Sponsors (6)
The bill improves early warning, transparency, and FDA responsiveness to drug shortages—helping patients and health systems plan and respond—at the cost of greater reporting burdens, possible higher drug prices, and risks from disclosure and data security that could harm suppliers or supply resilience.
Patients (especially those with chronic conditions) and hospitals/health systems receive earlier, more detailed warnings about impending drug shortages so clinicians can secure alternatives or adjust care to avoid treatment disruptions.
Hospitals, pharmacies, and other providers can better plan inventory and procurement because notices must include API sources, possible alternatives, and expected interruption durations, reducing the operational impact of shortages.
FDA and public‑health authorities gain more frequent and detailed supply‑chain data (biannual supplier lists plus voluntary ad hoc updates), improving detection of emerging shortages and enabling faster, targeted regulatory or import responses during emergencies.
Manufacturers face increased compliance and reporting costs from twice‑yearly detailed reports and more detailed shortage notices, which could raise drug prices or discourage production of low‑margin drugs, ultimately affecting patients and taxpayers.
Public disclosure of supplier identities, API sources, and production volumes could reveal commercially sensitive information, risking competitive harm, supply‑chain retaliation, export restrictions, or targeted exploitation that might worsen availability.
Most biological products and radiopharmaceuticals are excluded from the new notice/reporting requirements, leaving patients who rely on biologics less protected from shortages and continuing vulnerability to care disruption.
Based on analysis of 3 sections of legislative text.
Requires earlier, more detailed manufacturer notices of drug/API supply risks and twice‑annual supplier reporting to FDA, with voluntary interim reports allowed.
Introduced August 1, 2025 by Amy Klobuchar · Last progress August 1, 2025
Requires drug manufacturers and drug establishment registrants to give the Department of Health and Human Services earlier, more detailed notices when drugs or active pharmaceutical ingredients (APIs) are discontinued or at risk of supply interruptions, and to report supplier names and production amounts twice a year. Notices must include reasons, API sources, alternatives, associated devices, and expected interruption duration; timing rules include at least six months' notice for planned discontinuances and faster reporting for sudden demand or supply events.