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Generic Drug Safety: Manufacturers Can Add New Patient Warnings Faster.

This bill aims to enhance patient safety by allowing generic drug manufacturers to proactively update their drug labels with new warnings or safety information. This means that if new risk data emerges, generic drug makers can immediately inform patients without having to wait for the brand-name drug manufacturer to update their label first. This change should lead to quicker access to critical safety information regarding widely used medications.
Key points
Generic drug manufacturers gain the authority to independently add new safety warnings to their labels, mirroring the rights of brand-name drug producers.
The change is intended to ensure patients receive faster notification about potential risks or side effects associated with generic medications.
The FDA retains the power to mandate conforming label changes for the equivalent brand-name drug and other generics once a safety update is introduced.
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Additional Information
Print number: 118_S_2886
Sponsor: Sen. Van Hollen, Chris [D-MD]
Process start date: 2023-09-21
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Summarized by: gemini-2.5-flash-preview-09-2025
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Updated Drug Labeling for Patient Safety Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_S_2886.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2023-09-21.

What are the main provisions?

Key points include:

  • Generic drug manufacturers gain the authority to independently add new safety warnings to their labels, mirroring the rights of brand-name drug producers.
  • The change is intended to ensure patients receive faster notification about potential risks or side effects associated with generic medications.
  • The FDA retains the power to mandate conforming label changes for the equivalent brand-name drug and other generics once a safety update is introduced.
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. Van Hollen, Chris [D-MD].

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 2025-12-26.

CATEGORIES

Health