Short on Competition Act | ChamberLight

IN COMMITTEE· 119TH CONGRESS

Senate BillS 2345Health

Short on Competition Act

INTRO JUL 17· LAST ACTION JUL 17

READING

5MIN

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Introduced

In Committee

Reported

Passed Senate

Passed House

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To President

Became Law

WHAT THE BILL DOES

AI-written

This bill matters because it directly addresses the frustrating issues of high prescription drug prices and critical drug shortages that many Americans experience. By creating pathways for faster approval of generic drugs and temporary importation, it aims to boost competition in the drug market. More competition typically leads to lower prices and a more reliable supply of medications.

If this bill becomes law, voters could see more affordable prescription drugs and fewer instances where necessary medications are unavailable. It would provide the FDA with new tools to intervene in markets that aren't working well for consumers. If it doesn't pass, the existing challenges of drug affordability and scarcity might continue, without this specific legislative effort to increase market options and ensure timely access to medicines.

KEY PROVISIONS

5AI-extracted

PROVISION 01

Allows the FDA to authorize temporary importation of certain prescription drugs for up to 3 years if there is an actual or likely drug shortage.

This provision provides a mechanism to quickly address critical drug shortages, ensuring patients can access necessary medications.

PROVISION 02

Establishes a new definition for "marginally competitive drug markets" based on fewer than 5 commercially available drugs, the original drug being approved for at least 10 years, and expired patents.

This creates a specific trigger for intervention in markets where competition is lacking, aiming to bring down prices and increase availability.

PROVISION 03

For drugs in "marginally competitive drug markets," the FDA must authorize temporary importation and may expedite review of new generic drug applications and inspections.

This dual approach aims to both immediately increase supply through importation and foster long-term competition through faster generic approvals.

PROVISION 04

The authority for temporary importation automatically terminates after 3 years or when the drug shortage (or marginally competitive market condition) ends, whichever is sooner.

This ensures the importation is a temporary measure, reducing potential long-term impacts on domestic markets while addressing immediate needs.

PROVISION 05

Requires the FDA to include the number of drugs authorized for temporary importation in its annual report on drug shortages.

This increases transparency and allows for oversight of the new importation authority and its effectiveness.

SPONSORSHIP

1 + 3

COSPONSOR BREAKDOWNBIPARTISAN · 66%

DEM 1 REP 2 IND 0

ACTION TIMELINE

2 EVENTS

JUL 17

Introduced in Senate

INTROREFERRAL

JUL 17

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

INTROREFERRAL

BILL INFO

TypeSenate Bill

NumberS 2345

Congress119th

StatusIn Committee

IntroducedJul 17, 2025

Last actionJul 17, 2025

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IN COMMITTEE· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED JUL 17, 2025

Senate BillS 2345Health

Short on Competition Act

INTRODUCED JUL 17, 2025· LAST ACTION JUL 17, 2025

PASSAGE CHANCES

—%

READING

5 min

COSPONSORS

COMPLEXITY

Moderate

Call my reps Congress.gov

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

KEY PROVISIONS

AI-extracted

high

Allows the FDA to authorize temporary importation of certain prescription drugs for up to 3 years if there is an actual or likely drug shortage.

This provision provides a mechanism to quickly address critical drug shortages, ensuring patients can access necessary medications.

high

Establishes a new definition for "marginally competitive drug markets" based on fewer than 5 commercially available drugs, the original drug being approved for at least 10 years, and expired patents.

This creates a specific trigger for intervention in markets where competition is lacking, aiming to bring down prices and increase availability.

high

For drugs in "marginally competitive drug markets," the FDA must authorize temporary importation and may expedite review of new generic drug applications and inspections.

This dual approach aims to both immediately increase supply through importation and foster long-term competition through faster generic approvals.

med

The authority for temporary importation automatically terminates after 3 years or when the drug shortage (or marginally competitive market condition) ends, whichever is sooner.

This ensures the importation is a temporary measure, reducing potential long-term impacts on domestic markets while addressing immediate needs.

low

Requires the FDA to include the number of drugs authorized for temporary importation in its annual report on drug shortages.

This increases transparency and allows for oversight of the new importation authority and its effectiveness.

DEADLINES & DATES

AI-extracted

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

Up to 3 years

Secretary shall authorize importation of such drug for a period of up to 3 years.

Not later than 60 days

Secretary shall authorize importation... beginning not later than 60 days after receipt of the information under paragraph (1)(E).

3 years or when the drug shortage no longer applies

The authority to import a drug... shall terminate after 3 years, or when the drug shortage no longer applies, whichever occurs first.

At least 2 consecutive months

Determination of a marginally competitive market requires conditions to exist for at least 2 consecutive months.

At least 10 years

Determination of a marginally competitive market requires the applicable listed drug to have been approved at least 10 years before such determination.

GLOSSARY

AI-written

Generic prescription drug: A medication that is the same as a brand-name drug in dosage, safety, strength, how it's taken, quality, performance, and intended use, but is typically sold at a lower cost after the brand-name patent expires.
Drug shortage: A period when the demand or projected demand for a prescription drug in the United States exceeds its supply, making it difficult for patients to access the medication.
Expedited approval: A faster process for reviewing and approving new drugs or generic versions of existing drugs, often used for medications that address serious conditions or for which there is an unmet medical need.
Marginally competitive drug market: A specific market for a prescription drug where there are very few (fewer than 5) different versions of the drug available for sale, the original drug has been approved for at least 10 years, and its patents have expired.
Federal Food, Drug, and Cosmetic Act: The main law in the United States that gives the Food and Drug Administration (FDA) authority to regulate food, drugs, medical devices, and cosmetics.
Active ingredient: The component in a drug or medication that is biologically active and responsible for the drug's intended effects on the body.

ACTION TIMELINE

2 EVENTS

JUL 17, 25

Introduced in Senate

INTROREFERRAL

JUL 17, 25

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

INTROREFERRAL

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Health, Education, Labor, and Pensions CommitteeReferred

Jul 17, 2025

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Short on Competition Act

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

SPONSORSHIP

ACTION TIMELINE

BILL INFO

READER REACTIONS

Discussion

Short on Competition Act

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

DEADLINES & DATES

GLOSSARY

ACTION TIMELINE

SPONSORS

READER REACTIONS

What do you think?

Discussion

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