Next GEN Act of 2026

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:

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.

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.