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Reported covered position: Congressman Bruce Westerman (Legislative Assistant) Congressman Buddy Carter (Health Policy Advisor)
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.
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 · third_quarter · Q3
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Source: Senate LDA
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Protecting Patient Access to Cancer and Complex Therapies Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
340B PATIENTS Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
340B ACCESS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Pharmacists Fight Back in Medicare and Medicaid Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
Most Favored Patient Act of 2026
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
CLEAR LABELS Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
SECURE 340B Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Drug Competition Enhancement Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Stop STALLING Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Preserve Access to Affordable Generics and Biosimilars Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Biosimilar Red Tape Elimination Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
340B PATIENTS Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Medication Affordability and Patent Integrity Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
DRUG Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues H.R. 2214, DRUG Act
To amend the Impoundment Control Act of 1974 to require prior approval from Congress before the Comptroller General may pursue a civil action under such Act, and for other purposes.
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
ORPHAN Cures Act
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
EPIC Act of 2025
Client: TAKEDA PHARMACEUTICALS AMERICA INC · Firm: TAKEDA PHARMACEUTICALS AMERICA, INC.
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
H.R.1 492 , S. 832, EPIC Act of 2025, all pharmaceutical related provisions H.R. 7837 Most Favored Patient Act f 2026, all pharmaceutical related provisions H.R. 4299 Protecting Patient Access to Cancer & Complex Therapies Act, all pharmaceutical related provisions H.R. 6609 Pharmacists Fight Back in Medicare and Medicaid Act, all pharmaceutical related provisions P.L. 117-169 Inflation Reduction Act, all pharmaceutical related provisions IRA: Discussions on reform (non-H.R. 4299, e.g., Orphan Cures change, biosimilars, etc) IRA: Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Medicare: Proposals enhance patient access (e.g., protected classes, telehealth, coverage) Medicare: Proposals related to payment proposals (e.g., Part D, Part B, ASP, transparency) Medicaid: Proposals related to access or pricing GLOBE CMMI Model Executive Order
Administration's Global Tax Proposal Tax incentive issues as they relate to proposed global supply chain bills Discussions related to the repeal of the BEAT - provisions related to orphan drug tax credits
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 · second_quarter · Q2
Clarify or reform the 340B program Value-based drug contracting Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues SECURE 340B Act (bill# not listed yet) Senate Finance Committee Drug Pricing RFI
Issues related to proposed Tariffs - all pharmaceutical related provisions
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Filing targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 · first_quarter · Q1
FY 2025 Budget Resolution - Pharmaceutical Related Provisions
Discussions around Supply Chain implications
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues
General intellectual property policy issues Issues related to proposed Tariffs - all pharmaceutical related provisions
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) Request for Regulatory Clarification with Medicare Part B Group (CMS) Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Request for Regulatory Clarification with Medicare Administrative Contractor (CMS) Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
TAKEDA PHARMACEUTICALS AMERICA INC via TAKEDA PHARMACEUTICALS AMERICA, INC.
2025 · fourth_quarter · Q4
FY 2025 Budget Resolution - Pharmaceutical Related Provisions
Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues H.R. 2214, DRUG Act
Policies to enhance patient access to medicines in Medicaid including rebate, waiver policy and funding issues Policies to enhance patient access to medicines in Medicare Review of proposed rule regarding testing of Medicare part B prescription drug models Discussions related to rebates and Medicare part D - provisions related to the HHS-OIG Rebate Safe Harbor Proposals related to amending the protected classes in Medicare Medicare payment proposals Medicare telehealth proposals CMS Transparency in Coverage Final Rule (CMS-9915-F) CMS Medicaid Drug Rebate Proposed Rule - issues related to best price and survey Medicare Prescription Drug Inflation Rebate Program Part B Rebatable Drug Coinsurance Reduction Drug List Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2026 Discussions on biosimilars related to IRA Discussions on spillover related to the IRA Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2027 Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028 Discussions on reforming the Inflation Reduction Act Discussions on orphan drugs related to the IRA Discussions on treatment of small molecule drugs related to IRA H.R.1 492, S. 832, EPIC Act of 2025 H.R. 946, Optimizing Research Progress Hope and New (ORPHAN) Cures Act HR 4229 Protecting Patient Access to Cancer & Complex Therapies Act
General intellectual property policy issues Issues related to proposed Tariffs - all pharmaceutical related provisions
Discussions around Supply Chain implications
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE