Drug Shortage Prevention Act of 2025

The Drug Shortage Prevention Act of 2025 (S. 2665) would overhaul how the U.S. government and drug manufacturers handle potential shortages of critical drugs. It expands and tightens the notification system so manufacturers must alert the FDA (the Secretary) about any discontinuation, interruption, or other circumstances—such as rising demand or export restrictions—that could meaningfully disrupt U.S. supply of “covered drugs.” It also broadens the information that must be provided with these notices (including API sources and alternative suppliers) and requires more systematic reporting on supply chains. Additionally, the bill creates a more structured, twice-yearly reporting regime on active pharmaceutical ingredients and related materials, while allowing voluntary additional reporting. The aim is to improve transparency and accelerate responses to prevent or mitigate shortages, though it would increase compliance burdens on manufacturers. The bill defines which drugs count as “covered drugs” (life-supporting, life-sustaining, or critical to treating debilitating conditions, including during health emergencies) and excludes radio-pharmaceuticals and biological products unless the Secretary allows otherwise. Notifications would be due in more precise timeframes (typically six months before planned discontinuation; urgent cases within 10 business days for certain circumstances), and information would be distributed to relevant medical and patient organizations. Collectively, the changes are intended to give regulators and providers earlier visibility into shortages and the factors causing them, to support planning and patient care.