H.R. 946House119th Congress (2025-2027)In Committee

ORPHAN Cures Act

AI-Generated Summary

Updated November 24, 2025 at 3:03 AM UTC

The ORPHAN Cures Act amends the Social Security Act to broaden and clarify the exemption that orphan drugs receive from the federal Drug Price Negotiation Program. It tells the Secretary of Health and Human Services not to count periods when a drug was considered an orphan drug when determining eligibility timelines, and it expands the definition of orphan drugs to cover treatments for multiple rare diseases. This change affects how orphan drugs are treated under the price‑negotiation rules and could keep more such drugs out of mandatory price negotiations.

Key Provisions

Adds a new rule (subparagraph C) that when the government calculates how long a drug has been on the market for price‑negotiation purposes, any time the drug was classified as an orphan drug is ignored.
Changes the definition of an orphan drug so it can treat one or more rare diseases or conditions, rather than being limited to a single rare disease.

Legislative Activity

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2 earlier actions

HouseIntro Referral Latest Action

Sponsor introductory remarks on measure. (CR H535-536)

February 6, 2025

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HouseIntro Referral

Introduced in House

February 4, 2025

HouseIntro Referral

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.

Energy and Commerce Committee

February 4, 2025

HouseIntro Referral

Sponsor introductory remarks on measure. (CR H535-536)

February 6, 2025

Bill Text

Latest available legislative text

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Introduced in HouseIssued February 4, 2025

119th CONGRESS

1st Session

H. R. 946

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.

Short title

This Act may be cited as the Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act.

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).