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HR1672119th CongressWALLET

Maintaining Investments in New Innovation Act

Sponsored By: Representative Rep. Davis, Donald G. [D-NC-1]

Introduced

Summary

Extends market exclusivity for genetically targeted drugs. This bill would create a new category called "advanced drug product" and lengthen the exclusivity term for those products to protect access to genetically targeted technologies.

Show full summary
  • Drug developers and manufacturers: Advanced drug products would get longer market exclusivity, increasing the term from 7 years to 11 years for qualifying single source drugs.
  • Regulatory definition: The bill ties the "advanced drug product" label to genetically targeted technologies by referencing section 529A(c)(2) of the Federal Food, Drug, and Cosmetic Act and specifies products that modulate gene function.
  • Federal programs and administration: It relies on the existing exclusivity framework and makes no funding, eligibility, or new enforcement changes beyond the definitional and exclusivity adjustments.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 0 benefits, 1 costs, 0 mixed.

Longer exclusivity for gene-targeted drugs

This bill would extend exclusivity from 7 years to 11 years for some gene‑targeted, single‑source drugs. These “advanced drug products” use a genetic targeting method that can change how a gene or its product works. If enacted, this could delay entry of cheaper generics or biosimilars. Patients and health plans using these drugs could face higher prices while exclusivity lasts. The change would take effect upon enactment.

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Sponsors & CoSponsors

Sponsor

Rep. Davis, Donald G. [D-NC-1]

NC • D

Cosponsors

  • Joyce (PA)

    PA • R

    Sponsored 2/27/2025

  • Rep. Gottheimer, Josh [D-NJ-5]

    NJ • D

    Sponsored 2/27/2025

  • Tenney

    NY • R

    Sponsored 2/27/2025

  • Yakym

    IN • R

    Sponsored 2/27/2025

  • Rep. Morelle, Joseph D. [D-NY-25]

    NY • D

    Sponsored 2/27/2025

  • Hudson

    NC • R

    Sponsored 2/27/2025

  • Bean (FL)

    FL • R

    Sponsored 2/27/2025

  • Rep. Miller-Meeks, Mariannette [R-IA-1]

    IA • R

    Sponsored 2/27/2025

  • Allen

    GA • R

    Sponsored 2/27/2025

  • Van Duyne

    TX • R

    Sponsored 2/27/2025

  • Peters

    CA • D

    Sponsored 2/27/2025

  • Rep. Moore, Blake D. [R-UT-1]

    UT • R

    Sponsored 2/27/2025

  • Crenshaw

    TX • R

    Sponsored 2/27/2025

  • Rep. Dunn, Neal P. [R-FL-2]

    FL • R

    Sponsored 3/27/2025

  • Hern (OK)

    OK • R

    Sponsored 4/9/2025

  • Rep. Carey, Mike [R-OH-15]

    OH • R

    Sponsored 4/10/2025

  • Rep. Shreve, Jefferson [R-IN-6]

    IN • R

    Sponsored 5/9/2025

  • Pfluger

    TX • R

    Sponsored 5/13/2025

  • Sessions

    TX • R

    Sponsored 6/4/2025

  • McDowell

    NC • R

    Sponsored 6/10/2025

  • Kelly (PA)

    PA • R

    Sponsored 9/2/2025

  • Rep. Fleischmann, Charles J. "Chuck" [R-TN-3]

    TN • R

    Sponsored 9/17/2025

  • Rep. Meuser, Daniel [R-PA-9]

    PA • R

    Sponsored 9/30/2025

  • Malliotakis

    NY • R

    Sponsored 9/30/2025

  • Rep. Pettersen, Brittany [D-CO-7]

    CO • D

    Sponsored 9/30/2025

  • Balderson

    OH • R

    Sponsored 10/3/2025

  • Moore (NC)

    NC • R

    Sponsored 10/17/2025

  • Edwards

    NC • R

    Sponsored 10/31/2025

  • Rep. Moolenaar, John R. [R-MI-2]

    MI • R

    Sponsored 10/31/2025

  • Rep. Weber, Randy K. Sr. [R-TX-14]

    TX • R

    Sponsored 10/31/2025

  • Rep. Calvert, Ken [R-CA-41]

    CA • R

    Sponsored 10/31/2025

  • Fong

    CA • R

    Sponsored 11/4/2025

  • Jack

    GA • R

    Sponsored 11/10/2025

  • Rep. Moran, Nathaniel [R-TX-1]

    TX • R

    Sponsored 11/17/2025

  • Lee (FL)

    FL • R

    Sponsored 11/21/2025

  • Kean

    NJ • R

    Sponsored 11/21/2025

  • Haridopolos

    FL • R

    Sponsored 11/21/2025

  • Rep. Hinson, Ashley [R-IA-2]

    IA • R

    Sponsored 12/4/2025

  • Rep. Mullin, Kevin [D-CA-15]

    CA • D

    Sponsored 12/9/2025

  • Rep. Lawler, Michael [R-NY-17]

    NY • R

    Sponsored 1/13/2026

  • Barr

    KY • R

    Sponsored 3/20/2026

  • Bilirakis

    FL • R

    Sponsored 4/15/2026

Roll Call Votes

No roll call votes available for this bill.

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