To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
- Bill Number
- H.R. 1492
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-02-21: 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
- 2026-06-24T08:09:26Z
AI-Generated Summary
Purpose
This bill aims to standardize the timeline for when certain prescription drugs become eligible for price negotiations under Medicare's Drug Price Negotiation Program by aligning the waiting period for small-molecule drugs (like many traditional pills) with that of biologic drugs (complex medicines derived from living organisms).
Key Provisions
- Amends Section 1192(e)(1)(A)(ii) of the Social Security Act, which governs the Drug Price Negotiation Program established by the Inflation Reduction Act of 2022.
- Changes the exclusivity period for small-molecule drugs from 7 years to 11 years before they can be selected for negotiation.
- The change takes effect retroactively, as if it were part of the original 2022 law.
Significant Changes to Existing Law
- Under current law, biologic drugs are protected from price negotiation for 11 years after approval, while small-molecule drugs are protected for only 7 years.
- This bill eliminates this difference, extending protection for small-molecule drugs by 4 years, which delays their eligibility for Medicare price negotiations.
Potential Impacts
- On government agencies: The Centers for Medicare & Medicaid Services (CMS) may negotiate fewer small-molecule drugs in the short term, potentially increasing Medicare spending on these drugs by billions over time due to delayed price reductions.
- On citizens: Medicare beneficiaries, particularly older adults and those with chronic conditions, could face higher drug costs or copayments for small-molecule medications for an additional 4 years, affecting affordability of treatments for conditions like cancer or heart disease.
- On international relations: Minimal direct impact, though it could influence global pharmaceutical markets by extending U.S. market exclusivity, potentially affecting drug pricing and access in other countries.
- Overall, the change may slow efforts to lower prescription drug prices under Medicare, balancing innovation incentives with cost control.
Main Stakeholders Affected
- Pharmaceutical manufacturers: Companies producing small-molecule drugs (e.g., makers of statins or antibiotics) benefit from longer revenue protection periods, encouraging research and development.
- Medicare beneficiaries and patients: Those relying on Medicare Part D for drug coverage may experience prolonged higher prices.
- Taxpayers and government: Increased federal healthcare expenditures due to delayed negotiations.
- Healthcare providers: Indirectly affected through patient access to affordable medications.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens intellectual property protections for drug innovators by extending market exclusivity, but it does not alter patent laws directly; it modifies only Medicare negotiation rules. No apparent constitutional challenges, as it falls within Congress's authority over federal spending programs.
- Political: Could spark debate on drug pricing reforms, with supporters viewing it as promoting innovation and critics arguing it prioritizes industry profits over patient affordability. As a targeted amendment to a major 2022 law, it may influence broader bipartisan efforts on healthcare costs.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Murphy, Gregory F. [R-NC-3]
Cosponsors (68)
Rep. Davis, Donald G. [D-NC-1], Rep. Hudson, Richard [R-NC-9], Rep. Crenshaw, Dan [R-TX-2], Rep. Miller, Carol D. [R-WV-1], Rep. Tenney, Claudia [R-NY-24], Rep. Kean, Thomas H. [R-NJ-7], Rep. Miller-Meeks, Mariannette [R-IA-1], Rep. Malliotakis, Nicole [R-NY-11], Rep. Moore, Tim [R-NC-14], Rep. Dunn, Neal P. [R-FL-2], Rep. Van Duyne, Beth [R-TX-24], Rep. Buchanan, Vern [R-FL-16], Rep. Yakym, Rudy [R-IN-2], Rep. Moran, Nathaniel [R-TX-1], Rep. Pfluger, August [R-TX-11], Rep. McDowell, Addison [R-NC-6], Rep. Harris, Andy [R-MD-1], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Comer, James [R-KY-1], Rep. Steil, Bryan [R-WI-1], Rep. Allen, Rick W. [R-GA-12], Rep. Steube, W. Gregory [R-FL-17], Rep. Haridopolos, Mike [R-FL-8], Rep. Evans, Gabe [R-CO-8], Rep. Jack, Brian [R-GA-3], Rep. Knott, Brad [R-NC-13], Rep. Bean, Aaron [R-FL-4], Rep. Hill, J. French [R-AR-2], Rep. Kelly, Mike [R-PA-16], Rep. McCormick, Richard [R-GA-7], Rep. Bresnahan, Robert [R-PA-8], Rep. Weber, Randy K. Sr. [R-TX-14], Rep. Amodei, Mark E. [R-NV-2], Rep. Ogles, Andrew [R-TN-5], Rep. Rulli, Michael A. [R-OH-6], Rep. Smucker, Lloyd [R-PA-11], Rep. Houchin, Erin [R-IN-9], Rep. Flood, Mike [R-NE-1], Rep. Latta, Robert E. [R-OH-5], Rep. Cammack, Kat [R-FL-3], Rep. Balderson, Troy [R-OH-12], Rep. Harrigan, Pat [R-NC-10], Rep. Fedorchak, Julie [R-ND-At Large], Rep. Carey, Mike [R-OH-15], Rep. Rouzer, David [R-NC-7], Rep. Shreve, Jefferson [R-IN-6], Rep. Harshbarger, Diana [R-TN-1], Rep. Fry, Russell [R-SC-7], Rep. Hern, Kevin [R-OK-1], Rep. Goldman, Craig A. [R-TX-12] and 18 more
Recent Actions
- 2025-02-21: 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.
- 2025-02-21: 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.
- 2025-02-21: Introduced in House
- 2025-02-21: Introduced in House
Bill Versions
- To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. — issued 2025-02-21 — PDF (2 pages)