BioCentury
ARTICLE | Politics, Policy & Law

Tough path for pill penalty fix

Bipartisan House bill to extend IRA price negotiation window for small molecules to 13 years faces steep future

February 25, 2025 6:02 PM UTC

The attempt to mitigate the IRA’s disincentive to invest in small molecule drugs took a small step forward Tuesday with the introduction in the House of the Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492).

The bill seeks to eliminate the “pill penalty” by increasing the period small molecule drugs are exempt from Medicare price negotiation program to 13 years from 9 years. The change would make the period of exemption from price negotiation identical for drugs approved through NDA and BLA pathways. ...

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