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.

2/7/2025, 9:05 AM

Summary of Bill HR 1051

Bill 119 HR 1051, also known as the "Subsequent Entry of Generics Act," aims to amend the Federal Food, Drug, and Cosmetic Act to streamline the approval process for generic drugs. The bill allows for the approval of an abbreviated new drug application (ANDA) submitted by a subsequent applicant if the first applicant fails to commence commercial marketing within a certain period.

This legislation is designed to promote competition in the pharmaceutical industry by preventing delays in the approval of generic drugs. By allowing subsequent applicants to step in when the first applicant fails to bring their product to market in a timely manner, the bill aims to ensure that consumers have access to affordable generic medications.

In addition to addressing delays in the approval process, the bill also includes provisions for other purposes related to the regulation of generic drugs. Overall, Bill 119 HR 1051 seeks to improve access to affordable medications for Americans while promoting competition and innovation in the pharmaceutical industry.

Congressional Summary of HR 1051

This bill modifies provisions related to market exclusivity for a generic drug.

Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.

The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) the applicant certifies that there are no conditions that would prevent commercial marketing of the drug within 75 days of approval and that the applicant intends to do so, (3) a first applicant's application has been pending for at least 33 months, (4) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (5) no first applicant's application has been effectively approved on the date that all such conditions are met.

If an applicant fails to begin commercially marketing their drug within 75 days of approval via the aforementioned process, the applicant's approval is deemed tentative and the applicant is no longer eligible for subsequent approvals, unless the applicant certifies that the failure was due to unforeseen issues that have since been resolved.

Current Status of Bill HR 1051

Bill HR 1051 is currently in the status of Bill Introduced since February 6, 2025. Bill HR 1051 was introduced during Congress 119 and was introduced to the House on February 6, 2025. Bill HR 1051's most recent activity was Referred to the House Committee on Energy and Commerce. as of February 6, 2025

Bipartisan Support of Bill HR 1051

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Policy Area and Potential Impact of Bill HR 1051

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Alternate Title(s) of Bill HR 1051

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.