arrow_back Back to App

Increased Transparency in Generic Drug Approvals

New rules aim to make it easier for generic drug companies to get information from a government agency about whether their product is identical to the original drug. This is intended to speed up the introduction of cheaper drug alternatives to the market, potentially impacting the availability and cost of treatment for citizens.
Key points
Generic drug companies can now ask the government agency if their drug is the same as the original.
The agency must respond and point out any differences in ingredients or amounts.
If the agency confirms the drug is identical, it cannot change this decision unless the original drug was withdrawn for safety reasons or the agency made an error.
The agency has one year to develop guidelines on how it will assess drug identity.
article Official text account_balance Process page
Expired
Citizen Poll
No votes cast
Additional Information
Print number: 117_S_4338
Sponsor: Sen. Hassan, Margaret Wood [D-NH]
Process start date: 2022-05-26
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-2.5-flash-preview-04-17
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

Increasing Transparency in Generic Drug Applications Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_S_4338.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2022-05-26.

What are the main provisions?

Key points include:

  • Generic drug companies can now ask the government agency if their drug is the same as the original.
  • The agency must respond and point out any differences in ingredients or amounts.
  • If the agency confirms the drug is identical, it cannot change this decision unless the original drug was withdrawn for safety reasons or the agency made an error.
  • The agency has one year to develop guidelines on how it will assess drug identity.
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. Hassan, Margaret Wood [D-NH].

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 2025-12-29.

CATEGORIES

Health