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119-s-2665119th CongressWALLET

Drug Shortage Prevention Act of 2025

Sponsored By: Senator Klobuchar, Amy [D-MN]

Introduced

Summary

Would create a mandatory notification system requiring manufacturers to alert the Secretary about likely U.S. supply disruptions for critical medicines. It would narrow which products count as "covered drugs", set specific timelines and content for alerts, expand supply-chain reporting, and require the Secretary to share warnings with clinicians and patient groups.

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  • Manufacturers: Producers of designated "covered drugs" would have to report events likely to cause meaningful disruption, including permanent discontinuances, manufacturing interruptions, API shortages, increased demand, or export restrictions. Notifications must name API sources and possible alternatives, note if related devices contribute, estimate duration, and follow timelines such as at least 6 months before a planned discontinuance and as soon as practicable or within 10 business days for sudden demand or export problems.
  • Clinicians and patients: The Secretary would distribute notification information to physicians, health providers, and patient organizations so care teams and patients can plan for shortages and consider alternatives.
  • Scope and transparency: The Secretary could designate drugs as "covered" when they are life-supporting, life-sustaining, or critical for preventing or treating debilitating conditions, emergency care, surgery, or public health emergencies. The bill would also require semiannual supply-chain reports in March and September listing legal names of API and intermediate suppliers and the amounts manufactured from each, with an option for registrants to submit additional voluntary reports.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 0 benefits, 1 costs, 1 mixed.

New reporting rules for drug makers

This bill would make drug makers report supply problems and supplier details to the Secretary. Manufacturers would have to notify at least 6 months before planned stoppages. For sudden problems, they would report as soon as practicable and no later than 10 business days. Registrants would also file supply-chain reports twice a year, in March and September, naming API and in-process material suppliers and how much came from each.

Which drugs count as covered

This bill would define which medicines are "covered drugs" for early-warning rules. Covered drugs would include life-supporting or life-sustaining medicines, drugs for serious diseases, drugs used in emergency care or during surgery, and drugs critical in a declared public health emergency. It would exclude radiopharmaceutical products and would not include most biological products unless the Secretary says otherwise by rule.

Sponsors & CoSponsors

Sponsor

Klobuchar, Amy [D-MN]

MN • D

Cosponsors

  • Sen. Collins, Susan M. [R-ME]

    ME • R

    Sponsored 8/1/2025

  • Sen. Warren, Elizabeth [D-MA]

    MA • D

    Sponsored 8/1/2025

  • Sen. Murkowski, Lisa [R-AK]

    AK • R

    Sponsored 8/1/2025

  • Sen. Smith, Tina [D-MN]

    MN • D

    Sponsored 8/1/2025

  • Sen. Peters, Gary C. [D-MI]

    MI • D

    Sponsored 8/1/2025

Roll Call Votes

No roll call votes available for this bill.

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