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Greenville Reporter

Thursday, March 6, 2025

Murphy introduces EPIC Act addressing 'pill penalty' impact on drug innovation

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Gregory F. Murphy U.S. House of Representatives from North Carolina's 3rd district | Official U.S. House Headshot

Gregory F. Murphy U.S. House of Representatives from North Carolina's 3rd district | Official U.S. House Headshot

Congressman Greg Murphy, M.D., has introduced H.R. 1492, known as the Ensuring Pathways to Innovative Cures (EPIC) Act. This bipartisan legislation aims to address what is referred to as the "pill penalty" within the Inflation Reduction Act (IRA), which affects small molecule drugs. Murphy was joined by Representatives Don Davis and Richard Hudson in this legislative effort.

Murphy stated, "Small molecule drugs, basically pill-form medication, play an essential role in treating Americans battling cancer, neurological disorders, and other severe illnesses." He expressed concern that the IRA's pricing model hinders research and development efforts and limits treatment options for patients. He emphasized that American innovation is crucial for breakthroughs in disease eradication and criticized the "pill penalty" for potentially undermining progress.

Congressman Don Davis highlighted the importance of fostering innovation and investment in new medicines, particularly for underserved communities. "We must encourage innovation, investment, and the development of new medicines to treat unmet medical needs," he said.

Richard Hudson also commented on the need for incentives in drug development: "By creating incentives to develop new drugs, we can help ensure greater access to life-saving cures for patients."

The current structure under the IRA allows small molecule drugs to be selected for Medicare Drug Price Negotiation seven years after FDA approval. A two-year negotiation period follows before price controls are implemented at year nine. In contrast, biologics have a longer timeline before being subject to similar negotiations.

The financial burden of bringing a new drug to market can be substantial, ranging from hundreds of millions to billions of dollars. The limitations on recouping these costs have led many pharmaceutical companies to shift focus away from small molecule drugs. As a result, clinical trials have been paused or halted altogether.

A policy brief from the University of Chicago indicates that due to these disparities in timelines between small molecules and biologics under the IRA framework, there could be 188 fewer small molecule medicines developed, resulting in significant impacts on patient life-years.

Since September 2021 when the IRA was introduced, funding for small molecule research has reportedly decreased by 70%.

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