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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.

119th Congress Introduced by Nikki Budzinski

HR 1051 streamlines generic drug approvals, allowing faster market entry for subsequent applicants, boosting competition, and improving access to affordable medications.

Introduced in House
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WeVote Research Nonpartisan
Bill Summary · HR 1051

Summary of HR 1051: Abbreviated New Drug Application Amendments

Bill Number: HR 1051
Introduced: February 19, 2025
Status: Introduced in House
Primary Sponsors: Representatives D. Garner, Gonzales Worthen, Vaught, McCullough, Hudson, J. Mayberry

Purpose and Intent

HR 1051 aims to amend the Federal Food, Drug, and Cosmetic Act (FDCA) to facilitate the approval process for abbreviated new drug applications (ANDAs). The bill addresses situations where a first applicant fails to commence commercial marketing of a drug within a specified timeframe, allowing subsequent applicants to gain approval more efficiently. This legislative change is intended to enhance competition in the pharmaceutical market and improve access to medications.

Key Provisions

The bill proposes several significant amendments to Section 505(j) of the FDCA:

  1. Approval Process for Subsequent Applicants:

    • Allows a subsequent applicant to submit an ANDA if the first applicant does not begin commercial marketing within 75 days after approval.
    • The subsequent applicant must certify that there are no conditions preventing them from marketing the drug within this period.

  2. Conditions for Approval:

    • At least 33 months must have passed since the first applicant submitted their application.
    • The first applicant must not have received effective approval on the date the conditions for the subsequent applicant are met.

  3. Tentative Approval:

    • If the subsequent applicant does not commence marketing within the specified 75 days, their application will be deemed tentatively approved.
    • The applicant must notify the FDA if they cannot commence marketing due to unforeseen events.

  4. Exclusivity Period:

    • The bill maintains a 180-day exclusivity period for the first applicant, but allows for the potential approval of subsequent applications under specific conditions.

Impact

  • Pharmaceutical Companies: The bill primarily affects pharmaceutical manufacturers by potentially increasing competition and reducing delays in bringing generic drugs to market.
  • Patients and Consumers: By facilitating quicker access to generic medications, the bill aims to lower drug prices and improve availability for consumers.
  • Healthcare System: The changes could lead to reduced healthcare costs associated with prescription medications, benefiting both patients and insurers.

Procedural Aspects

  • Legislative Timeline:
    • February 19, 2025: Bill filed and referred to the House Committee on Energy and Commerce.
    • February 25, 2025: The bill was read, amended, and reported correctly engrossed.
    • February 27, 2025: The bill was read and adopted.

Conclusion

HR 1051 seeks to streamline the approval process for generic drugs, promoting competition and enhancing patient access to affordable medications. By addressing the challenges faced by subsequent applicants, the bill aims to create a more efficient pharmaceutical market while ensuring that patients benefit from timely access to necessary treatments.

Compiled from official sources — confirm details with the bill’s official record.

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