ORPHAN Cures Act

Sponsored byRep. Joyce, John [R-PA-13]PA· Introduced 4 February 2025

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Latest action

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

6 February 2025·1 year ago

Summary

Introduced in House · Updated 8 May 2025

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.

Timeline

5 actions

Sponsor introductory remarks on measure. (CR H535-536)
6 February 2025 · IntroReferral
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
4 February 2025 · IntroReferral
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
4 February 2025 · IntroReferral
Introduced in House
4 February 2025 · IntroReferral
Introduced in House
4 February 2025 · IntroReferral

Sponsorship

18 cosponsors

Sponsor

Rep. Joyce, John [R-PA-13]PA

Cosponsors

Democrat950%
Republican950%

Republican:Rep. Bresnahan, Robert P. [R-PA-8]PA
Democrat:Rep. Gray, Adam [D-CA-13]CA
Republican:Rep. Crenshaw, Dan [R-TX-2]TX
Democrat:Rep. Salinas, Andrea [D-OR-6]OR
Republican:Rep. Dunn, Neal P. [R-FL-2]FL
Republican:Rep. Smucker, Lloyd [R-PA-11]PA
Republican:Rep. Kean, Thomas H. [R-NJ-7]NJ
Democrat:Rep. Titus, Dina [D-NV-1]NV
Democrat:Rep. Bynum, Janelle [D-OR-5]OR
Democrat:Rep. Thanedar, Shri [D-MI-13]MI
Republican:Rep. Hudson, Richard [R-NC-9]NC
Democrat:Rep. Peters, Scott H. [D-CA-50]CA
Democrat:Rep. Keating, William R. [D-MA-9]MA
Democrat:Rep. Davis, Donald G. [D-NC-1]NC
Republican:Rep. Bilirakis, Gus M. [R-FL-12]FL
Democrat:Rep. Gottheimer, Josh [D-NJ-5]NJ
Republican:Rep. Miller-Meeks, Mariannette [R-IA-1]IA
Republican:Rep. Hern, Kevin [R-OK-1]OK

Classification

Policy area

Health

Legislative subjects

Health care costs and insuranceMedicarePrescription drugs

Cosponsor momentum

Cumulative over time

Track ORPHAN Cures Act as it moves through Congress