Prescription Information Modernization Act of 2025

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.

Client expense: $770,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, White House Office

Advocating for the Patients Right to Know Their Medication Act (HR 5133), which requires the information to be provided in printed form. Opposing the Pharmaceutical Information Modernization Act of 2025 (H.R. 4132/S. 2027), which would allow the FDA to finalize a proposed rule permitting drug manufacturers to send prescribing information electronically, instead of on printed paper.

Client expense: $50,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Provided updates to Members of Congress, Congressional staff, and federal agencies on developments in clean diesel, zero emissions, and fuel efficiency technologies for commercial vehicles and discussed regulatory issues including EPA's proposed rulemaking to modify the 2027 NOx emissions standard for medium- and heavy-duty engines and NHTSA's 2027 vehicle fuel efficiency standards.

Client expense: $170,000 · Firm income: Not reported

Government targets: Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Highway Traffic Safety Administration (NHTSA), SENATE, Transportation, Dept of (DOT), White House Office

340B: Biologic/Small molecule drug negotiation eligibility within HR 7174/S.832 EPIC Act; CDC Type 1 Diabetes Awareness and Education within LHHS appropriations; Clinical Trial Diversity; Clinical Trial Data Requirements in AG Appropriations Bill; Copay Accumulators; COPD Education and Awareness within LHHS appropriations; COPD Research Funding within LHHS appropriations; Delinking; Drug Pricing - General; Drug Price Negotiations within Inflation Reduction Act; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; Issues related to HR 1 One Big Beautiful Bill; HR 6423/S864 HELP Copays Act; HR 2880: Protecting Patients Against PBM Abuses Act; HR 5376:Inflation Reduction Act; HRSA - Type 1 Diabetes Screening within LHHS appropriations; Influenza Vaccines; Insurance Design/Utilization Management; Intellectual Property; International Reference Pricing; Most Favored Nation; Orphan Drug Negotiation within HR 5539/S 3131 Orphan Cures Act; Out of Pocket Cap; Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization; Patient Experience/Patient Focused Drug Development within the FDA/AG Appropriations; Pharmacy Benefit Managers (PBM) Reform; Rare Pediatric Priority Review Voucher Program Reauthorization within HR 7834; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 864 HELP Copays Act: S. 1339 (118th): PBM Reform Act; S. 1375: HELP Copays Act; S. 1542 (118th) DRUG Act; S. 2027: Prescription Information Modernization Act; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $920,000 · Firm income: Not reported

S. 891, the Bipartisan Health Care Act Part D Formulary Design and Generic Drug Tiering HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages S. 2658, The Medication Affordability and Patent Integrity Act

Client expense: $360,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Essential Medicines Strategic Stockpile Department of Defense Essential Medicines Strategic Stockpile Prescription Information Modernization Act (H.R.4132/S.2027) Mitigation of Drug Shortages Pharmaceutical supply chain resilience National Defense Authorization Act (NDAA - H.R.8800) Supply Chain Resiliency Most Favored Nation drug pricing proposals Direct to Consumer proposals CMS FY 2026 Medicares Part B Physician Fee Schedule Rule CMS ASP Certification Break Up Big Medicine Act (S. 3822) Management Services Organization (MSO) Role and value of community specialty physicians and MSOs Pandemic and All-Hazards Preparedness/Protecting Americans from All Hazards Preparedness Act (PAHPA) Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 4299)

Client expense: $510,000 · Firm income: Not reported

Microelectronics and Advanced Computing; Digital electronics engineering. as follows: H.R.8800/S.4784, National Defense Authorization Act for Fiscal Year 2027 H.R.9495, Department of Defense Appropriations Act, 2027 Budget Reconciliation President's 2027 Budget request and justifications Monitor the following: Quantum computing related issues Cybersecurity related issues S.3971, Small Business Innovation and Economic Security Act, Reauthorization issues Public Law 119-21, One Big Beautiful Bill Act, Golden Dome and Implementation issues Executive Orders Artificial Intelligence Federal Acquisition Reform related issues

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Microelectronics and Advanced Computing; Digital electronics engineering. as follows: H.R.8800/S.4784, National Defense Authorization Act for Fiscal Year 2027 H.R.9495, Department of Defense Appropriations Act, 2027 Budget Reconciliation President's 2027 Budget request and justifications Monitor the following: Quantum computing related issues Cybersecurity related issues S.3971, Small Business Innovation and Economic Security Act, Reauthorization issues Public Law 119-21, One Big Beautiful Bill Act, Golden Dome and Implementation issues Executive Orders Artificial Intelligence Federal Acquisition Reform related issues

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocating for the Patients Right to Know Their Medication Act (HR 5133), which requires the information to be provided in printed form. Opposing the Pharmaceutical Information Modernization Act of 2025 (H.R. 4132/S. 2027), which would allow the FDA to finalize a proposed rule permitting drug manufacturers to send prescribing information electronically, instead of on printed paper.

Client expense: $50,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

340B: Biologic/Small molecule drug negotiation eligibility within HR 7174/S.832 EPIC Act; CDC Type 1 Diabetes Awareness and Education within LHHS appropriations; Clinical Trial Diversity; Copay Accumulators; COPD Education and Awareness within LHHS appropriations; COPD Research Funding within LHHS appropriations; Delinking; Drug Pricing - General; Drug Price Negotiations within Inflation Reduction Act; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; Issues related to HR 1 One Big Beautiful Bill; HR 6423/S864 HELP Copays Act; HR 2880: Protecting Patients Against PBM Abuses Act; HR 5376:Inflation Reduction Act; HRSA - Type 1 Diabetes Screening within LHHS appropriations; Influenza Vaccines; Insurance Design/Utilization Management; Intellectual Property; International Reference Pricing; Most Favored Nation; Orphan Drug Negotiation within HR 5539/S 3131 Orphan Cures Act; Out of Pocket Cap; Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization; Patient Experience/Patient Focused Drug Development within the FDA/AG Appropriations; Pharmacy Benefit Managers (PBM) Reform; Rare Pediatric Priority Review Voucher Program Reauthorization within HR 7834; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 864 HELP Copays Act: S. 1339 (118th): PBM Reform Act; S. 1375: HELP Copays Act; S. 1542 (118th) DRUG Act; S. 2027: Prescription Information Modernization Act; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $2,580,000 · Firm income: Not reported

Essential Medicines Strategic Stockpile Department of Defense Essential Medicines Strategic Stockpile Prescription Information Modernization Act (H.R.4132/S.2027) Mitigation of Drug Shortages Pharmaceutical supply chain resilience National Defense Authorization Act FY2026 (NDAA) Supply Chain Resiliency Most Favored Nation drug pricing proposals Direct to Consumer proposals CMS Medicare Part B Physician Fee Schedule Rule Break Up Big Medicine Act (S. 3822) CMS FY 2026 Medicares Part B Physician Fee Schedule: Proposed Changes to Bonafide Service Fees Role and value of community specialty physicians and MSOs

Client expense: $1,150,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

S. 891, the Bipartisan Health Care Act Part D Formulary Design and Generic Drug Tiering H.R. 1843 / S. 1302 - Increasing Transparency in Generic Drug Applications Act HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages S.2658 - The Medication Affordability and Patent Integrity Act

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062: RAPID Reserve Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.

Client expense: $840,000 · Firm income: Not reported

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

Client expense: $2,280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Advocating for the Patients Right to Know Their Medication Act (HR 5133), which requires the information to be provided in printed form. Opposing the Pharmaceutical Information Modernization Act of 2025 (H.R. 4132/S. 2027), which would allow the FDA to finalize a proposed rule permitting drug manufacturers to send prescribing information electronically, instead of on printed paper.

Client expense: $50,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Advocating for the Patients Right to Know Their Medication Act, which requires the information to be provided in printed form. (Awaiting bill number) Opposing the Pharmaceutical Information Modernization Act of 2025 (H.R. 4132/S. 2027), which would allow the FDA to finalize a proposed rule permitting drug manufacturers to send prescribing information electronically, instead of on printed paper.

Client expense: $50,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

340B: Biologic/Small molecule drug negotiation eligibility within HR 7174/S.832 EPIC Act; CDC Type 1 Diabetes Awareness and Education within LHHS appropriations; Clinical Trial Diversity; Copay Accumulators; COPD Education and Awareness within LHHS appropriations; COPD Research Funding within LHHS appropriations; Delinking; Drug Price Negotiations - General; Drug Price Negotiations within Inflation Reduction Act; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; Issues related to HR 1 One Big Beautiful Bill; HR 830 (118th) HELP Copays Act; HR 2880: Protecting Patients Against PBM Abuses Act; HR 5143 (118th) Vaccines Access Improvement Act; HR 5376: Inflation Reduction Act; HRSA - Type 1 Diabetes Screening within LHHS appropriations; Influenza Vaccines; Insurance Design; Intellectual Property; International Reference Pricing; Most Favored Nation; Orphan Drug Negotiation within HR 5539/S 3131 Orphan Cures Act; Out of Pocket Cap; Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization; Pharmacy Benefit Managers (PBM) Reform; Rare Pediatric Priority Review Voucher Program Reauthorization within HR 7834; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 864 HELP Copays Act: S. 1339 (118th): PBM Reform Act; S. 1375: HELP Copays Act; S. 1542 (118th) DRUG Act; S. 2027: Prescription Information Modernization Act; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $1,100,000 · Firm income: Not reported

S. 891, the Bipartisan Health Care Act Part D Formulary Design and Generic Drug Tiering H.R. 1843 / S. 1302 - Increasing Transparency in Generic Drug Applications Act HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages S.2658 - The Medication Affordability and Patent Integrity Act

Client expense: $490,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Strategic National Stockpile Essential Medicines Strategic Stockpile Department of Defense Essential Medicines Strategic Stockpile Prescription Information Modernization Act (H.R.4132/S.2027) Mitigation of Drug Shortages Pharmaceutical supply chain resilience Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). SUPPORT for Patients and Communities Reauthorization Act of 2025 (H.R. 2483/S.2121) Medical Supply Resiliency Act (H.R. 2231) National Defense Authorization Act FY2026 (NDAA) Supply Chain Resiliency Most Favored Nation drug pricing proposals CMS Proposed Medicare Physician Fee Schedule Rule

Client expense: $1,910,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469 - BIOSECURE Act of 2025. Quotas on Controlled Substances.

Client expense: $1,150,000 · Firm income: Not reported

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

340B: Biologic/Small molecule drug negotiation eligibility within HR 7174; EPIC Act; CDC Type 1 Diabetes Awareness and Education within LHHS appropriations; Clinical Trial Diversity; Copay Accumulators; COPD Education and Awareness within LHHS appropriations; COPD Research Funding within LHHS appropriations; Delinking; Drug Price Negotiations within Inflation Reduction Act; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; issues related to HR 1 One Big Beautiful Bill; HR 1503: Prescription Information Modernization Act of 2023; HR 2880: Protecting Patients Against PBM Abuses Act; HR 5376: Inflation Reduction Act; HRSA - Type 1 Diabetes Screening within LHHS appropriations; Influenza Vaccines; Insurance Design; Intellectual Property; International Reference Pricing; Most Favored Nation; Orphan Drug Negotiation within HR 5539/S 3131 Orphan Cures Act; Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization; Pharmacy Benefit Managers (PBM) Reform; Rare Pediatric Priority Review Voucher Program Reauthorization within HR 7834; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 864 HELP Copays Act: S. 1339: PBM Reform Act; S. 1375 S. 1542: DRUG Act; S. 2027: Prescription Information Modernization Act; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $1,590,000 · Firm income: Not reported

Strategic National Stockpile. Essential Medicines Strategic Stockpile Prescription Information Modernization Act (H.R.4132/S.2027) Mitigation of Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). SUPPORT for Patients and Communities Reauthorization Act of 2025 (H.R. 2483/S.2121) Medical Supply Resiliency Act National Defense Authorization Act FY2026 (NDAA) Supply Chain Resiliency Most Favored Nation drug pricing proposals One Big Beautiful Bill Act / Budget Reconciliation (H.R.1) CMS Proposed Medicare Physician Fee Schedule Rule

Client expense: $680,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062: RAPID Reserve Act. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars Act.

Client expense: $640,000 · Firm income: Not reported

S. 891, the Bipartisan Health Care Act Part D Formulary Design and Generic Drug Tiering H.R. 1843 / S. 1302 - Increasing Transparency in Generic Drug Applications Act HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages S.2658 - The Medication Affordability and Patent Integrity Act

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Advocating for the Patients Right to Know Their Medication Act, which requires the information to be provided in printed form. (Awaiting bill number) Opposing the Pharmaceutical Information Modernization Act of 2025 (H.R. 4132/S. 2027), which would allow the FDA to finalize a proposed rule permitting drug manufacturers to send prescribing information electronically, instead of on printed paper.

Client expense: $50,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

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

Support Reforms to 340B Program Support H.R. 4132 (PIMA) Support S. 2027 (PIMA) Support Reforms to 340B Program Oppose S. 2372 Oppose H.R. 4581 Support elimination of CMMI Support elimination of CMMI Oppose MFN policies/Support 340B reform

Client expense: $60,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support Reforms to 340B Program Support H.R. 4132 (PIMA) Support S. 2027 (PIMA) Support Reforms to 340B Program Oppose S. 2372 Oppose H.R. 4581 Support elimination of CMMI Support elimination of CMMI Oppose MFN policies/Support 340B reform

Client expense: $60,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocating for the Patients Right to Know Their Medication Act, which requires the information to be provided in printed form. (Awaiting bill number) Opposing the Pharmaceutical Information Modernization Act of 2025 (H.R. 4132/S. 2027), which would allow the FDA to finalize a proposed rule permitting drug manufacturers to send prescribing information electronically, instead of on printed paper.

Client expense: $50,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

340B: Biologic/Small molecule drug negotiation eligibility within HR 7174; EPIC Act; CDC Type 1 Diabetes Awareness and Education within LHHS appropriations; Clinical Trial Diversity; Copay Accumulators; COPD Education and Awareness within LHHS appropriations; COPD Research Funding within LHHS appropriations; Delinking; Drug Price Negotiations within Inflation Reduction Act; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; issues related to HR 1 One Big Beautiful Bill; HR 1503: Prescription Information Modernization Act of 2023; HR 2880: Protecting Patients Against PBM Abuses Act; HR 5376: Inflation Reduction Act; HR 830: HELP Copays Act; HRSA - Type 1 Diabetes Screening within LHHS appropriations; Influenza Vaccines; Insurance Design; Intellectual Property; International Reference Pricing; Most Favored Nation; Orphan Drug Negotiation within HR 5539/S 3131 Orphan Cures Act; Out of Pocket Cap (OOP); Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization; Pharmacy Benefit Managers (PBM) Reform; Rare Pediatric Priority Review Voucher Program Reauthorization within HR 7834; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 864 HELP Copays Act: S. 1339: PBM Reform Act; S. 1375 S. 1542: DRUG Act; S. 2027: Prescription Information Modernization Act; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $1,050,000 · Firm income: Not reported

S. 891, the Bipartisan Health Care Act Part D Formulary Design and Generic Drug Tiering H.R. 1843 / S. 1302 - Increasing Transparency in Generic Drug Applications Act HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages The Medication Affordability and Patent Integrity Act

Client expense: $590,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Strategic National Stockpile. Essential Medicines Strategic Stockpile Prescription Information Modernization Act (H.R.4132/S.2027) Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). SUPPORT Act Reauthorization Medical Supply Resiliency Act National Defense Authorization Act (NDAA) Supply Chain Resiliency Budget Reconciliation Most Favored Nation drug pricing proposals

Client expense: $760,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.

Client expense: $650,000 · Firm income: Not reported