ORPHAN Cures Act
- Bill Number
- S. 1862
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-05-22: Read twice and referred to the Committee on Finance. (text: CR S3119)
- Last Updated
- 2025-12-05T21:54:24Z
Official Summary
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.
Sponsor
Cosponsors (1)
Recent Actions
- 2025-05-22: Read twice and referred to the Committee on Finance. (text: CR S3119)
- 2025-05-22: Introduced in Senate
Bill Versions
- Optimizing Research Progress Hope And New Cures Act — issued 2025-05-22 — PDF (2 pages)