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Faster Access to Drugs for Serious Diseases

This act creates a new pathway for faster approval of drugs for serious, life-threatening diseases. This means patients may get earlier access to promising therapies, but with additional monitoring and risk disclosure requirements. Private and federal health insurance will be required to cover these drugs.
Key points
Drugs for serious diseases can be approved faster, speeding up patient access.
Patients taking these drugs must participate in registries to monitor their health and side effects.
Health insurers, both private and federal, cannot deny coverage for these drugs on the basis of them being experimental.
Pharmaceutical companies will have limited legal liability for these drugs, unless their conduct was reckless or willful misconduct.
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Additional Information
Print number: 118_HR_4408
Sponsor: Rep. Gallagher, Mike [R-WI-8]
Process start date: 2023-06-30
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Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Promising Pathway Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_HR_4408.

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 2023-06-30.

What are the main provisions?

Key points include:

  • Drugs for serious diseases can be approved faster, speeding up patient access.
  • Patients taking these drugs must participate in registries to monitor their health and side effects.
  • Health insurers, both private and federal, cannot deny coverage for these drugs on the basis of them being experimental.
  • Pharmaceutical companies will have limited legal liability for these drugs, unless their conduct was reckless or willful misconduct.
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. Gallagher, Mike [R-WI-8].

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 2025-12-25.

CATEGORIES

Health