Maintaining Investments in New Innovation Act
- Bill Number
- H.R. 1672
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-02-27: 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.
- Last Updated
- 2026-06-26T08:07:47Z
AI-Generated Summary
Purpose
The Maintaining Investments in New Innovation Act (H.R. 1672) aims to encourage the development of innovative drugs by extending market protections for genetically targeted technologies. These are advanced treatments that interact with genes to modify their function, such as suppressing or activating them to treat diseases. By doing so, the bill seeks to ensure continued access to these cutting-edge therapies under Medicare programs.
Key Provisions
- Extension of Exclusivity Period: Amends Section 1192(e) of the Social Security Act, which deals with drug pricing negotiations under Medicare.
- Definition of Advanced Drug Product: Introduces a new term for drugs that use "genetically targeted technology" (as defined in the Federal Food, Drug, and Cosmetic Act). This technology modulates (alters) the function of a gene or its protein product.
- Specific Change: For these advanced drugs, the exclusivity period before Medicare can negotiate prices increases from 7 years to 11 years. This applies to "qualifying single source drugs," which are typically high-cost medications without generic competition.
Significant Changes to Existing Law
- Under current law (from the Inflation Reduction Act of 2022), Medicare's drug price negotiation program grants a 7-year exclusivity period for single-source drugs, after which the government can negotiate lower prices.
- This bill modifies that by creating a longer 11-year period specifically for genetically targeted drugs, providing extended protection from price controls to incentivize research and development.
- It cross-references the Federal Food, Drug, and Cosmetic Act for the definition of genetically targeted technology, ensuring consistency with FDA regulations.
Potential Impacts
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) will delay price negotiations for these drugs, potentially increasing short-term Medicare spending on innovative treatments but fostering long-term innovation in gene-based therapies.
- On Citizens: Patients with rare or genetic diseases (e.g., those treated by gene therapies for conditions like spinal muscular atrophy) may gain better access to new treatments due to encouraged development, though it could delay lower prices and affect affordability.
- On International Relations: Minimal direct impact, but it may influence global pharmaceutical investment by signaling U.S. support for biotech innovation, potentially attracting international research partnerships.
Main Stakeholders Affected
- Pharmaceutical Companies: Developers of gene therapies (e.g., firms like those producing CRISPR-based or RNA-targeted drugs) benefit from longer market exclusivity, reducing financial risks in high-cost R&D.
- Patients and Healthcare Providers: Individuals relying on advanced genetic treatments gain from increased availability, while doctors and hospitals may see more options for personalized medicine.
- Government and Taxpayers: Medicare and federal budget planners face higher near-term costs but potential savings from breakthroughs in disease treatment.
- Generic Drug Manufacturers: Delayed entry into the market for these specialized drugs, limiting competition.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens intellectual property-like protections in healthcare law without altering patent rules, potentially facing challenges if seen as favoring industry over public access to affordable drugs. It harmonizes Social Security Act provisions with FDA oversight.
- Constitutional: No direct conflicts; aligns with Congress's authority to regulate interstate commerce and healthcare spending under the Spending Clause.
- Political: Bipartisan sponsorship (from both parties) highlights broad support for biotech innovation amid debates on drug pricing. It could spark discussions on balancing innovation incentives with cost controls, especially post-Inflation Reduction Act.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Davis, Donald G. [D-NC-1]
Cosponsors (46)
Rep. Joyce, John [R-PA-13], Rep. Gottheimer, Josh [D-NJ-5], Rep. Tenney, Claudia [R-NY-24], Rep. Yakym, Rudy [R-IN-2], Rep. Morelle, Joseph D. [D-NY-25], Rep. Hudson, Richard [R-NC-9], Rep. Bean, Aaron [R-FL-4], Rep. Miller-Meeks, Mariannette [R-IA-1], Rep. Allen, Rick W. [R-GA-12], Rep. Van Duyne, Beth [R-TX-24], Rep. Peters, Scott H. [D-CA-50], Rep. Moore, Blake D. [R-UT-1], Rep. Crenshaw, Dan [R-TX-2], Rep. Dunn, Neal P. [R-FL-2], Rep. Hern, Kevin [R-OK-1], Rep. Carey, Mike [R-OH-15], Rep. Shreve, Jefferson [R-IN-6], Rep. Pfluger, August [R-TX-11], Rep. Sessions, Pete [R-TX-17], Rep. McDowell, Addison P. [R-NC-6], Rep. Kelly, Mike [R-PA-16], Rep. Fleischmann, Charles J. "Chuck" [R-TN-3], Rep. Meuser, Daniel [R-PA-9], Rep. Malliotakis, Nicole [R-NY-11], Rep. Pettersen, Brittany [D-CO-7], Rep. Balderson, Troy [R-OH-12], Rep. Moore, Tim [R-NC-14], Rep. Edwards, Chuck [R-NC-11], Rep. Moolenaar, John R. [R-MI-2], Rep. Weber, Randy K. Sr. [R-TX-14], Rep. Calvert, Ken [R-CA-41], Rep. Fong, Vince [R-CA-20], Rep. Jack, Brian [R-GA-3], Rep. Moran, Nathaniel [R-TX-1], Rep. Lee, Laurel M. [R-FL-15], Rep. Kean, Thomas H. [R-NJ-7], Rep. Haridopolos, Mike [R-FL-8], Rep. Hinson, Ashley [R-IA-2], Rep. Mullin, Kevin [D-CA-15], Rep. Lawler, Michael [R-NY-17], Rep. Barr, Andy [R-KY-6], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Langworthy, Nicholas A. [R-NY-23], Rep. Smith, Adrian [R-NE-3], Rep. Smucker, Lloyd [R-PA-11], Rep. Evans, Gabe [R-CO-8]
Recent Actions
- 2025-02-27: 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.
- 2025-02-27: 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.
- 2025-02-27: Introduced in House
- 2025-02-27: Introduced in House
Bill Versions
- Maintaining Investments in New Innovation Act — issued 2025-02-27 — PDF (2 pages)