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Maintaining Investments in New Innovation Act
To amend title XI of the Social Security Act to protect access to genetically targeted technologies.
Summary
This bill amends the Medicare drug price negotiation program to extend the protection period for drugs using genetically targeted technologies from 7 years to 11 years before they become subject to Medicare price negotiations. The bill defines "advanced drug products" as drugs that incorporate or utilize genetically targeted technology designed to modulate gene function, including suppression, up-regulation, or activation of genes or their associated products. This extended protection period aligns genetically targeted drugs with the 11-year protection already granted to biologic drugs, while standard drugs continue to have a 7-year protection period. The bill aims to provide manufacturers of gene-targeting therapies with additional time to recover development and commercialization costs before facing Medicare price negotiations. This extends the timeframe during which these drugs can be priced without government negotiation limits.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
48 cosponsors
- Rep. Allen, Rick W. [R-GA-12] (R-GA)
- Rep. Balderson, Troy [R-OH-12] (R-OH)
- Rep. Barr, Andy [R-KY-6] (R-KY)
- Rep. Bean, Aaron [R-FL-4] (R-FL)
- Rep. Bilirakis, Gus M. [R-FL-12] (R-FL)
- Rep. Calvert, Ken [R-CA-41] (R-CA)
- Rep. Carey, Mike [R-OH-15] (R-OH)
- Rep. Carter, Earl L. "Buddy" [R-GA-1] (R-GA)
- Rep. Crenshaw, Dan [R-TX-2] (R-TX)
- Rep. Dunn, Neal P. [R-FL-2] (R-FL)
- Rep. Edwards, Chuck [R-NC-11] (R-NC)
- Rep. Evans, Gabe [R-CO-8] (R-CO)
- Rep. Fleischmann, Charles J. "Chuck" [R-TN-3] (R-TN)
- Rep. Fong, Vince [R-CA-20] (R-CA)
- Rep. Gottheimer, Josh [D-NJ-5] (D-NJ)
- Rep. Haridopolos, Mike [R-FL-8] (R-FL)
- Rep. Hern, Kevin [R-OK-1] (R-OK)
- Rep. Hinson, Ashley [R-IA-2] (R-IA)
- Rep. Hudson, Richard [R-NC-9] (R-NC)
- Rep. Jack, Brian [R-GA-3] (R-GA)
- Rep. Joyce, John [R-PA-13] (R-PA)
- Rep. Kean, Thomas H. [R-NJ-7] (R-NJ)
- Rep. Kelly, Mike [R-PA-16] (R-PA)
- Rep. Langworthy, Nicholas A. [R-NY-23] (R-NY)
- Rep. Lawler, Michael [R-NY-17] (R-NY)
- Rep. Lee, Laurel M. [R-FL-15] (R-FL)
- Rep. Malliotakis, Nicole [R-NY-11] (R-NY)
- Rep. McDowell, Addison P. [R-NC-6] (R-NC)
- Rep. Meuser, Daniel [R-PA-9] (R-PA)
- Rep. Miller-Meeks, Mariannette [R-IA-1] (R-IA)
- Rep. Moolenaar, John R. [R-MI-2] (R-MI)
- Rep. Moore, Blake D. [R-UT-1] (R-UT)
- Rep. Moore, Tim [R-NC-14] (R-NC)
- Rep. Moran, Nathaniel [R-TX-1] (R-TX)
- Rep. Morelle, Joseph D. [D-NY-25] (D-NY)
- Rep. Moskowitz, Jared [D-FL-23] (D-FL)
- Rep. Mullin, Kevin [D-CA-15] (D-CA)
- Rep. Peters, Scott H. [D-CA-50] (D-CA)
- Rep. Pettersen, Brittany [D-CO-7] (D-CO)
- Rep. Pfluger, August [R-TX-11] (R-TX)
- Rep. Sessions, Pete [R-TX-17] (R-TX)
- Rep. Shreve, Jefferson [R-IN-6] (R-IN)
- Rep. Smith, Adrian [R-NE-3] (R-NE)
- Rep. Smucker, Lloyd [R-PA-11] (R-PA)
- Rep. Tenney, Claudia [R-NY-24] (R-NY)
- Rep. Van Duyne, Beth [R-TX-24] (R-TX)
- Rep. Weber, Randy K. Sr. [R-TX-14] (R-TX)
- Rep. Yakym, Rudy [R-IN-2] (R-IN)
Actions (2)
- Feb 27, 2025 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. · house
- Feb 27, 2025 Introduced in House
More bills on these subjects (8)
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Similar bills (6)
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Text versions (1)
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Full text
IN THE HOUSE OF REPRESENTATIVES
February 27, 2025
Mr. Davis of North Carolina (for himself, Mr. Joyce of Pennsylvania, Mr. Gottheimer, Ms. Tenney, Mr. Yakym, Mr. Morelle, Mr. Hudson, Mr. Bean of Florida, Mrs. Miller-Meeks, Mr. Allen, Ms. Van Duyne, Mr. Peters, Mr. Moore of Utah, and Mr. Crenshaw) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
A BILL
To amend title XI of the Social Security Act to protect access to genetically targeted technologies.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “Maintaining Investments in New Innovation Act”.
SEC. 2. AMENDMENT TO DEFINITION OF QUALIFYING SINGLE SOURCE DRUG.
Section 1192(e) of the Social Security Act (42 U.S.C. 1320f-1(e)) is amended—
(1) in paragraph (1)(A)(ii), by inserting “(or, in the case of an advanced drug product (as defined in paragraph (4)), 11 years)” after “7 years”; and
(2) by adding at the end the following new paragraph:
“(4) Advanced drug product defined.—For purposes of paragraph (1)(A)(ii), the term ‘advanced drug product’ means a drug that incorporates or utilizes a genetically targeted technology (as defined in section 529A(c)(2) of the Federal Food, Drug, and Cosmetic Act) that may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product.”. <all>
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