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Easier Access to Experimental Drugs for Serious Illnesses

New rules aim to facilitate access to experimental drugs for individuals with serious or life-threatening diseases for which no other effective therapies exist. These changes could accelerate the availability of innovative treatments, offering hope to patients in difficult situations.
Key points
Experimental drugs designated as breakthrough therapies or authorized for expanded access will be more quickly available to patients.
The facilitations apply to substances actively under investigation with the potential to treat serious diseases where other therapeutic options are lacking.
If a drug no longer meets the criteria or is approved, its status can be changed, ensuring control over its distribution.
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Status:
Expired
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Additional Information
Print number: 118_HR_1393
Sponsor: Rep. Dean, Madeleine [D-PA-4]
Process start date: 2023-03-07
System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.
Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

To amend the Controlled Substances Act to define currently accepted medical use with severe restrictions, and for other purposes.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_HR_1393.

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 2023-03-07.

What are the main provisions?

Key points include:

  • Experimental drugs designated as breakthrough therapies or authorized for expanded access will be more quickly available to patients.
  • The facilitations apply to substances actively under investigation with the potential to treat serious diseases where other therapeutic options are lacking.
  • If a drug no longer meets the criteria or is approved, its status can be changed, ensuring control over its distribution.
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 Rep. Dean, Madeleine [D-PA-4].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-24.

What is the impact of this bill?

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.

CATEGORIES

Health Courts and Law