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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
This bill amends the Social Security Act's Drug Price Negotiation Program to extend the period before engineered cyclic peptides can be subject to price negotiation from 7 years to 11 years after market approval. An engineered cyclic peptide is defined as a synthetic polymer of amino acids with at least one cyclic structure, developed using laboratory screening methods, containing no more than 40 amino acids, and designed for oral, inhaled, or self-administered use. The change applies to drug lists published after the bill's enactment.
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Sponsor (1)
3 cosponsors
Actions (2)
- May 15, 2026 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. · house
- May 15, 2026 Introduced in House
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Full text
IN THE HOUSE OF REPRESENTATIVES
May 15, 2026
Mr. Morelle (for himself, Mr. Gottheimer, Mr. Pfluger, and Mr. Kean) introduced the following bill; which was 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
A BILL
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.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “Next Generation Medicines Act of 2026” or the “Next GEN Act of 2026”.
SEC. 2. ADJUSTING RULES FOR ENGINEERED CYCLIC PEPTIDES UNDER DRUG PRICE NEGOTIATION PROGRAM.
(a) In General.—Section 1192(e) of the Social Security Act (42 U.S.C. 1320f-1(e)) is amended—
(1) in paragraph (1)(A)(ii), by inserting “(or, in the case of an engineered cyclic peptide (as defined in paragraph
(5)), 11 years)” after “7 years”; and
(2) by adding at the end the following new paragraph:
“(5) Engineered cyclic peptide defined.—In this subsection, the term ‘engineered cyclic peptide’ means a polymer that—
“(A) is composed principally of amino acids;
“(B) contains not less than 1 cyclic structure produced through head-to-tail cyclization, head-to- side-chain cyclization, side-chain-to-tail cyclization, or side-chain-to-side-chain cyclization;
“(C) contains not more than 40 amino acids;
“(D) was identified for development using a genetically encoded library screening method;
“(E) is not naturally derived; and
“(F) is orally administered, inhaled, or otherwise self-administered.”.
(b) Effective Date.—The amendments made by this section shall apply with respect to lists published under section 1192(a) of the Social Security Act (42 U.S.C. 1320f-1(a)) on or after the date of the enactment of this section. <all>
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