Next GEN Act of 2026
- Bill Number
- H.R. 8857
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-05-15: 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
- 2026-06-18T15:36:59Z
AI-Generated Summary
## Purpose The legislation amends the Social Security Act to modify eligibility rules under the Medicare Drug Price Negotiation Program for a specific category of drugs known as engineered cyclic peptides. Its goal is to extend the timeframe before these products can be selected for price negotiation.
## Key Provisions
- Changes the selection timeline in Section 1192(e)(1)(A)(ii) from 7 years to 11 years after approval for engineered cyclic peptides.
- Adds a new definition in Section 1192(e)(5) for "engineered cyclic peptide," requiring the product to:
- Consist primarily of amino acids.
- Include at least one cyclic structure formed by head-to-tail, head-to-side-chain, side-chain-to-tail, or side-chain-to-side-chain cyclization.
- Contain no more than 40 amino acids.
- Be identified through genetically encoded library screening.
- Not be naturally derived.
- Be orally administered, inhaled, or self-administered.
- Applies the new rules to negotiation lists published on or after the date of enactment.
## Significant Changes to Existing Law This bill alters the existing 7-year qualification period for single-source drugs under the Drug Price Negotiation Program by creating a longer 11-year period specifically for engineered cyclic peptides that meet the new statutory definition. It introduces a detailed, multi-part definition that did not previously exist in the law.
## Potential Impacts
- Government agencies: Extends the period before the Centers for Medicare & Medicaid Services can negotiate prices for qualifying products, potentially affecting Medicare spending timelines.
- Citizens: May delay price reductions for certain medicines, influencing out-of-pocket costs for Medicare beneficiaries who use these drugs.
- International relations: No direct effects identified in the legislation.
## Main Stakeholders Affected
- Pharmaceutical manufacturers developing or marketing engineered cyclic peptides.
- Medicare beneficiaries and the Centers for Medicare & Medicaid Services.
- Health care providers and payers involved in Medicare drug coverage.
## Notable Legal, Constitutional, or Political Implications The bill makes targeted changes within the existing framework of the Social Security Act without altering broader constitutional authorities or creating new regulatory structures. It focuses exclusively on adjusting qualification periods for a narrowly defined class of products.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Morelle, Joseph D. [D-NY-25]
Cosponsors (3)
Rep. Gottheimer, Josh [D-NJ-5], Rep. Pfluger, August [R-TX-11], Rep. Kean, Thomas H. [R-NJ-7]
Recent Actions
- 2026-05-15: 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.
- 2026-05-15: 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.
- 2026-05-15: Introduced in House
- 2026-05-15: Introduced in House
Bill Versions
- Next Generation Medicines Act of 2026 — issued 2026-05-15 — PDF (3 pages)