flaws of the IRA and supporting the EPIC Act, which restores incentives for life sciences investment based on scientific potential rather than arbitrary policy barriers,” said John Stanford, Executive Director of the Incubate Coalition. “His dedication to ending the pill penalty will create a fairer system, drive innovation, and ensure patients have access to the breakthrough treatments they need.”
“The schizophrenia community has been marginalized for decades. Now, people with this brain disease stand to suffer even more as the IRA endangers the promise of new schizophrenia treatments,” said Gordon Lavigne, CEO of the Schizophrenia & Psychosis Action Alliance. “The EPIC Act is a much-needed fix that will help ensure that everyone with schizophrenia has access to a treatment that works for them. For the 2.5 million people living with schizophrenia in the United States, future treatment innovation is a matter of survival and dignity.”
“As an organization representing the voice of cancer patients, survivors, and caregivers across America, the Cancer Support Community (CSC) would like to thank Senator Tillis alongside Senators Blackburn, Budd, Lankford, and Daines for introducing the Ensuring Pathways to Innovative Cures (EPIC) Act,” said Sally Werner, Chief Executive Officer, Cancer Support Community. “Small molecule drugs are essential for the treatment of many cancers and are more accessible for patients due to their cost and convenience of taking them at home. Innovative oral cancer drugs are bringing improved efficacy and reduced side effects to patients, improving their treatment and lives. The EPIC Act would eliminate the unnecessary distinction between small and large molecule drugs in the IRA, allowing both to be eligible for negotiation eleven years after FDA approval. We must continue to ensure that all patients have access to the treatment best suited for them and that policies accurately reflect the needs and input of patients who will be most impacted by them.”
Background:
Under the Inflation Reduction Act's price-fixing model, small molecule drugs are eligible for selection in the “Medicare Drug Price Negotiation” program seven years after FDA approval. A two-year “negotiation period” follows, with price controls taking effect in year nine. Conversely, biologics become eligible for selection 11 years after FDA approval, with price controls going into effect in year 13.
The cost to bring a new drug to market can range from several hundred million to several billion dollars. The IRA is crippling innovation by reducing the ability to recoup losses incurred during drug research and development, with many pharmaceutical companies halting research into groundbreaking treatments. This has left individuals battling cancer, mental health conditions, and rare disease without hope.
The impact is already devastating. R&D funding for small molecule medicines has plummeted by 70% since the IRA’s introduction in September 2021 and funding continues to be shifted to other projects. According to a University of Chicago policy brief, due to the 9-13 disparity, 188 fewer small molecule medicines will come to market, leading to a staggering 116 million life-years lost.
Full text of the bill is available HERE.
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