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Faster Drug Access: Provisional Approvals and Patient Registries for Serious Diseases

This act establishes a new pathway for faster, provisional approval of drugs for serious diseases, including COVID-19, potentially accelerating access to new treatments. Patients using these drugs will need to provide informed consent and participate in observational registries to monitor their health, ensuring data collection on safety and effectiveness. Private and federal health programs will be prohibited from denying coverage for these drugs due to their experimental status.
Key points
Accelerated Drug Approval: The FDA can provisionally approve drugs for serious diseases, including pandemics, potentially reducing waiting times for new therapies.
Mandatory Consent and Patient Registries: Patients taking provisionally approved drugs must give informed consent and participate in registries to collect data on their health and side effects.
Coverage for Treatment: Private insurers and federal health programs cannot deny coverage for provisionally approved drugs on the grounds of them being experimental.
Limited Manufacturer Liability: Manufacturers of provisionally approved drugs will have limited legal liability, unless their conduct is reckless, grossly negligent, or an intentional tort.
Patient Advocate General: A Patient Advocate General position will be created within the FDA to assist patients and their families using these drugs.
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Additional Information
Print number: 117_S_1644
Sponsor: Sen. Braun, Mike [R-IN]
Process start date: 2021-05-13
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Summarized by: gemini-2.5-flash
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 117_S_1644.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2021-05-13.

What are the main provisions?

Key points include:

  • Accelerated Drug Approval: The FDA can provisionally approve drugs for serious diseases, including pandemics, potentially reducing waiting times for new therapies.
  • Mandatory Consent and Patient Registries: Patients taking provisionally approved drugs must give informed consent and participate in registries to collect data on their health and side effects.
  • Coverage for Treatment: Private insurers and federal health programs cannot deny coverage for provisionally approved drugs on the grounds of them being experimental.
  • Limited Manufacturer Liability: Manufacturers of provisionally approved drugs will have limited legal liability, unless their conduct is reckless, grossly negligent, or an intentional tort.
  • Patient Advocate General: A Patient Advocate General position will be created within the FDA to assist patients and their families using these drugs.
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 2026-01-02.

CATEGORIES

Health