Prescription Information Modernization Act of 2023

Part D Formulary Design and Generic Drug Tiering S. 1302 - Increasing Transparency in Generic Drug Applications Act H.R. 1843 - Increasing Transparency in Generic Drug Applications Act S. 775 - Increasing Transparency in Generic Drug Applications Act HR1503/S. 2916, Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 5461 Ensuring Access to Lower-Cost Medicies for Seniors Act Drug Shortages S. 891, the Bipartisan Health Care Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), 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: LHHS approps; Clinical Trial Diversity; Copay Accumulators; COPD Education and Awareness: LHHS approps; COPD Research Funding: LHHS approps; Delinking; Drug Price Negotiations; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; HR 946- Orphan Drug Negotiation: Orphan Cures Act; 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: LHHS approps; Influenza Vaccines; Insulin Pricing-General; Insurance Design; Intellectual Property; 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 1262/ S. 932: Give Kids a Chance Act; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 1339: PBM Reform Act; S. 864: HELP Copays Act; S. 1542: DRUG Act; S. 2916: Prescription Information Modernization Act of 2023; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Type 1 Diabetes Screening; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $2,540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1244, Reducing Drug Prices for Seniors Act H.R. 1492, To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. H.R. 1503/S. 2916, Prescription Information Modernization Act of 2023 H.R. 1968, Full-Year Continuing Appropriations and Extensions Act, 2025 S. 1040, Drug Competition Enhancement Act S. 1339, Pharmacy Benefit Manager Reform Act S. 2076 Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; Prescription drug cost-sharing; Anti-microbial Resistance; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines issues; Vaccine misinformation; Measles, Mumps, and Rubella (MMR) immunizations; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical supply channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; FY-2025 Budget and Appropriations Legislation; Intellectual property protection and trade issues; WTO IP Waiver for COVID therapeutics; Animal Health; Animal Health Technology Issues; Animal Health Policy Issues: Animal Drug User Fee Act (ADUFA) & Funding for Electronic Animal Traceability; One Health Issues; General pharmaceutical issues; Vaccine Injury Compensation Program (VICP); Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms; Food and Drug Administration issues; Public Health Issues.

Client expense: $2,600,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.

Client expense: $530,000 · Firm income: Not reported

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

Issues related to prescription-to- over the counter switch; issues related to influenza vaccines; issues related to 340B; issues related to Respiratory Syncytial Virus (RSV) access; general issues related to vaccines; issues related to clinical trial diversity; general issues related to drug pricing; issues related to out of pocket (OOP); general issues to insulin pricing; issues related to Additional Condition for Prescription Use (ACNU); issues related to copay accumulators; issues related to HR3656 "Vaccine Access Improvement Act"; issues related to Vaccine Issues Compensation Program (VICP); issues related to HR 830 "HELP Copays Act"; issues related to Pandemic and All-Hazards Preparedness Act (PAHPA)reauthorization; issues related to HR 1503 "Prescription Information Modernization Act of 2023"; general issues related FDA; issues related to FDA Drug Development; issues related to Pharmacy Benefit Managers (PBMs); issues related to insurance design; issues related to S. 1542 "DRUG Act"; issues related to S. 1375 "HELP Copays Act"; issues related to tax credits; issues related to S. 1339 "PBM Reform Act"; issues related to delinking; issues related to HR 2880 "Protecting Patients Against PBM Abuse Act"; issues related to Type 1 Diabetes screening; issues related to intellectual property; issues related to Transplant; issues related HR 5339 and S. 3131 "Orphan Cures Act"; Rare Pediatric Priority Review Voucher Program related to HR 7834 "Creating Hope Reauthorization Act of 2024"; Orphan Drug Negotiation within HR5378 "Inflation Reduction Act"; issues related to drug price negotiations; issues related to COPD Research funding; Biologic/Small Molecule drug negotiation eligibility within HR7174 "EPIC Act"; CDC Type 1 Diabetes Awareness and Education with LHHS appropriations; issues related to S.4504 "SCREEN for Type 1 Diabetes"; issues related to HRSA - Type 1 Diabetes Screening in LHHS Appropriations; general issues related to Inflation Reduction Act; issues related to Routine Immunizations Rates; issues related to HR5376 "Inflation Reduction Act"; issues related to Rebate Pass Through; and issues related to S. 2916 "Prescription Information Modernization Act of 2023";

Client expense: $690,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution. Seniors Access to Critical Medications Act of 2023 (H.R. 5526/S.3458) Department of Defense Essential Medicines Strategic Stockpile Amendment to NDAA Health Care Cybersecurity Improvement Act of 2024 (S.4054) Broadening Utilization of Proven and Effective Treatment for Recovery Act or the BUPE for Recovery Act (H.R.9886/S.5271)

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

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

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages Issues related to Levothyroxine.

Client expense: $210,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages

Client expense: $230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing; issues related to pharmaceutical supply chain; issues related to modernization of prescribing information for physicians and pharmacists; Improved Access to Affordable Medications Act, S. 1120; Increasing Transparency in Generic Drug Applications, S.775 and HR 3839; Part D Formulary Design and Generic Drug Tiering; Prescription Information Modernization Act, HR 1503.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Package Inserts/E-Labeling Issues (H.R. 1503 Prescription Information Modernization Act of 2023). Issues related to the Vaccine Injury Compensation Program.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 111-148 Affordable Care Act, modifications Prior authorization utilization policies Medicare Access and CHIP Reauthorization Act (P.L. 114-10) Improvement Issues Medicare Physician Payment Issues Drug Pricing and Shortages Issues Medicare Part B Drug Price Issues Expansion of Telehealth Services Vision Research Funding Implementation of No Surprises Act S. 652/H.R. 2630, the Safe Step Act The Ensuring Lasting Smiles Act Medicare Coverage for Low Vision Devices S. 1573/H.R. 3226 - Preemie Reauthorization Act of 2023 H.R.2474 - Strengthening Medicare for Patients and Providers Act Healthcare Workforce Issues H.R. 6545, the Physician Fee Schedule Update and Improvements Act H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023 H.R. 6487/S. 3805, the No Fees for EFTs Act H.R. 4968, the GOLD CARD Act H.R. 830/S. 1375, the Help Ensure Lower Patient Copays Act (HELP Copays Act) H.R. 2748, the Contact Lens Prescription Verification Modernization Act H.R. 1503, the Prescription Information Modernization Act of 2023 H.R. 7745, the Embracing Anti-Discrimination, Unbiased Curriculum, and Advancing Truth in Education (EDUCATE) Act Funding for the Pediatric Specialty Loan Repayment Program H.R. 8400, the Early Detection of Vision Impairments for Children Act of 2024 (EDVI Act) H.R. 8702/S. 4532, the Improving Seniors Timely Access to Care Act H.R.9747 - Continuing Appropriations and Extensions Act, 2025

Client expense: $258,819 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program or elsewhere. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting the extension of the SBIR program. Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Opposing proposed FTC changes to non-compete clauses. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377). Supporting the Protecting Patients Against PBM Abuses Act (H.R. 2880). Supporting the PASTEUR Act (H.R. 2940 and S. 1355). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391 and S. 2764). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Maintaining Investments in New Innovation (MINI) Act (H.R. 5547). Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174). Supporting "cap and smooth" efforts within the Inflation Reduction Act's cap on out-of-pocket expenses. Supporting CMS proposed rule, CMS-1809-P, to include separate payment for diagnostic radiopharmaceuticals in CY2025.

Client expense: $53,142 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription-to- over the counter switch; issues related to influenza vaccines; issues related to 340B; issues related to Respiratory Syncytial Virus (RSV) access; issues related to RSV Immunizations; general issues related to vaccines; issues related to clinical trial diversity; general issues related to drug pricing; issues related to out of pocket (OOP); general issues to insulin pricing; issues related to HR 5376 "Inflation Reduction Act"; issues related to Additional Condition for Prescription Use (ACNU); issues related to copay accumulators; issues related to HR3656 "Vaccine Access Improvement Act"; issues related to Vaccine Issues Compensation Program (VICP); issues related to HR 830 "HELP Copays Act"; issues related to Pandemic and All-Hazards Preparedness Act (PAHPA)reauthorization; issues related to HR 1503 "Prescription Information Modernization Act of 2023"; general issues related FDA; issues related to FDA Drug Development; issues related to Pharmacy Benefit Managers (PBMs); issues related to insurance design; issues related to S. 1542 "DRUG Act"; issues related to S. 1375 "HELP Copays Act"; issues related to tax credits; issues related to S. 1339 "PBM Reform Act"; issues related to delinking; issues related to HR 2880 "Protecting Patients Against PBM Abuse Act"; issues related to Type 1 Diabetes screening; issues related to pandemic preparedness; issues related to intellectual property; issues related to Transplant; issues related HR 5339 and S. 3131 "Orphan Cures Act"; Rare Pediatric Priority Review Voucher Program related to HR 7834 "Creating Hope Reauthorization Act of 2024"; Orphan Drug Negotiation within HR5378 "Inflation Reduction Act"; issues related to drug price negotiations; issues related to COPD Research funding; Biologic/Small Molecule drug negotiation eligibility within HR7174 "EPIC Act"; CDC Type 1 Diabetes Awareness and Education with LHHS appropriations; issues related to HR 8698 and S.4504 "SCREEN for Type 1 Diabetes"; issues related to HRSA - Type 1 Diabetes Screening; general issues related to Inflation Reduction Act; issues related to March-In rights; and issues related to Routine Immunizations Rates.

Client expense: $1,815,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution. Seniors Access to Critical Medications Act of 2023 (H.R. 5526/S.3458) Department of Defense Essential Medicines Strategic Stockpile Amendment to NDAA Health Care Cybersecurity Improvement Act of 2024 (S.4054) Drug Supply Chain Security Act (DSCSA)

Client expense: $570,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Package Inserts/E-Labeling Issues (H.R. 1503 Prescription Information Modernization Act of 2023). Issues related to the Vaccine Injury Compensation Program.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.

Client expense: $530,000 · Firm income: Not reported

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

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program or elsewhere. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting the extension of the SBIR program. Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Opposing proposed FTC changes to non-compete clauses. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377). Supporting the Protecting Patients Against PBM Abuses Act (H.R. 2880). Supporting the PASTEUR Act (H.R. 2940 and S. 1355). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391 and S. 2764). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Maintaining Investments in New Innovation (MINI) Act (H.R. 5547). Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174). Supporting "cap and smooth" efforts within the Inflation Reduction Act's cap on out-of-pocket expenses. Supporting CMS proposed rule, CMS-1809-P, to include separate payment for diagnostic radiopharmaceuticals in CY2025.

Client expense: $58,505 · Firm income: Not reported

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

P.L. 111-148 Affordable Care Act, modifications Prior authorization utilization policies Medicare Access and CHIP Reauthorization Act (P.L. 114-10) Improvement Issues Medicare Physician Payment Issues Drug Pricing and Shortages Issues Medicare Part B Drug Price Issues Expansion of Telehealth Services Vision Research Funding Implementation of No Surprises Act S. 652/H.R. 2630, the Safe Step Act The Ensuring Lasting Smiles Act Medicare Coverage for Low Vision Devices S. 1573/H.R. 3226 - Preemie Reauthorization Act of 2023 H.R.2474 - Strengthening Medicare for Patients and Providers Act Healthcare Workforce Issues H.R. 6545, the Physician Fee Schedule Update and Improvements Act H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023 H.R. 6487/S. 3805, the No Fees for EFTs Act H.R. 4968, the GOLD CARD Act H.R. 830/S. 1375, the Help Ensure Lower Patient Copays Act (HELP Copays Act) H.R. 2748, the Contact Lens Prescription Verification Modernization Act H.R. 1503, the Prescription Information Modernization Act of 2023 H.R. 7745, the Embracing Anti-Discrimination, Unbiased Curriculum, and Advancing Truth in Education (EDUCATE) Act Funding for the Pediatric Specialty Loan Repayment Program H.R. 8400, the Early Detection of Vision Impairments for Children Act of 2024 (EDVI Act) H.R. 8702/S. 4532, the Improving Seniors Timely Access to Care Act

Client expense: $295,134 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to drug pricing; issues related to pharmaceutical supply chain; issues related to modernization of prescribing information for physicians and pharmacists; Improved Access to Affordable Medications Act, S. 1120; Increasing Transparency in Generic Drug Applications, S.775 and HR 3839; Part D Formulary Design and Generic Drug Tiering; Prescription Information Modernization Act, HR 1503.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to health information technology, Medicare, healthcare and telehealth, including the Telehealth Expansion Act (H.R. 1843 / S. 1001), the Telehealth Benefit Expansion for Workers Act (H.R. 824), the CONNECT for Health Act (S. 2016 / H.R. 4189), the Telehealth Modernization Act (H.R. 7623 / S. 3967), and the Primary Care Enhancement Act (H.R. 3029 / S. 628); issues related to pharmacy, including the Prescription Information Modernization Act (H.R. 1503) and the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (S. 3430); and issues related to Fiscal Year 2024 appropriations bills and the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 (H.R. 9029).

Client expense: $4,470,000 · Firm income: Not reported

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

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription-to- over the counter switch; issues related to influenza vaccines; issues related to 340B; issues related to Respiratory Syncytial Virus (RSV) access; issues related to RSV Immunizations; general issues related to vaccines; issues related to clinical trial diversity; general issues related to drug pricing; issues related to out of pocket (OOP); general issues to insulin pricing; issues related to HR 5376 "Inflation Reduction Act"; issues related to Additional Condition for Prescription Use (ACNU); issues related to copay accumulators; issues related to HR3656 "Vaccine Access Improvement Act"; issues related to Vaccine Issues Compensation Program (VICP); issues related to HR 830 "HELP Copays Act"; issues related to Pandemic and All-Hazards Preparedness Act (PAHPA)reauthorization; issues related to HR 1503 "Prescription Information Modernization Act of 2023"; general issues related FDA; issues related to FDA Drug Development; issues related to Pharmacy Benefit Managers (PBMs); issues related to insurance design; issues related to S. 1542 "DRUG Act"; issues related to S. 1375 "HELP Copays Act"; issues related to tax credits; issues related to S. 1339 "PBM Reform Act"; issues related to delinking; issues related to HR 2880 "Protecting Patients Against PBM Abuse Act"; issues related to Type 1 Diabetes screening; issues related to pandemic preparedness; issues related to intellectual property; issues related to Transplant; issues related HR 5339 and S. 3131 "Orphan Cures Act"; Rare Pediatric Priority Review Voucher Program related to HR 7834 "Creating Hope Reauthorization Act of 2024"; Orphan Drug Negotiation within HR5378 "Inflation Reduction Act"; issues related to drug price negotiations; issues related to COPD Research funding; Biologic/Small Molecule drug negotiation eligibility within HR7174 "EPIC Act"; CDC Type 1 Diabetes Awareness and Education with LHHS appropriations; issues related to HR 8698 and S.4504 "SCREEN for Type 1 Diabetes"; issues related to HRSA - Type 1 Diabetes Screening; general issues related to Inflation Reduction Act; issues related to March-In rights; and issues related to Routine Immunizations Rates.

Client expense: $860,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Digital communication of prescribing information. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution. Seniors Access to Critical Medications Act of 2023 (H.R. 5526) Department of Defense Essential Medicines Strategic Stockpile Amendment to NDAA Health Care Cybersecurity Improvement Act of 2024 (S.4054)

Client expense: $440,000 · Firm income: Not reported

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

Package Inserts/E-Labeling Issues (H.R. 1503 Prescription Information Modernization Act of 2023). Issues related to the Vaccine Injury Compensation Program.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 111-148 Affordable Care Act, modifications Prior authorization utilization policies Medicare Access and CHIP Reauthorization Act (P.L. 114-10) Improvement Issues Medicare Physician Payment Issues Drug Pricing and Shortages Issues Medicare Part B Drug Price Issues Expansion of Telehealth Services Vision Research Funding Implementation of No Surprises Act S. 652/H.R. 2630, the Safe Step Act The Ensuring Lasting Smiles Act Medicare Coverage for Low Vision Devices S. 1573/H.R. 3226 - Preemie Reauthorization Act of 2023 H.R.2474 - Strengthening Medicare for Patients and Providers Act Healthcare Workforce Issues H.R. 6545, the Physician Fee Schedule Update and Improvements Act H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023 H.R. 6487/S. 3805, the No Fees for EFTs Act H.R. 4968, the GOLD CARD Act H.R. 830/S. 1375, the Help Ensure Lower Patient Copays Act (HELP Copays Act) H.R. 2748, the Contact Lens Prescription Verification Modernization Act H.R. 1503, the Prescription Information Modernization Act of 2023 H.R. 7745, the Embracing Anti-Discrimination, Unbiased Curriculum, and Advancing Truth in Education (EDUCATE) Act Funding for the Pediatric Specialty Loan Repayment Program H.R. 8400, the Early Detection of Vision Impairments for Children Act of 2024 (EDVI Act) H.R. 8702/S. 4532, the Improving Seniors Timely Access to Care Act Impacts of the Change Healthcare cyberattack on physician practices

Client expense: $300,425 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Issues related to drug pricing; issues related to pharmaceutical supply chain; issues related to modernization of prescribing information for physicians and pharmacists; Improved Access to Affordable Medications Act, S. 1120; Increasing Transparency in Generic Drug Applications, S.775 and HR 3839; Part D Formulary Design and Generic Drug Tiering; Prescription Information Modernization Act, HR 1503; and Presidents Emergency Plan for AIDS Relief Reauthorization.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program or elsewhere. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting the extension of the SBIR program. Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Opposing proposed FTC changes to non-compete clauses. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377). Supporting the Protecting Patients Against PBM Abuses Act (H.R. 2880). Supporting the PASTEUR Act (H.R. 2940 and S. 1355). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391 and S. 2764). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Maintaining Investments in New Innovation (MINI) Act (H.R. 5547). Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174).

Client expense: $47,171 · Firm income: Not reported

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

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern__ Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues H.R.7024 - Tax Relief for American Families and Workers Act of 2024 Vaccine provisions of the Inflation Reduction Act

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

Issues related to prescription-to- over the counter switch; issues related to influenza vaccines; issues related to 340B; issues related to Respiratory Syncytial Virus (RSV) access; issues related to RSV Immunizations; issues related to routine immunization rates; general issues related to vaccines; issues related to clinical trial diversity; general issues related to drug pricing; issues related to out of pocket (OOP); general issues to insulin pricing; issues related to HR 5376 "Inflation Reduction Act"; issues related to Additional Condition for Prescription Use (ACNU); issues related to copay accumulators; issues related to HR3656 "Vaccine Access Improvement Act"; issues related to Vaccine Issues Compensation Program (VICP); issues related to HR 830 "HELP Copays Act"; issues related to Pandemic and All-Hazards Preparedness Act (PAHPA)reauthorization; issues related to HR 1503 "Prescription Information Modernization Act of 2023"; general issues related FDA; issues related to FDA Drug Development; issues related to Pharmacy Benefit Managers (PBMs); issues related to insurance design; issues related to S. 1542 "DRUG Act"; issues related to S. 1375 "HELP Copays Act"; issues related to tax credits; issues related to S. 1339 "PBM Reform Act"; issues related to "INSULIN ACT"; issues related to delinking; issues related to HR 2880 "Protecting Patients Against PBM Abuse Act"; HR 4421 "Preparing for All Hazards Pathogens Reauthorization Act"; issues related to HR 2923 "Living Donor Protection Act"; issues related to Type 1 Diabetes screening; issues related to pandemic preparedness; issues related to intellectual property; issues related to Transplant; issues related to Seasonal Influenza Vaccines; issues related HR 5339 and S. 3131 "Orphan Cures Act"; issues related to HR 7834 "Creating Hope Reauthorization Act of 2024"; issues related to HR 7174 "EPIC Act"; issues related to Inflation Reduction Act, issues related to drug price negotiations; issues related to COPD Research funding; and issues related to HR 6283 "DRUG Act".

Client expense: $2,160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to health information technology, healthcare and telehealth, including the Telehealth Expansion Act (H.R. 1843 / S. 1001), the Telehealth Benefit Expansion for Workers Act (H.R. 824), the CONNECT for Health Act (S. 2016 / H.R. 4189), the Telehealth Modernization Act (H.R. 7623 / S. 3967), and the Primary Care Enhancement Act (H.R. 3029 / S. 628); and issues related to pharmacy, including the Prescription Information Modernization Act (H.R. 1503) and the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (S. 3430); and issues related to Fiscal Year 2024 appropriations bills.

Client expense: $4,350,000 · Firm income: Not reported

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

H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $9,600,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Digital communication of prescribing information. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages. Block, Report and Suspend Suspicious Shipments Act (H.R.501). Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2024 National Defense Authorization Act. FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution.

Client expense: $1,190,000 · Firm income: Not reported

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

Issues related to drug pricing; issues related to pharmaceutical supply chain; issues related to modernization of prescribing information for physicians and pharmacists; Improved Access to Affordable Medications Act, S. 1120; Increasing Transparency in Generic Drug Applications, S.775 and HR 3839; Part D Formulary Design and Generic Drug Tiering; Prescription Information Modernization Act, HR 1503; and Presidents Emergency Plan for AIDS Relief Reauthorization.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 111-148 Affordable Care Act, modifications Prior authorization utilization policies Medicare Access and CHIP Reauthorization Act (P.L. 114-10) Improvement Issues Medicare Physician Payment Issues Drug Pricing and Shortages Issues Medicare Part B Drug Price Issues Expansion of Telehealth Services Vision Research Funding Implementation of No Surprises Act The Improving Seniors' Timely Access to Care Act S. 652/H.R. 2630, the Safe Step Act The Ensuring Lasting Smiles Act Medicare Coverage for Low Vision Devices S. 1573/H.R. 3226 - Preemie Reauthorization Act of 2023 H.R.2474 - Strengthening Medicare for Patients and Providers Act Healthcare Workforce Issues H.R. 6545, the Physician Fee Schedule Update and Improvements Act H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023 H.R. 6487/S. 3805, the No Fees for EFTs Act H.R. 4968, the GOLD CARD Act H.R. 830/S. 1375, the Help Ensure Lower Patient Copays Act (HELP Copays Act) H.R. 2748, the Contact Lens Prescription Verification Modernization Act H.R. 1503, the Prescription Information Modernization Act of 2023 H.R. 7745, the Embracing Anti-Discrimination, Unbiased Curriculum, and Advancing Truth in Education (EDUCATE) Act

Client expense: $385,441 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 1503, Prescription Information Modernization Act of 2023, regarding all provisions. H.R. 1173, Patients Right to Know Their Medication Act of 2023, regarding all provisions. Issues surrounding e-label appropriations policy rider.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Office of Science & Technology Policy (OSTP), SENATE

Package Inserts/E-Labeling Issues (H.R. 1503 Prescription Information Modernization Act of 2023). Issues related to the Vaccine Injury Compensation Program.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Promoting continued access to pharmaceutical printed packaging information, including promotion for H.R. 1173, the Patients' Right to Know Their Medication Act of 2023, and H.R. 1503, and FDA's proposed PMI rule.

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

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

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Supporting the PASTEUR Act S. 1355 and H.R. 2940. Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Opposing WHO TRIPS waivers. Supporting the extension of the SBIR program. Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Opposing proposed FTC changes to non-compete clauses. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Submitted comments to CMS concerning Transitional Coverage for Emerging Technologies (TCET) pathway. Opposing the SMART Act (S. 1246). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391/S. 2764). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407).

Client expense: $55,282 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE