arrow_back Back to App

Faster Approval of Generic Drugs with New Safety Information

This act aims to accelerate the market entry of more affordable generic drugs. It allows for their approval even if certain safety information, protected by exclusivity for original drugs, is missing. This means citizens could gain quicker access to cheaper drug alternatives, potentially lowering healthcare costs.
Key points
Generic drugs can be approved faster, even if their labels omit safety information protected by exclusivity for original drugs.
Essential safety information will still be required on generic drug labels to ensure safe use.
The act does not affect existing exclusivity rights for original drugs but facilitates access to cheaper alternatives.
This could lead to lower drug costs for patients and increased availability of important treatments.
article Official text account_balance Process page
Expired
Citizen Poll
No votes cast
Additional Information
Print number: 117_HR_2831
Sponsor: Rep. Barragan, Nanette Diaz [D-CA-44]
Process start date: 2021-04-26
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

Prompt Approval of Safe Generic Drugs Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_HR_2831.

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 2021-04-26.

What are the main provisions?

Key points include:

  • Generic drugs can be approved faster, even if their labels omit safety information protected by exclusivity for original drugs.
  • Essential safety information will still be required on generic drug labels to ensure safe use.
  • The act does not affect existing exclusivity rights for original drugs but facilitates access to cheaper alternatives.
  • This could lead to lower drug costs for patients and increased availability of important treatments.
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. Barragan, Nanette Diaz [D-CA-44].

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 2025-12-27.

CATEGORIES

Health