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Stronger Drug Approvals: New Rules for Accelerated Pathways

This act aims to enhance the safety of drugs approved through accelerated pathways. It means pharmaceutical companies will be required to confirm the effectiveness of their products more quickly and reliably, providing citizens with greater confidence in the medications they take. If effectiveness is not confirmed, the drug can be withdrawn from the market faster, and labels will clearly state the approval status.
Key points
Pharmaceutical companies must conduct mandatory studies to confirm the effectiveness of drugs approved via accelerated pathways before they reach the market.
If studies do not progress or effectiveness is not confirmed, the drug can be quickly withdrawn, protecting patients from ineffective treatments.
Labels for accelerated approval drugs will clearly state this status and the need for further studies, increasing patient awareness.
Penalties for lack of diligence in studies or untimely reporting are introduced to ensure greater corporate accountability.
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Additional Information
Print number: 117_HR_6963
Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6]
Process start date: 2022-03-07
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OFFICIAL LEGAL TITLE

Accelerated Approval Integrity Act of 2022

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_HR_6963.

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 2022-03-07.

What are the main provisions?

Key points include:

  • Pharmaceutical companies must conduct mandatory studies to confirm the effectiveness of drugs approved via accelerated pathways before they reach the market.
  • If studies do not progress or effectiveness is not confirmed, the drug can be quickly withdrawn, protecting patients from ineffective treatments.
  • Labels for accelerated approval drugs will clearly state this status and the need for further studies, increasing patient awareness.
  • Penalties for lack of diligence in studies or untimely reporting are introduced to ensure greater corporate accountability.
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. Pallone, Frank, Jr. [D-NJ-6].

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 2025-12-28.

CATEGORIES

Health