H.R. 946 · 119th Congress
ORPHAN Cures Act
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R
JoyceSponsor18 cosponsors · 9 D, 9 R
R
Bilirakis
DD
D
Davis
JG
D
Gottheimer
RH
R
Hudson
KH
R
Hern
WK
D
Keating
MM
R
Miller-Meeks
SP
D
Peters
ST
D
Thanedar
JB
D
Bynum
TK
R
Kean
LS
R
Smucker
DT
D
Titus
ND
R
Dunn
AS
D
Salinas
DC
R
Crenshaw
AG
D
Gray
RB
R
Bresnahan9 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act
What it does: CRS summary · Introduced in House · Feb 4, 2025
Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act
This bill modifies certain provisions under the Medicare Drug Price Negotiation Program with respect to orphan drugs.
The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation. The program does not apply to orphan drugs that are approved to treat only one rare disease or condition.
The bill modifies these provisions so as to exclude any period in which a drug was an orphan drug from market approval calculations. It also excludes orphan drugs that are approved to treat more than one rare disease or condition from the program.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: ORPHAN Cures Act
Also known as: Optimizing Research Progress Hope And New Cures Act
Latest action (Feb 6, 2025): Sponsor introductory remarks on measure. (CR H535-536)
Policy area: Health · Origin: House · Introduced: Feb 4, 2025
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.