[Congressional Record Volume 171, Number 112 (Saturday, June 28, 2025)]
[Senate]
[Pages S4025-S4026]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2617. Mr. BARRASSO submitted an amendment intended to be proposed 
to amendment SA 2360 proposed by Mr. Thune (for Mr. Graham) to the bill 
H.R. 1, to provide for reconciliation pursuant to title II of H. Con. 
Res. 14; which was ordered to lie on the table; as follows:

       At the appropriate place in title VII, insert the 
     following:

     SEC. __. 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

[[Page S4026]]

     526(a)(2) of the Federal Food, Drug, and Cosmetic Act)''.
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