Patient Access to Urgent-Use Pharmacy Compounding Act of 2023

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023; H.R. 8749, Safer Compounding in Hospitals Act

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

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

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. Advocate for a stable supply of medications and mitigate drug shortages. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals. Advocate for implementation of language to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (enacted as part of P.L. 117-328, Consolidated Appropriations Act, 2023, H.R. 2617). Support S. 127, Pharmacy Benefit Manager Transparency Act Support H.R. 830/ S. 1375, the Help Ensure Lower Patient (HELP) Copays Act. Support S. 935, the Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2630/S. 652, Safe Step Act. Support H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act

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

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; 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. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; S. 2780, Medication Affordability and Patent Integrity Act; S. 2305, Biosimilar Red Tape Elimination Act; H.R. 6986/S.3583, to address patent thickets; H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); H.R. 8574, 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act); S.150, the Affordable Prescription Drug for Patients Act; S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023; H.R. 8749, Safer Compounding in Hospitals Act

Client expense: $120,000 · Firm income: Not reported

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

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. Advocate for a stable supply of medications and mitigate drug shortages. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals. Advocate for implementation of language to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (enacted as part of P.L. 117-328, Consolidated Appropriations Act, 2023, H.R. 2617). Support S. 127, Pharmacy Benefit Manager Transparency Act Support H.R. 830/ S. 1375, the Help Ensure Lower Patient (HELP) Copays Act. Support S. 935, the Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2630/S. 652, Safe Step Act. Support H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act

Client expense: $1,060,000 · Firm income: Not reported

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024; Comments on implementation and enforcement of recent changes to USP Chapter <797>, regarding the Compounded Sterile Preparations (CSPs) in Category 3 to the FDA; Comments to FDA on "Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act" [Docket No.FDA-2024-N-0668]; Comments to FDA on " Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"[Docket No. FDA-2023-N-0061]; H.R.9096, the Pharmacists Fight Back Act; Comments to FDA on Docket No. FDA-2023-N-4806 - Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comment.

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; 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. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act; H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; H.R. 6986/S.3583, to address patent thickets; S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act); H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); H.R. 8574, 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act; S.150, the Affordable Prescription Drug for Patients Act; S. 148, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act); S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024; Comments on implementation and enforcement of recent changes to USP Chapter <797>, regarding the Compounded Sterile Preparations (CSPs) in Category 3 to the FDA; Comments on "Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act" [Docket No.FDA-2024-N-0668]; Comments on " Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"[Docket No. FDA-2023-N-0061];

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023

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

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

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. Advocate for a stable supply of medications and mitigate drug shortages. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals. Advocate for implementation of language to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (enacted as part of P.L. 117-328, Consolidated Appropriations Act, 2023, H.R. 2617). Support S. 127, Pharmacy Benefit Manager Transparency Act Support H.R. 830/ S. 1375, the Help Ensure Lower Patient (HELP) Copays Act. Support S. 935, the Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2630/S. 652, Safe Step Act. Support H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act

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

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: 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

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

Client expense: Not reported · Firm income: $40,000

Government targets: 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. 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

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; 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. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure; Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R. 4508, Hidden Fee Disclosure Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; H.R. 6986/S.3583, to address patent thickets.

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024;

Client expense: $320,000 · Firm income: Not reported

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023

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

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

Educate policymakers on issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, ProtectingPatients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title Ill of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients' Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R. 4508, Hidden Fee Disclo sure Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modemizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0). Educate policymakers on H.R.3285 - Faimess for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 6986/S.3583, to address patent thickets.

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2025 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. Advocate for a stable supply of medications and mitigate drug shortages. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals. Advocate for implementation of language to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (enacted as part of P.L. 117-328, Consolidated Appropriations Act, 2023, H.R. 2617). Support S. 127, Pharmacy Benefit Manager Transparency Act Support H.R. 830/ S. 1375, the Help Ensure Lower Patient (HELP) Copays Act. Support S. 935, the Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2630/S. 652, Safe Step Act. Support H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act

Client expense: $700,000 · Firm income: Not reported

Issues related to the Drug Quality and Security Act, Compounding Pharmacy, Reimbursement, and Patient Access, animal compounding, and H.R.167 - Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. H.R.3810 - Drug Origin Transparency Act of 2023.

Client expense: Not reported · Firm income: $40,000

Government targets: 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. 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. 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. 2940/S. 1355: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. Inflation Reduction Act - provisions related to vaccines and pharmaceuticals. 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. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act 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. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: Increasing Transparency in Generic Drug Applications Act H.R. 4115: The Lower Drug Costs for Families Act H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 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 (DRUG) Act 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. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act 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. 1217: Prescription Drug Impact Act of 2023 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. 1374: Patient Right to Shop Act 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. 2840: Bipartisan Primary Care and Health Workforce 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 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 High deductible health plans/HSA 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 Anticounterfeiting policy issues Artificial intelligence policy issues H.R.5143 - Vaccine Access Improvement Act - reform the vaccine injury compensation program H.R. 5142 - Vaccine Injury Compensation Modernization Act -- reform the vaccine injury compensation program S.1542/H.R.6283 - Delinking Revenue from Unfair Gouging Act - commercial delinking of PBM prices Labor HHS Appropriations Inflation Reduction Act of 2022, provisions related to Part D redesign and Medicare negotiation; 340B reform proposals

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; 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. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; S. 2052, Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R. 4508, Hidden Fee Disclosure Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R. 3285 - Fairness for Patient Medications Act; H.R. ___, the Stop Drug Shortages Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023.

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2024 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2024 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023

Client expense: $140,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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. 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. 3134: Emergency Access to Insulin Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act 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. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency 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. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act of 2023 H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 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 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. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act 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. 1217: Prescription Drug Impact Act of 2023 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. 1374: Patient Right to Shop Act 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. 2840: Bipartisan Primary Care and Health Workforce 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 User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director 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 High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse 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 Anticounterfeiting policy issues Artificial intelligence policy issues

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 382, the Pandemic is Over Act; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 5142, the Vaccine Injury Compensation Modernization Act of 2023; H.R. 5143, the Vaccine Access Improvement Act of 2023; S. 2305, the Biosimilar Red Tape Elimination Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023

Client expense: $330,000 · Firm income: Not reported

Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. Advocate for a stable supply of medications and mitigate drug shortages. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals. Advocate for implementation of language to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (enacted as part of P.L. 117-328, Consolidated Appropriations Act, 2023, H.R. 2617). Support S. 127, Pharmacy Benefit Manager Transparency Act Support H.R. 830/ S. 1375, the Help Ensure Lower Patient (HELP) Copays Act. Support S. 935, the Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2630/S. 652, Safe Step Act. Support H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act

Client expense: $520,000 · Firm income: Not reported

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691 Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; 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. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act. S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; PBM Oversight Act of 2023; Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R. 4508, Hidden Fee Disclosure Act; H.R.3285 - Fairness for Patient Medications Act; S.2973, Modernizing and Ensuring PBM Accountability Act. H.R.3285 - Fairness for Patient Medications Act; H.R. ___, the Stop Drug Shortages Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023.

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. 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. 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 Benefit Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2940/S. 1355: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act 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. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 HR 4223 - National AI Commission Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 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 HR 5027 - Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 H.R. 5142 - Vaccine Injury Compensation Modernization Act -- reform the vaccine injury compensation program H.R.5143 - Vaccine Access Improvement Act - reform the vaccine injury compensation program H.R. 5376: Share the Savings with Seniors Act HR 5378 - Lower Costs, More Transparency Act (PBM transparency provisions, Q1/Q2 provisions) 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. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act 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. 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. 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. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1909, The Pharmacy DIR Reform to Reduce Senior Drug Costs Act. HR 830 HELP Copays Act. S. 2076 PASTEUR Act of 2021. S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333 - Pandemic and All Hazards Preparedness Act reauthorization PBB S. 2474: Share the Savings with Seniors Act S 2965 - Modernizing and Ensuring PBM Accountability Act 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 High deductible health plans/HSA policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse 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 Anticounterfeiting policy issues White Paper on AI in Healthcare Labor HHS Appropriations Modernizing and Ensuring PBM Accountability Post-TDAPA policies at CMS - seeking Congressional letter to CMS

Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. Advocate for a stable supply of medications and mitigate drug shortages. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals. Advocate for implementation of language to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (enacted as part of P.L. 117-328, Consolidated Appropriations Act, 2023, H.R. 2617). Support S. 127, Pharmacy Benefit Manager Transparency Act Support H.R. 830/ S. 1375, the Help Ensure Lower Patient (HELP) Copays Act. Support S. 935, the Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2630/S. 652, Safe Step Act. Support H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act

Client expense: $1,120,000 · Firm income: Not reported

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. 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. 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. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act 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. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 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. 5539: ORPHAN Cures Act 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. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act 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. 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. 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. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director 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 High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse 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 Anticounterfeiting policy issues

Issues related to implementation of the Drug Quality and Security Act, issues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 167, the Patient Access to Urgent Use Pharmacy Compounding Act of 2023; patient access to compounded medications; H.R. 3810 - Drug Origin Transparency Act of 2023

Client expense: $140,000 · Firm income: Not reported

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

Issues related to the regulation of pharmacy compounding. Issues related to preserving patient access to compounded medications. Fiscal Year 2024 Appropriations HR167, the Patient Access to Urgent Use Compounded Medication Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE