S. 3019

119 S3019 IS: No Big Blockbuster Bailouts Act
 U.S. Senate
 2025-10-21
 text/xml
 EN
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  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.