S. 1862Senate119th Congress (2025-2027)In Committee

ORPHAN Cures Act

Introduced May 22, 2025

AI-Generated Summary

Updated November 24, 2025 at 12:23 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 not to count periods when a drug was considered an orphan drug when measuring eligibility time, and it expands the definition of orphan drugs to include treatments for multiple rare diseases. The changes affect how orphan drugs are treated under the price‑negotiation rules.

Key Provisions

  • Adds a new rule (subparagraph C) stating 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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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Finance. (text: CR S3119)

May 22, 2025

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SenateIntro Referral

Introduced in Senate

May 22, 2025

SenateIntro Referral

Read twice and referred to the Committee on Finance. (text: CR S3119)

May 22, 2025

Floor Debate

2 members

What members said about S. 1862 on the floor

1 Republican1 Democrat
Jack Reed
Sen. Jack ReedD-RI · May 22, 2025

Mr. President, critical programs for Americans from all walks of life are under threat right now: Medicare and Medicaid. The Trump administration and my colleagues on the other side of the aisle are…

John Barrasso
Sen. John BarrassoR-WY · May 22, 2025

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

John Barrasso
Sen. John BarrassoR-WY · May 22, 2025

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Bill Text

Latest available legislative text

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Introduced in SenateIssued May 22, 2025

II

119th CONGRESS

1st Session

S. 1862

IN THE SENATE OF THE UNITED STATES

May 22, 2025

Mr. Barrasso (for himself and Mr. Heinrich) introduced the following bill; which was read twice and referred to the Committee on Finance

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.

1.

Short title

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

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).