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Reported covered position: Asst Secretary for Legislation, Dept of Health and Human Services; Principal Deputy Assistant Secretary for Legislation, Dept of Health and Human Services; Deputy Health Policy Director, U.S. Senate Committee on Health, Education, Labor and Pension
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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Mikaela Naylon Give Kids a Chance Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2026 · second_quarter · Q2
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments HR 1990 - American Innovation and R&D Competitiveness Act of 2025 S.1605 - International Competition for American Jobs Act S.1639 - American Innovation and Jobs Act S.3841 - Last Sale Valuation Act of 2026 Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals Pharmaceutical investment and pricing issues in ex-US countries US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
Source: Senate LDA
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments HR 1990 - American Innovation and R&D Competitiveness Act of 2025 S.1605 - International Competition for American Jobs Act S.1639 - American Innovation and Jobs Act S.3841 - Last Sale Valuation Act of 2026 Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals Pharmaceutical investment and pricing issues in ex-US countries US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments.
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments HR 1990 - American Innovation and R&D Competitiveness Act of 2025 S.1605 - International Competition for American Jobs Act S.1639 - American Innovation and Jobs Act S.3841 - Last Sale Valuation Act of 2026 Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals Pharmaceutical investment and pricing issues in ex-US countries US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
American Innovation and R&D Competitiveness Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments HR 1990 - American Innovation and R&D Competitiveness Act of 2025 S.1605 - International Competition for American Jobs Act S.1639 - American Innovation and Jobs Act S.3841 - Last Sale Valuation Act of 2026 Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals Pharmaceutical investment and pricing issues in ex-US countries US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
Clinical Trial Modernization Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Prescription Information Modernization Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Defending American Jobs and Investment Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments HR 1990 - American Innovation and R&D Competitiveness Act of 2025 S.1605 - International Competition for American Jobs Act S.1639 - American Innovation and Jobs Act S.3841 - Last Sale Valuation Act of 2026 Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals Pharmaceutical investment and pricing issues in ex-US countries US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
Lowering Drug Costs for American Families Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Genomic Answers for Children’s Health Act of 2026
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
SECURE 340B Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
International Competition for American Jobs Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments HR 1990 - American Innovation and R&D Competitiveness Act of 2025 S.1605 - International Competition for American Jobs Act S.1639 - American Innovation and Jobs Act S.3841 - Last Sale Valuation Act of 2026 Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals Pharmaceutical investment and pricing issues in ex-US countries US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
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
American Innovation and Jobs Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments HR 1990 - American Innovation and R&D Competitiveness Act of 2025 S.1605 - International Competition for American Jobs Act S.1639 - American Innovation and Jobs Act S.3841 - Last Sale Valuation Act of 2026 Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals Pharmaceutical investment and pricing issues in ex-US countries US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Prescription Information Modernization Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Last Sale Valuation Act of 2026
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
Tax proposals building on One Big Beautiful Bill Act law and implementation (R&D expensing, BEAT, FDII, Corporate Alternative Minimum Tax) HR 591 - Defending American Jobs and Investment Act HR 1414 - Camerons Law, to restore orphan drug research tax credit HR 1911 - To amend the Internal Revenue Code of 1986 to provide that certain payments to foreign related parties subject to sufficient foreign tax are not treated as base erosion payments HR 1990 - American Innovation and R&D Competitiveness Act of 2025 S.1605 - International Competition for American Jobs Act S.1639 - American Innovation and Jobs Act S.3841 - Last Sale Valuation Act of 2026 Issues related to a Most Favored Nations policy in Medicare and Medicaid Issues related to the renewable energy tax credits and other energy credits included in the Inflation Reduction Act Most Favored Nations and pharmaceutical R&D innovation Most Favored Nation drug pricing proposals Pharmaceutical investment and pricing issues in ex-US countries US trade tools (investigations, tariffs, trade agreements, congressional oversight, rules of origin, CBP enforcement, investment screening) US-Mexico-Canada trade agreement (USMCA)
Clinical Trial Modernization Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Give Kids a Chance Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Mikaela Naylon Give Kids a Chance Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Mikaela Naylon Give Kids a Chance Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Mikaela Naylon Give Kids a Chance Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Mikaela Naylon Give Kids a Chance Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Prescription Information Modernization Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Prescription Information Modernization Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Lowering Drug Costs for American Families Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Prescription Information Modernization Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Prescription Information Modernization Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Give Kids a Chance Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Give Kids a Chance Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Give Kids a Chance Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Give Kids a Chance Act of 2025
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Medical Supply Chain Resiliency Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
S.998 - Medical Supply Chain Resiliency Act Section 232 tariffs on pharmaceuticals Section 301 investigations Comments for USTR 2026 National Trade Estimate (NTE) report (tariff and non-tariff barriers) Supply Chain and trade barriers that need addressing (National Security Commission on Emerging Biotechnology) Department of Commerce Bureau of Industry and Security API survey Issues related to critical supply chains reshoring investments Issues related to importation of drugs Most favored nation policies related to pharmaceuticals Tariffs/trade policies related to tariffs on pharmaceuticals Issues related to direct-to-consumer advertising by pharmaceutical manufacturers Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) Pharmaceutical manufacturing (general education)
Medical Supply Chain Resiliency Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
S.998 - Medical Supply Chain Resiliency Act Section 232 tariffs on pharmaceuticals Section 301 investigations Comments for USTR 2026 National Trade Estimate (NTE) report (tariff and non-tariff barriers) Supply Chain and trade barriers that need addressing (National Security Commission on Emerging Biotechnology) Department of Commerce Bureau of Industry and Security API survey Issues related to critical supply chains reshoring investments Issues related to importation of drugs Most favored nation policies related to pharmaceuticals Tariffs/trade policies related to tariffs on pharmaceuticals Issues related to direct-to-consumer advertising by pharmaceutical manufacturers Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) Pharmaceutical manufacturing (general education)
Medical Supply Chain Resiliency Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
S.998 - Medical Supply Chain Resiliency Act Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) Pharmaceutical manufacturing (general education)
Prescription Information Modernization Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Prescription Information Modernization Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
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 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. 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
Prescription Information Modernization Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
Prescription Information Modernization Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Medicaid VBPs for Patients Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
Medicaid VBPs for Patients Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Medicaid VBPs for Patients Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
American Innovation and R&D Competitiveness Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
American Innovation and R&D Competitiveness Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
American Innovation and R&D Competitiveness Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
American Innovation and R&D Competitiveness Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Give Kids a Chance Act of 2024
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Access to Genetic Counselor Services Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
Access to Genetic Counselor Services Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Access to Genetic Counselor Services Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Share the Savings with Seniors Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Lower Costs, More Transparency Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
E-labeling; Issues related to the HR 7085, the BIOSECURE Act, and US manufacturing of pharmaceuticals; Issues related to PBM reform.
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. 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
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
E-labeling Issues related to PBM reform. Issues related to the HR 7085, the BIOSECURE Act US manufacturing of pharmaceuticals
Give Kids a Chance Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Prescription Information Modernization Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Prescription Information Modernization Act of 2023
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
ORPHAN Cures Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
American Innovation and Jobs Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
American Innovation and Jobs Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
American Innovation and Jobs Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
American Innovation and Jobs Act
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Inflation Reduction Act of 2022
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Inflation Reduction Act of 2022
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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
Inflation Reduction Act of 2022
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
Issues related to Pharmacy Benefit Managers (PBMs) Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169)
Inflation Reduction Act of 2022
Client: ASTRAZENECA PHARMACEUTICALS LP · Firm: ASTRAZENECA PHARMACEUTICALS LP
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.
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.2673, American Innovation and R&D Competitiveness Act of 2023.
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
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
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2026 · first_quarter · Q1
Commerce Section 232 tariffs on pharmaceuticals Section 301 investigations Tariffs/trade policies related to tariffs on pharmaceuticals Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) Pharmaceutical manufacturing (general education)
Issues related to a Most Favored Nations policy in Medicare and Medicaid Most Favored Nation drug pricing proposals 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 and inflation penalties Medicaid Drug Rebate Program proposed rule 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 Issues related to the digital communication of prescribing information for drugs Issues related to e-labeling and allowing FDA to finalize a rule to allow digital versions of prescriptions Centers for Medicare and Medicaid Innovation (CMMI) policy issues Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR), White House Office
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2025 · fourth_quarter · Q4
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
S.998 - Medical Supply Chain Resiliency Act Section 232 tariffs on pharmaceuticals Section 301 investigations Comments for USTR 2026 National Trade Estimate (NTE) report (tariff and non-tariff barriers) Supply Chain and trade barriers that need addressing (National Security Commission on Emerging Biotechnology) Department of Commerce Bureau of Industry and Security API survey Issues related to critical supply chains reshoring investments Issues related to importation of drugs Most favored nation policies related to pharmaceuticals Tariffs/trade policies related to tariffs on pharmaceuticals Issues related to direct-to-consumer advertising by pharmaceutical manufacturers Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) Pharmaceutical manufacturing (general education)
Filing targets: Bureau of Industry and Security (BIS), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Trade Representative (USTR), White House Office
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2025 · third_quarter · Q3
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
S.998 - Medical Supply Chain Resiliency Act Section 232 tariffs on pharmaceuticals Section 301 investigations Comments for USTR 2026 National Trade Estimate (NTE) report (tariff and non-tariff barriers) Supply Chain and trade barriers that need addressing (National Security Commission on Emerging Biotechnology) Department of Commerce Bureau of Industry and Security API survey Issues related to critical supply chains reshoring investments Issues related to importation of drugs Most favored nation policies related to pharmaceuticals Tariffs/trade policies related to tariffs on pharmaceuticals Issues related to direct-to-consumer advertising by pharmaceutical manufacturers Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) Pharmaceutical manufacturing (general education)
Filing targets: Bureau of Industry and Security (BIS), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Trade Representative (USTR), White House Office
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2025 · second_quarter · Q2
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
S.998 - Medical Supply Chain Resiliency Act Trade and tariffs (general education, country-specific tariffs, sector-specific tariffs) Pharmaceutical manufacturing (general education)
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR), White House Office
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2025 · first_quarter · Q1
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
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2024 · fourth_quarter · Q4
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
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
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2024 · third_quarter · Q3
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.
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2024 · second_quarter · Q2
E-labeling
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
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2024 · first_quarter · Q1
Issues related to Pharmacy Benefit Managers (PBMs) Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169)
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 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
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2023 · fourth_quarter · Q4
FDA modernization policy issues Reauthorization of newborn screening programs 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 diagnostics for patients with rare diseases Issues related to FDA proposed regulation of lab developed tests Issues related to drug pricing Issues related to reform of pharmacy benefit managers Issues related to RSV vaccination Issues related to the price and manufacture of inhaled medicines Issues related to implementation of AMP Cap repeal Issues related to a Medicaid Drug Rebate Program proposed rule Issues related to importation of drugs Issues related to march-in rights Issues related to artificial intelligence (AI) Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties S. 1339, Pharmacy Benefit Manager Reform Act H.R. 5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act) H.R. 5539/S.3131 ORPHAN Cures Act, expanding orphan drug exclusion in IRA
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2023 · third_quarter · Q3
-Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare negotiation and Medicare Part D reform and redesign and inflation penalties. -Issues related to the orphan drug exclusion of the Inflation Reduction Act. -Issues related to reauthorization of the Pandemics and All-Hazards Preparedness Act (PAHPRA). 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 diagnostics for patients with rare diseases. -PBM reform -FDA modernization policy issues -FDA reform initiatives -Reauthorization of newborn screening programs. -H.R. 5539 ORPHAN Cures Act.
-Issues related to implementation of the 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. -Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies. -Issues related to the Medicaid Drug Rebate Program -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. -Medicare patient access to rare disease therapies, Part B and Part D drugs. -Medicaid (Medicaid Drug Rebate Program) stacking issues. -Value-based payment arrangements. -Efforts to improve coding, coverage, and access for rare disease therapies. -General issues related to diagnostic reimbursement. -S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act -H.R. 3876 Access to Genetic Counselor Services Act of 2023. -HR 5539, Orphan Cures Act (expanding orphan drug exclusion in IRA)
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2023 · second_quarter · Q2
H.R. 4368, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024. H. Rept. 118-24, S. Rept. 118-44 -- Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations. S. 2131, To provide for a limitation on availability of funds for Independent Agencies, National Historical Publications and Records Commission, Grants Program for fiscal year 2024.
Pharmaceutical IP and patent reform. S. 142, Preserve Access to Affordable Generics and Biosimilars Act. S. 150, Affordable Prescriptions for Patients Act of 2023. S. 1214, RARE Act.
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2023 · first_quarter · Q1
S. 142, Preserving Access to Affordable Generics and Biosimilars Act; S. 150, Affordable Prescriptions for Patients Act of 2023; Pharmaceutical IP Patent Reform TRIPS waiver
Issues pertaining to pharmacy benefit management (PBM) reform, including S. 127, the Pharmacy Benefit Manager Transparency Act
Issues related to clinical trial diversity; Issues related to workforce development; Issues related to the biopharmaceutical supply chain; Pandemic and All-Hazards Preparedness Reauthorization; General issues related to rare disease and orphan drugs; FDA modernization policy issues; Reauthorization of newborn screening programs; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases; Issues related to rare disease patients with employer sponsored insurance; 340b reform; Sustainability; Discussions with USG (BARDA/HHS team) to discuss possible contracts; Issues related to Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations; Medicare Part D; Medicare Part B; Medicare oncology populations; Drug Pricing, including H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (117th Congress); H.R. 1503, Prescription Information Modernization Act of 2023; H.R. 1613, Drug Pricing Transparency in Medicaid Act of 2023; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Issues related to the orphan drug exclusion of the Inflation Reduction Act; Specific focus on drug negotiation (orphan drug exemption language), Medicare Part D reform, and inflation penalties; H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; Issues related to lung cancer screening. Issues related to Pharmacy Benefit Managers (PBMs), including S. 127, Pharmacy Benefit Manager Transparency Act of 2023; S. 113, Prescription Pricing for the People Act of 2023.
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2022 · fourth_quarter · Q4
H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act
IP and Antitrust; H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435- Affordable Prescriptions for Patients Act of 2021 S. 1425- Stop STALLING Act Trade; Supply Chain and Manufacturing; H.R. 4521-United States Innovation and Competition Act of 2021, H. Rept. 117-235 Trade; Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2022 · third_quarter · 3A
Amendment to Montreal Protocol ("Kigali Amendment")
H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines
ASTRAZENECA PHARMACEUTICALS LP via ASTRAZENECA PHARMACEUTICALS LP
2022 · third_quarter · Q3
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform S. 4417, the PTAB Reform Act TRIPS IP Waiver Issues related to manufacturer patent protections at the World Health Organization
Amendment to Montreal Protocol ("Kigali Amendment")
Sustainability & Zero Carbon; Items related to environmental sustainability and our Ambition Zero Carbon efforts
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR), White House Office
Issues related to FDA Orange Book patent listings
E-labeling Issues related to PBM reform. Issues related to the HR 7085, the BIOSECURE Act US manufacturing of pharmaceuticals
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office
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. 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.
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform; Issues related to pharmaceutical intellectual property (IP); General patent issues; Issues related to FDA Orange Book patent listings.
E-labeling; Issues related to the HR 7085, the BIOSECURE Act, and US manufacturing of pharmaceuticals; Issues related to PBM reform.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform Issues related to pharmaceutical intellectual property (IP) General patent issues
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 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
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform TRIPS Waiver General patent issues Issues related to pharmaceutical intellectual property (IP)
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
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
Issues related to Pharmacy Benefit Managers (PBMs) Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Issues related to pharmacy benefit manager (PBM) reform
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. 2673, American Innovation and R&D Competitiveness Act of 2023
Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169) Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies 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 Medicare patient access to rare disease therapies, Part B and Part D drugs Medicaid Drug Rebate Program proposed rule, specifically the stacking rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies General issues related to diagnostic reimbursement 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.5378/S. 3430, the LOWER COSTS, MORE TRANSPARENCY ACT, In Senate - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (Better Act), S. 1339, Pharmacy Benefit Manager Reform Act
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform TRIPS Waiver General patent issues Issues related to pharmaceutical intellectual property (IP)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office
-Issues related to Pharmacy Benefit Managers (PBMs). -Issues related to pharmacy benefit management (PBM) reform -Issues related to implementation of the Inflation Reduction Act of 2022 (Public Law No. 117-169). -General advocacy on PBMs, IRA, inhalers -Issues related to the orphan drug exclusion of the Inflation Reduction Act. -Issues related to 340B reform. -Issues related to the 340B Drug Pricing Program
-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.2673, American Innovation and R&D Competitiveness Act of 2023.
Issues related to pharmaceutical patents
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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.2673, American Innovation and R&D Competitiveness Act of 2023.
Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies. 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. Issues pertaining to implementation of the Inflation Reduction Act, H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). Medicare patient access to rare disease therapies, Part B and Part D drugs. Value-based payment arrangements. Efforts to improve coding, coverage, and access for rare disease therapies. General issues related to diagnostic reimbursement. S 2085, the Medicare Multi-Cancer Early Detection Screening Coverage 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. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to clinical trial diversity. Issues related to lung cancer screening. Issues related to drug shortages. Issues related to workforce development. Issues related to the biopharmaceutical supply chain. Issues related to reauthorization of the Pandemics and All-Hazards Preparedness Act (PAHPRA). Issues related to rare disease patients with employer sponsored insurance. Issues related to Reform of pharmacy benefit managers. Issues related to the Cancer Moonshot Initiative. Issues related to Medicare reimbursement of patient navigators. Issues related to 340B. Issues related to drug shortages. Issues related to electronic prescribing labeling. FDA modernization policy issues. Reauthorization of newborn screening programs. 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 diagnostics for patients with rare diseases. H.R. 1503, Prescription Information Modernization Act of 2023. H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act.
Issues related to Pharmacy Benefit Managers (PBMs). Issues related to 340B reform. Issues related to prescription drug shortages. Issues related to the orphan drug exclusion of the Inflation Reduction Act. Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169). S. 113, Prescription Pricing for the People Act of 2023. S. 127, Pharmacy Benefit Manager Transparency Act of 2023. S. 1038, Drug Price Transparency in Medicaid Act of 2023. H.R. 1613 Drug Pricing Transparency in Medicaid Act of 2023. H.R. 3561, PATIENT Act of 2023.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office
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; Issues pertaining to implementation of the Inflation Reduction Act,H.R.5376 - Inflation Reduction Act of 2022 (Public Law No. 117-169); Medicare patient access to rare disease therapies, Part B and Part D drugs; Value-based payment arrangements; efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement.
Section 174 R&D Amortization; International tax issues; Issues related to the Orphan Drug Tax Credit; Issues related to the deduction of research and development expenditures; H.R. 1350, Camerons Law.
Issues related to Agriculture, Rural Development, and Food & Drug Administration appropriations; Issues related to the Labor, Health and Human Services, and Education appropriations.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 1730/S. 670- Speeding Therapy Access Today Act H.R. 1946, S. 1873. Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 5030/ S. 2706 DIVERSE Trials Act HR 5376, Inflation Reduction Act reconciliation bill; Medicare price negotiation provision and Part D redesign; Preventative healthcare services and screenings; Issues related to preventative services and screenings for underrepresented communities H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 Accelerating Access for Patients Act; H.R.7667 - Food and Drug Amendments of 2022; S. 1548, H.R. 3085/H.R. 7845. ENACT Act of 2021 S.4348 - FDASLA Act of 2022; General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; 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 pharmacy benefit managers (PBMs); general issues related to insurance coverage of specialty treatments Issues related to clinical trial diversity COVID-19; COVID-19 vaccine and therapy development Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. E-Labeling EVUSHELD Issues related to repeal of the Medicaid AMP Cap. Issues related to drug pricing, IRA Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees;
Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts.
H.R. 7559 E-labeling; and issues related to appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts (PI). 340B; Issues related to the 340B drug discount program
H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 1946, S. 1873. Medicare Multi-Cancer Early Detection Screening Coverage; H.R. 2617-accelerated approval in the Omnibus year end H.R. 4065, S. 1971 (section 101), P.L. 117-328, H.R. 2617 Kidney disease screening, Expanding Medicare annual wellness benefit to include kidney disease screening. H.R. 5260 - Reduced Costs and Continued Cures Act; HR. 5376- Inflation Reduction Act; Build Back Better Act; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Preventative healthcare services and screenings Issues related to preventative services and screenings for underrepresented communities IRA implementation, Pub. L. 117-169 Medicare Reform(s); Issues related to Medicare Part B and Part D pricing reform. General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding, coverage, and access for rare disease therapies; issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; general issues related to diagnostic reimbursement
H.R. 2617,Consolidated Appropriations Act, 2023 H.R. 7559 E-labeling; and issues related to appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts (PI). H.R. 8239/S. 4661, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act H.R. 8295/S. 4659,Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, H. Rept. 117-392, H. Rept. 117-403, H. Res. 1531. CTD, accelerated approval in the Omnibus year end, Consolidated Appropriations Act, 2023; P.L. 117-328.
H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1425- Stop STALLING Act S. 1435- Affordable Prescriptions for Patients Act of 2021 TRIPS / IP Waiver Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform, and Antitrust;
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Appropriations, FY 2023; H.R 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 6833, P.L 117-180, Affordable Insulin Now Act H.R. 8294, ransportation, Housing and Urban Development, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, and Veterans Affairs Appropriations Act, 2023 H.R. 8295/S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023
H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act
Sustainability & Zero Carbon; Items related to environmental sustainability and our Ambition Zero Carbon efforts
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - The Inflation Reduction Act of 2022; General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure General issues related to diagnostic reimbursement
Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform S. 4417, the PTAB Reform Act TRIPS IP Waiver Issues related to manufacturer patent protections at the World Health Organization
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
H.R. 7559 and issues related to an appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts Issues related to the 340B drug discount program
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines
Appropriations, FY 2023; H.R 8239, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023 H.R. 6833, P.L 117-180, Affordable Insulin Now Act H.R. 8294, ransportation, Housing and Urban Development, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, and Veterans Affairs Appropriations Act, 2023 H.R. 8295/S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023
H.R. 2623 - Camerons Law H.R. 5376 - Build Back Better Act Issues related to the Orphan Drug Tax Credit Issues related to the deduction of research and development expenditures Issues related to corporate and international tax reform S. 749/H.R 1304 - American Innovation and Jobs Act
H.R. 7559 and issues related to an appropriations hold on funding for a 2014 FDA rule that would provide electronic flexibilities related to package inserts Issues related to the 340B drug discount program
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - The Inflation Reduction Act of 2022; General issues related to patient access to rare disease therapies, Part B and Part D drugs; Issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; Value-based payment arrangements; Efforts to improve coding, coverage, and access for rare disease therapies; Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies; General issues related to diagnostic reimbursement S. 1873/H.R. 1946 - Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 Issues related to preventative services and screenings for underrepresented communities H.R 4065/S. 1971 (Section 101) - Expanding Medicare annual wellness benefit to include kidney disease screening CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure General issues related to diagnostic reimbursement
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office