[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 1862 Introduced in Senate (IS)] <DOC> 119th CONGRESS 1st Session S. 1862 To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program. _______________________________________________________________________ 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. 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 ``Optimizing Research Progress Hope And New Cures Act'' or the ``ORPHAN Cures Act''. SEC. 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)''. <all>