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ORPHAN Cures Act

USA119th CongressS-1862| Senate 
| Updated: 5/22/2025
John Barrasso

John Barrasso

Republican Senator

Wyoming

Cosponsors (1)
Martin Heinrich (Democratic)

Finance Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The ORPHAN Cures Act aims to modify the Medicare Drug Price Negotiation Program by expanding and clarifying the exclusion for orphan drugs. This legislation amends the Social Security Act to ensure that drugs designated for one or more rare diseases or conditions are eligible for this exclusion, broadening the current definition which limited it to drugs for only one rare disease. A key provision also clarifies that any period during which a drug holds orphan drug status will not be counted when determining the time elapsed for its eligibility in the drug price negotiation program. This effectively pauses the negotiation clock for drugs while they are being developed or marketed for rare diseases, potentially extending their period of exclusion from price negotiation.
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Timeline

Bill from Previous Congress

S 118-3131
ORPHAN Cures Act
Feb 6, 2025

Latest Companion Bill Action

HR 119-946
Sponsor introductory remarks on measure. (CR H535-536)
May 22, 2025
Introduced in Senate
May 22, 2025
Read twice and referred to the Committee on Finance. (text: CR S3119)
  • Bill from Previous Congress

    S 118-3131
    ORPHAN Cures Act


  • February 6, 2025

    Latest Companion Bill Action

    HR 119-946
    Sponsor introductory remarks on measure. (CR H535-536)


  • May 22, 2025
    Introduced in Senate


  • May 22, 2025
    Read twice and referred to the Committee on Finance. (text: CR S3119)

Health

Related Bills

  • HR 119-946: ORPHAN Cures Act

ORPHAN Cures Act

USA119th CongressS-1862| Senate 
| Updated: 5/22/2025
The ORPHAN Cures Act aims to modify the Medicare Drug Price Negotiation Program by expanding and clarifying the exclusion for orphan drugs. This legislation amends the Social Security Act to ensure that drugs designated for one or more rare diseases or conditions are eligible for this exclusion, broadening the current definition which limited it to drugs for only one rare disease. A key provision also clarifies that any period during which a drug holds orphan drug status will not be counted when determining the time elapsed for its eligibility in the drug price negotiation program. This effectively pauses the negotiation clock for drugs while they are being developed or marketed for rare diseases, potentially extending their period of exclusion from price negotiation.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 118-3131
ORPHAN Cures Act
Feb 6, 2025

Latest Companion Bill Action

HR 119-946
Sponsor introductory remarks on measure. (CR H535-536)
May 22, 2025
Introduced in Senate
May 22, 2025
Read twice and referred to the Committee on Finance. (text: CR S3119)
  • Bill from Previous Congress

    S 118-3131
    ORPHAN Cures Act


  • February 6, 2025

    Latest Companion Bill Action

    HR 119-946
    Sponsor introductory remarks on measure. (CR H535-536)


  • May 22, 2025
    Introduced in Senate


  • May 22, 2025
    Read twice and referred to the Committee on Finance. (text: CR S3119)
John Barrasso

John Barrasso

Republican Senator

Wyoming

Cosponsors (1)
Martin Heinrich (Democratic)

Finance Committee

Health

Related Bills

  • HR 119-946: ORPHAN Cures Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted