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Faster Drug Access and Importation to Combat Shortages and Low Competition.

This bill aims to increase the availability of prescription drugs by speeding up generic approvals and allowing temporary importation. It establishes mechanisms to quickly bring drugs from abroad during shortages or when the market lacks sufficient competition. Citizens can expect improved access to essential therapies and potentially lower costs.
Key points
Temporary Drug Importation: The FDA can authorize importing drugs from trusted countries for up to 3 years if a shortage exists in the US.
Boosting Competition: Markets with low competition (fewer than 5 available drugs, expired patents) will be treated like shortage markets, accelerating generic approvals.
Expedited Generic Review: For markets identified as marginally competitive, the review and inspection process for new generic drug applications will be fast-tracked.
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Additional Information
Print number: 118_S_845
Sponsor: Sen. Klobuchar, Amy [D-MN]
Process start date: 2023-03-16
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Summarized by: gemini-flash-latest
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Short on Competition Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_S_845.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2023-03-16.

What are the main provisions?

Key points include:

  • Temporary Drug Importation: The FDA can authorize importing drugs from trusted countries for up to 3 years if a shortage exists in the US.
  • Boosting Competition: Markets with low competition (fewer than 5 available drugs, expired patents) will be treated like shortage markets, accelerating generic approvals.
  • Expedited Generic Review: For markets identified as marginally competitive, the review and inspection process for new generic drug applications will be fast-tracked.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Klobuchar, Amy [D-MN].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-27.

CATEGORIES

Health Economy