CAROLINE QUAT

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 4132/S 2027, Prescription Information Modernization 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

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo 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 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 the US manufacturing of pharmaceuticals 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 most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals

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

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo 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 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 the US manufacturing of pharmaceuticals 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 most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals

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

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

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo 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 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 the US manufacturing of pharmaceuticals 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 most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals

H.R. 9599 The SECURE 340B Act Pharmaceutical supply chain manufacturing Policies related to the use of international reference pricing in Medicare/Medicaid 340B rebate model Part B and Part D drugs Medicare drug price negotiation Medicare Part D reform Definition of Qualified Single Source Drug (QSSD) for purposes of Medicare drug price negotiation Medicare patient access to cancer screening Medicare patient access to rare disease therapies Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements

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

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo 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 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 the US manufacturing of pharmaceuticals 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 most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals

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

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo 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 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 the US manufacturing of pharmaceuticals 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 most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals

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

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 4132/S 2027, Prescription Information Modernization 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

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

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo 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 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 the US manufacturing of pharmaceuticals 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 most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo 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 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 the US manufacturing of pharmaceuticals 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 most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals

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 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. 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

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 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

H.R.591 - Defending American Jobs and Investment Act HR 1414 - Cameron's Law, to restore orphan drug research tax credit H.R.1990 - American Innovation and R&D Competitiveness Act of 2025 H.R.4695 - Unfair Tax Prevention Act Expiring provisions of the Tax Cut and Jobs Act law Tax reform in budget reconciliation Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) pharmaceutical manufacturing (general education) Issues related to tariffs Issues related to the 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

H.R.591 - Defending American Jobs and Investment Act HR 1414 - Cameron's Law, to restore orphan drug research tax credit H.R.1990 - American Innovation and R&D Competitiveness Act of 2025 H.R.4695 - Unfair Tax Prevention Act Expiring provisions of the Tax Cut and Jobs Act law Tax reform in budget reconciliation Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) pharmaceutical manufacturing (general education) Issues related to tariffs Issues related to the 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

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. 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.591 - Defending American Jobs and Investment Act HR 1414 - Cameron's Law, to restore orphan drug research tax credit H.R.1990 - American Innovation and R&D Competitiveness Act of 2025 H.R.4695 - Unfair Tax Prevention Act Expiring provisions of the Tax Cut and Jobs Act law Tax reform in budget reconciliation Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) pharmaceutical manufacturing (general education) Issues related to tariffs Issues related to the 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

H.R.591 - Defending American Jobs and Investment Act HR 1414 - Cameron's Law, to restore orphan drug research tax credit H.R.1990 - American Innovation and R&D Competitiveness Act of 2025 H.R.4695 - Unfair Tax Prevention Act Expiring provisions of the Tax Cut and Jobs Act law Tax reform in budget reconciliation Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) pharmaceutical manufacturing (general education) Issues related to tariffs Issues related to the 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 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 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 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

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

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 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

H.R. 1350, Camerons Law H.R. 5376 - Share the Savings with Seniors Act S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023. Issues related to the Orphan Drug Tax Credit; issues related to the deduction of research and development expenditures

Issues related to COVID vaccine access and reimbursement; Issues related to the Orphan Drug Tax Credit; issues related to the deduction of research and development expenditures; H.R. 1350, Camerons Law; S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023.

H.R. 1350, Camerons Law S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023. Issues related to the Orphan Drug Tax Credit; issues related to the deduction of research and development expenditures

HR 1503/S 2916 Prescription Information Modernization Act Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions Medicare patient access to rare disease therapies, Part B and Part D drugs Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare drug price negotiation Medicare Part D reform and inflation penalties Medicaid Drug Rebate Program proposed rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies Medicaid Drug Rebate Program proposed rule, specifically the stacking rule General issues related to diagnostic reimbursement

Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169); e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions; Value-based payment arrangements; CMMI; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Efforts to improve coding, coverage, and access for rare disease therapies; Medicaid Drug Rebate Program proposed rule, specifically the stacking rule; Medicare patient access to rare disease therapies, Part B and Part D drugs; Centers for Medicare and Medicaid Innovation (CMMI) policy issues; Center for Medicare and Medicaid Innovation models; General issues related to diagnostic reimbursement; H.R. 5539/S. 3131 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act; HR1503/S2916 Prescription Information Modernization Act; H.R. 3876 Access to Genetic Counselor Services Act of 2023; H.R. 2666 Medicaid VBPs for Patients Act.

Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169); e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions; Value-based payment arrangements; CMMI; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Efforts to improve coding, coverage, and access for rare disease therapies; Medicaid Drug Rebate Program proposed rule, specifically the stacking rule; Medicare patient access to rare disease therapies, Part B and Part D drugs; Centers for Medicare and Medicaid Innovation (CMMI) policy issues; Center for Medicare and Medicaid Innovation models; General issues related to diagnostic reimbursement; H.R. 5539/S. 3131 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act; HR1503/S2916 Prescription Information Modernization Act; H.R. 3876 Access to Genetic Counselor Services Act of 2023; H.R. 2666 Medicaid VBPs for Patients Act.

H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies General issues related to diagnostic reimbursement Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies

H.R. 5539/S. 3131 Orphan Cures Act, (amdending orphan drug exclusion in IRA) H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Medicaid Drug Rebate Program Proposed Rule Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies General issues related to diagnostic reimbursement Efforts to improve coding, coverage, and access for rare disease therapies

Issues related to the deduction of research and development expenditures S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023 Education on tax in preparation for 2025 tax legislation

Issues related to COVID vaccine access and reimbursement; Issues related to the Orphan Drug Tax Credit; issues related to the deduction of research and development expenditures; H.R. 1350, Camerons Law; S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023.

H.R. 1350, Camerons Law S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023. Issues related to the Orphan Drug Tax Credit; issues related to the deduction of research and development expenditures

H.R. 1350, Camerons Law H.R. 5376 - Share the Savings with Seniors Act S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023. Issues related to the Orphan Drug Tax Credit; issues related to the deduction of research and development expenditures

H.R. 5539/S. 3131, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act H.R.7085 BioSecure Act; Issues related to the BIOSECURE Act and US manufacturing of pharmaceuticals HR 3433/S 2897, 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 expanding/amending the orphan drug exclusion in IRA Issues related to the price and manufacture of inhaled medicines Issues related to the IRAs drug price negotiation program Issues related to importation of drugs Issues related to drug pricing Issues related to RSV monoclonal antibody manufacture and distribution Issues related to FDA proposed regulation of lab developed tests Issues related to pharmacy benefit managers (PBM) reform Issues related to FDA Orange Book patent listings Issues related to COVID vaccine access and reimbursement Issues related to COPD patient access through CMMI demonstration models General issues related to health equity in rare disease and clinical trials General issues related to rare disease and orphan drugs Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS AZ sustainability platform FDA modernization policy issues Reauthorization of the pediatric priority review voucher program

H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies General issues related to diagnostic reimbursement Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies

Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169); e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions; Value-based payment arrangements; CMMI; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Efforts to improve coding, coverage, and access for rare disease therapies; Medicaid Drug Rebate Program proposed rule, specifically the stacking rule; Medicare patient access to rare disease therapies, Part B and Part D drugs; Centers for Medicare and Medicaid Innovation (CMMI) policy issues; Center for Medicare and Medicaid Innovation models; General issues related to diagnostic reimbursement; H.R. 5539/S. 3131 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act; HR1503/S2916 Prescription Information Modernization Act; H.R. 3876 Access to Genetic Counselor Services Act of 2023; H.R. 2666 Medicaid VBPs for Patients Act.

H.R. 5539/S. 3131 Orphan Cures Act, (amdending orphan drug exclusion in IRA) H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Medicaid Drug Rebate Program Proposed Rule Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies General issues related to diagnostic reimbursement Efforts to improve coding, coverage, and access for rare disease therapies

H.R. 1350, Camerons Law H.R. 5376 - Share the Savings with Seniors Act S.866/H.R.2673, American Innovation and R&D Competitiveness Act of 2023. Issues related to the Orphan Drug Tax Credit; issues related to the deduction of research and development expenditures

H.R.7085 Biosecure Act H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA H.R.5378, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), Pharmacy Benefit Manager Reform Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties Patent listings of drug-device combinations Reauthorization of newborn screening programs Reauthorization of the pediatric priority review voucher program RSV Vaccine issues FDA modernization policy issues Medicare drug price negotiation Medicaid Drug Rebate Program proposed rule PBM Reform (misc. bills) Issues related to reform of pharmacy benefit managers Issues related to FDA proposed regulation of lab developed tests Issues related to the orphan drug exclusion of the Inflation Reduction Act Issues related to the price and manufacture of inhaled medicines Issues related to march-in rights Issues related to drug pricing Issues related to importation of drugs Sustainability issues as a general topic General issues related to health equity in rare disease and clinical trials General issues related to diagnostics for patients with rare diseases General issues related to rare disease and orphan drugs

H.R.7085 Biosecure Act H.R. 5539/S.3131 ORPHAN Cures Act, amending orphan drug exclusion in IRA Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties issues related to expanding orphan drug exclusion in IRA Reauthorization of newborn screening programs Reauthorization of the pediatric priority review voucher program FDA modernization policy issues Issues related to FDA proposed regulation of lab developed tests Medicare drug price negotiation Medicaid Drug Rebate Program proposed rule PBM Reform (misc. bills) Issues related to reform of pharmacy benefit managers General issues related to health equity in rare disease and clinical trials General issues related to diagnostics for patients with rare diseases General issues related to rare disease and orphan drugs Issues related to drug pricing Issues related to the price and manufacture of inhaled medicines Issues related to importation of drugs Issues related to march-in rights

H.R.7085 Biosecure Act H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA H.R.5378, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), Pharmacy Benefit Manager Reform Act Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties Patent listings of drug-device combinations Reauthorization of newborn screening programs Reauthorization of the pediatric priority review voucher program RSV Vaccine issues FDA modernization policy issues Medicare drug price negotiation Medicaid Drug Rebate Program proposed rule PBM Reform (misc. bills) Issues related to reform of pharmacy benefit managers Issues related to FDA proposed regulation of lab developed tests Issues related to the orphan drug exclusion of the Inflation Reduction Act Issues related to the price and manufacture of inhaled medicines Issues related to march-in rights Issues related to drug pricing Issues related to importation of drugs Sustainability issues as a general topic General issues related to health equity in rare disease and clinical trials General issues related to diagnostics for patients with rare diseases General issues related to rare disease and orphan drugs

Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169); e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions; Value-based payment arrangements; CMMI; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Efforts to improve coding, coverage, and access for rare disease therapies; Medicaid Drug Rebate Program proposed rule, specifically the stacking rule; Medicare patient access to rare disease therapies, Part B and Part D drugs; Centers for Medicare and Medicaid Innovation (CMMI) policy issues; Center for Medicare and Medicaid Innovation models; General issues related to diagnostic reimbursement; H.R. 5539/S. 3131 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act; HR1503/S2916 Prescription Information Modernization Act; H.R. 3876 Access to Genetic Counselor Services Act of 2023; H.R. 2666 Medicaid VBPs for Patients Act.

H.R. 5539/S. 3131 Orphan Cures Act, (amdending orphan drug exclusion in IRA) H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Medicaid Drug Rebate Program Proposed Rule Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies General issues related to diagnostic reimbursement Efforts to improve coding, coverage, and access for rare disease therapies

H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) H.R. 3876 Access to Genetic Counselor Services Act of 2023 H.R. 2666 Medicaid VBPs for Patients Act H.R. 5539 Orphan Cures Act, (expanding orphan drug exclusion in IRA) Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies General issues related to diagnostic reimbursement Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies

H.R. 5539/S. 3131, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act H.R.7085 BioSecure Act; Issues related to the BIOSECURE Act and US manufacturing of pharmaceuticals HR 3433/S 2897, 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 expanding/amending the orphan drug exclusion in IRA Issues related to the price and manufacture of inhaled medicines Issues related to the IRAs drug price negotiation program Issues related to importation of drugs Issues related to drug pricing Issues related to RSV monoclonal antibody manufacture and distribution Issues related to FDA proposed regulation of lab developed tests Issues related to pharmacy benefit managers (PBM) reform Issues related to FDA Orange Book patent listings Issues related to COVID vaccine access and reimbursement Issues related to COPD patient access through CMMI demonstration models General issues related to health equity in rare disease and clinical trials General issues related to rare disease and orphan drugs Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS AZ sustainability platform FDA modernization policy issues Reauthorization of the pediatric priority review voucher program

H.R. 5539/S.3131 ORPHAN Cures Act, amending orphan drug exclusion in IRA; Issues related to expanding orphan drug exclusion in IRA; Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); FDA modernization policy issues; Issues related to FDA proposed regulation of lab developed tests; Reauthorization of the pediatric priority review voucher program; Reauthorization of newborn screening programs; Medicare drug price negotiation; Medicaid Drug Rebate Program proposed rule; Medicare Part D reform and inflation penalties; Issues related to drug pricing; Issues related to reform of pharmacy benefit managers; PBM Reform (misc. bills); General issues related to health equity in rare disease and clinical trials; General issues related to rare disease and orphan drugs; Issues related to the price and manufacture of inhaled medicines; Education to Hill staff on next generation propellant and PFAS; AZ sustainability platform; Issues related to importation of drugs; Issues related to march-in rights; Issues related to RSV monoclonal antibody manufacture and distribution; Issues related to COPD patient access through CMMI demonstration models; Rare Pediatric Disease Priority Review Voucher; H.R.7085 BioSecure Act.

H.R. 5539/S.3131 ORPHAN Cures Act, amending orphan drug exclusion in IRA; Issues related to expanding orphan drug exclusion in IRA; Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language); FDA modernization policy issues; Issues related to FDA proposed regulation of lab developed tests; Reauthorization of the pediatric priority review voucher program; Reauthorization of newborn screening programs; Medicare drug price negotiation; Medicaid Drug Rebate Program proposed rule; Medicare Part D reform and inflation penalties; Issues related to drug pricing; Issues related to reform of pharmacy benefit managers; PBM Reform (misc. bills); General issues related to health equity in rare disease and clinical trials; General issues related to rare disease and orphan drugs; Issues related to the price and manufacture of inhaled medicines; Education to Hill staff on next generation propellant and PFAS; AZ sustainability platform; Issues related to importation of drugs; Issues related to march-in rights; Issues related to RSV monoclonal antibody manufacture and distribution; Issues related to COPD patient access through CMMI demonstration models; Rare Pediatric Disease Priority Review Voucher; H.R.7085 BioSecure Act.

H.R. 5539/S. 3131, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act H.R.7085 BioSecure Act; Issues related to the BIOSECURE Act and US manufacturing of pharmaceuticals HR 3433/S 2897, 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 expanding/amending the orphan drug exclusion in IRA Issues related to the price and manufacture of inhaled medicines Issues related to the IRAs drug price negotiation program Issues related to importation of drugs Issues related to drug pricing Issues related to RSV monoclonal antibody manufacture and distribution Issues related to FDA proposed regulation of lab developed tests Issues related to pharmacy benefit managers (PBM) reform Issues related to FDA Orange Book patent listings Issues related to COVID vaccine access and reimbursement Issues related to COPD patient access through CMMI demonstration models General issues related to health equity in rare disease and clinical trials General issues related to rare disease and orphan drugs Reauthorization of the pediatric priority review voucher program Education to Hill staff on next generation propellant and PFAS AZ sustainability platform FDA modernization policy issues Reauthorization of the pediatric priority review voucher program