arrow_back Back to App

Faster Drug Access for Life-Threatening Illnesses: Provisional Approval Pathway.

This Act establishes a new, accelerated pathway for the provisional approval of drugs treating serious or life-threatening conditions. This allows patients quicker access to promising therapies before they complete the full FDA approval process. Patients must provide informed consent acknowledging the risks and are required to participate in observational registries to track their health data.
Key points
Drugs for life-threatening diseases can be evaluated for provisional approval within 90 days based on early evidence of safety and efficacy.
Health insurers and Federal programs cannot deny coverage for these drugs solely because they are provisionally approved or considered experimental.
Patients must participate in mandatory registries to monitor their data and sign informed consent acknowledging the reduced testing and associated risks.
Drug manufacturers receive limited legal liability protection against claims of unsafety or ineffectiveness, except in cases of gross negligence or willful misconduct.
article Official text account_balance Process page
Expired
Citizen Poll
No votes cast
Additional Information
Print number: 118_S_1906
Sponsor: Sen. Braun, Mike [R-IN]
Process start date: 2023-06-08
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-3-pro-preview
Source data: api.congress.gov
AI work logs for this document launch

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_S_1906.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2023-06-08.

What are the main provisions?

Key points include:

  • Drugs for life-threatening diseases can be evaluated for provisional approval within 90 days based on early evidence of safety and efficacy.
  • Health insurers and Federal programs cannot deny coverage for these drugs solely because they are provisionally approved or considered experimental.
  • Patients must participate in mandatory registries to monitor their data and sign informed consent acknowledging the reduced testing and associated risks.
  • Drug manufacturers receive limited legal liability protection against claims of unsafety or ineffectiveness, except in cases of gross negligence 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 Sen. Braun, Mike [R-IN].

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 2025-12-30.

CATEGORIES

Health