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Improved Access to Orphan Drugs: New Pricing Rules

This act aims to improve access to drugs for rare diseases, known as orphan drugs. These changes may affect the availability and cost of treatment for individuals with rare conditions, potentially accelerating the introduction of new therapies to the market.
Key points
Orphan drugs (for rare diseases) will have an extended exclusion period from the drug price negotiation program, potentially encouraging their production.
The definition of an orphan drug will be broadened to include drugs for one or more rare diseases, increasing the number of eligible therapies.
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Status:
Introduced
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Additional Information
ORPHAN Cures Act
Print number: HR 946
Sponsor: Rep. Joyce, John [R-PA-13]
Process start date: 2025-02-04
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Summarized by: gemini-2.5-flash
Source data: api.congress.gov
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Summary & Status

Key Questions about Improved Access to Orphan Drugs: New Pricing Rules

A structured overview of the legislative process, official sources, status and civic context.

What is the official ID of this bill?

The official print number for this legislation is HR 946.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2025-02-04.

What are the main provisions?

Key points include:

  • Orphan drugs (for rare diseases) will have an extended exclusion period from the drug price negotiation program, potentially encouraging their production.
  • The definition of an orphan drug will be broadened to include drugs for one or more rare diseases, increasing the number of eligible therapies.

What is the specific legal status?

The current status is Introduced.

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 Rep. Joyce, John [R-PA-13].

What is the latest detailed status?

The latest detailed status is: Sponsor introductory remarks on measure. (CR H535-536)

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-23.

Analysis and Potential Impact of HR 946

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge. Review our public AI processing logs for full transparency, and use Lustra to track active legislation for instant status push notifications.

CATEGORIES

Health