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H.R. 843 119th Congress House

Prompt Approval of Safe Generic Drugs Act

Official title: To amend the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling, and for other purposes.

Introduced: January 31, 2025 Introduced by: Nanette Diaz Barragán Democratic · California See on congress.gov
Health Drug safety, medical device, and laboratory regulationMarketing and advertising
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 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 31, 2025
Referred to the House Committee on Energy and Commerce.
Jan 31, 2025
Introduced in House
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What's happening now January 31, 2025

Referred to the House Committee on Energy and Commerce.

 Plain-English summary Congressional Research Service

Prompt Approval of Safe Generic Drugs Act

This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.

Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.

Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances. 

For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.

 Bill text 1 version

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 Lobbying activity 7

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APA
U.S. Congress. (2026). H.R. 843: Prompt Approval of Safe Generic Drugs Act. 119th Congress. Open America. https://openamerica.io/bill/119-HR-843/
MLA
"H.R. 843: Prompt Approval of Safe Generic Drugs Act." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-HR-843/.
Bluebook (legal)
H.R. 843, 119th Cong. (2026), https://openamerica.io/bill/119-HR-843/.
Markdown link
[H.R. 843: Prompt Approval of Safe Generic Drugs Act](https://openamerica.io/bill/119-HR-843/)
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