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H.R. 946

U.S. HouseIntroduced

Summary

H.R. 946, the ORPHAN Cures Act, was introduced in the House on Feb 4, 2025 by Rep. John Joyce (R) with 18 co-sponsors. It last saw action on Feb 6, 2025: Sponsor introductory remarks on measure. (CR H535-536).


Record

Text

H.R. 946 has 18 co-sponsors.

hb946/introduced-in-house.txt
119 HR 946 IH: Optimizing Research Progress Hope And New Cures Act
U.S. House of Representatives
2025-02-04
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
I 119th CONGRESS 1st Session H. R. 946 IN THE HOUSE OF REPRESENTATIVES February 4, 2025 Mr. Joyce of Pennsylvania (for himself, Mr. Davis of North Carolina , Mr. Hern of Oklahoma , Mr. Peters , Mrs. Miller-Meeks , Mr. Keating , Mr. Hudson , Mr. Thanedar , Mr. Bilirakis , and Mr. Gottheimer ) introduced the following bill; which was 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 A BILL
To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.
1.
Short title
This Act may be cited as the Optimizing Research Progress Hope And New Cures Act or the ORPHAN Cures Act .
2.
Expanding and clarifying the exclusion for orphan drugs under the Drug Price Negotiation Program
Section 1192(e) of the Social Security Act ( 42 U.S.C. 1320f–1(e) ) is amended—
(1)
in paragraph (1), by adding at the end the following new subparagraph:
(C)
Treatment of former orphan drugs
In calculating the amount of time that has elapsed with respect to the approval of a drug or licensure of a biological product under subparagraph (A)(ii) and subparagraph (B)(ii), respectively, the Secretary shall not take into account any period during which such drug or product was a drug described in paragraph (3)(A).
; and
(2)
in paragraph (3)(A)—
(A)
by striking only one rare disease or condition and inserting one or more rare diseases or conditions ; and
(B)
by striking such disease or condition and inserting one or more rare diseases or conditions (as such term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act) .

Tracker

The tracker indicates the progress of this legislation as it moves through the legislative process.

  1. Introduced2025-02-04
  2. Passed House
  3. Passed Senate
  4. Conference
  5. To President
  6. Became Law

CRS Summary

The summaries are the Congressional Research Service’s, one per stage. Read them in full.

Introduced in House Feb 4, 2025

hb946/introduced-in-house.md

Shown Here:
Introduced in House (02/04/2025)

Sponsors

Rep. John Joyce (R) sponsors H.R. 946, and 18 members have co-sponsored it, 9 of them from the day it was introduced.

Committees

H.R. 946 went before 2 committees: Ways and Means and Energy and Commerce.

Ways and Means
Ways and Means
Referred To · Feb 4, 2025 · 1,160 Bills
Energy and Commerce
Energy and Commerce
Referred To · Feb 4, 2025 · 1,636 Bills

Actions

H.R. 946 has taken 3 actions since Feb 4, 2025, the latest on Feb 6, 2025.

ChamberAction
Feb 6, 2025
House
Sponsor introductory remarks on measure. (CR H535-536)
Feb 4, 2025
House
Introduced in House
Feb 4, 2025
House
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.Energy and Commerce Committee

Votes

H.R. 946 has not gone to a roll call.

1 bill is related to H.R. 946.

Titles

H.R. 946 goes by 4 titles, 2 of them short titles.

  • ORPHAN Cures Act — Display Title
  • ORPHAN Cures Act — Short Title(s) as Introduced
  • Optimizing Research Progress Hope And New Cures Act — Short Title(s) as Introduced
  • To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program. — Official Title as Introduced

Lobbying

59 clients hired 53 firms and 322 registered lobbyists who named H.R. 946 in 296 quarterly filings, 2025 to 2026. Reported under the Lobbying Disclosure Act; a filing’s income covers everything its registrant worked that quarter, so the amounts below are the filings’, not this bill’s.

Filed under Medicare/Medicaid, Health Issues, Taxation/Internal Revenue Code, Trade (domestic/foreign), Budget/Appropriations, Pharmacy, Copyright/Patent/Trademark, Medical/Disease Research/Clinical Labs.

Clients

Who paid to be heard, by how many filings named the bill. The 20 that filed most often, of 59.

ClientBusinessStateFirmsFilingsReported
ALNYLAM PHARMACEUTICALS, INC.Pharmaceutical manufacturer.Massachusetts421$1.2M
INCYTE CORPORATIONBiopharmaceutical company.Delaware417$750K
ASTRAZENECA PHARMACEUTICALS LPBiopharmaceutical Company.Delaware314$640K
TRAVERE THERAPEUTICSPrescription pharmaceutical manufacturer of medications.California213$480K
ALKERMES, INC.Biopharmaceutical companyMassachusetts210$400K
BIOTECHNOLOGY INNOVATION ORGANIZATIONAdvocacy organization for the biotechnology industry.District of Columbia310$400K
IONIS PHARMACEUTICALS, INC.Biotechnology company.California210$220K
JAZZ PHARMACEUTICALS, INC.Specialty pharmaceuticalsCalifornia28$100K
NOVARTISDistrict of Columbia18
ALEXION PHARMACEUTICALS, INC.Rare Disease Pharmaceutical company.Massachusetts27$480K
GSK (FKA GLAXOSMITHKLINE INC.)District of Columbia17
LUNDBECK LLCDistrict of Columbia17
CALIFORNIA LIFE SCIENCESA public policy research and advocacy organization for California's biomedical industry.District of Columbia16$240K
ACADIA PHARMACEUTICALSCalifornia16
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP)District of Columbia16
DAIICHI SANKYO INCDistrict of Columbia16
JOHNSON & JOHNSON SERVICES INCNew Jersey16
NEUROCRINE BIOSCIENCES, INCCalifornia16
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICADistrict of Columbia16
PTC THERAPEUTICS, INC.New Jersey16

Firms

Registrants who filed on the bill, by filings.

Lobbyists

Named on the filings that cite the bill. The 20 named most often, of 322.

Filings

The documents themselves, on the Senate’s Lobbying Disclosure site, largest reported first.

ClientRegistrantPeriodReportedDocument
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAPHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA2025 first_quarter$12.9M1st Quarter - Report
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAPHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA2026 first_quarter$12.2M1st Quarter - Report
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAPHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA2025 third_quarter$9M3rd Quarter - Report
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAPHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA2025 fourth_quarter$8.4M4th Quarter - Report
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAPHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA2025 second_quarter$7.6M2nd Quarter - Report
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAPHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA2026 second_quarter$7.4M2nd Quarter - Report
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP)AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)2026 first_quarter$5.3M1st Quarter - Report
AARPAARP2025 second_quarter$5.1M2nd Quarter - Report
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP)AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)2025 first_quarter$4.8M1st Quarter - Report
PFIZER INC.PFIZER INC.2025 first_quarter$4.2M1st Quarter - Report
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP)AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)2025 third_quarter$4.2M3rd Quarter - Report
NOVARTISNOVARTIS2025 first_quarter$4.2M1st Quarter - Report
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP)AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)2025 fourth_quarter$4.1M4th Quarter - Report
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP)AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)2025 second_quarter$4.1M2nd Quarter - Report
NOVARTISNOVARTIS2026 first_quarter$3.9M1st Quarter - Report
PFIZER INC.PFIZER INC.2025 second_quarter$3.7M2nd Quarter - Amendme…
PFIZER INC.PFIZER INC.2025 second_quarter$3.7M2nd Quarter - Amendme…
AMGEN INCAMGEN, INC.2025 first_quarter$3.6M1st Quarter - Report
AMGEN INCAMGEN, INC.2025 fourth_quarter$3.6M4th Quarter - Report
AMGEN INCAMGEN, INC.2025 third_quarter$3.6M3rd Quarter - Report

Classification

The Congressional Research Service files H.R. 946 under Health, one of its 31 policy areas, and gives it 3 legislative subjects.

CRS Subjects

CRS assigns every bill one policy area from its 31; H.R. 946’s is Health.

hr946/policy-areas.txt
HealthAgriculture and FoodAnimalsArmed Forces and National SecurityArts, Culture, ReligionCivil Rights and Liberties, Minority IssuesCommerceCongressCrime and Law EnforcementEconomics and Public FinanceEducationEmergency ManagementEnergyEnvironmental ProtectionFamiliesFinance and Financial SectorForeign Trade and International FinanceGovernment Operations and PoliticsHousing and Community DevelopmentImmigrationInternational AffairsLabor and EmploymentLawNative AmericansPublic Lands and Natural ResourcesScience, Technology, CommunicationsSocial WelfareSports and RecreationTaxationTransportation and Public WorksWater Resources Development

Legislative Subjects

H.R. 946 carries 3 of CRS’s legislative subjects, from Health care costs and insurance to Prescription drugs.

hr946/subjects.txt
Health care costs and insuranceMedicarePrescription drugs

Source: congress.gov · legiscan.com