119-hr946

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 946 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 946

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 HOUSE OF REPRESENTATIVES

 February 4, 2025

 Mr. Joyce of Pennsylvania (for himself, Mr. Davis of North Carolina, 
 Mr. Hern of Oklahoma, Mr. Peters, Mrs. Miller-Meeks, Mr. Keating, Mr. 
Hudson, Mr. Thanedar, Mr. Bilirakis, and Mr. Gottheimer) introduced the 
 following bill; which was referred to the Committee on Energy and 
 Commerce, and in addition to the Committee on Ways and Means, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
 committee concerned

_______________________________________________________________________

 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)''.
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