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Reported covered position: Congressman Tom Davis
How to read the money
Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2026 · third_quarter · Q3
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
Source: Senate LDA
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2296: National Defense Authorization Act (NDAA) for Fiscal Year 2026 Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR Medical Device Safety FDA Streamlining FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining FY27 National Defense Authorization Act - Domestic Production of Essential Medicines CMS Preference for Domestic Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform Net Elective Cost Policy: PBM Reform Through Bid Transparency Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC) Procurement
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2296: National Defense Authorization Act (NDAA) for Fiscal Year 2026 Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR Medical Device Safety FDA Streamlining FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining FY27 National Defense Authorization Act - Domestic Production of Essential Medicines CMS Preference for Domestic Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform Net Elective Cost Policy: PBM Reform Through Bid Transparency Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC) Procurement
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act Section 301 Investigation re: Germany Issues Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines PTAB Proposed Rule - Discretionary Denials and One and Done Federal Procurement Preferences for Domestic Medicines Drug Shortages and Supply Chain Resilience
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes.
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
Expedited Access to Biosimilars Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act Section 301 Investigation re: Germany Issues Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines PTAB Proposed Rule - Discretionary Denials and One and Done Federal Procurement Preferences for Domestic Medicines Drug Shortages and Supply Chain Resilience
Expedited Access to Biosimilars Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
Expedited Access to Biosimilars Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act Section 301 Investigation re: Germany Issues Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines PTAB Proposed Rule - Discretionary Denials and One and Done Federal Procurement Preferences for Domestic Medicines Drug Shortages and Supply Chain Resilience
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2296: National Defense Authorization Act (NDAA) for Fiscal Year 2026 Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR Medical Device Safety FDA Streamlining FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining FY27 National Defense Authorization Act - Domestic Production of Essential Medicines CMS Preference for Domestic Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform Net Elective Cost Policy: PBM Reform Through Bid Transparency Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC) Procurement
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2296: National Defense Authorization Act (NDAA) for Fiscal Year 2026 Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR Medical Device Safety FDA Streamlining FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining FY27 National Defense Authorization Act - Domestic Production of Essential Medicines CMS Preference for Domestic Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform Net Elective Cost Policy: PBM Reform Through Bid Transparency Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC) Procurement
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
National Defense Authorization Act for Fiscal Year 2026
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2296: National Defense Authorization Act (NDAA) for Fiscal Year 2026 Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR Medical Device Safety FDA Streamlining FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining FY27 National Defense Authorization Act - Domestic Production of Essential Medicines CMS Preference for Domestic Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform Net Elective Cost Policy: PBM Reform Through Bid Transparency Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC) Procurement
National Defense Authorization Act for Fiscal Year 2026
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2296: National Defense Authorization Act (NDAA) for Fiscal Year 2026 Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR Medical Device Safety FDA Streamlining FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining FY27 National Defense Authorization Act - Domestic Production of Essential Medicines CMS Preference for Domestic Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform Net Elective Cost Policy: PBM Reform Through Bid Transparency Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC) Procurement
Medication Affordability and Patent Integrity Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) PTAB: Proposed Rule, Settled Expectations, Patent Thickets and Ancillary Product Patents, Discretionary Denials
Medication Affordability and Patent Integrity Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) PTAB Proposed Rule - Discretionary Denials and One and Done Ancillary Product Patent Reform
Medication Affordability and Patent Integrity Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
Medication Affordability and Patent Integrity Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
Medication Affordability and Patent Integrity Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Drug Shortages and Supply Chain Resilience PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
Medication Affordability and Patent Integrity Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) Domestic Manufacturing of Essential Medicines
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act US Drug Enforcement Administration Quota FDA/PTO Coordination USPTO Practices Most Favored Nation (MFN) Proposed Rule Biosimilar Tariffs Domestic Manufacturing Tariffs Medical Devices Generic Medicines Industry Net Effective Cost Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Interagency Patent Coordination and Improvement Act of 2025
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Interagency Patent Coordination and Improvement Act of 2025
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act US Drug Enforcement Administration Quota FDA/PTO Coordination USPTO Practices Most Favored Nation (MFN) Proposed Rule Biosimilar Tariffs Domestic Manufacturing Tariffs Medical Devices Generic Medicines Industry Net Effective Cost Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Affordable Prescriptions for Patients Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Affordable Prescriptions for Patients Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Preserve Access to Affordable Generics and Biosimilars Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Preserve Access to Affordable Generics and Biosimilars Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Interagency Patent Coordination and Improvement Act of 2025
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Interagency Patent Coordination and Improvement Act of 2025
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Expedited Access to Biosimilars Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act US Drug Enforcement Administration Quota FDA/PTO Coordination USPTO Practices Most Favored Nation (MFN) Proposed Rule Biosimilar Tariffs Domestic Manufacturing Tariffs Medical Devices Generic Medicines Industry Net Effective Cost Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Expedited Access to Biosimilars Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Expedited Access to Biosimilars Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Biosimilar Red Tape Elimination Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act US Drug Enforcement Administration Quota FDA/PTO Coordination USPTO Practices Most Favored Nation (MFN) Proposed Rule Biosimilar Tariffs Domestic Manufacturing Tariffs Medical Devices Generic Medicines Industry Net Effective Cost Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act US Drug Enforcement Administration Quota FDA/PTO Coordination USPTO Practices Most Favored Nation (MFN) Proposed Rule Biosimilar Tariffs Domestic Manufacturing Tariffs Medical Devices Generic Medicines Industry Net Effective Cost Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Medication Affordability and Patent Integrity Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Fair Accountability and Innovative Research Drug Pricing Act of 2019
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Elijah E. Cummings Lower Drug Costs Now Act
Client: FRESENIUS KABI USA LLC · Firm: FRESENIUS KABI USA LLC
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) Domestic Manufacturing of Essential Medicines
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) PTAB: Proposed Rule, Settled Expectations, Patent Thickets and Ancillary Product Patents, Discretionary Denials
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2026 · second_quarter · Q2
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act Section 301 Investigation re: Germany Issues Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines PTAB Proposed Rule - Discretionary Denials and One and Done Federal Procurement Preferences for Domestic Medicines Drug Shortages and Supply Chain Resilience
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) PTAB Proposed Rule - Discretionary Denials and One and Done Ancillary Product Patent Reform
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Drug Shortages and Supply Chain Resilience PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2026 · first_quarter · 1A
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2296: National Defense Authorization Act (NDAA) for Fiscal Year 2026 Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR Medical Device Safety FDA Streamlining FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining FY27 National Defense Authorization Act - Domestic Production of Essential Medicines CMS Preference for Domestic Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform Net Elective Cost Policy: PBM Reform Through Bid Transparency Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC) Procurement
PTAB Proposed Rule - Restrict Use of IPR Patent Legislation Ancillary Product Patent Reform Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining
Medical Device Safety Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Federal Procurement Preferences for Domestic Medicines Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC)
CMS Preference for Domestic Essential Medicines Net Elective Cost Policy: PBM Reform Through Bid Transparency
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2026 · first_quarter · Q1
Medical Device Safety Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Federal Procurement Preferences for Domestic Medicines Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC)
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2296: National Defense Authorization Act (NDAA) for Fiscal Year 2026 Biosimilar Tariffs and USPTO Proposed Rule PTAB Proposed Rule - Restrict Use of IPR Medical Device Safety FDA Streamlining FY27 Appropriations: Domestic Production of Essential Medicines; Chemical-free Medical Devices Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining FY27 National Defense Authorization Act - Domestic Production of Essential Medicines CMS Preference for Domestic Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform Net Elective Cost Policy: PBM Reform Through Bid Transparency Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) Industrial Base Management and Supply Chain (IBMSC) Procurement
CMS Preference for Domestic Essential Medicines Net Elective Cost Policy: PBM Reform Through Bid Transparency
PTAB Proposed Rule - Restrict Use of IPR Patent Legislation Ancillary Product Patent Reform Clinical Trials for Biosimilars; Interchangeability Biosimilar Market Entry through Regulatory Streamlining
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2025 · fourth_quarter · Q4
Drug Shortages and Medicaid Specialty Drug Pharmacy Payment Reform
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act US Drug Enforcement Administration Quota FDA/PTO Coordination USPTO Practices Most Favored Nation (MFN) Proposed Rule Biosimilar Tariffs Domestic Manufacturing Tariffs Medical Devices Generic Medicines Industry Net Effective Cost Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
PTAB Discretionary Denials
Drug Shortages Domestic Manufacturing Tariffs Medical Devices Most Favored Nation (MFN) Proposed Rule Biosimilar Tariffs Generic Medicines
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2025 · third_quarter · 3A
Drug Shortages and Medicaid ERISA Fiduciary Duty IRA Reform
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2025 · third_quarter · Q3
PTAB Discretionary Denials
Drug Shortages and Medicaid ERISA Fiduciary Duty IRA Reform
S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2025 · second_quarter · Q2
PBM reform, including spread pricing, AWP setting and/or dispense rate policy, ASP policy, any willing pharmacy laws in Medicare, third party essential medicine testing
Sec. 232 investigation on pharmaceutical sector, tariffs, Buy America policies, Most Favored Nations Executive Order, reciprocal tariffs, essential medicines drug shortages related to trade agreements.
PBM reform, patent reform, ASP reform, international reference pricing, IRA Medicare negotiation, inflation penalty, most favored nations executive order, AWP reform, U.S. manufacturer preferencing, Medicare conditions of participation relating to resiliency standards linked to government reimbursement, 340b reform including PBM-owned 340b pharmacies, Medicare formulary policy and specialty tier reform, generics on generic tiers, Medicaid generics penalty, IRA inflationary penalty, manufacturer discount program
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2025 · first_quarter · Q1
Buy America legislation, tariffs, tax incentives, regulatory barriers to generic and biosimilar launch
Section 232 investigation into pharmaceuticals and unfair trade practices
Sec. 232 investigation on pharmaceutical sector, tariffs, made in America
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2024 · fourth_quarter · Q4
Pharmaceutical supply chain and API procurement, Global drug shortages, Tax reform
PBM reform, IRA Medicare Direct Negotiation, FDA/PTO
Tax incentives for American production of pharmaceutical product, opioid taxes
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2024 · third_quarter · Q3
Tax incentives for American production of pharmaceutical product, opioid taxes
Pharmaceutical supply chain and API procurement, Global drug shortages, Tax reform
IRA, Part D redesign, rebates, AMP CAP, inflationary penalties, mid-year formulary changes, patent reform, terminal disclaimers, ancillary product patents
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2024 · second_quarter · 2A
Tax incentives for American production of pharmaceutical product, opioid taxes
Pharmaceutical supply chain and API procurement, Global drug shortages, Tax reform
Rebate reform, any willing pharmacy, PBM reform, IRA Medicare Direct Negotiation, DIR fees
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2024 · second_quarter · Q2
Tax incentives for American production of pharmaceutical product, opioid taxes
Pharmaceutical supply chain and API procurement, Global drug shortages, Tax reform
Rebate reform, any willing pharmacy, PBM reform, IRA Medicare Direct Negotiation, DIR fees
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2024 · first_quarter · Q1
Tax incentives for American production of pharmaceutical product, opioid taxes
Pharmaceutical supply chain and API procurement, Global drug shortages, Tax reform
IRA, Part D redesign, rebates, AMP CAP, inflationary penalties, mid-year formulary changes
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2023 · fourth_quarter · Q4
IRA, Part D redesign, rebates, AMP CAP, inflationary penalties, mid-year formulary changes
Pharmaceutical supply chain and API procurement, Global drug shortages, Tax reform
Rebate reform, any willing pharmacy, PBMs, IRA Medicare Direct Negotiation, DIR fees
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2023 · third_quarter · Q3
IRA, Part D redesign, rebates, AMP CAP, inflationary penalties, mid-year formulary changes
Rebate reform, any willing pharmacy, PBMs, IRA Medicare Direct Negotiation, DIR fees
Tax incentives for American production of pharmaceutical product, opioid taxes
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2023 · second_quarter · Q2
Pharmaceutical supply chain and API procurement, Global drug shortages, Tax reform
Tax incentives for American production of pharmaceutical product, opioid taxes
Rebate reform, any willing pharmacy, PBMs, IRA Medicare Direct Negotiation, DIR fees
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2023 · first_quarter · Q1
Tax incentives for American production of pharmaceutical product, opioid taxes
IRA, Part D redesign, rebates, AMP CAP, inflationary penalties, mid-year formulary changes
Rebate reform, any willing pharmacy
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2022 · fourth_quarter · Q4
Drug pricing legislation, Biosimilars, Patent Reform, Rebate Reform, BLOCKING Act, Electronic Labeling, FDA Foreign Inspection backlog, Reconciliation, FDA User Fee legislation
Buy America, supply chain integrity
Tax Reform, Section 199, BEAT, Gilty, Buy America, Patent Reform
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2022 · third_quarter · Q3
Buy America, supply chain integrity
Drug pricing legislation, Biosimilars, Patent Reform, Rebate Reform, BLOCKING Act, Electronic Labeling, FDA Foreign Inspection backlog, Reconciliation, FDA User Fee legislation
Tax Reform, Section 199, BEAT, Gilty, Buy America, Patent Reform
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2022 · second_quarter · Q2
Drug pricing legislation, Biosimilars, Patent Reform, Rebate Reform, BLOCKING Act, Electronic Labeling, FDA Foreign Inspection backlog, Reconciliation, FDA User Fee legislation
Rebate Reform, Medicare Part D Redesign, Inflationary penalties, Drug pricing legislation, International reference pricing, Medicare direct negotiations, reconciliation
Buy America, supply chain integrity
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2022 · first_quarter · Q1
Rebate Reform, Medicare Part D Redesign, Inflationary penalties, Drug pricing legislation, International reference pricing, Medicare direct negotiations, reconciliation
Drug pricing legislation, Biosimilars, Patent Reform, Rebate Reform, BLOCKING Act, Electronic Labeling, FDA Foreign Inspection backlog, Reconciliation, FDA User Fee legislation
Buy America, supply chain integrity
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2021 · fourth_quarter · Q4
Drug pricing legislation, Biosimilars, Patent Reform, Rebate Reform, BLOCKING Act, Electronic Labeling, FDA Foreign Inspection backlog, Reconciliation
Tax Reform, Section 199, BEAT, Gilty, Buy America, Patent Reform
Buy America, supply chain integrity
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2021 · third_quarter · Q3
Drug pricing legislation, Biosimilars, Patent Reform, Rebate Reform, BLOCKING Act, Electronic Labeling, FDA Foreign Inspection backlog, Reconciliation
Tax Reform, Section 199, BEAT, Gilty, Buy America
Buy America, supply chain integrity
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2021 · second_quarter · Q2
Tax Reform, Section 199, BEAT, Gilty, Buy America
Buy America, supply chain integrity
Rebate Reform, Medicare Part D Redesign, Inflationary penalties, Drug pricing legislation, International reference pricing, Medicare direct negotiations
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2021 · first_quarter · Q1
Drug pricing legislation, Biosimilars, Patent Reform, Rebate Reform, BLOCKING Act, Electronic Labeling, FDA Foreign Inspection backlog
Tax Reform, Section 199, BEAT, Gilty, Buy America
Rebate Reform, Medicare Part D Redesign, Inflationary penalties, Drug pricing legislation, International reference pricing, Medicare direct negotiations
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2020 · fourth_quarter · Q4
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2020 · third_quarter · Q3
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2020 · second_quarter · Q2
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2020 · third_quarter · RA
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2020 · first_quarter · Q1
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2019 · fourth_quarter · 4A
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
FRESENIUS KABI USA LLC via FRESENIUS KABI USA LLC
2019 · third_quarter · RR
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
PTAB Discretionary Denials
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
BEAT, AMT, U.S. manufacturing incentives
Drug pricing, PBM Reform, patent reform, biosimilars, generics, medical devices, FDA approvals, DEHP
Buy America legislation, tariffs, tax incentives, regulatory barriers to generic and biosimilar launches, patent waivers
Section 232 investigation into pharmaceuticals and unfair trade practices
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
PBM reform, including spread pricing, AWP policy, ASP policy
PBM reform, patent reform, ASP reform, international reference pricing, IRA Medicare negotiation, inflation penalty
BEAT, AMT, U.S. manufacturing incentives
Drug pricing, PBM Reform, patent reform, biosimilars, generics, medical devices, FDA approvals, DEHP
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
Patent Reform, terminal disclaimers, ancillary product patents
Buy America legislation, potential manufacturing tariffs, tax reform on fill and finish pharmaceutical products
IRA, Part D redesign, rebates, AMP CAP, inflationary penalties, mid-year formulary changes, patent reform, terminal disclaimers, ancillary product patents
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Rebate reform, any willing pharmacy, PBM reform, IRA Medicare Direct Negotiation, DIR fees
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
IRA, Part D redesign, rebates, AMP CAP, inflationary penalties, mid-year formulary changes, patent reform, terminal disclaimers, ancillary product patents
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
IRA, Part D redesign, rebates, AMP CAP, inflationary penalties, mid-year formulary changes, patent reform, terminal disclaimers, ancillary product patents
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Rebate reform, any willing pharmacy, PBMs, IRA Medicare Direct Negotiation, DIR fees
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Tax incentives for American production of pharmaceutical product, opioid taxes
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Pharmaceutical supply chain and API procurement, Global drug shortages, Tax reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
IRA, Part D redesign, rebates, AMP CAP, inflationary penalties, mid-year formulary changes
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Pharmaceutical supply chain and API procurement, Global drug shortages, Tax reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Rebate Reform, Medicare Part D Redesign, Inflationary penalties, Drug pricing legislation, International reference pricing, Medicare direct negotiations, reconciliation
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Rebate Reform, Medicare Part D Redesign, Inflationary penalties, Drug pricing legislation, International reference pricing, Medicare direct negotiations, reconciliation
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Tax Reform, Section 199, BEAT, Gilty, Buy America, Patent Reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Tax Reform, Section 199, BEAT, Gilty, Buy America, Patent Reform
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Rebate Reform, Medicare Part D Redesign, Inflationary penalties, Drug pricing legislation, International reference pricing, Medicare direct negotiations, reconciliation
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, White House Office
Rebate Reform, Medicare Part D Redesign, Inflationary penalties, Drug pricing legislation, International reference pricing, Medicare direct negotiations, reconciliation
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Drug pricing legislation, Biosimilars, Patent Reform, Rebate Reform, BLOCKING Act, Electronic Labeling, FDA Foreign Inspection backlog
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Buy America
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
Issues impacting the pharmaceutical industry, including coverage, coding, and payment policy for both public and private payers, regulatory, tax, trade, manufacturing, and intellectual property.
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA
BLOCKING Act, Medical device tax, opioids, intellectual property, data exclusivity, CURES, Medicare Part A, B, C, D, Medicaid rebates and inflationary penalties, HR3, Biosimilars, generic medicines, S1391, PDPRA