S 1862 Re-checks Congress.gov for new actions and updates the bill's status, and fills in any sponsors, committees, or related bills that are missing. It does not re-pull sponsors/cosponsors/committees/related — those rarely change — and it skips all work if nothing has changed upstream, so it's cheap to click.
To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.
Summary
The bill would amend the Drug Price Negotiation Program provisions of the Social Security Act to expand the exclusion for orphan drugs. It would clarify that when determining how long a drug has been approved, time during which the drug was designated as an orphan drug does not count toward the exclusion period. The bill would also expand the definition of orphan drugs eligible for exclusion to include drugs that treat one or more rare diseases, rather than limiting it to drugs treating only one rare disease. These changes would extend the period that orphan drugs remain excluded from Medicare price negotiations.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Sen. Barrasso, John [R-WY] (R-WY)
1 cosponsor
- Sen. Heinrich, Martin [D-NM] (D-NM)
Actions (2)
- May 22, 2025 Read twice and referred to the Committee on Finance. (text: CR S3119) · senate
- May 22, 2025 Introduced in Senate
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
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.
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)”. <all>
Comments