The Drug Shortage Prevention Act of 2025 strengthens requirements for drug manufacturers to notify the FDA about potential medicine shortages. Under this bill, manufacturers of critical drugs—defined as life-saving, life-sustaining, or drugs used to treat debilitating diseases—must alert the FDA when they face production disruptions, ingredient supply problems, increased demand, or export restrictions that could lead to meaningful shortages. Manufacturers must provide this notification at least 6 months before a planned discontinuance, within 10 business days of unexpected supply problems, or as soon as practicable if advance notice isn't feasible. The bill also requires drug makers to report twice yearly (in March and September) on their suppliers of active pharmaceutical ingredients and production materials, giving the FDA better visibility into supply chain vulnerabilities. The legislation does not specify new funding but directs the FDA to share shortage information with healthcare providers, physicians, and patient organizations to help them prepare for potential drug availability issues.
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