119 S3019 IS: No Big Blockbuster Bailouts Act U.S. Senate 2025-10-21 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. 3019 IN THE SENATE OF THE UNITED STATES October 21, 2025 Mr. Welch (for himself, Mr. Wyden, and Ms. Cortez Masto) 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 provide for the treatment of orphan drugs under the Medicare Drug Price Negotiation Program.
1.
Short title
This Act may be cited as the No Big Blockbuster Bailouts Act.
2.
Treatment of orphan drugs under the Medicare 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), in the matter preceding subparagraph (A), by striking through (4) and inserting and (3); (2) in paragraph (3)— (A) by striking subparagraph (A); (B) by redesignating subparagraphs (B) and (C) as subparagraphs (A) and (B), respectively; and (C) in subparagraph (A)(iii), as redesignated by subparagraph (B) of this paragraph, by striking with respect to and inserting subject to paragraph (4), with respect to; and (3) by striking paragraph (4) and inserting the following new paragraph: (4)
Treatment of orphan drugs
In the case of a drug that is designated as a drug for one or more rare diseases or conditions and for which the only approved indication (or indications) is for one or more such rare diseases or conditions (as such term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act), paragraph (3)(A) shall be applied by substituting $400,000,000 for $200,000,000 in clause (i) of such paragraph. . (b)
Application
The amendments made by subsection (a) shall apply with respect to initial price applicability years (as defined in section 1191(b) of the Social Security Act (42 U.S.C. 1320f(b))) beginning on or after January 1, 2028.