119th Congress · introduced in the House · Feb 4, 2025
ORPHAN Cures Act
Official title from Congress.gov
Latest action (Feb 6, 2025): Sponsor introductory remarks on measure. (CR H535-536)
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in House (Feb 4, 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.
Includes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Sponsor introductory remarks on measure. (CR H535-536)
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.
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.
Introduced in House
Introduced in House
Actions from Congress.gov, newest first.
Health care costs and insurance · Medicare · Prescription drugs
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 23, 2026.
353 citations; showing the 25 most recently posted.
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Medicare/Medicaid
$2,560,000
Spent on own lobbying
…osimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
EMD SERONO INC · lobbying firm or registrant: EMD SERONO, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$730,000
Spent on own lobbying
P.L. 119-21 (H.R. 1): One Big Beautiful Bill Act; provisions related to Title VII, Subtitle B H.R. 946: Orphan CURES Act; all provisions H.R. 2214: DRUG Act; all provisions H.R. 4317: PBM Reform Act of 2025; all provisions H.R. 6703: Lower Health Care Premiums f…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CHRONIC CARE POLICY ALLIANCE · lobbying firm or registrant: CHRONIC CARE POLICY ALLIANCE
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
Amount not reported
SB 864 - HELP Copays Act HR 946 - Orphan Cures Act SB 832/ HR 1492 - EPIC Act HR 1520 - Charlotte Woodward Organ Transplant Discrimination Prevention Act HR 3514 - Improving Seniors Timely Ac…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. View filing
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP) · lobbying firm or registrant: AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$3,010,000
Spent on own lobbying
…Manager financing and regulation H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM repo…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$7,040,000
Spent on own lobbying
…026 S. 4189: INSULIN Act of 2026 S. 5043: Secure Drug Supply Chain Act of 2026 S. 5244: SUSTAIN 340B Act H.R. 1: One Big Beautiful Bill Act (Public Law 119-21) H.R. 946: ORPHAN Cures Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates und…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
GSK (FKA GLAXOSMITHKLINE INC.) · lobbying firm or registrant: GSK (FKA GLAXOSMITHKLINE INC.)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$1,530,000
Spent on own lobbying
…S. 4189: INSULIN Act of 2026 S. 5043: Secure Drug Supply Chain Act of 2026 S. 5244: SUSTAIN 340B Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates und…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
JAZZ PHARMACEUTICALS, INC. · lobbying firm or registrant: AVENUE SOLUTIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
Issues related to Most Favored Nation (MFN) drug pricing proposal; Issues related to Senate Finance Dear Colleague process; H.R. 946/S. 1862, ORPHAN Cures Act; S. 3019, No Big Blockbuster Bailouts Act (NOBBBA)
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
INCYTE CORPORATION · lobbying firm or registrant: W STRATEGIES, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$60,000
Paid to lobbying firm
Issues related to Medicaid Drug Rebate program rule. Public Law 119-21: One Big Beautiful Bill Act, as it relates to H.R.946 - ORPHAN Cures Act. Issues related to drug pricing including potential legislation to impose Most Favored Nation pricing in Medicare. CMS Guard demonstration p…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
JOHNSON & JOHNSON SERVICES INC · lobbying firm or registrant: JOHNSON & JOHNSON SERVICES, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$2,220,000
Spent on own lobbying
…c Labeling Act, regarding all provisions - H.R. 929/S. 266, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, regarding all provisions - H.R. 946 ORPHAN Cures Act, regarding all provisions - S.864, HELP Copays Act, regarding all provisions - H.R. 2214, Delinking Revenue from Unfair Gouging (DRUG) Act, re…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
JAZZ PHARMACEUTICALS, INC. · lobbying firm or registrant: JAZZ PHARMACEUTICALS, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$550,000
Spent on own lobbying
…nnabis-derived therapies Most Favored Nation drug pricing Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act HR 946: Orphan Cures Act Legislation Related to the Repeal or Reform of Orphan Cures Section 232 Tariffs
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PTC THERAPEUTICS, INC. · lobbying firm or registrant: PTC THERAPEUTICS, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$170,000
Spent on own lobbying
…ate Program Issues related to implementation of Public Law No. 117-169 - The Inflation Reduction Act of 2022, specifically the orphan drug exemption, including H.R. 946 - The Optimizing Research Progress Hope and New Cures Act and the small molecule penalty, including H.R. 1492 - The Ensuring Pathways to Innovative Cures Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
TRAVERE THERAPEUTICS · lobbying firm or registrant: ALSTON & BIRD LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$80,000
Paid to lobbying firm
Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and c…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
TRAVERE THERAPEUTICS · lobbying firm or registrant: ALSTON & BIRD LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$80,000
Paid to lobbying firm
Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Mos…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NOVARTIS · lobbying firm or registrant: NOVARTIS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$840,000
Spent on own lobbying
…ograms Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
INCYTE CORPORATION · lobbying firm or registrant: INCYTE CORPORATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$380,000
Spent on own lobbying
H.R. 946 / S. 1862, Orphan Cures Act implementation H. Res. 1331, Expressing support for "Hidradenitis Suppurativa Awareness Week" Issues related to Medicaid rebates Is…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BOEHRINGER INGELHEIM USA CORPORATION · lobbying firm or registrant: BOEHRINGER INGELHEIM USA CORPORATION, FORMERLY REPORTED AS BOEHRINGER INGELHEIM PHARMACEUTICALS, INC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$1,020,000
Spent on own lobbying
…es related to prescription drug pricing and value Issues regarding implementation of the Inflation Reduction Act, including H.R. 1492/S.832 - EPIC Act of 2025; H.R. 946/S. 1862, the Optimizing Research Progress Hope and New (ORPHAN) Cures Act Issues related to the Treat and Reduce Obesity Act The Access to Prescription Digital…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NEUROCRINE BIOSCIENCES, INC · lobbying firm or registrant: NEUROCRINE BIOSCIENCES, INC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$940,000
Spent on own lobbying
…related to implementation of the Inflation Reduction Act, P.L. 117-169, including potential changes to the structure of and reimbursement for Medicare Part D. H.R. 946 - Orphan Cures Act H.R. 1492 / S. 832 - Ensuring Pathways to Innovative Cures (EPIC) Act Issues related to drug pricing
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BIOGEN · lobbying firm or registrant: BIOGEN
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$880,000
Spent on own lobbying
…o specific bill. H.R.1492/S.832, EPIC Act, equalizes the negotation period between small-molecule and biologic candidates under the Drig Price Negotiation laws H.R.946, ORPHAN CURES Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASTRAZENECA PHARMACEUTICALS LP · lobbying firm or registrant: W STRATEGIES, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$80,000
Paid to lobbying firm
Issues around drug pricing. Public Law 119-21: One Big Beautiful Bill Act, as it relates to H.R.946 - Orphan Cures Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
DAIICHI SANKYO INC · lobbying firm or registrant: DAIICHI SANKYO, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$370,000
Spent on own lobbying
Discussions regarding H.R.946, the ORPHAN Cures Act Discussions related to H.R.2319, the Women and Lung Cancer Research and Preventative Services Act Discussions regarding H.R.4299,the Prot…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
TRAVERE THERAPEUTICS · lobbying firm or registrant: TRAVERE THERAPEUTICS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$100,000
Spent on own lobbying
HR 946 and S. 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act); related provisions in H.R.1, One Big Beautiful Bill Act; Most Favored Nation a…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASTRAZENECA PHARMACEUTICALS LP · lobbying firm or registrant: TODD STRATEGY GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Pharmacy
$80,000
Paid to lobbying firm
…maceutical supply chain manufacturing. Pharmaceutical pricing negotiations. H.R.3521/S.4440: Clinical Trials Modernization Act. H.R.5509/S.2903: Safe Step Act. H.R.946/S.1862: Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NOVARTIS, INC. · lobbying firm or registrant: TODD STRATEGY GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
…ncer Research. Supply Chain Integrity and Traceability. PBM Reform. Coverage of Accelerated Approval Products. Drug Benefit Design. Orphan Drug Issues. S. 1682/H.R.946: ORPHAN Cures Act. Reimbursement and Coverage of Innovative Products. Lower Costs, More Transparency Act. Lower Costs, More Cures Act. Patient Cost-Sharing. St…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
EMD SERONO INC. · lobbying firm or registrant: TODD STRATEGY GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
P.L.119-21 (H.R. 1): One Big Beautiful Bill Act. H.R.946: Orphan CURES Act. S.864: HELP Copays Act; all provisions. S.1862: Orphan CURES Act; all provisions. Executive Order 14216: Expanding Access to In Vitro Fertil…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
IONIS PHARMACEUTICALS, INC. · lobbying firm or registrant: LMH STRATEGIC SOLUTIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Health Issues
$30,000
Paid to lobbying firm
Pediatric Review Reauthorization. H.R.946/S.1862: ORPHAN Cures Act. H.R.1672: Maintaining Investments in New Innovation (MINI) Act. H.R.1262/S.932: Give Kids a Chance Act of 2025.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing