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119th Congress

H.R. 946

ORPHAN Cures Act

  1. Introduced
  2. In committee
  3. Passed House
  4. Passed Senate
  5. To President
  6. Became law
Sponsor
John Joyce(R-PA)
Introduced
Feb 4, 2025
Policy area
Health
Committees
House Committee on Energy and Commerce; House Committee on Ways and Means
Official text
Introduced in House · Congress.gov page

Cosponsors (18)

Original cosponsors (9)

Added later (9)

Summary

Summary by the Congressional Research Service· describes the “Introduced in House” version

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.

Roll-call votes

No recorded votes on this bill.

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