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Approval of Subsequent Generic Drug Applications Upon First Applicant Delay

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.
article Official text account_balance Process page
Introduced
Citizen Poll
No votes cast
Additional Information
Print number: 119_HR_1051
Sponsor: Rep. Budzinski, Nikki [D-IL-13]
Process start date: 2025-02-06
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Summarized by: gemini-3-pro-preview
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

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.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_HR_1051.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2025-02-06.

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.
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: View full text

Who is the primary sponsor?

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

What is the latest detailed status?

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

Is this summary verified?

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

CATEGORIES

Health