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HR. 1843 · 119th Congress

To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

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Bill details

Introduced: 3/5/2025
Status: Referred to the House Committee on Energy and Commerce.
Bill ID: 119hr1843
Latest action: Referred to the House Committee on Energy and Commerce.

Summary

Introduced in House

This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.

Source: BILLSUM · Summary date: 3/5/2025

District impact notes

1 notes
NEUTRAL
4/1/2026

This bill requires the FDA to inform generic drug applicants about how their products compare to brand-name drugs and to explain any differences. • This policy could matter locally by potentially affecting the availability and pricing of generic medications in the area. • Local healthcare providers and pharmacies may need to adjust their practices based on the updated guidance from the FDA regarding generic drug approvals. • There may be questions about how effectively the FDA can implement these transparency measures without delaying the approval process for new generic drugs. AI-generated from official bill summary and plain-English note; verify with official text.

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Summary source label: BILLSUM
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About this data

Non-partisan by design
OurCongress provides plain-English context without endorsements, political interpretation, or advocacy.
Official sources
Data is sourced from official government records (e.g., Congress.gov, GovInfo, Clerk of the House, and the U.S. Senate).
AI-generated text
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Last updated: 4/1/2026Source: BILLSUMBill: 119hr1843Learn more →