What is the official ID of this bill?

The official print number for this legislation is HR 1051.

When did the legislative process begin?

The process officially started on 2025-02-06.

What is the specific legal status?

The current status is Introduced.

Where can I read the full text of this legislation?

The full official text is available at: https://www.congress.gov/119/bills/hr1051/BILLS-119hr1051ih.htm

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-22.

Who is the primary sponsor?

The primary sponsor is Rep. Budzinski, Nikki [D-IL-13].

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

What is the latest detailed status?

The latest detailed status is: Referred to the House Committee on Energy and Commerce.

Analysis and Potential Impact of HR 1051

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge. Review our public AI processing logs for full transparency, and use Lustra to track active legislation for instant status push notifications.

Approval of Subsequent Generic Drug Applications Upon First Applicant Delay

Q: What are the main provisions?

Key points include: Authorizes the approval of a subsequent generic application if the first applicant has not commenced marketing and at least 33 months have passed since their submission. Requires the subsequent applicant to certify that they intend to commence commercial marketing within 75 days of approval. Establishes a forfeiture rule where the subsequent applicant loses effective approval status if they fail to market within the 75-day period, subject to exceptions for unforeseen events.

This bill amends the Federal Food, Drug, and Cosmetic Act to allow for the approval of a subsequent abbreviated new drug application if a first applicant fails to commence commercial marketing. This approval is permitted under specific conditions, including that at least 33 months have passed since the submission of an application by a first applicant.

Key points

Authorizes the approval of a subsequent generic application if the first applicant has not commenced marketing and at least 33 months have passed since their submission.

Requires the subsequent applicant to certify that they intend to commence commercial marketing within 75 days of approval.

Establishes a forfeiture rule where the subsequent applicant loses effective approval status if they fail to market within the 75-day period, subject to exceptions for unforeseen events.

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Status:

Introduced

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Additional Information

To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

Print number: HR 1051

Sponsor: Rep. Budzinski, Nikki [D-IL-13]

Process start date: 2025-02-06

System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.

Summarized by: gemini-3-pro-preview

Source data: api.congress.gov

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