To amend title XI of the Social Security Act to adjust which engineered cyclic peptides are qualifying single source drugs for purposes of the Drug Price Negotiation Program.

Summary of HR 8857 (119th Congress)

Purpose and intent

HR 8857 proposes amending Title XI of the Social Security Act to modify the criteria used to determine which engineered cyclic peptides qualify as single-source drugs for purposes of the Drug Price Negotiation Program. The bill aims to adjust the eligibility standards so that certain engineered cyclic peptide drugs are treated differently within the program’s framework, potentially affecting which drugs are subject to negotiation and at what terms.

Key provisions and changes

• Amendment target: Title XI of the Social Security Act, focusing on the Drug Price Negotiation Program established under the federal program.
• Subject of amendment: Criteria for qualifying as single-source drugs among engineered cyclic peptides. The bill seeks to redefine or refine the eligibility standards that determine when these drugs are considered single-source for negotiation purposes.
• Scope of impact within the program: By altering the qualification criteria, the bill could expand or narrow the set of engineered cyclic peptide drugs that are eligible for the Drug Price Negotiation Program’s requirements and processes.
• Administrative implications: Changes would influence how federal agencies classify drugs for negotiation, potentially affecting bid timing, price negotiation negotiations, and related reporting requirements under the program.

Who/what would be affected

• Manufacturers and sponsors of engineered cyclic peptide drugs: Their products could be reclassified under the program’s single-source criteria, influencing eligibility and negotiation dynamics.
• The Drug Price Negotiation Program: Administrative and procedural aspects of eligibility determinations and the negotiation workflow could be altered.
• Medicare/Medicaid and payer landscape: Since the Drug Price Negotiation Program targets federal reimbursement considerations, the downstream effect could affect drug pricing, formulary decisions, and patient access through federal programs.

Procedural and timeline aspects

• Introduced in the House: May 15, 2026.
• Referral: Referred to the Committee on Energy and Commerce and to the Committee on Ways and Means, for consideration of provisions within their jurisdictions.
• Next steps: If advanced, the bill would undergo committee review, potential amendments, and floor consideration. Any passage would then move to the Senate (and potentially to conference committees) and ultimately to the President for signature or veto.

Additional context

• The bill has three co-sponsors: August Pfluger, Joe Morelle, and Josh Gottheimer.
• The legislative language would need to be reviewed to understand the precise definitional changes and their practical thresholds (e.g., what constitutes “engineered cyclic peptides,” specific criteria for “single-source,” and how the change interacts with existing negotiation timelines and price-setting mechanics).

If you’d like, I can provide a comparison with current law’s treatment of engineered cyclic peptides and single-source drugs within the Drug Price Negotiation Program, or extract the exact statutory language once it’s available.