houseStanding
Ways and Means Committee
- Referred To
← Back to federal legislationOfficial committee record ↗
H.R. 946In committee
ORPHAN Cures Act
Introduced: Feb 4, 2025
Latest action date: Feb 6, 2025
Latest development
Sponsor introductory remarks on measure. (CR H535-536)
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- Congress
- 119th Congress
- Introduced
- Feb 4, 2025
- Recorded roll calls
- 0
Status detail: The most advanced recorded stage is committee consideration.
Plain-language overview
What this bill does
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.
Civixly topics
What this legislation is about
Civixly topics make federal and state legislation comparable. They are derived from the official CRS policy area and legislative subjects.
Official CRS policy area
Health
View 3 official legislative subjects
Health care costs and insuranceMedicarePrescription drugs
Committee activity
Committees and subcommittees that received, reviewed, marked up, or reported this legislation.
Official committee record ↗
houseStanding
Energy and Commerce Committee
- Referred To
Amendments
Proposed changes to this measure, with their latest official outcome or action from Congress.gov.
No amendments are listed for this measure.
Checked against Congress.gov Sep 14, 2026.
Action timeline
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View full action timeline4 actions
Sponsor introductory remarks on measure. (CR H535-536)
IntroReferralLibrary of CongressIntroduced in House
IntroReferralLibrary of CongressIntroduced in House
IntroReferralLibrary of CongressReferred 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.
IntroReferralHouse floor actions
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