Drug Shortage Prevention Act of 2025

This bill aims to prevent drug shortages by making drug makers tell the FDA sooner when they can’t meet demand. Manufacturers of critical medicines must notify the FDA if they plan to stop making a drug, if production is interrupted, or if anything else—like a sudden jump in demand or export limits—means they won’t be able to supply enough. Notices must include why it’s happening, how long it may last, where key ingredients come from and possible backups, and whether any device used to prepare or give the drug is part of the problem. The FDA should share shortage information with doctor, provider, and patient groups to help them prepare and respond (for example, to switch treatments or manage supplies) .

“Covered drugs” include medicines that support or sustain life, treat or prevent serious diseases, are used in emergencies or surgery, or are critical during a declared public health emergency. These do not include radiopharmaceuticals and generally do not include biologics unless FDA says otherwise in rules. The bill also increases supply chain reporting to the FDA to twice a year, which can help spot risks earlier and keep essential medicines available .

• Key timing: companies must give notice at least 6 months before stopping or interrupting production when possible, and within 10 business days after a sudden issue like a demand spike; if that’s not possible, they must notify as soon as they can .

Small summary table:

• Who is affected:
  • Drug manufacturers of critical medicines (covered drugs)
• What changes:
  • Must notify FDA about supply problems, include details on causes, duration, and ingredient sources; FDA shares info with medical and patient groups; increased twice-yearly supply chain reporting
• When:
  • Notice at least 6 months ahead for planned stops/interruptions; within 10 business days for sudden issues like demand surges; otherwise as soon as possible