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HR 946119th CongressIntroduced

ORPHAN Cures Act

Introduced: Oct 28, 2025
Standard Summary
Comprehensive overview in 1-2 paragraphs

Expands orphan drug exclusions in Medicare drug price negotiation program.

Key Points

  • 1Clarifies orphan drug exclusions under Inflation Reduction Act
  • 2Treats drugs for one or more rare diseases as eligible
  • 3Excludes time periods when drugs had orphan designation
  • 4Amends Social Security Act §1192(e)
  • 5Protects incentives for rare disease drug development

Impact Areas

Pharmaceutical industryOrphan drug developersMedicare drug pricingRare disease patients
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