Drug Shortage Prevention Act of 2025

Bill Number

S. 2665

Origin Chamber

Senate

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-08-01: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Last Updated

2025-09-18T19:59:54Z

AI-Generated Summary

Purpose of the Legislation

The Drug Shortage Prevention Act of 2025 aims to prevent shortages of critical drugs by requiring drug manufacturers to provide earlier and more detailed notifications to the U.S. Food and Drug Administration (FDA) about potential supply disruptions, including those caused by increased demand. It expands existing reporting rules to improve transparency in drug supply chains and help the government respond proactively to risks affecting the availability of essential medications.

Key Provisions

• Notification Requirements for Manufacturers:
• Manufacturers of "covered drugs" (defined below) must notify the FDA of:
• Permanent discontinuances or interruptions in drug or active pharmaceutical ingredient (API) production likely to cause significant supply disruptions.
• Other issues, such as sudden increases in demand or export restrictions, that could prevent meeting U.S. demand without delays or shortfalls.
• Notifications must include reasons for the issue (if known), API sources and alternatives, details on any related devices for drug preparation or administration, expected duration, and other FDA-requested information.

• Timing of Notifications:
• At least 6 months in advance for planned discontinuances or interruptions.
• As soon as practicable, or within 10 business days, for demand increases or unforeseen issues.
• If advance notice isn't possible, notifications must still be sent immediately.

• Information Distribution:
• The FDA must share details of potential shortages or disruptions with relevant groups, such as physician, healthcare provider, and patient organizations, using appropriate methods.

• Supply Chain Reporting:
• Drug registrants must report to the FDA twice a year (March and September) on their supply chains, including legal names of API and material suppliers, and the amounts of drugs produced using each source.
• Voluntary additional reporting is allowed at other times specified by the FDA.

• Definition of Covered Drugs:
• Drugs intended for human use that are life-supporting, life-sustaining, or used to prevent/treat debilitating diseases/conditions.
• Includes drugs critical for emergency care, surgery, or public health emergencies (as declared under the Public Health Service Act).
• Excludes radiopharmaceuticals (drugs using radioactive materials) and biologics (products derived from living organisms, like vaccines), unless the FDA specifies otherwise in regulations.

Significant Changes to Existing Law

• Amends Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which previously focused mainly on notifications for discontinuances or interruptions in life-saving drug production:
• Updates the section heading from "discontinuance or interruption in the production of life-saving drugs" to "notification of issues affecting domestic supply of critical drugs."
• Replaces key subsections to broaden triggers beyond just production halts, adding demand surges and export issues.
• Expands the scope from "life-saving" drugs to a wider category of "covered drugs," including those for debilitating conditions and public health emergencies.
• Shortens the advance notice period from the previous 6 months (for some cases) to include faster reporting for demand-related issues.
• Amends Section 510(j) of the FD&C Act to increase supply chain reporting frequency from once a year to twice a year and add details on API/material suppliers and usage quantities, enhancing traceability.

Potential Impacts

• On Government Agencies: The FDA will receive more timely and detailed data, enabling better forecasting, mitigation strategies (e.g., stockpiling or alternative sourcing), and coordination during shortages. This could reduce administrative burdens from reactive responses to crises.
• On Citizens and Patients: Improved supply stability for critical medications, potentially preventing delays in treatments for serious illnesses, emergencies, or public health threats, leading to better health outcomes and reduced healthcare disruptions.
• On Manufacturers and Supply Chains: Increased compliance costs and reporting obligations, but incentives for better planning to avoid penalties. May encourage diversification of suppliers to minimize risks.
• On International Relations: Indirect effects through requirements to report export restrictions, which could influence U.S. trade discussions or reliance on foreign APIs, but no direct changes to international agreements.

Main Stakeholders Affected

• Drug Manufacturers: Primary reporters, facing new notification and semi-annual supply chain disclosure duties.
• FDA (as the Secretary of Health and Human Services): Gains enhanced monitoring tools and responsibilities for information distribution.
• Healthcare Providers and Patients: Benefit from advanced warnings of shortages, allowing time to seek alternatives; patient and physician organizations will receive FDA-shared updates.
• Supply Chain Partners: API and material suppliers may see increased scrutiny through required disclosures.

Notable Legal, Constitutional, or Political Implications

• Legal Implications: Strengthens FDA's regulatory authority under the FD&C Act to oversee drug supplies without creating new enforcement powers; relies on existing rulemaking for biologics inclusions. Could lead to regulations clarifying "meaningful disruption" (a significant supply shortfall) to avoid ambiguity in compliance.
• Constitutional Implications: Aligns with Congress's commerce clause powers to regulate interstate drug markets and protect public health; no apparent conflicts with due process or free speech, as reporting is limited to factual supply data.
• Political Implications: Bipartisan support (introduced by senators from both parties) reflects consensus on addressing drug shortages as a public health priority, potentially influencing future FDA funding or emergency preparedness policies. May set precedents for broader supply chain transparency in other sectors, like medical devices.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Klobuchar, Amy [D-MN]

Cosponsors (5)

Sen. Collins, Susan M. [R-ME], Sen. Warren, Elizabeth [D-MA], Sen. Murkowski, Lisa [R-AK], Sen. Smith, Tina [D-MN], Sen. Peters, Gary C. [D-MI]

Recent Actions

• 2025-08-01: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
• 2025-08-01: Introduced in Senate

Bill Versions

• Drug Shortage Prevention Act of 2025 — issued 2025-08-01 — PDF (7 pages)