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ORPHAN Cures Act

H.R. 946 Rep. John Joyce (R-PA-13) In committee
Bill text PDF
  1. Introduced Feb 4
  2. Committee Feb 4
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Feb 4, 2025Next: House vote
628d ago Feb 6, 2025: Sponsor introductory remarks on measure. (CR H535-536)
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
22companies, 172 filings
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Member trades
34trades in the last 90 days
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Companies lobbying on this bill

22 companies
Companies by sector
Biotech & Pharma 22
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Summary

Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act

Full summary3 paragraphs

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.

Library of Congress summary, Feb 4, 2025

Summary versions
  • Introduced in HouseFeb 4, 2025

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.