Maintaining Investments in New Innovation Act
Sponsored By: Representative Davis (NC)
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.
Sponsors & CoSponsors
Sponsor
Davis (NC)
NC • D
Cosponsors
Joyce (PA)
PA • R
Sponsored 2/27/2025
Rep. Gottheimer, Josh [D-NJ-5]
NJ • D
Sponsored 2/27/2025
Rep. Tenney, Claudia [R-NY-24]
NY • R
Sponsored 2/27/2025
Rep. Yakym, Rudy [R-IN-2]
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
Rep. Malliotakis, Nicole [R-NY-11]
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
Rep. Fong, Vince [R-CA-20]
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
Mullin
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
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov