HR946
Introductory remarks
ORPHAN Cures Act
- Federal
- House
- Introduced Feb 4, 2025
- Session 119
Bill Text
Version IHThis Act may be cited as the Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act.
Section 1192(e) of the Social Security Act (42 U.S.C. 1320f–1(e)) is amended—
in paragraph (1), by adding at the end the following new subparagraph:
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).
in paragraph (3)(A)—
by striking only one rare disease or condition and inserting one or more rare diseases or conditions; and
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).
Section 1192(e) of the Social Security Act (42 U.S.C. 1320f–1(e)) is amended—
in paragraph (1), by adding at the end the following new subparagraph:
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).
in paragraph (3)(A)—
by striking only one rare disease or condition and inserting one or more rare diseases or conditions; and
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).
Legislative Timeline
5 actions-
Sponsor introductory remarks on measure. (CR H535-536)
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Introduced in House
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Introduced in House
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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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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.