ORPHAN Cures Act

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5539 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 5539

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 HOUSE OF REPRESENTATIVES

                           September 18, 2023

 Mr. Joyce of Pennsylvania (for himself and Mr. Nickel) 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

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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 1191(e) of the Social Security Act (42 U.S.C. 1320f(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''.
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