Official Summaries

Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act

This bill modifies certain provisions under the Medicare Drug Price Negotiation Program with respect to orphan drugs.

The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation. The program does not apply to orphan drugs that are approved to treat only one rare disease or condition.

The bill modifies these provisions so as to exclude any period in which a drug was an orphan drug from market approval calculations. It also excludes orphan drugs that are approved to treat more than one rare disease or condition from the program.

Current Full Text

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

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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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