ORPHAN Cures Act

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3131 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 3131

To amend title XI of the Social Security Act to expand and clarify the 
  exclusion for orphan drugs under the Drug Price Negotiation Program.


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                   IN THE SENATE OF THE UNITED STATES

                            October 25, 2023

  Mr. Barrasso (for himself and Mr. Carper) introduced the following 
  bill; which was read twice and referred to the Committee on Finance

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                                 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 taken 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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