119th Congress · introduced in the Senate · May 22, 2025
ORPHAN Cures Act
Official title from Congress.gov
Latest action (May 22, 2025): Read twice and referred to the Committee on Finance. (text: CR S3119)
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in Senate (May 22, 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.
Read twice and referred to the Committee on Finance. (text: CR S3119)
Introduced in Senate
Actions from Congress.gov, newest first.
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 24, 2026.
129 citations; showing the 25 most recently posted.
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
…Act; all provisions S. 882: Patients Before Middlemen Act; all provisions S. 891: Bipartisan Health Care Act; provisions related to Titles I, II, VIII, and IX S. 1862: Orphan CURES Act; all provisions S. 3345: PBM Price Transparency and Accountability Act; all provisions Executive Order #14216: Expanding Access to In Vitro 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
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: 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 Issues relat…
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
…d 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 Therape…
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 and internati…
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
…al 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
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 Fertilization. Executive Order 14297: Delivering Most-Favored-Nation Pre…
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
ALNYLAM PHARMACEUTICALS, INC. · lobbying firm or registrant: LMH STRATEGIC SOLUTIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
General Medicare and Medicaid Issues. H.R.1672: Maintaining Investments in New Innovation (MINI) Act. H.R.946/S.1862: ORPHAN Cures Act. Pediatric Review Reauthorization.
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
LUNDBECK LLC · lobbying firm or registrant: LUNDBECK LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 15, 2026 · issue area: Medicare/Medicaid
$130,000
Spent on own lobbying
…lasses policy Medicare Part D Smoothing Benefit - FY 2026 and FY2027 Labor-HHS Appropriations Orphan drug exclusion in the Inflation Reduction Act - H.R. 946 & S. 1862, ORPHAN Cures Act Small molecule discrepancy in the Inflation Reduction Act - H.R. 1492 & S. 832, The EPIC Act Issues pertaining to the Most Favored Nation dru…
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 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 21, 2026 · issue area: Health Issues
$700,000
Spent on own lobbying
…Act; all provisions S. 882: Patients Before Middlemen Act; all provisions S. 891: Bipartisan Health Care Act; provisions related to Titles I, II, VIII, and IX S. 1862: Orphan CURES Act; all provisions S. 3345: PBM Price Transparency and Accountability Act; all provisions Executive Order: Expanding Access to In Vitro Fertiliz…
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 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Medicare/Medicaid
$710,000
Spent on own lobbying
…d 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 Therape…
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 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
…ug pricing proposal; Issues related to implementation of the Inflation Reduction Act of 2022; Issues related to Senate Finance Dear Colleague process; H.R. 946/S. 1862, 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
INCYTE CORPORATION · lobbying firm or registrant: INCYTE CORPORATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Medicare/Medicaid
$750,000
Spent on own lobbying
H.R. 946 / S. 1862, Orphan Cures Act implementation H. Res. 1331, Expressing support for "Hidradenitis Suppurativa Awareness Week" S. 2658, Medication Affordability and Patent In…
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 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Pharmacy
$140,000
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 and internati…
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
ALNYLAM PHARMACEUTICALS, INC. · lobbying firm or registrant: TIBER CREEK GROUP
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 19, 2026 · issue area: Medicare/Medicaid
$60,000
Paid to lobbying firm
Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act; Issues related to H.R. 1672 - Maintaining Investments in New Innovation Act; Issues related to Medicare and Medicaid 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
LUNDBECK LLC · lobbying firm or registrant: LUNDBECK LLC
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 16, 2026 · issue area: Medicare/Medicaid
$180,000
Spent on own lobbying
…lasses policy Medicare Part D Smoothing Benefit - FY 2026 and FY2027 Labor-HHS Appropriations Orphan drug exclusion in the Inflation Reduction Act - H.R. 946 & S. 1862, ORPHAN Cures Act Small molecule discrepancy in the Inflation Reduction Act - H.R. 1492 & S. 832, The EPIC Act Issues pertaining to the Most Favored Nation dru…
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 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 5, 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
ALNYLAM PHARMACEUTICALS, INC. · lobbying firm or registrant: LMH STRATEGIC SOLUTIONS
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 5, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
General Medicare and Medicaid Issues. H.R.1672: Maintaining Investments in New Innovation (MINI) Act. H.R.946/S.1862: ORPHAN Cures Act. Pediatric Review Reauthorization.
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 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Health Issues
$820,000
Spent on own lobbying
…Act; all provisions S. 882: Patients Before Middlemen Act; all provisions S. 891: Bipartisan Health Care Act; provisions related to Titles I, II, VIII, and IX S. 1862: Orphan CURES Act; all provisions S. 3345: PBM Price Transparency and Accountability Act; all provisions Executive Order: Expanding Access to In Vitro Fertiliz…
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
BEONE MEDICINES USA, INC. (FKA BEIGENE USA, INC.) · lobbying firm or registrant: TIBER CREEK GROUP
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Health Issues
$70,000
Paid to lobbying firm
…Inflation Reduction Act of 2022 (PL 117-169); Issues related to the implementation of the American Relief Act of 2025 (PL 118-158); Issues related to H.R. 946/S. 1862 - ORPHAN Cures Act; Issues related to the One Big Beautiful Bill Act (PL 119-21).
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 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Medicare/Medicaid
$480,000
Spent on own lobbying
H.R. 946 / S. 1862, Orphan Cures Act implementation H.R. 1262 Give Kids a Chance Act Issues related to Medicaid rebates Issues related to implementation of the Inflation Reductio…
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 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Medicare/Medicaid
$1,165,000
Spent on own lobbying
…d 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 Therape…
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 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Pharmacy
$200,000
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 and internati…
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: TIBER CREEK GROUP
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 18, 2026 · issue area: Medicare/Medicaid
$80,000
Paid to lobbying firm
Issues related to Medicare Part D and Part B Pricing Reform; Issues related to Medicaid Rebates; Issues related to H.R. 946/S. 1862 - 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