Next GEN Act of 2026
Sponsored By: Representative Morelle, Joseph D. [D-NY-25]
Introduced
Summary
Would give certain engineered cyclic peptide drugs a longer single-source period under the federal Drug Price Negotiation Program — 11 years instead of 7. It adds a statutory definition of "engineered cyclic peptide" and ties that definition to which drugs get the extended period for negotiation purposes.
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- Drug makers: Drugs that meet six specific criteria would qualify for an 11-year period instead of the current 7-year period. This can change which products count as single-source drugs for the program.
- The Drug Price Negotiation Program: The bill adds a new paragraph to the Social Security Act that defines engineered cyclic peptides by composition, cyclization, length, discovery method, origin, and route of administration.
- Timing and scope: The change would apply only to lists published on or after enactment, so future negotiation lists would use the new definition when deciding which peptides get the longer statutory period.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
Delay Medicare drug price talks for peptides
This bill would treat certain "engineered cyclic peptides" as subject to an 11-year timing rule for Medicare drug price negotiations instead of the usual 7 years. It would define those peptides as polymers mainly made of amino acids, with no more than 40 amino acids, 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, identified using genetically encoded library screening, not naturally derived, and taken orally, by inhalation, or otherwise self-administered. The change would apply to negotiation lists published under section 1192(a) on or after the date of enactment. As a result, price talks for these drugs would be delayed, which could postpone negotiated price reductions reaching Medicare patients.
Sponsors & CoSponsors
Sponsor
Morelle, Joseph D. [D-NY-25]
NY • D
Cosponsors
Rep. Gottheimer, Josh [D-NJ-5]
NJ • D
Sponsored 5/15/2026
Rep. Pfluger, August [R-TX-11]
TX • R
Sponsored 5/15/2026
Rep. Kean, Thomas H. [R-NJ-7]
NJ • R
Sponsored 5/15/2026
Roll Call Votes
No roll call votes available for this bill.
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