119 S1862 IS: Optimizing Research Progress Hope And New Cures Act U.S. Senate 2025-05-22 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II 119th CONGRESS 1st Session S. 1862 IN THE SENATE OF THE UNITED STATES May 22, 2025 Mr. Barrasso (for himself and Mr. Heinrich) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.

1.

Short title

This Act may be cited as the Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act.

2.

Expanding and clarifying the exclusion for orphan drugs under the Drug Price Negotiation Program

Section 1192(e) of the Social Security Act (42 U.S.C. 1320f–1(e)) is amended— (1) in paragraph (1), by adding at the end the following new subparagraph: (C)

Treatment of former orphan drugs

In calculating the amount of time that has elapsed with respect to the approval of a drug or licensure of a biological product under subparagraph (A)(ii) and subparagraph (B)(ii), respectively, the Secretary shall not take into account any period during which such drug or product was a drug described in paragraph (3)(A). ; and (2) in paragraph (3)(A)— (A) by striking only one rare disease or condition and inserting one or more rare diseases or conditions; and (B) by striking such disease or condition and inserting one or more rare diseases or conditions (as such term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act).