ORPHAN Cures Act

House Bill

H.R. 946

119th Congress

ORPHAN Cures Act

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

Introduced:Feb 4, 2025

Primary Sponsor

Frank J. Pallone Jr.

Representative

Democratic

NJ-6

Cosponsors

18

Quick Stats

Policy Area

Health

Summary

This bill modifies the Medicare Drug Price Negotiation Program to better protect orphan drugs from price negotiation. It excludes time a drug spent as an orphan drug from market approval calculations and exempts orphan drugs approved for multiple rare diseases from negotiation.

Latest Action

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

AI Summary

Plain-English explanation of this bill

This bill modifies the Medicare Drug Price Negotiation Program to better protect orphan drugs from price negotiation. It excludes time a drug spent as an orphan drug from market approval calculations and exempts orphan drugs approved for multiple rare diseases from negotiation.

Last updated: 1/5/2026

Official Summary

Congressional Research Service summary

Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures ActThis 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.

Key Points

Main provisions of the bill

Excludes orphan drug period from market approval calculations
Exempts orphan drugs treating multiple rare diseases
Modifies Medicare Drug Price Negotiation Program
Aims to protect rare disease drug development incentives
Addresses concerns about orphan drug investment returns

How This Impacts Americans

Potential effects on citizens and communities

Drug manufacturers developing treatments for rare diseases would face less risk of their drugs being subject to Medicare price negotiation. This could help maintain incentives to develop orphan drugs while critics worry it creates loopholes in drug pricing reforms.

Policy Areas

Primary Policy Area

Health

Related Subjects

Health care costs and insurance

Medicare

Prescription drugs

Scope & Jurisdiction

Jurisdiction Level

federal

Congressional Session

119th Congress

Citation Reference

946, 119th Congress (2025). "ORPHAN Cures Act". Source: Voter's Right Platform. https://votersright.org/bills/118-hr-946