H.R. 946 119th Congress House

ORPHAN Cures Act

Official title: To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.

Introduced: February 4, 2025 Introduced by: John Joyce Republican · Pennsylvania See on congress.gov

Health Health care costs and insuranceMedicarePrescription drugs

Everywhere this bill has been 3 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Feb 6, 2025

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

Feb 4, 2025

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.

Feb 4, 2025

Introduced in House

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What's happening now February 6, 2025

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

Plain-English summary Congressional Research Service

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.

Related & companion bills 1

Bill text 1 version

Introduced in House Formatted Text PDF Formatted XML

Source documents hosted by congress.gov.

Committees of jurisdiction 2

Energy and Commerce Committee
House of Representatives
Ways and Means Committee
House of Representatives

Lobbying activity 325

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

BIOTECHNOLOGY INNOVATION ORGANIZATION
for BIOTECHNOLOGY INNOVATION ORGANIZATION · District of Columbia · 3rd Quarter 2026 (July 1 - Sep 30)
EMD SERONO, INC.
for EMD SERONO INC · District of Columbia · 3rd Quarter 2026 (July 1 - Sep 30)
CHRONIC CARE POLICY ALLIANCE
for CHRONIC CARE POLICY ALLIANCE · California · 3rd Quarter 2026 (July 1 - Sep 30)
AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)
for AMERICA'S HEALTH INSURANCE PLANS INC (AHIP) · District of Columbia · 3rd Quarter 2026 (July 1 - Sep 30)
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
for PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · District of Columbia · 3rd Quarter 2026 (July 1 - Sep 30)
GSK (FKA GLAXOSMITHKLINE INC.)
for GSK (FKA GLAXOSMITHKLINE INC.) · District of Columbia · 3rd Quarter 2026 (July 1 - Sep 30)

Bodies those filers lobbied

HOUSE OF REPRESENTATIVES
321 filings
SENATE
310 filings
Centers For Medicare and Medicaid Services (CMS)
111 filings
Health & Human Services, Dept of (HHS)
109 filings
White House Office
55 filings
Food & Drug Administration (FDA)
51 filings
U.S. Trade Representative (USTR)
46 filings
Executive Office of the President (EOP)
45 filings

A filing lists the bills it worked on and the parts of government it contacted in separate sections, so these are the bodies those filers named anywhere in the filing, not a per-bill breakdown.

See all 325 filings →

Cosponsors 18