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S 1862 119th Congress Senate Health

ORPHAN Cures Act

Introduced: May 22, 2025 Introduced by: Barrasso, John Republican · Wyoming See on congress.gov
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 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 22, 2025
Read twice and referred to the Committee on Finance. (text: CR S3119)
May 22, 2025
Introduced in Senate
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 Plain-English summary Congressional Research Service

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.

What's happening now May 22, 2025

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

 Related & companion bills 1
  • HR 946 Related bill ORPHAN Cures Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 90

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

  • LUNDBECK LLC
    for LUNDBECK LLC · District of Columbia · 2nd Quarter (Apr 1 - June 30) 2026
  • LMH STRATEGIC SOLUTIONS
    for IONIS PHARMACEUTICALS, INC. · California · 2nd Quarter (Apr 1 - June 30) 2026
  • LMH STRATEGIC SOLUTIONS
    for ALNYLAM PHARMACEUTICALS, INC. · Massachusetts · 2nd Quarter (Apr 1 - June 30) 2026
  • EMD SERONO, INC.
    for EMD SERONO INC · District of Columbia · 1st Quarter (Jan 1 - Mar 31) 2026
  • TIBER CREEK GROUP
    for BEONE MEDICINES USA, INC. (FKA BEIGENE USA, INC.) · Massachusetts · 1st Quarter (Jan 1 - Mar 31) 2026
  • INCYTE CORPORATION
    for INCYTE CORPORATION · Delaware · 1st Quarter (Jan 1 - Mar 31) 2026
See all 90 filings →
 Cosponsors 1
All 1 Democratic 1
D
Heinrich, Martin
New Mexico · May 22, 2025
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1862: ORPHAN Cures Act. 119th Congress. Open America. https://openamerica.io/bill/119-S-1862/
MLA
"S. 1862: ORPHAN Cures Act." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-1862/.
Bluebook (legal)
S. 1862, 119th Cong. (2026), https://openamerica.io/bill/119-S-1862/.
Markdown link
[S. 1862: ORPHAN Cures Act](https://openamerica.io/bill/119-S-1862/)
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