Requires Early Warnings of Drug Shortages
S2665-119 · Introduced Aug 1, 2025
Why it matters
Early warnings could help the FDA act sooner when medicines run low. Patients who rely on life-sustaining drugs could face fewer gaps in supply.
What it does
- Requires drug makers to notify the FDA within 10 days of possible shortages
- Covers rising demand, export limits, and other shortage risks for critical drugs
- Applies to both prescription and nonprescription drugs
- Requires drug makers to report production amounts twice a year, not yearly
- Requires makers to name suppliers of key active ingredients
In committee
Next: a committee vote
- Introduceddone
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About this bill
Would require drug makers to notify the FDA within 10 days when demand or export limits could cause a shortage of critical drugs. Would also require twice-yearly production reports.
Drug Shortage Prevention Act of 2025
Perspectives
💬 The case for
Patient and health groups would likely say early warnings help prevent shortages of important medicines. Earlier reports give regulators more time to respond.
💬 The case against
Some drug makers would likely say the reporting adds paperwork and cost. They may also worry that short deadlines are hard to meet.
Sponsored by
Sponsor details for this federal bill are at the source link.
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