Drug Shortage Prevention Act of 2025

LEGISLATIVE PROGRESS

STEP 2 OF 8

Introduced

In Committee

Reported

Passed Senate

Passed House

Conference

To President

Became Law

Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law

WHAT THE BILL DOES

AI-written

Drug shortages can have serious, even life-threatening, consequences for patients, leading to delayed treatments, substitute medications that may be less effective, or increased healthcare costs. This bill matters because it tries to tackle drug shortages proactively by creating an early warning system. If this bill becomes law, the government and healthcare providers would get advance notice about potential drug supply problems, not just when a drug is about to disappear, but even when demand suddenly spikes. This early heads-up could allow for actions like increasing production elsewhere, finding alternative suppliers, or rationing existing supplies more effectively, ultimately helping to ensure that critical medications are available when people need them. Without this bill, the current system provides less foresight, making it harder to prevent or mitigate shortages once they are imminent.

KEY PROVISIONS

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Requires drug manufacturers to notify the FDA of increased demand, export restrictions, or any other circumstance likely to cause a meaningful disruption in the supply of critical drugs, in addition to existing requirements for discontinuance or interruption.

This provision expands the triggers for mandatory reporting, providing earlier warnings for a broader range of potential shortage causes beyond just production issues.

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Broadens the definition of 'covered drug' to include drugs that are life-supporting, life-sustaining, or intended for use in preventing or treating debilitating diseases, including those critical during public health emergencies.

This ensures a wider array of essential medications are subject to the shortage prevention reporting requirements, increasing patient safety.

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Mandates earlier notification timelines for certain circumstances (10 business days for increased demand) and requires more detailed information in reports, including active pharmaceutical ingredient (API) sources and alternative sources.

Earlier and more comprehensive data allows the FDA and healthcare providers more time to respond and mitigate potential shortages.

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Amends existing law to require drug manufacturers to report on their supply chains semi-annually (March and September), detailing suppliers of active pharmaceutical ingredients and other materials.

This provides the FDA with ongoing visibility into the robustness and vulnerabilities of drug supply chains, crucial for long-term shortage prevention.

DEADLINES & DATES

AI-extracted

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At least 6 months prior to the date of discontinuance or interruption.

Notification to the Secretary (FDA) of permanent discontinuance or interruption in drug manufacture.

As soon as practicable, or not later than 10 business days after the onset of the circumstance.

Notification to the Secretary (FDA) of circumstances like increased demand or export restriction likely to lead to a meaningful shortfall.

Once during the month of March each year and once during the month of September each year.

Semi-annual reporting on supply chains, including active pharmaceutical ingredient suppliers.

GLOSSARY

AI-written

Federal Food, Drug, and Cosmetic Act: The main law that gives the Food and Drug Administration (FDA) authority to regulate food, drugs, medical devices, and cosmetics in the U.S.
Covered drug: A medication that is life-supporting, life-sustaining, or used to treat a serious, debilitating condition, including those needed in emergencies or public health crises.
Active pharmaceutical ingredient (API): The component of a drug that produces its intended health effects, as opposed to inactive ingredients like fillers or coatings.
Meaningful disruption: A significant problem or interruption in the supply of a drug that could affect patients' access to it.
Public health emergency: A declaration by the Secretary of Health and Human Services signaling a disease or health condition that poses a significant risk to public health, often warranting special government actions.

ACTION TIMELINE

2 EVENTS

AUG 1, 25

Introduced in Senate

INTROREFERRAL

AUG 1, 25

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

INTROREFERRAL

READER REACTIONS

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MORE INFORMATION

Committee Referrals

Health, Education, Labor, and Pensions CommitteeReferred

Aug 1, 2025

senate

Drug Shortage Prevention Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

SPONSORSHIP

ACTION TIMELINE

BILL INFO

READER REACTIONS

Discussion

Drug Shortage Prevention Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

DEADLINES & DATES

GLOSSARY

ACTION TIMELINE

SPONSORS

READER REACTIONS

What do you think?

Discussion

MORE INFORMATION

Committee Referrals

Search

Drug Shortage Prevention Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

SPONSORSHIP

ACTION TIMELINE

BILL INFO

READER REACTIONS

Discussion

Drug Shortage Prevention Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

DEADLINES & DATES

GLOSSARY

ACTION TIMELINE

SPONSORS

READER REACTIONS

What do you think?

Discussion

MORE INFORMATION

Committee Referrals