Bill brief/S2665/119th Congress
S.2665 – Drug Shortage Prevention Act of 2025 to improve reporting on critical drug supply problems
Official title
Drug Shortage Prevention Act of 2025
This bill changes the Federal Food, Drug, and Cosmetic Act to require more reporting about problems and demand spikes for certain important drugs. It mainly affects drug manufacturers and the Food and Drug Administration (FDA). It was introduced in the Senate and sent to the Health, Education, Labor, and Pensions Committee.
Bill
S2665
Introduced
Date not available
Sponsor
Sponsor not listed
Chamber
Senate
What the bill does
What this bill does
The bill updates existing law so that manufacturers of certain “covered drugs” must notify the Secretary of Health and Human Services (through the FDA) about problems that could affect the U. S. supply. This includes permanently stopping production, temporary interruptions that may cause a meaningful disruption, problems with active pharmaceutical ingredients (APIs), and other issues like sudden increases in demand or export limits.
Manufacturers must also explain the reasons for the problem, list API sources and any known alternatives, say if any device used to prepare or give the drug is part of the problem, and provide the expected length of the interruption, plus any other information the Secretary requires. The bill sets timelines for these notices. Manufacturers must generally give notice at least 6 months before they stop or interrupt production.
For sudden issues such as demand spikes or export limits, they must notify as soon as possible, and no later than 10 business days after the problem starts; if they cannot meet these timelines, they must still notify as soon as they can. The Secretary is directed, when possible, to share information about such supply problems and likely shortages with physician, health provider, and patient organizations.
The bill also changes the definition of “covered drug” to focus on drugs for human use that are life-supporting, life-sustaining, or used to prevent or treat debilitating diseases or conditions, including drugs used in emergencies, during surgery, or that are critical to public health during a declared public health emergency. It excludes radiopharmaceutical products and certain other products the Secretary designates, and generally excludes biological products unless regulations say otherwise. In addition, the bill strengthens supply chain reporting.
Drug manufacturers who register with the FDA must report twice a year (in March and September) instead of once a year. Their reports must include the legal names of suppliers of APIs and intermediate or in-process materials, any extra information the Secretary requires about those suppliers, and how much of each drug is made using each supplier’s materials. Manufacturers may also voluntarily submit this same information at other times if the Secretary asks for it.
Impact
Why it matters—and who it affects
Why it matters
Drug shortages can affect patients who need medicines for emergencies, surgery, or treatment of serious or long-lasting conditions. By requiring earlier and more detailed notices from manufacturers, the FDA may have more time and information to try to manage or lessen shortages. The bill also aims to give health care organizations and patient groups earlier warnings so they can plan. The bill’s expanded reporting on suppliers and production amounts could give the FDA a clearer picture of where drugs and their ingredients come from and where weak points in the supply chain might be. This may help in planning for public health emergencies, but the exact effects will depend on how the FDA uses the data and how manufacturers respond. Because some products, such as most biological products and radiopharmaceuticals, are excluded unless the Secretary acts to include them, the bill focuses mainly on a defined set of critical, non-biologic drugs. How much this will reduce shortages overall is not stated in the text and is uncertain.
The debate
The case for it—and the concerns
These are the main arguments surrounding the bill, not Modern Action’s position.
Arguments in support
- Earlier and broader notifications of potential shortages may give the FDA more time to coordinate responses, find alternative suppliers, or adjust guidance to help maintain patient access to critical drugs.
- Detailed supply chain reporting on APIs and intermediate materials could help identify vulnerabilities, such as heavy reliance on a small number of suppliers or specific regions, and inform risk mitigation strategies.
- Including demand spikes and export restrictions as reportable events acknowledges that shortages are not only caused by manufacturing problems and may improve preparedness during public health emergencies.
- Sharing shortage information with provider and patient groups can support better planning, such as adjusting prescribing practices or conserving limited supplies in a transparent way.
- Clear definitions of which drugs are “covered” may focus resources and attention on medicines that are most essential to patient care and public health.
Concerns and tradeoffs
- Additional reporting and notification requirements may increase administrative and compliance burdens on manufacturers, especially smaller firms, potentially raising costs.
- Twice-yearly detailed supply chain reports, including supplier identities and production volumes, could raise concerns about protection of confidential business information and competitive data.
- The requirement to notify within 10 business days of certain triggering events may be challenging if companies lack systems to quickly detect and assess demand spikes or other emerging issues.
- Excluding most biological products and radiopharmaceuticals may leave important categories of therapies outside the core protections, potentially creating uneven oversight of shortages.
- If not matched with added resources or clear response plans at the FDA, collecting more data may not translate into faster or more effective actions to prevent or resolve shortages.
- The bill changes the focus of the relevant law from only “life-saving drugs” to a broader set of “critical drugs,” which may expand which products trigger mandatory notifications.
- “Other circumstances” that require notice include demand increases and export restrictions, which can arise outside the manufacturer’s direct control, potentially leading to more frequent reporting.
- Although biological products are generally excluded, the Secretary is given authority through regulation to bring some biological products under these requirements in the future.
Check the details
Key facts
- Expands required manufacturer notification beyond production stoppages to include spikes in demand, export restrictions, and other circumstances likely to cause meaningful drug supply disruptions.
- Requires notification to include reasons for the problem, API sources and known alternatives, related device issues, expected duration, and any additional information the Secretary requires.
- Sets a general 6‑month advance notice requirement for planned discontinuations or interruptions and a “as soon as practicable,” but no later than 10 business days, timeline for sudden circumstances like increased demand.
- Directs the Secretary, to the maximum extent practicable, to share information about likely shortages of covered drugs with physician, health provider, and patient organizations.
- Redefines “covered drug” to include life-supporting, life-sustaining, and certain debilitating-disease drugs, including those used in emergency care, surgery, or during a declared public health emergency.
- Excludes radiopharmaceutical drug products and other products designated by the Secretary from the “covered drug” category, and generally excludes biological products unless regulations extend coverage.
- Increases the frequency of required drug manufacturing reports from once a year to twice a year (March and September) for registered manufacturers.
- Requires manufacturers to report the legal names of suppliers of APIs and intermediate and in-process materials, plus the amount of drug produced using materials from each supplier.
Legislative record
How far the bill has moved
Health
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · Aug 1, 2025
- Introduced
- 2Senate Committee
- 3Senate Floor Vote
- 4Passed Senate
- 5House Review
- 6Passed Both Chambers
- 7Signed into Law
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