EMILY MACE

E-labeling (allowing health care providers to receive prescribing information for drugs electronically rather than in paper form from manufacturers) Issues related to increasing production of US manufacturing HR 4132/S 2027, Prescription Information Modernization Act

Potential for a second reconciliation bill and potential offsets (increase in corporate tax rate, Sec 899 taxation) Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal IRS guidance on R&D tax credit Base Erosion and Anti-Abuse Tax (BEAT) tax Corporate alternative minimum tax (CAMT) interaction with R&D expensing Global Intangible Low-Taxed Income (GILTI), Foreign-Derived Intangible Income (FDII) deduction OECD Pillar Two side by side deal Workforce Tax Credits USMCA negotiations Pharmaceutical pricing negotiations Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Interaction of state and federal R&D credits Issues related to international tax rules including HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit S.1605 - International Competition for American Jobs Act

CMMI GENEROUS Demo Medicare Part B ASP compliance FDA modernization policy Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) BIOSECURE Act implementation Issues related to the Medicare title in the One Big Beautiful Bill Act Issues related to the IRA definition of a drug for purposes of price negotiation selection Duplicate discounts as required by IRA Issues related to direct-to-consumer drug delivery policy options Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues related to 340B Rebate Model Pilot Program for IRA compliance Issues related to next generation propellant and PFAS Issues related to the US manufacturing of pharmaceuticals Issues related to the price and manufacture of inhaled medicines Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to vaccine access and vaccine R&D Issues related to FDA Orange Book patent listings Issues related to the recruitment of patients for clinical trials Issues related to most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to ACIP recommendations Policies related to international reference pricing for pharmaceuticals Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act HR 6166, the Lowering Drug Costs for American Families Act

HR 7118 Genomic Answers for Children's Health Act HR 9599 The SECURE 340B Act Policies related to the use of international reference pricing in Medicare/Medicaid 340B rebate model Issues related to Part B and Part D drug access Medicare drug price negotiation Medicare patient access to cancer screening Medicare patient access to rare disease therapies Efforts to improve coding, coverage, and access for rare disease therapies Issues related to e-labeling and allowing FDA to finalize a rule to allow digital versions of prescriptions Issues related to a Most Favored Nations policy in Medicare and Medicaid Most Favored Nation drug pricing proposals Issues related to the digital communication of prescribing information for drugs

HR 3521/ S 4440 Clinical Trial Modernization Act HR 946/S 1862 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act Discuss Vaccine concerns Cell Therapy Broad discussion on drug pricing CMMI GENEROUS Demo FDA modernization policy 340B policy Demo for CMMI regarding copay caps Policies related to international reference pricing for pharmaceuticals Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues and policies related to 340B Rebate Model Pilot Program for IRA compliance Issues related to most-favored nations drug pricing proposals Issues related to implementation and/or expansion of the Inflation Reduction Act (IRA) Issues related to the price and manufacture of inhaled medicines Issues related to next generation propellant and PFAS Issues related to vaccine access and vaccine R&D, including ACIP recommendations Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials clinical trial modernization act

CMMI GENEROUS Demo Medicare Part B ASP compliance FDA modernization policy Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) BIOSECURE Act implementation Issues related to the Medicare title in the One Big Beautiful Bill Act Issues related to the IRA definition of a drug for purposes of price negotiation selection Duplicate discounts as required by IRA Issues related to direct-to-consumer drug delivery policy options Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues related to 340B Rebate Model Pilot Program for IRA compliance Issues related to next generation propellant and PFAS Issues related to the US manufacturing of pharmaceuticals Issues related to the price and manufacture of inhaled medicines Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to vaccine access and vaccine R&D Issues related to FDA Orange Book patent listings Issues related to the recruitment of patients for clinical trials Issues related to most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to ACIP recommendations Policies related to international reference pricing for pharmaceuticals Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act HR 6166, the Lowering Drug Costs for American Families Act

HR 7118 Genomic Answers for Children's Health Act HR 9599 The SECURE 340B Act Policies related to the use of international reference pricing in Medicare/Medicaid 340B rebate model Issues related to Part B and Part D drug access Medicare drug price negotiation Medicare patient access to cancer screening Medicare patient access to rare disease therapies Efforts to improve coding, coverage, and access for rare disease therapies Issues related to e-labeling and allowing FDA to finalize a rule to allow digital versions of prescriptions Issues related to a Most Favored Nations policy in Medicare and Medicaid Most Favored Nation drug pricing proposals Issues related to the digital communication of prescribing information for drugs

Potential for a second reconciliation bill and potential offsets (increase in corporate tax rate, Sec 899 taxation) Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal IRS guidance on R&D tax credit Base Erosion and Anti-Abuse Tax (BEAT) tax Corporate alternative minimum tax (CAMT) interaction with R&D expensing Global Intangible Low-Taxed Income (GILTI), Foreign-Derived Intangible Income (FDII) deduction OECD Pillar Two side by side deal Workforce Tax Credits USMCA negotiations Pharmaceutical pricing negotiations Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Interaction of state and federal R&D credits Issues related to international tax rules including HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit S.1605 - International Competition for American Jobs Act

HR 3521/ S 4440 Clinical Trial Modernization Act HR 946/S 1862 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act Discuss Vaccine concerns Cell Therapy Broad discussion on drug pricing CMMI GENEROUS Demo FDA modernization policy 340B policy Demo for CMMI regarding copay caps Policies related to international reference pricing for pharmaceuticals Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues and policies related to 340B Rebate Model Pilot Program for IRA compliance Issues related to most-favored nations drug pricing proposals Issues related to implementation and/or expansion of the Inflation Reduction Act (IRA) Issues related to the price and manufacture of inhaled medicines Issues related to next generation propellant and PFAS Issues related to vaccine access and vaccine R&D, including ACIP recommendations Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials clinical trial modernization act

CMMI GENEROUS Demo Medicare Part B ASP compliance FDA modernization policy Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) BIOSECURE Act implementation Issues related to the Medicare title in the One Big Beautiful Bill Act Issues related to the IRA definition of a drug for purposes of price negotiation selection Duplicate discounts as required by IRA Issues related to direct-to-consumer drug delivery policy options Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues related to 340B Rebate Model Pilot Program for IRA compliance Issues related to next generation propellant and PFAS Issues related to the US manufacturing of pharmaceuticals Issues related to the price and manufacture of inhaled medicines Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to vaccine access and vaccine R&D Issues related to FDA Orange Book patent listings Issues related to the recruitment of patients for clinical trials Issues related to most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to ACIP recommendations Policies related to international reference pricing for pharmaceuticals Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act HR 6166, the Lowering Drug Costs for American Families Act

E-labeling (allowing health care providers to receive prescribing information for drugs electronically rather than in paper form from manufacturers) Issues related to increasing production of US manufacturing HR 4132/S 2027, Prescription Information Modernization Act

CMMI GENEROUS Demo Medicare Part B ASP compliance FDA modernization policy Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) BIOSECURE Act implementation Issues related to the Medicare title in the One Big Beautiful Bill Act Issues related to the IRA definition of a drug for purposes of price negotiation selection Duplicate discounts as required by IRA Issues related to direct-to-consumer drug delivery policy options Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues related to 340B Rebate Model Pilot Program for IRA compliance Issues related to next generation propellant and PFAS Issues related to the US manufacturing of pharmaceuticals Issues related to the price and manufacture of inhaled medicines Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to vaccine access and vaccine R&D Issues related to FDA Orange Book patent listings Issues related to the recruitment of patients for clinical trials Issues related to most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to ACIP recommendations Policies related to international reference pricing for pharmaceuticals Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act HR 6166, the Lowering Drug Costs for American Families Act

HR 3521/ S 4440 Clinical Trial Modernization Act HR 946/S 1862 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act Discuss Vaccine concerns Cell Therapy Broad discussion on drug pricing CMMI GENEROUS Demo FDA modernization policy 340B policy Demo for CMMI regarding copay caps Policies related to international reference pricing for pharmaceuticals Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues and policies related to 340B Rebate Model Pilot Program for IRA compliance Issues related to most-favored nations drug pricing proposals Issues related to implementation and/or expansion of the Inflation Reduction Act (IRA) Issues related to the price and manufacture of inhaled medicines Issues related to next generation propellant and PFAS Issues related to vaccine access and vaccine R&D, including ACIP recommendations Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials clinical trial modernization act

CMMI GENEROUS Demo Medicare Part B ASP compliance FDA modernization policy Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) BIOSECURE Act implementation Issues related to the Medicare title in the One Big Beautiful Bill Act Issues related to the IRA definition of a drug for purposes of price negotiation selection Duplicate discounts as required by IRA Issues related to direct-to-consumer drug delivery policy options Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues related to 340B Rebate Model Pilot Program for IRA compliance Issues related to next generation propellant and PFAS Issues related to the US manufacturing of pharmaceuticals Issues related to the price and manufacture of inhaled medicines Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to vaccine access and vaccine R&D Issues related to FDA Orange Book patent listings Issues related to the recruitment of patients for clinical trials Issues related to most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to ACIP recommendations Policies related to international reference pricing for pharmaceuticals Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act HR 6166, the Lowering Drug Costs for American Families Act

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 1503/S 2916, Prescription Information Modernization Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Orphan drugs and diseases Education to Hill staff on next generation propellant and PFAS Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Reforms to the 340B program; Issues related to mitigation of 340B Issues related to the price and manufacture of inhaled medicines Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to direct-to-consumer drug delivery policy options Policies related to international reference pricing for pharmaceuticals Issues related to environmental sustainability Company sustainability policy issues FDA modernization policy issues Issues related to FDA Orange Book patent listings Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Tariffs/trade policies related to tariffs on pharmaceuticals Most favored nation policies related to pharmaceuticals Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the Medicare title in the One Big Beautiful Bill Act

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

H.R.946 - Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) Issues related to Inflation Reduction Act (IRA) consideration of small molecule drugs, biologics, and genetically targeted technologies Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to e-labeling Issues related to the price and manufacture of inhaled medicines Issues related to the IRAs drug price negotiation program Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to FDA Orange Book patent listings Issues related to environmental sustainability Issues related to FDA modernization Policies related to international reference pricing for pharmaceuticals Policies related to 340B rebate model for IRA compliance Policies related to the definition of a qualifying single source drug under the IRA Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Company sustainability policy issues General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Education to Hill staff on next generation propellant and PFAS FDA modernization policy issues Tariffs/trade policies related to tariffs on pharmaceuticals

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 1503/S 2916, Prescription Information Modernization Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Orphan drugs and diseases Education to Hill staff on next generation propellant and PFAS Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Reforms to the 340B program; Issues related to mitigation of 340B Issues related to the price and manufacture of inhaled medicines Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to direct-to-consumer drug delivery policy options Policies related to international reference pricing for pharmaceuticals Issues related to environmental sustainability Company sustainability policy issues FDA modernization policy issues Issues related to FDA Orange Book patent listings Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Tariffs/trade policies related to tariffs on pharmaceuticals Most favored nation policies related to pharmaceuticals Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the Medicare title in the One Big Beautiful Bill Act

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Tax reform in budget reconciliation and Byrd rules Issues related to proposed Sec. 899 Issues related to international tax rules (GILTI/FDII/BEAT) Tariffs (general education, country-specific tariffs, sector-specific tariffs) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Education on tax in preparation for 2025 tax legislation

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Tax reform in budget reconciliation and Byrd rules Issues related to proposed Sec. 899 Issues related to international tax rules (GILTI/FDII/BEAT) Tariffs (general education, country-specific tariffs, sector-specific tariffs) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Education on tax in preparation for 2025 tax legislation

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Tax reform in budget reconciliation and Byrd rules Issues related to proposed Sec. 899 Issues related to international tax rules (GILTI/FDII/BEAT) Tariffs (general education, country-specific tariffs, sector-specific tariffs) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Education on tax in preparation for 2025 tax legislation

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Tax reform in budget reconciliation and Byrd rules Issues related to proposed Sec. 899 Issues related to international tax rules (GILTI/FDII/BEAT) Tariffs (general education, country-specific tariffs, sector-specific tariffs) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Education on tax in preparation for 2025 tax legislation

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 1503/S 2916, Prescription Information Modernization Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Orphan drugs and diseases Education to Hill staff on next generation propellant and PFAS Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Reforms to the 340B program; Issues related to mitigation of 340B Issues related to the price and manufacture of inhaled medicines Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to direct-to-consumer drug delivery policy options Policies related to international reference pricing for pharmaceuticals Issues related to environmental sustainability Company sustainability policy issues FDA modernization policy issues Issues related to FDA Orange Book patent listings Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Tariffs/trade policies related to tariffs on pharmaceuticals Most favored nation policies related to pharmaceuticals Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the Medicare title in the One Big Beautiful Bill Act

H.R.946 - Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) Issues related to Inflation Reduction Act (IRA) consideration of small molecule drugs, biologics, and genetically targeted technologies Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to e-labeling Issues related to the price and manufacture of inhaled medicines Issues related to the IRAs drug price negotiation program Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to FDA Orange Book patent listings Issues related to environmental sustainability Issues related to FDA modernization Policies related to international reference pricing for pharmaceuticals Policies related to 340B rebate model for IRA compliance Policies related to the definition of a qualifying single source drug under the IRA Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Company sustainability policy issues General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Education to Hill staff on next generation propellant and PFAS FDA modernization policy issues Tariffs/trade policies related to tariffs on pharmaceuticals

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

Implementation of One Big Beautiful Bill Act law (corporate minimum tax, R&D expensing) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Tax reform in budget reconciliation and Byrd rules Section 899 tax proposal Interaction of state and federal R&D credits Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Issues related to international tax rules (GILTI/FDII/BEAT) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Education on tax in preparation for 2025 tax legislation

HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1990 - American Innovation and R&D Competitiveness Act of 2025 HR 2423 - Unfair Tax Prevention Act S 1605 - International Competition for American Jobs Act Expiring provisions of the Tax Cut and Jobs Act law - deduction of research and development expenditures Tax reform in budget reconciliation and Byrd rules Issues related to proposed Sec. 899 Issues related to international tax rules (GILTI/FDII/BEAT) Tariffs (general education, country-specific tariffs, sector-specific tariffs) Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Education on tax in preparation for 2025 tax legislation

HR 1, One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 1503/S 2916, Prescription Information Modernization Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Orphan drugs and diseases Education to Hill staff on next generation propellant and PFAS Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Reforms to the 340B program; Issues related to mitigation of 340B Issues related to the price and manufacture of inhaled medicines Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to direct-to-consumer drug delivery policy options Policies related to international reference pricing for pharmaceuticals Issues related to environmental sustainability Company sustainability policy issues FDA modernization policy issues Issues related to FDA Orange Book patent listings Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Tariffs/trade policies related to tariffs on pharmaceuticals Most favored nation policies related to pharmaceuticals Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the Medicare title in the One Big Beautiful Bill Act

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

H.R.946 - Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) Issues related to Inflation Reduction Act (IRA) consideration of small molecule drugs, biologics, and genetically targeted technologies Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to e-labeling Issues related to the price and manufacture of inhaled medicines Issues related to the IRAs drug price negotiation program Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to FDA Orange Book patent listings Issues related to environmental sustainability Issues related to FDA modernization Policies related to international reference pricing for pharmaceuticals Policies related to 340B rebate model for IRA compliance Policies related to the definition of a qualifying single source drug under the IRA Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Company sustainability policy issues General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Education to Hill staff on next generation propellant and PFAS FDA modernization policy issues Tariffs/trade policies related to tariffs on pharmaceuticals

HR 1, One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 1503/S 2916, Prescription Information Modernization Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Orphan drugs and diseases Education to Hill staff on next generation propellant and PFAS Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Reforms to the 340B program; Issues related to mitigation of 340B Issues related to the price and manufacture of inhaled medicines Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to direct-to-consumer drug delivery policy options Policies related to international reference pricing for pharmaceuticals Issues related to environmental sustainability Company sustainability policy issues FDA modernization policy issues Issues related to FDA Orange Book patent listings Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Tariffs/trade policies related to tariffs on pharmaceuticals Most favored nation policies related to pharmaceuticals Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the Medicare title in the One Big Beautiful Bill Act

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act. Issues related to the Medicare title in the One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act BIOSECURE Act H.R.6166, the Lowering Drug Costs for American Families Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Issues related to mitigation of 340B; Issues related to 340B Rebate Model Pilot Program Issues related to the price and manufacture of inhaled medicines Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS Issues related to next generation propellant and PFAS Issues related to drug pricing Policies related to international reference pricing for pharmaceuticals Issues related to the US manufacturing of pharmaceuticals Issues related to direct-to-consumer drug delivery policy options General issues related to vaccine safety, efficacy, and access Issues related to vaccine access and vaccine R&D General issues related to rare disease and orphan drugs General issues related to health equity in rare disease and clinical trials General issues related to ACIP recommendations FDA modernization policy issues Issues related to FDA Orange Book patent listings Issues related to the ARPA-H HEROES program Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to use of AI in R&D and manufacturing

HR 1, One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 1503/S 2916, Prescription Information Modernization Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Orphan drugs and diseases Education to Hill staff on next generation propellant and PFAS Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Reforms to the 340B program; Issues related to mitigation of 340B Issues related to the price and manufacture of inhaled medicines Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to direct-to-consumer drug delivery policy options Policies related to international reference pricing for pharmaceuticals Issues related to environmental sustainability Company sustainability policy issues FDA modernization policy issues Issues related to FDA Orange Book patent listings Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Tariffs/trade policies related to tariffs on pharmaceuticals Most favored nation policies related to pharmaceuticals Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the Medicare title in the One Big Beautiful Bill Act

HR 1, One Big Beautiful Bill Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 1503/S 2916, Prescription Information Modernization Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); consideration of small molecule drugs, biologics, and genetically targeted technologies; duplicate discounts as required by IRA; Policies related to the definition of a qualifying single source drug under the IRA; Issues related to the IRA definition of a drug for purposes of price negotiation selection; Issues related to expanding/amending the orphan drug exclusion in IRA Orphan drugs and diseases Education to Hill staff on next generation propellant and PFAS Issues related to pharmacy benefit manager (PBM) reform; Policies related to 340B rebate model for IRA compliance; Reforms to the 340B program; Issues related to mitigation of 340B Issues related to the price and manufacture of inhaled medicines Issues related to drug pricing Issues related to the US manufacturing of pharmaceuticals Issues related to importation of drugs Issues related to direct-to-consumer drug delivery policy options Policies related to international reference pricing for pharmaceuticals Issues related to environmental sustainability Company sustainability policy issues FDA modernization policy issues Issues related to FDA Orange Book patent listings Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to rare disease and orphan drugs General issues related to ACIP recommendations Tariffs/trade policies related to tariffs on pharmaceuticals Most favored nation policies related to pharmaceuticals Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the Medicare title in the One Big Beautiful Bill Act