I
119THCONGRESS
1
STSESSION 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
FEBRUARY4, 2025
Mr. J
OYCEof Pennsylvania (for himself, Mr. DAVISof North Carolina, Mr.
H
ERNof Oklahoma, Mr. PETERS, Mrs. MILLER-MEEKS, Mr. KEATING,
Mr. H
UDSON, Mr. THANEDAR, Mr. BILIRAKIS, and Mr. GOTTHEIMER)
introduced the following bill; which was referred to the Committee on En-
ergy 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 jurisdic-
tion 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 Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Optimizing Research 4
Progress Hope And New Cures Act’’ or the ‘‘ORPHAN 5
Cures Act’’. 6
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•HR 946 IH
SEC. 2. EXPANDING AND CLARIFYING THE EXCLUSION FOR 1
ORPHAN DRUGS UNDER THE DRUG PRICE 2
NEGOTIATION PROGRAM. 3
Section 1192(e) of the Social Security Act (42 U.S.C. 4
1320f–1(e)) is amended— 5
(1) in paragraph (1), by adding at the end the 6
following new subparagraph: 7
‘‘(C) T
REATMENT OF FORMER ORPHAN 8
DRUGS.—In calculating the amount of time that 9
has elapsed with respect to the approval of a 10
drug or licensure of a biological product under 11
subparagraph (A)(ii) and subparagraph (B)(ii), 12
respectively, the Secretary shall not take into 13
account any period during which such drug or 14
product was a drug described in paragraph 15
(3)(A).’’; and 16
(2) in paragraph (3)(A)— 17
(A) by striking ‘‘only one rare disease or 18
condition’’ and inserting ‘‘one or more rare dis-19
eases or conditions’’; and 20
(B) by striking ‘‘such disease or condition’’ 21
and inserting ‘‘one or more rare diseases or 22
conditions (as such term is defined in section 23
526(a)(2) of the Federal Food, Drug, and Cos-24
metic Act)’’. 25
Æ
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